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 company’s 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 Ranbaxy’s 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.

“Today’s 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.

Tags: medical patents, Pfizer, atorvastatin, Lipitor, Ranbaxy, atovastatin enantiomer patent

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.

Tags: Bantry Bay Seafood, azaspiracid toxins

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.

Tags: FDA Approval, FDA News, Bone Marrow Stimulator, Nplate, romiplostim, corticosteroids, immunoglobulin, splenectomy, myelodysplasia, Amgen, Inc

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.

Tags: FDA Guidance, FDA Health Advisory, dietary ingredient, vitamins, minerals, amino acids, Dietary supplements, enzyme supplements

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."

Tags: FDA Announcement, influenza vaccines, Afluria, Fluarix, FluLaval, FluMist, Fluvirin, Fluzone

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.

Tags: fda warning, counterfeit drugs, Medicine Shoppe pharmacies

Three Beef Recalls This Week, S&S Foods LLC, Dallas City Packing, Nebraska Beef, Ltd. Recalls 1.2 Million Pounds Of Beef Due To E.coli Contamination.

There are a lot of beef recalls this week and better check your stocks and your freezers. Be safe.
Recallr: S&S Foods LLC. Recalls 153,630 pounds of frozen ground beef due to E.Coli Contamination
Recallr: Dallas City Packing, Inc. Recalls Cattle Heads That Contain Prohibited Tonsils.
Recallr: Nebraska Beef, Ltd. Recalls 1.2 Million Pounds Of Beef Due To E.coli Contamination.

Tags: USDA Recall, Beef Recall, FSIS Recall, Nebraska Beef Recall, Coleman Natural beef recall, CDC, E. coli O157:H7, Dallas City Packing Beef recall,S&S Foods LLC Recall,

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.

Tags: influenza Vaccine, Novartis, Fluvirin

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

Tags: Drug Approvals, FDA Approval, pediatric patients, CANCIDAS, echinocandin therapy, Candidemia, Aspergillosis

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.

Tags: Medicinal Marijuana, Cannabis, HIV, Medical Research, HIV Drug, Pain Relief, Neuropsychopharmacology, San Diego School of Medicine, cannabinoids

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

Tags: Health Canada, Health Canada warning, Rize 2 The Occasion, erectile dysfunction, sildenafil, nitroglycerin, Canada Vigilance Program

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.

Tags: Raw Milk, Salmonella, E. coli, Listeria, Food and Drug Regulations, pasteurized 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

Tags: Listeria monocytogenes, USDA Recall, Food Recall, Chicken Recall, World Class Canapes Recall

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

Tags: National Child Measurement Programme, child obesity, Primary Care Trusts

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.
Tags: Actavis Totowa Recall, FDA Recall, Drug Recall

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

Tags: GWT, google health, Google web tool kit

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

Tags: Resveratrol, aging control, Longevinex, Experimental Gerontology, Nutriceutical matrix