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Thursday, December 04, 2008

Healthcare Providers Get A Lift From Google

Healthcare providers are always looking for efficiency (so they say) and the with the internet and the IT infrastructure extending beyond record rooms, they have to change with times to provide a better health care to masses and have better returns at the same time.
Instead of archaic ways of patient records staying inside a dusty room, now they travel with patients, where ever they go, securely. And physicians have access to these at all times.
Google in its health care efforts, are doing marvelous things and we have even covered how the Google health was build. But like most things, innovations are going further everyday and so Google have arranged a free webinar to be held on December 10th 2008 at 10:00AM, and you can attend from anywhere.
The session will include a current look at Google Health, which empowers patients to securely organize and manage their health information online. Follow the link to get more information

Official Google Blog: Helping healthcare providers become more efficient

Wednesday, December 03, 2008

Healthy America, Vermont Leads!


United Health Foundation has released it's findings for year 2008. It looks like we Americans managed not to change much in our health for the fourth consecutive year. The data gathered and analyzed by UHF ranges from smoking, drinking, health insurance to air pollution and crime rates.
The results (UHF Key Findings) shows that Vermont leads the nation as the healthiest state for the second year in a row. It is followed by Hawaii (2), New Hampshire (3), Minnesota (4), and Utah (5). Louisiana is ranked as the least-healthy state, while Mississippi (49), South Carolina (48), Tennessee (47) and Texas (46) remain in the bottom five. Each of these states continues to struggle with difficult socioeconomic challenges that manifest themselves in these rankings.
Utah (5) currently leads the nation as the state with the lowest prevalence of smoking. Other states making progress against the nation’s biggest health challenges include Massachusetts (6), which leads the nation as the state with the lowest uninsured rate, and Colorado (19), which ranks as the state with the lowest national prevalence of obesity. A comparison of state rankings from 2007 to 2008 indicates that 36 states had positive changes in their overall health scores and 14 experienced declines.

Sunday, September 28, 2008

2009 Medicare Prescription Drug Plan Options

For Immediate Release: Thursday, September 25, 2008
Contact: CMS Office of Public Affairs
202-690-6145


CMS REMINDS MEDICARE BENEFICIARIES TO REVIEW AND COMPARE THEIR CURRENT DRUG COVERAGE

Today, CMS Acting Administrator Kerry Weems announced the 2009 Medicare prescription drug and Medicare Advantage plan options. Approximately 97 percent of beneficiaries enrolled in a stand-alone prescription drug plan (PDP) will have access to Medicare drug and health plans in 2009 whose premiums would be the same or less than their coverage in 2008.

“As we enter the fourth year of the Medicare Part D prescription drug program, we continue to see high satisfaction rates among beneficiaries and high participation among plans,” said Weems. “However, plans do change their offerings from year to year. Some beneficiaries may see significant premium increases or changes, such as reduced coverage in the gap, if they stay in the same prescription drug plan in 2009. We encourage individual beneficiaries to review how their plans are changing and what other options are available to them to determine which plan best meets their needs.”

In every state, beneficiaries will have access to at least one prescription drug plan with premiums of less than $20 a month, except for beneficiaries living in Alaska who will have access to one prescription drug plan at $23 a month. Those who qualify for the full Medicare subsidy will pay no premiums or deductibles in these plans. The national average monthly premium for the basic Medicare drug benefit in 2009 is projected to average approximately $28.

Beneficiaries will continue to have access to prescription drug plans that offer a wide range of design options, including zero deductible plans. Plans with coverage in the gap for generics are available in every state.

In 2009, 100 percent of beneficiaries will have access to a Medicare Advantage plan. Many beneficiaries will continue to have access to Medicare Advantage plans that have prescription drug coverage (MA-PDs) and more than 93 percent of people with Medicare will have access to a MA-PD for a $0 premium and with a $0 drug deductible.

Marketing of 2009 plans will begin October 1 under new marketing requirements. “These new requirements are meant to protect Medicare beneficiaries from deceptive or high-pressure marketing tactics by insurance companies and their agents,” said Weems.

This fall CMS will be conducting numerous outreach events to help new beneficiaries and help those already enrolled understand their plan choices. “We want to make sure that every beneficiary knows where to go for individualized advice and counseling,” said Weems.

Details about the specific plans in each region will be available mid-October at www.medicare.govand 1-800-MEDICARE. Open enrollment for prescription drug coverage begins November 15 and ends December 31. Beneficiaries who want to review their current coverage as well as the other options available to them will have access to information and assistance from many sources including:

  • A notice of any coverage changes from their current prescription drug plan, by October 31st ,
  • The enhanced Medicare Drug Plan Finder, available in mid-October;
  • Toll free information available 24/7 at 1-800-MEDICARE (1-800-633-4227);
  • The annual Medicare & You 2009 handbook that explains Medicare coverage, to be mailed in October; and
  • Local organizations such as the State Health Insurance Assistance Programs and thousands of other Medicare partner organizations that will provide personalized assistance throughout the fall.

The list of national stand-alone prescription drug plans and state specific fact sheets can be found at: http://www.cms.hhs.gov/center/openenrollment.asp

The Link to the 2009 Landscape Data: http://www.cms.hhs.gov/PrescriptionDrugCovGenIn/

“Beneficiaries should expect to hear from the health and prescription drug plans in their communities and should be assured that CMS has new oversight tools available to ensure they have a positive experience,” said Weems.

Melamine Contamination Advisory Update By FDA

FOR IMMEDIATE RELEASE
Statement
September 26, 2008

Media Inquiries:
Stephanie Kwisnek, 301-827-0955
Consumer Inquiries:
888-INFO-FDA


FDA Updates Health Information Advisory on Melamine Contamination

The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products are being recalled by the Taiwanese company, King Car Food Industrial Co. Ltd., due to possible contamination with melamine. King Car Food Industrial Co. used a non-dairy creamer manufactured by Shandong Duqing Inc., China, which was found to be contaminated with melamine. The recalled products are:

  • Mr. Brown Mandheling Blend Instant Coffee (3-in-1)
  • Mr. Brown Arabica Instant Coffee (3-in-1)
  • Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1)
  • Mr. Brown Caramel Macchiato Instant Coffee (3-in-1)
  • Mr. Brown French Vanilla Instant Coffee (3-in-1)
  • Mr. Brown Mandhling Blend instant Coffee (2-in-1)
  • Mr. Brown Milk Tea (3-in-1)

The FDA recommends that consumers not consume any of the above Mr. Brown instant coffee and milk tea products. The FDA also recommends that retailers and foodservice operators remove the products from sale or service.

As of September 25, 2008, the FDA testing of milk based products imported into the United States from China has not found melamine contamination.

The FDA is working with regulatory agencies in other countries. The New Zealand Food Safety Authority reports that its testing of White Rabbit Creamy Candies has shown melamine contamination at high levels. In light of the widespread contamination of milk and milk-based products in China and the New Zealand Food Safety Authority’s finding, the FDA recommends that consumers not eat White Rabbit Creamy Candy and that retailers and foodservice operations remove the product from sale or service.

To date, the FDA is not aware of any illnesses in the United States stemming from consumption of either White Rabbit Creamy Candy or the Mr. Brown instant coffee and milk tea products.

Individuals who have experienced any health problems after consuming either White Rabbit Creamy Candy or any of the identified Mr. Brown coffee and tea products are advised to contact their health care professional.

Background

On September 12, 2008, in light of reports from China of melamine contaminated infant formula, the FDA issued a Health Information Advisory to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Chinese communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants.

The FDA had contacted the companies who manufacture infant formula for distribution in the United States and received, from the companies, information that they are not importing formula or sourcing milk-based materials from China.

At the same time, the FDA—in conjunction with state and local officials—began a nation-wide investigation to check Asian markets for Chinese manufactured infant formula that may have been brought into the United States. In particular, this effort focused on areas of the country with large Chinese communities, such as Los Angeles, San Francisco, Seattle and New York. To date, investigators have visited more than 1,400 retail markets and have not found Chinese infant formula present on shelves in these markets.

The FDA also advises consumers not to purchase infant formula manufactured in China from Internet sites or from other sources.

The FDA has taken, and will continue to take, proactive measures to help ensure the safety of the American food supply. In conjunction with state and local officials, the FDA will continue to check Asian markets for food items that are imported from China and that could contain a significant amount of milk or milk proteins. In addition, the FDA has broadened its domestic and import sampling and testing of milk-derived ingredients and finished food products containing milk, such as candies, desserts, and beverages that could contain these ingredients from Chinese sources. Milk-derived ingredients include whole milk powder, non-fat milk powder, whey powder, lactose powder, and casein.

In addition to state and local governments, the FDA is working in close cooperation with Customs and Border Protection within the U.S. Department of Homeland Security, the U.S. Department of Agriculture, other federal agencies, and foreign governments.

#

Additional Information

QFCO, Inc. Recalls White Rabbit Candy Because of Possible Health Risk (Sept. 26, 2008)

Monday, September 08, 2008

FDA Posts First Quarterly Report Of Potential Safety Issues On Drugs.

The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS).

The information is being provided under provisions of the Food and Drug Administration Amendments Act, signed into law Sept. 27, 2007. The law requires that FDA inform the public each quarter of new safety information or potential signals of serious risk, based on the agency's review of adverse event reports contained in AERS.

The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because FDA has identified a potential safety issue.

"My message to patients is this: Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research.

Drugs that appear on the agency's new AERS-based table, titled "Potential Signals of Serious Risks/New Safety Information," are identified by FDA reviewers based on reports from the FDA's AERS database, which contains millions of reports of adverse events submitted to FDA by drug manufacturers, health care professionals and patients. For a drug to appear on this report, an FDA reviewer will have determined there is a reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug. The drugs for which issues have been identified are under evaluation for the listed potential risk.

This first quarterly report, posted to FDA's Web site today, lists 20 drugs along with the potential safety issue associated with each drug. Each quarter, a new report will be posted to FDA's Web site listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS. The quarterly reports will not be cumulative; they will list only drugs for which new safety information or potential signals of serious risks have been identified through AERS during the previous quarter.

A new quarterly report listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS will be posted to the FDA's Web site every three months.

"Over the past two years, FDA has become much more proactive in our communication about possible safety problems," Woodcock said. "Patients and health care professionals have told us that they want to be informed about possible safety problems sooner. They want to know when FDA is in the early stages of looking into a potential safety problem. Congress took note of this when it directed us to post this quarterly report of potential safety issues."

Related links:

Web posting, "Potential Signals of Serious Risks/New Safety Information"

Friday, September 05, 2008

DNA Test to Measure Hepatitis B Virus Levels Approved By FDA.

The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient’s blood. Assessing a patient’s viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.

The COBAS TaqMan HBV Test extracts and then amplifies sections of viral DNA from human plasma or serum. The viral DNA sections are measured to establish a baseline level before beginning treatment, and then used again during treatment to assess an individual’s response to therapy. (The baseline level of hepatitis B virus should decrease with successful treatment.) The test is used with other clinical findings, such as results from biochemical and serological testing.

“Measuring a patient’s HBV viral load is an important aspect of managing chronic hepatitis B infections,” said Daniel G. Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “The COBAS TaqMan test gives health care providers a new and sensitive tool for this process.”

HBV is the most serious type of viral hepatitis, infecting about two billion people worldwide each year, according to the World Health Organization. A vaccine for HBV has been available in the United States since 1982. However, according to the Centers for Disease Control and Prevention, about 1.25 million people in the United States have chronic hepatitis B. Another 60,000 become infected each year and some 5,000 die from hepatitis B-related complications.

HBV is spread through sexual exposure, use of infected needles, and transmitted from infected mother to child during birth. Symptoms occur in about 70 percent of patients, and include abdominal pain, jaundice, fatigue, loss of appetite, nausea, and vomiting.

COBAS TaqMan HBV Test is manufactured by Roche Diagnostic Division, Basel, Switzerland.

Thursday, September 04, 2008

TNF-Blocker Drug Manufacturers Must Highlight Risk of Fungal Infections

FOR IMMEDIATE RELEASE
September 4, 2008

Media Inquiries:
Susan Cruzan, 301-827-6242
Rita Chappelle, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections
Agency invokes new authorities under FDAAA to alert patients and prescribers to risk

The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.

The four drugs, known as tumor necrosis factor alpha blockers (TNF-alpha blockers), which suppress the immune system, are approved to treat a variety of conditions which may include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease.

FDA today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 to require manufacturers of TNF inhibitors to make safety-related changes to prescribing information, or labeling.

“Under the FDA's new authorities, we can require safety label changes and a risk evaluation and mitigation strategy, known as REMS, when the agency becomes aware of new safety information,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products, Center for Drug Evaluation and Research. “Requiring the risks to be highlighted will help health care professionals be more vigilant in watching for these adverse events, and is necessary to ensure that the benefits of these drugs outweigh their risks.”

Since the initial approval of the four TNF blockers, the prescribing information for these drugs has included information about the risk of serious infections, including fungal infections. However, based on reports reviewed by FDA, health care professionals are not consistently recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment.

Patients taking TNF blockers should be aware that they are more susceptible to serious fungal infections. Those who develop a persistent fever, cough, shortness of breath, and fatigue should promptly seek medical attention. To assist in the diagnosis, those being treated with TNF blockers should tell their health care professionals where they live and what areas they have recently visited. Patients who develop a fungal infection may be advised to stop the TNF blocker until they recover.

FDA has reviewed 240 reports of histoplasmosis, an infection caused by the fungusHistoplasma capsulatum, in patients being treated with Enbrel, Humira, or Remicade. The majority of the reports involved people in the Ohio River and Mississippi River valleys (the fungus is commonly found in those areas). In at least 21 of the reports, histoplasmosis was initially not recognized by health care professionals, and antifungal treatment was delayed. Twelve of those patients died.

The FDA reviewed one reported case of histoplasmosis in a patient taking Cimzia. The FDA also has received reports of cases of coccidioidomycosis and blastomycosis, including deaths, in patients treated with TNF blockers.

TNF blocker manufacturers are required to submit safety labeling changes, including strengthened warnings and revisions to the Medication Guides to the FDA within 30 days or to provide a reason why they do not believe labeling changes are necessary.

If they do not submit new language, or if the FDA disagrees with the new language the company proposes, the Food and Drug Administration Amendments Act of 2007 provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information.

Medication Guides will become part of a REMS for Humira and Remicade and are already part of a REMS for Enbrel and Cimzia. The manufacturers for all four of these drugs will also be required to educate prescribers about the risks.

For more information: http://www.fda.gov/cder/drug/InfoSheets/HCP/TNF_blockersHCP.htm

Friday, August 29, 2008

Danish Court Upholds Two Lipitor Patents, Preventing Ranbaxy Generic Product Launch before 2011

NEW YORK--(BUSINESS WIRE)--Pfizer Inc said today that the Eastern Division of the High Court in Copenhagen, Denmark has ruled in the companys favor in challenges to two of its patents covering atorvastatin, the active ingredient in Lipitor. The basic (DK 171,588) and enantiomer (EP 409,281) patents were challenged by generics manufacturer Ranbaxy.

The court ruled that the basic patent, which expires in November 2011, would be infringed by Ranbaxys generic atorvastatin product. The court also ruled that the atovastatin enantiomer patent is valid. That patent expires in July 2010. The decision, which is subject to possible appeal, prevents Ranbaxy from launching its generic product before November 2011.

Todays decision is an important outcome for Pfizer and other medical innovators who invest in high-risk research to develop life-saving medicines for millions of patients, said Pfizer Denmark Country Manager Karin Verland.

Thursday, August 28, 2008

Do Not Eat Certain Mussel Products from Bantry Bay Seafood, FDA

FOR IMMEDIATE RELEASE
August 15, 2008


Media Inquiries:
Michael Herndon, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood

The U.S. Food and Drug Administration (FDA) is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods, imported from Ireland, because they may be contaminated with azaspiracid toxins, a group of naturally occurring marine toxins known to cause nausea, vomiting, diarrhea, and stomach cramps.

Azaspiracid toxins are odorless, tasteless, and cannot be destroyed or neutralized by freezing or cooking, including boiling. Individuals who have experienced gastrointestinal symptoms such as those noted above after eating any of the products listed below should consult their health care professional. Symptoms typically occur within hours of consumption and persist for two to three days.

In July, two people in Washington state became ill after eating the company's "Mussels in a Garlic Butter Sauce." FDA tested unopened product from the same production lot and found that it contained the azaspiracid toxins.

Consumers should throw out the following Bantry Bay Seafood frozen cooked products with "Best before end" dates ranging from January 23, 2009, to November 15, 2009:

* Mussels in a Garlic Butter Sauce
* Mussels in White Wine Sauce
* Mussels in Tomato and Garlic Sauce

The "Best before end" dates are displayed on the side of the box in the following format: MM:DD:YY. Products to be thrown out are marked with dates 01:23:09 through 11:15:09.

These products are sold frozen in 1 pound cardboard packages in stores throughout the United States.

The FDA also recommends that retailers and foodservice operators remove these products, and any food in which these products were used as an ingredient, from sale or service.

Azaspiracid toxins were an unknown marine toxin until 1995, when they were identified and linked to an outbreak of foodborne illnesses associated with consumption of Irish shellfish. The toxins have since been identified in other shellfish from the west coast of Europe. They have never been detected in shellfish harvested from U.S. waters.

First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts Approved By FDA.

FOR IMMEDIATE RELEASE
August 22, 2008

Media Inquiries:
Karen Riley, 301-827-6244
Consumer Inquiries:
888-INFO-FDA


FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts

The U.S. Food and Drug Administration today approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.

The condition, which usually develops in adults, is known as chronic immune thrombocytopenic purpura (ITP), a disease that results in a low number of platelets, the blood components that help with clotting. In patients with chronic ITP, the immune system is believed to destroy platelets and the patient's bone marrow is often unable to compensate for this loss.

"This product is important in that it offers a new approach to the treatment of patients with an uncommon blood disorder who are often very ill," said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA.

The estimated 140,000 people with chronic ITP are prone to bruising and at risk for life-threatening bleeding. Current medical treatment includes corticosteroids and immunoglobulin. Surgery to remove the spleen, a procedure known as a splenectomy, may help some patients. Nplate is approved only for patients with chronic ITP who do not respond sufficiently to current treatments.

FDA based its approval on two randomized clinical trials of about 125 patients who had received at least one prior ITP treatment. One study enrolled patients who still had their spleen, the other enrolled patients who did not.

During six months of treatment, patients who received Nplate had significantly higher platelet counts and maintained those higher counts compared to those who did not receive the drug. The response to Nplate was higher in those patients who still had their spleen than in those patients who had undergone a splenectomy. In those patients who did not receive Nplate, only one experienced a sustained increase in platelet counts.

Safety concerns with Nplate include fibrous deposits in the bone marrow and the possibility that once Nplate is stopped, platelet counts could drop below what they were before beginning treatment.

Additional risks include blood clots due to excessive increases in platelets and, if Nplate were given to patients with an abnormal blood condition known as myelodysplasia, a risk for a form of blood cancer known as acute leukemia. Myelodysplasia, which is associated with low platelet counts, predisposes some patients to leukemia. In a study of 44 patients who had myelodysplasia and received Nplate, four patients developed leukemia. Further clinical trials in patients with predisposing conditions for leukemia will be needed to determine whether the development of leukemia may relate to the use of Nplate. Nplate is approved only for use among patients with chronic ITP.

A Risk Evaluation and Mitigation Strategy (REMS) has been developed to address the risks of Nplate therapy. Under the Food and Drug Administration Amendments Act of 2007, FDA has determined that a REMS is necessary for the benefits of Nplate to outweigh the risks of the product. The REMS will include a Medication Guide for patients and requires that all prescribers and patients enroll in a special program to track the long term safety of Nplate therapy.

Nplate is manufactured by Amgen, Inc. of Thousand Oaks, Calif.

Monday, August 11, 2008

Dietary Supplements 101 Form FDA

Click here or on the image above to receive a PDF version of this Paper From FDA.

The law defines dietary supplements in part as products taken by mouth that contain a "dietary ingredient." Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet.

Dietary supplements come in many forms, including tablets, capsules, powders, energy bars, and liquids. These products are available in stores throughout the United States, as well as on the Internet. They are labeled as dietary supplements and include among others

  • vitamin and mineral products
  • "botanical" or herbal products—These come in many forms and may include plant materials, algae, macroscopic fungi, or a combination of these materials.
  • amino acid products—Amino acids are known as the building blocks of proteins and play a role in metabolism.
  • enzyme supplements—Enzymes are complex proteins that speed up biochemical reactions.

People use dietary supplements for a wide assortment of reasons. Some seek to compensate for diets, medical conditions, or eating habits that limit the intake of essential vitamins and nutrients. Other people look to them to boost energy or to get a good night's sleep. Postmenopausal women consider using them to counter a sudden drop in estrogen levels.

Talk with a Health Care Professional

The Food and Drug Administration (FDA) suggests that you consult with a health care professional before using any dietary supplement. Many supplements contain ingredients that have strong biological effects, and such products may not be safe in all people.

If you have certain health conditions and take these products, you may be putting yourself at risk. Your health care professional can discuss with you whether it is safe for you to take a particular product and whether the product is appropriate for your needs. Here is some general advice:

  • Dietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases. They cannot completely prevent diseases, as some vaccines can. However, some supplements are useful in reducing the risk of certain diseases and are authorized to make label claims about these uses. For example, folic acid supplements may make a claim about reducing the risk of birth defects of the brain and spinal cord.
  • Using supplements improperly can be harmful. Taking a combination of supplements, using these products together with medicine, or substituting them in place of prescribed medicines could lead to harmful, even life-threatening, results.
  • Some supplements can have unwanted effects before, during, or after surgery. For example, bleeding is a potential side effect risk of garlic, ginkgo biloba, ginseng, and Vitamin E. In addition, kava and valerian act as sedatives and can increase the effects of anesthetics and other medications used during surgery. Before surgery, you should inform your health care professional about all the supplements you use.
How Are Supplements Regulated?

You should know the following if you are considering using a dietary supplement.

  • Federal law requires that every dietary supplement be labeled as such, either with the term "dietary supplement" or with a term that substitutes a description of the product's dietary ingredient(s) for the word "dietary" (e.g., "herbal supplement" or "calcium supplement").
  • Federal law does not require dietary supplements to be proven safe to FDA's satisfaction before they are marketed.
  • For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA's satisfaction that the claim is accurate or truthful before it appears on the product.
  • In general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.
  • Dietary supplement advertising, including ads broadcast on radio and television, falls under the jurisdiction of the Federal Trade Commission.
  • Once a dietary supplement is on the market, FDA has certain safety monitoring responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion.
  • Dietary supplement firms must report to FDA any serious adverse events that are reported to them by consumers or health care professionals.
  • Dietary supplement manufacturers do not have to get the agency's approval before producing or selling these products.
  • It is not legal to market a dietary supplement product as a treatment or cure for a specific disease, or to alleviate the symptoms of a disease.
  • There are limitations to FDA oversight of claims in dietary supplement labeling. For example, FDA reviews substantiation for claims as resources permit.
Are Supplements Safe?

Many dietary supplements have clean safety histories. For example, millions of Americans responsibly consume multi-vitamins and experience no ill effects.

Some dietary supplements have been shown to be beneficial for certain health conditions. For example, the use of folic acid supplements by women of childbearing age who may become pregnant reduces the risk of some birth defects.

Another example is the crystalline form of vitamin B12, which is beneficial in people over age 50 who often have a reduced ability to absorb naturally occurring vitamin B12. But further study is needed for some other dietary supplements.

Some supplements have had to be recalled because of proven or potential harmful effects. Reasons for these recalls include

  • microbiological, pesticide, and heavy metal contamination
  • absence of a dietary ingredient claimed to be in the product
  • the presence of more or less than the amount of the dietary ingredient claimed on the label

In addition, unscrupulous manufacturers have tried to sell bogus products that should not be on the market at all.
Before taking a dietary supplement, make sure that the supplement is safe for you and appropriate for the intended purpose.

Be a Safe and Informed Consumer

  • Let your health care professional advise you on sorting reliable information from questionable information.
  • Contact the manufacturer for information about the product you intend to use.
  • Be aware that some supplement ingredients, including nutrients and plant components, can be toxic. Also, some ingredients and products can be harmful when consumed in high amounts, when taken for a long time, or when used in combination with certain other drugs, substances, or foods.
  • Do not self-diagnose any health condition. Work with health care professionals to determine how best to achieve optimal health.
  • Do not substitute a dietary supplement for a prescription medicine or therapy, or for the variety of foods important to a healthful diet.
  • Do not assume that the term "natural" in relation to a product ensures that the product is wholesome or safe.
  • Be wary of hype and headlines. Sound health advice is generally based upon research over time, not a single study.
  • Learn to spot false claims. If something sounds too good to be true, it probably is.

Report Problems

Adverse effects with dietary supplements should be reported to FDA as soon as possible. If you experience such an adverse effect, contact or see your health care professional immediately. Both of you are then encouraged to report this problem to FDA. For information on how to do this, go to www.cfsan.fda.gov/~dms/ds-rept.html.

Adverse effects can also be reported to the product's manufacturer or distributor through the address or phone number listed on the product's label. Dietary supplement firms are required to forward reports they receive about serious adverse effects to FDA within 15 days.

For a general, nonserious complaint or concern about dietary supplements, contact your local FDA District Office (www.cfsan.fda.gov/~dms/district.html).

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

2008-2009 Flu Vaccines Approved By FDA

FDA Approves 2008-2009 Flu Vaccines

The U.S. Food and Drug Administration (FDA) today announced that it has approved this year's seasonal influenza vaccines that include new strains of the virus likely to cause flu in the United States during the 2008-2009 season.

The six vaccines and their manufacturers are: CSL Limited, Afluria; GlaxoSmithKline Biologicals, Fluarix; ID Biomedical Corporation of Quebec, FluLaval; MedImmune Vaccines Inc., FluMist; Novartis Vaccines and Diagnostics Limited, Fluvirin; and Sanofi Pasteur Inc., Fluzone.

Approval information and specific indications can be found at http://www.fda.gov/cber/flu/flu2008.htm.

This season's vaccines contain three strains of the influenza virus that disease experts expect to be the most likely cause of the flu in the United States.

Each season's vaccines are modified to reflect the virus strains most likely to be circulating. The closer the match between the circulating strains and the strains in the vaccines, the better the protection.

There is always a possibility of a less than optimal match between the virus strains predicted to circulate and what virus strains end up causing the most illness. Even if the vaccines and the circulating strains are not an exact match, they will provide some protection and may reduce the severity of the illness or prevent flu-related complications.

"One of the biggest challenges in the fight against influenza is producing new vaccines every year," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "There is no other instance where new vaccines must be made every year. The approval of flu vaccines is a part of FDA's mission to promote the health of Americans throughout the year."

The FDA changed all three strains for this year's influenza vaccine—an unusual occurrence, as usually only one or two strains are updated from year to year. A list of the strains included in the 2008-2009 vaccine can be found at http://www.fda.gov/cber/flu/flu2008.htm. Of note, two of the three strains recommended for the U.S. this year are now in use for the Southern Hemisphere's 2008 influenza season, which is currently underway.

Each year, experts from the FDA, World Health Organization, U.S. Centers for Disease Control and Prevention (CDC), and other institutions study virus samples and patterns collected throughout the year from around the world in an effort to identify strains that may cause the most illness in the upcoming season.

Based on those forecasts and on the recommendations of its Advisory Committee, the FDA each February decides on the three strains that manufacturers should include in their vaccines for the U.S. population. The FDA makes this decision early in the year so that manufacturers have enough time to produce the new vaccines.

Vaccination remains the cornerstone of preventing influenza, a contagious respiratory illness caused by influenza viruses. According to the CDC, every year an average of 5 to 20 percent of the U.S. population gets the flu, more than 200,000 are hospitalized from flu complications and there are about 36,000 flu-related deaths. Some individuals—the elderly, young children, and people with chronic medical conditions —are at higher risk for flu-related complications. Vaccination of these groups and of health care personnel is critical.

"Currently, only 40 percent of health care workers in the United States are vaccinated against influenza," said Department of Health and Human Services' Assistant Secretary of Health Joxel Garcia, M.D., M.B.A.

"Increasing the number of vaccinated health care personnel can be a strong front in the annual battle against the flu," said Garcia. "Health care workers can set an example for the patients they serve as well as decrease the likelihood of contracting and transmitting the virus."

FDA Warns Consumers About Medicine Shoppe Pharmacies As They May Have Received Drugs That Were Either Expired Or Suspected Counterfeit.

FOR IMMEDIATE RELEASE
August 8, 2008

Media Inquiries:
Rita Chappelle, 240-753-8603
Consumer Inquiries:
888-INFO-FDA


FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies
Expired and suspected counterfeit prescription drugs found at pharmacies

The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.

The products in question include:

  • Lisinopril (20 milligrams)
  • Guaifenesin/Dextromethorphan (600 mg and 1000 mg)
  • Gabapentin (100 mg, 300 mg and 400 mg)
  • Metoprolol (50 mg)
  • Nifedipine (30 mg)
  • Diclofenac Sodium (30 mg)
  • Glucophage (500 mg Extended Release)
  • Glucovance (125 mg and 500 mg)
  • Glipizide/Metformin (2.50 mg/250 mg)
  • Furosemide (20 mg)
  • Tamoxifen Citrate (10 mg)
  • Metformin HCl ER (500 mg)
  • Calcitrol (0.25 micrograms)

The FDA has no evidence that any other Medicine Shoppe pharmacies outside of the 8035A Liberty Road and 5900 Reisterstown Road facilities are involved.

Because the safety and efficacy of the listed drugs has not been established, the FDA is strongly advising consumers who filled prescriptions for these drugs at these two pharmacies to contact their prescribing physician immediately for new prescriptions. Additionally, consumers in possession of the above listed prescription drugs from these pharmacies should call FDA at 800-521-5783 for further information on how to dispose of the drugs.

Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.

Thursday, August 07, 2008

Novartis Ships Fluvirin® Influenza Virus Vaccine with three new strains for the 2008-2009 influenza season

Novartis begins shipment to US of Fluvirin® Influenza Virus Vaccine with three new strains for the 2008-2009 influenza season

  • Delivery of Fluvirin supports planning and scheduling of public health influenza vaccination efforts
  • At least 20 million doses available by the end of September, when widespread vaccination campaigns usually begin
  • Additional manufacturing capacity recently approved by FDA for Fluvirin pre-filled syringes

Basel, August 7, 2008 - Novartis announced today that it started shipments of its Fluvirin® Influenza Virus Vaccine to US health care facilities and practitioners for the 2008/2009 influenza season.
The company is producing up to 40 million doses of Fluvirin, with the World Health Organization recommended change in all three virus strains included in the influenza vaccine composition[1]. This year's influenza vaccine contains the following three strains of the influenza virus:
  • A/Brisbane/59/2007 (H1N1)-like virus (A/Brisbane/59/2007 IVR-148)
  • A/Brisbane/10/2007 (H3N2)-like virus (A/Uruguay/716/2007 NYMC X-175C)
  • B/Florida/4/2006-like virus (B/Florida/4/2006)
Novartis expects to deliver at least 20 million doses by the end of September, when widespread vaccination campaigns usually begin, and strives to ship the remainder by October 31.

More Information.

FDA approves an expanded label for CANCIDAS®, The first and only echinocandin therapy approved in the United States for pediatric patients with fungal infections.

WHITEHOUSE STATION, N.J., Aug. 5, 2008 - Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded label for CANCIDAS®, which makes it the first and only echinocandin therapy approved in the United States for the treatment of pediatric patients aged 3 months to 17 years with indicated fungal infections.
In the United States, CANCIDAS is now indicated in adults and pediatric patients (3 months and older) for:
  • Empirical therapy for presumed fungal infections in febrile, neutropenic patients
  • Treatment of Candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. CANCIDAS has not been studied in endocarditis, osteomyelitis and meningitis due to Candida
  • Treatment of Esophageal Candidiasis
  • Treatment of Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies (i.e., amphotericin B, lipid formulations of amphotericin B, and/or itraconazole). CANCIDAS has not been studied as initial therapy for invasive aspergillosis.
The efficacy and safety of CANCIDAS has not been adequately studied in prospective clinical trials involving neonates and infants under 3 months of age.
"In the pediatric population, safety and tolerability can be especially critical. With the expanded label for CANCIDAS that now includes use in pediatric patients aged 3 months to 17 years, clinicians have a new option – with both a demonstrated efficacy and safety profile – for treating these pediatric patients with indicated fungal infections," said Dr. Theoklis Zaoutis, assistant professor, Pediatrics and Epidemiology, Division of Infectious Diseases, Children's Hospital, Philadelphia, and lead study investigator.
The expanded label for CANCIDAS is based on data from five prospective clinical studies involving 171 pediatric patients. Two clinical trials demonstrated the efficacy of CANCIDAS for the treatment of pediatric patients with indicated fungal infections, and demonstrated a safety and tolerability profile comparable to that of adults. The expanded label also includes consistent dosing for pediatric patients across all indications based on multiple pharmacokinetic studies.

As part of the expanded label, precise dosing of CANCIDAS in pediatric patients aged 3 months to 17 years should be based on the patient's body surface area (BSA). For all indications, a single 70-mg/m² loading dose (not to exceed an actual dose of 70 mg) should be administered on Day One, followed by 50 mg/m² daily thereafter (not to exceed an actual dose of 70 mg daily).² CANCIDAS is the only antifungal with well-studied BSA dosing in pediatric patients.
Safety and efficacy of CANCIDAS evaluated when used as empirical therapy
In one clinical trial, the safety and efficacy profile of CANCIDAS was assessed when used as empirical therapy against suspected fungal infections in patients 2 to 17 years of age with persistent fever and neutropenia (seriously ill patients with persistent fever and low white blood cell counts).

The study was a prospective randomized, double-blind, multi-center, comparative trial involving a total of 82 patients aged 2 to 17 years. Patients were randomized using a 2:1 ratio of CANCIDAS (n= 56) to AmBisome® liposomal amphotericin B, or AmBisome (n=26), a standard treatment option against invasive fungal infections, and were given either CANCIDAS 50 mg/m² daily following a 70 mg/m² loading dose on Day One (not to exceed 70 mg daily) or AmBisome 3 mg/kg daily. Patients were stratified based on risk category (high-risk patients had undergone allogeneic stem cell transplantation or had relapsed acute leukemia). Twenty-seven percent of patients in both treatment groups were high risk.

The study design and criteria for overall favorable response were similar to the corresponding study in adult patients. An overall favorable response required meeting each of the following criteria: no documented breakthrough fungal infections up to seven days after completion of treatment, survival for seven days after completion of study therapy, no discontinuation of the study drug because of drug-related toxicity or lack of efficacy, resolution of fever during the period of neutropenia, and successful treatment of any documented baseline fungal infection.
The favorable overall response rates were 46.4 percent (26 of 56) in the CANCIDAS group versus 32.0 percent (8 of 25) in the AmBisome group. The favorable response rates for high-risk patients were 60 percent (9 of 15) in the CANCIDAS group versus 0 percent (0 of 7) in the AmBisome group. The favorable response rates for low-risk patients were 41.5 percent (17 of 41) in the CANCIDAS group versus 44.4 percent (8 of 18) in the AmBisome group. Fewer patients experienced serious drug-related adverse events with CANCIDAS (0.6 percent; n=1) than AmBisome (11.5 percent; n=3). The therapy discontinuation rate due to drug-related adverse reaction was 1.2 percent with CANCIDAS (n=2) and 11.5 percent with AmBisome (n=3).
Efficacy and safety studied in documented fungal infections
Another prospective, open-label, non-comparative study estimated the safety and efficacy of CANCIDAS in pediatric patients aged 3 months to 17 years with candidemia and other Candida infections, esophageal candidiasis, and invasive aspergillosis (as salvage therapy).
The study design and criteria for favorable response were similar to the corresponding studies in adult patients. A favorable response for patients with candidemia and other Candida infections required both symptom/sign resolution/improvement and microbiological clearance of the Candida infection. Favorable overall response at five to seven days following discontinuation of study therapy for patients with esophageal candidiasis required both complete resolution of symptoms and significant endoscopic improvement. A favorable response for patients with invasive aspergillosis was defined as either complete resolution (complete response) or clinically meaningful improvement (partial response) of all signs and symptoms and attributable radiographic findings.
The efficacy of CANCIDAS in pediatric patients with these documented fungal infections was supported by the study results. Specifically, the favorable response rates were 81 percent (30 of 37) of patients with candidemia and other Candida infections, 100 percent (1 of 1) of patients with esophageal candidiasis, and 50 percent (5 of 10) of patients with invasive aspergillosis as salvage therapy.
Selected important risk information about CANCIDAS
CANCIDAS is contraindicated in patients with hypersensitivity to any component of the product. Concomitant use of CANCIDAS with cyclosporine should be limited to patients for whom the potential benefit outweighs the potential risk of increased hepatic enzyme abnormalities.
Laboratory abnormalities in liver function tests have been seen in healthy volunteers and patients treated with CANCIDAS. In some patients with serious underlying conditions who were receiving multiple medications concomitantly with CANCIDAS, isolated cases of clinically significant hepatic dysfunction, hepatitis, or hepatic failure have been reported; a causal relationship to CANCIDAS has not been established. Patients who develop abnormal liver function tests during therapy with CANCIDAS should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing therapy with CANCIDAS. There is no clinical experience in adult patients with severe hepatic insufficiency (Child-Pugh score >9) and in pediatric patients with any degree of hepatic insufficiency.

Possible histamine mediated symptoms have been reported, including rash, facial swelling, pruritus, sensation of warmth and bronchospasm. Anaphylaxis has been reported during administration of CANCIDAS.
The most common adverse reactions in adult patients treated with CANCIDAS (greater than or equal to 10 percent), irrespective of causality, are: diarrhea, pyrexia, chills, alanine aminotransferase/aspartate aminotransferase (ALT/AST) increase, blood alkaline phosphatase increase and decrease of blood potassium.
The most common adverse reactions in pediatric patients treated with CANCIDAS, irrespective of causality, were pyrexia (29.2 percent), blood potassium decreased (15.2 percent), diarrhea (14.0 percent), increased AST (11.7 percent), rash (11.7 percent), increased ALT (11.1 percent), hypotension (11.1 percent), and chills (11.1 percent). The proportion of patients who experienced an infusion-related adverse reaction was 21.6 percent in the group treated with CANCIDAS and 34.6 percent in the group treated with AmBisome.

When CANCIDAS is co-administered to pediatric patients with inducers of drug clearance, such as rifampin, efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, a dose of CANCIDAS of 70 mg/m² daily (not to exceed 70 mg) should be considered. For patients receiving CANCIDAS and tacrolimus, standard monitoring of tacrolimus blood concentrations and appropriate tacrolimus dosage adjustments are recommended.
The efficacy and safety of CANCIDAS has not been adequately studied in prospective clinical trials involving neonates and infants under 3 months of age. Although limited pharmacokinetic data were collected in neonates and infants below 3 months of age, these data are insufficient to establish a safe and effective dose of caspofungin in the treatment of neonatal candidiasis. Invasive candidiasis in neonates has a higher rate of central nervous system and multi-organ involvement than in older patients; the ability of CANCIDAS to penetrate the blood-brain barrier and to treat patients with meningitis and endocarditis is unknown.
For more details about CANCIDAS, please see the prescribing information.
About CANCIDAS
CANCIDAS is a member of the echinocandin class of antifungals. CANCIDAS inhibits the synthesis of (1,3)-D-glucan, an integral component of the fungal cell wall. CANCIDAS should be administered via slow intravenous infusion over approximately one hour. CANCIDAS should not be administered by I.V. bolus administration.

New Source

Wednesday, August 06, 2008

Neuropathic Pain in HIV Could Be Eased With Medicinal Marijuana (Cannabis)

In a double-blind, placebo-controlled clinical trial to assess the impact of smoked medical cannabis, or marijuana, on the neuropathic pain associated with HIV, researchers at the University of California, San Diego School of Medicine found that reported pain relief was greater with cannabis than with a placebo. The study, sponsored by the University of California Center for Medical Cannabis Research (CMCR) based at UC San Diego, will be published on line, August 6 in the journal Neuropsychopharmacology.

Led by Ronald J. Ellis, M.D., Ph.D., associate professor of neurosciences at UCSD School of Medicine, the study looked at 28 HIV patients with neuropathic pain not adequately controlled by other pain-relievers, including opiates. They took part in the controlled study as outpatients at the UCSD Medical Center. The proportion of subjects achieving pain reduction of 30 percent or more was greater for those smoking cannabis than those smoking the placebo.

“Neuropathy is a chronic and significant problem in HIV patients as there are few existing treatments that offer adequate pain management to sufferers,” Ellis said.

“We found that smoked cannabis was generally well-tolerated and effective when added to the patient’s existing pain medication, resulting in increased pain relief.”

Each trial participant participated in five study phases over seven weeks. During two five-day phases, randomly selected participants smoked either cannabis or placebo cigarettes made from whole plant material with cannabinoids (the psychoactive compound found in marijuana) removed, both provided by the National Institute on Drug Abuse. Outcome was tested by standardized tests measuring analgesia (lessened pain sensation), improvement in function and relief of pain-associated emotional distress.

Using verbal descriptors of pain magnitude, cannabis was associated with an average reduction of pain intensity from ‘strong’ ‘to mild-to-moderate’ in cannabis smokers, according to Ellis. Also, cannabis was associated with a sizeable (46% versus 18% for placebo) proportion of patients reporting clinically meaningful pain relief.

The study’s findings are consistent with and extend other recent research supporting the short-term efficacy of cannabis for neuropathic pain, also sponsored by the CMCR.

“This study adds to a growing body of evidence that indicates that cannabis is effective, in the short-term at least, in the management of neuropathic pain,” commented Igor Grant, M.D., professor of psychiatry and director of the CMCR.

The CMCR coordinates and supports cannabis research throughout the state of California. Research focuses on the potential medicinal benefits of cannabis for diseases and conditions as specified by the National Academy of Sciences, Institute of Medicine Report (1999) and by the Workshop on the Medical Utility of Marijuana, National Institutes of Health (1997).

Grant noted that this is the fourth CMCR sponsored study to provide convergent evidence that cannabis can help in relieving these types of pain. The previous studies were conducted with CMCR support by Donald I. Abrams, M.D., Professor of Clinical Medicine at UCSF, who reported efficacy in short-term treatment of HIV neuropathy (Neurology, 2007, 68:515-521); by Mark Wallace, M.D., Program Director for the UCSD Center for Pain Medicine, who found that normal volunteers subjected to chemically induced pain which mimics neuropathy also responded to medium doses of cannabis (Anesthesiology, 2007, 107(5):785-796); and by Barth Wilsey, M.D., Director of the UC Davis Analgesic Research Center, who also reported benefit from smoked cannabis in a group of patients with neuropathy of multiple origins (Journal of Pain, 2008 Jun;9(6):506-21).

Additional contributors to the study, all from the UCSD School of Medicine, include Will Toperoff, RN, FNP, Department of Neurosciences; Florin Vaida, Ph.D., Family and Preventive Medicine; Geoff van den Brande, RN, Medicine; J. Gonzales, Pharm.D., Pharmacy; Ben Gouaux, Heather Bentley, CCRA, and J. Hampton Atkinson, M.D., Psychiatry.

Health Canada Warns Not To Use Rize 2 The Occasion or Any Unauthorized Erectile Dysfunction Products

Warning
2008-124
August 06, 2008
For immediate release

OTTAWA - Health Canada is warning consumers not to use Rize 2 The Occasion capsules (Rize2), an unauthorized product promoted for the treatment of erectile dysfunction, because it may pose serious health risks. Rize 2 contains an undeclared pharmaceutical ingredient similar to the prescription drug sildenafil which should only be used under the supervision of a health care professional. The product may pose serious health risks, especially for patients with pre-existing medical conditions such as heart problems, those who may be taking heart medications, or those who may be at risk for strokes.

Use of sildenafil by patients with heart disease can result in serious cardiovascular side-effects such as sudden cardiac death, heart attack, stroke, low blood pressure, chest pain and abnormal heartbeat. Additionally, use of sildenafil may be associated with other side-effects including vision loss, seizures, sudden decrease or loss of hearing, dizziness, prolonged erections, headaches, flushing, nasal congestion, indigestion and abdominal pain. Sildenafil should not be used by individuals taking any type of nitrate drug (e.g., nitroglycerin) due to the risk of developing potentially life-threatening low blood pressure.

The distributor, Cana International Distributing, is conducting a voluntary recall of all lots of Rize 2 that are available at retail outlets across Canada and over the Internet. Health Canada advises retailers to remove this product from their shelves, and consumers should return the product to the place of purchase. Canadians who have used Rize 2 and are concerned about their health should consult with a health care professional. Health Canada is taking steps to confirm that the product has been removed from the Canadian market.

In addition to Rize 2, Health Canada advises consumers not to use any unauthorized erectile dysfunction products, and recommends that consumers talk to a health care professional about authorized treatments for erectile dysfunction.

Health Canada is also reminding consumers to be cautious regarding the purchase of health products over the Internet or from outside of Canada, as these products may not have been assessed to the same standards as products approved for sale on the Canadian market.

Authorized health products will bear either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM). This authorization indicates that the products have been assessed by Health Canada for safety, effectiveness and quality.

Consumers requiring more information about this advisory can contact Health Canada=s public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709. To report a suspected adverse reaction to this health product, please contact the Canada Vigilance Program of Health Canada by one of the following methods:

Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789

Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9

E-mail: CanadaVigilance@hc-sc.gc.ca

Health Canada Warns On Drinking Raw Milk (Unpasteurized Milk)

OTTAWA - Health Canada would like to remind Canadians not to drink raw (unpasteurized) milk because it could contain bacteria that can make you seriously ill.
Several different kinds of bacteria that could be found in raw milk, such as Salmonella, E. coli and Listeria, have been linked to food-borne illness. These bacteria can lead to very serious health conditions ranging from fever, vomiting and diarrhea to life-threatening kidney failure, miscarriage and death. Children, pregnant women, the elderly and individuals with compromised immune systems are particularly at risk.
Because of these health concerns, Food and Drug Regulations require that all milk available for sale in Canada be pasteurized. Pasteurization kills the organisms that cause disease while keeping the nutritional properties of milk intact. Raw milk has not been treated to make it safe.
Milk is an important food and contains many nutrients essential for good health, especially calcium and vitamin D.
Unpasteurized milk has historically been linked to many serious diseases. However, the number of food-borne diseases from milk has dramatically decreased since pasteurization of milk was made mandatory by Health Canada in 1991.
The sale of raw milk is strictly prohibited under the Food and Drug Regulations. Raw milk cheese is allowed for sale and considered safe because the manufacturing process for cheese helps to eliminate many pathogens found in raw milk.
Although raw milk is not allowed to be sold in Canada, people have become ill after drinking raw milk when visiting farms. Some dairy farmers are also consuming milk from their own animals. While pasteurized milk is now the standard, there are some Canadians who continue to prefer raw milk because of perceived health benefits. However, any possible benefits are far outweighed by the serious risk of illness from drinking raw milk.

World Class Canapes, Inc., Recalls Chicken Products

According to recallr, DBC, Inc., doing business as World Class Canapes, Inc., a Wilmington, Mass., firm, is recalling approximately 285 pounds of ready-to-eat chicken products that may be contaminated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service announced today.

Recallr: World Class Canapes, Inc., Recalls Ready-to-eat Chicken Products

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Monday, August 04, 2008

British Parents To Be Informed Of Overweight Children

From September this year, parents of children who have been weighed and measured at school could automatically receive their child's results in a bid to get parents to be more aware about healthy lifestyles, and help their children achieve a healthy weight, Health Minister Ivan Lewis announced today.

The National Child Measurement Programme weighs and measures the height of all primary school children in reception class and Year 6 (aged 4-5 and 10-11). This year, the Government is urging Primary Care Trusts (PCTs) to send parents the results so that parents don't have to ask for them.

At this stage, about 40 percent of local primary health care trusts have said they intend to automatically contact parents in the next school year, and a further 40 percent will decide when they see the new guidance issued today.

Today's guidance will help PCTs implement this new approach and includes example letters for parents.

Eighty per cent of schoolchildren - an increase of 32 per cent compared to the previous year - in Reception Year and Year 6 were weighed and measured in 2006/7.

This national movement for change will enable every citizen in the country at every stage of their lives to get the encouragement and support they need to be healthy - from what they see on the television, to what they buy in the local supermarket, to the resources at their disposal in the local community, to how they travel to and from work or school, to the information and advice they get from health professionals.

The Government is calling on everyone - from the smallest community keep fit class to the biggest retailers in the land - to join in this campaign to change the way people in England live their lives.

http://www.dh.gov.uk/healthyliving



Recallr: Actavis Totowa Recalls All Drug Products Manufactured at its Little Falls, New Jersey Facility.

Morristown, NJ, August 1, 2008 -- Actavis Totowa LLC, a generic drug manufacturer, is announcing a voluntary recall, to the retail level, of all drug products manufactured at its Little Falls, New Jersey facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.

The inspection at Little Falls revealed operations which did not meet the FDA's or Actavis' standards for good manufacturing practices. Actavis Totowa is voluntarily recalling these products from the pharmacy/retail level, which includes wholesalers and hospitals. The company has informed the FDA regarding this action.

Recallr: Actavis Totowa Recalls All Drug Products Manufactured at its Little Falls, New Jersey Facility.
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Sunday, August 03, 2008

How The Google Health Was Built.

I have spoken about Google Health when It was announced a while ago. It was a good idea from the inception even though some people were skeptical about it. It just another place where you can organize your health information, keep it up to date and have it available anywhere there is Internet access, for you or for your doctor.
But what I found today at the Google web tool kit was how Google Health was built with the Google Web Toolkit, and the Health team share the experience of building the Google Health. So if you are interested, follow the link below


Building healthy applications with GWT - Google Health


Saturday, August 02, 2008

Resveratrol-based Nutriceutical Shown To Affect 9-Fold More Longevity Genes Than Resveratrol Or A Limited-Calorie Diet Alone

San Dimas, CA · July 30, 2008 /PRNewswire/ – Researchers report that a proprietary Nutriceutical matrix (Longevinex®) exhibits striking effects upon genes controlling energy metabolism, nine times broader than research-grade resveratrol and calorie restriction (mouse study- Experimental Gerontology, early online edition, July 2008, for August hard-bound edition) at doses of resveratrol 17-320 fold lower than used in previous animal studies.

In a breakthrough study using laboratory mice, the matrix of Nutriceuticals was found to produce more striking changes in gene expression, and influence more genes, in comparison to mice placed on research-grade resveratrol or a calorie restricted (CR) diet. The Nutriceutical matrix favorably affected more biological pathways (by 3-4 fold) compared to CR. The study utilized microrrays which provide data on the expression level of over 20,000 genes. The study was conducted in mouse heart tissue.

The results of the mouse study were unexpected and surprising, pointing to a synergistic action when multiple natural molecules are employed. The Nutriceutical matrix provided red wine molecules resveratrol and quercetin and the rice bran factor known as IP6. All three are mineral-chelating (key-lay-ting) molecules.

The short-term study not only showed the Nutriceutical matrix exerted broader effects upon gene expression than CR or resveratrol, but molecularly mimicked gene patterns typically seen with long-term calorie restriction.

Of the 2829 genes significantly affected by any of the three dietary interventions employed (CR, resveratrol, or Nutriceutical matrix), the limited calorie diet affected about 187 genes (7%), resveratrol about 224 genes (8%), while the Nutriceutical matrix influenced 1711 genes (61%), over a 9-fold difference.

Recent studies that have captured the public's attention have focused on molecules that can slow aging and have been narrowly focused on the sirtuin family of genes and their activation by resveratrol, known as a red wine molecule. Recently researchers have reported that entire gene networks rather than single genes are involved in metabolic disorders, such as elevated blood sugar and cancer. Researchers report that gene array testing can detect genes affected by an unhealthy diet before there is change shown in the blood sample. [Nature March 16, 2008]

The Nutriceutical matrix of natural molecules (Longevinex®) exhibited a much broader impact upon gene expression and more strikingly affected key genes, like Pdk4 and Pgc1 alpha, involved in mitochondrial energy metabolism.

Only the Nutriceutical matrix, and not resveratrol or a long-term calorie restricted diet, upregulated the Foxo1 gene which enters the cell nucleus and promotes the expression of key longevity genes.

These effects were accomplished with a relatively low human equivalent dose of resveratrol. At about 1/15th the dose employed in a prior widely acclaimed mouse study (Nature Magazine Nov. 1, 2006) the Nutriceutical matrix was able to exert more demonstrable genomic effects.

Prior animal studies employed the human equivalent of 1565, 360 and 343 milligrams of resveratrol to produce longevity effects. The Nutriceutical matrix exerted 9-fold greater effect over the mouse genome at the equivalent daily human dose of resveratrol of 100 milligrams per day. According to this study, if data from mice is applicable to humans, some widely promoted mega-dose resveratrol pills, providing 500 to 1000 milligrams of resveratrol, would not exert as broad an effect over the human genome as the lower-dose resveratrol when provided in a matrix of other mineral-chelating natural molecules.

The discovery was made utilizing laser scanning technology to measure levels of messenger-RNA from thousands of genes in tissues obtained from test animals. Researchers used a commercially available GeneChip® (Affymetrix), which is about the size of a credit card.

Mice and humans share about 99% of their 30,000 genes. Most gene expression changes caused by aging are partially or completely prevented by CR. This discovery is suggestive of a day when humans could molecularly avert the effects of over-eating as well as slow or even reverse the aging process without having to deprive themselves of food.

A life-long CR diet is anticipated to influence more than the 200 genes shown in this short-term study, but the Nutriceutical matrix exerted influence much sooner, raising the possibility that adherence long-term CR may not be required to obtain the same benefits.

The study was sponsored by Resveratrol Partners LLC, maker of Longevinex®, a patent-applied-for Nutriceutical ( www.longevinex.com).

News Media Contacts:

Bill Sardi
Longevinex (Resveratrol Partners LLC)
San Dimas, CA
Telephone: 909 596-9507
Facsimile: 909 596-9189
bsardi@aol.com

Friday, July 25, 2008

California Bans Trans Fats, State Wide.

Governor Arnold Schwarzenegger today signed AB 97 by Assemblymember Tony Mendoza (D-Norwalk), which will phase out the use of trans fats in all California restaurants beginning in 2010 and from all baked goods by 2011.

"California is a leader in promoting health and nutrition, and I am pleased to continue that tradition by being the first state in the nation to phase out trans fats," Governor Schwarzenegger said. "Consuming trans fat is linked to coronary heart disease, and today we are taking a strong step toward creating a healthier future for California."

Scientific evidence demonstrates a strong association between the consumption of artificial trans fat and the development of coronary heart disease and stroke, as well as other chronic conditions such as diabetes. According to the New England Journal of Medicine, eliminating artificial trans fats from the food supply could prevent between six and 19 percent of heart attacks and related deaths each year. Coronary heart disease is California's leading cause of death, and AB 97 will be a strong step toward removing this harmful substance from the foods that Californians purchase and consume.

The Governor's leadership has put in place some of the nation's most innovative and successful strategies to promote health and nutrition. The Governor has:

Trans fat is linked to the following health issues:

  • Trans fat increases the risk of developing coronary heart disease - the leading cause of death in the U.S. "Like saturated fat, trans fat also raises the low density lipoprotein (LDL or "bad") cholesterol in the blood. But, unlike saturated fat, trans fat lowers high density lipoprotein (HDL or "good") cholesterol in the blood. An elevated LDL cholesterol increases the risk of developing coronary heart disease." (U.S. FDA: Center for Food Safety and Applied Nutrition, "Questions and Answers about Trans Fat Nutrition Labeling," Press Release, 1/1/06)
  • University of Maryland research suggests that kids who consume trans fats early on will develop heart disease sooner. "Children who start at age three or four eating a steady diet of fast food, pop tarts, commercially prepared fish sticks, stick margarine, cake, candy, cookies and microwave popcorn can be expected to get heart disease earlier than kids who are eating foods without trans fats... Some of our research here at the University of Maryland has shown that kids as young as eight, nine and 10 already have the high cholesterol and blood fats that clog arteries. By starting healthy eating habits early, parents can help their children avoid heart attacks and stroke." (Mary Beth Sodus, "Trans Fats 101," University of Maryland Medical Center)
  • According to the American Heart Association, trans fat should make up less than one percent of calories for Americans over two. "Another major change in the dietary recommendations is a lower goal for saturated fat - from less than 10 percent to less than seven percent - and establishing a goal for trans fatty acids of less than one percent of total calories." (American Heart Association, "Association releases new diet and lifestyle recommendations," Press Release, 6/19/06)

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