Vitamin D may Aid Colon Cancer More than Other Cancer Patients

In a prospective study, "serum vitamin D" levels were unrelated to cancer mortality, but colon cancer levels were lower among those with higher serum vitamin D levels.
Previously Vitamin D, believed to be useful to protect against cancer by many people, may not be a strong anti-cancer agent except for colon cancer, according to a new study published in the Journal of the National Cancer Institute.
The study was conducted by Dr. D. Michal Freedman, from the National Cancer Institute in Bethesda, Maryland, and his colleagues, Anne C. Looker, Shih-Chen Chang, Barry I. Graubard. They analyzed data from the third national Health and Nutrition Examination Survey to examine the relationship between levels of circulating vitamin D in the blood and cancer mortality in a group of 16,818 participants aged 17 and older

"Over the past several years, a number of publications have suggested that vitamin D can reduce deaths from various forms of cancer," said Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society. "This is a further bit of evidence that leads us to call for further investigations before we make recommendations for the general population."

The Study is published on Journal of The National Cancer Institute Nov 7, 2007

Tags: Cancer, Vitamin D, Serum Vitamin D

Autism Screening Urged by Pediatricians.

CHICAGO (AP) — The country's leading pediatricians group is making its strongest push yet to have all children screened for autism twice by age 2, warning of symptoms such as babies who don't babble at 9 months and 1-year-olds who don't point to toys.

The advice is meant to help both parents and doctors spot autism sooner. There is no cure for the disorder, but experts say that early therapy can lessen its severity.

Symptoms to watch for and the call for early screening come in two new reports. They are being released by the American Academy of Pediatrics on Monday at its annual meeting in San Francisco and will appear in the November issue of the journal Pediatrics and on the group's Web site — http://www.aap.org/.

The reports list numerous warning signs, such as a 4-month-old not smiling at the sound of Mom or Dad's voice, or the loss of language or social skills at any age.

Experts say one in 150 U.S. children have the troubling developmental disorder.

Tags: autism, autism screening, American Academy of Pediatrics, AAP

Methicillin-Resistant Staphylococcus aureus (MRSA), How Could We Help to Prevent It in Schools

The Centers for Disease Control, CDC, along with parents and school officials, wants to do everything possible to protect students from MRSA skin infections. These are commonly asked questions that will help parents and school officials prevent the spread of MRSA in schools.

But what struck me to be standing out is;

How do I protect myself from getting MRSA?

• You can protect yourself by:

• practicing good hygiene (e.g., keeping your hands clean by washing with soap and water or using an alcohol-based hand sanitizer and showering immediately after participating in exercise);

• covering skin trauma such as abrasions or cuts with a clean dry bandage until healed;

• avoiding sharing personal items (e.g., towels, razors) that come into contact with your bare skin; and using a barrier (e.g., clothing or a towel) between your skin and shared equipment such as weight-training benches;

• maintaining a clean environment by establishing cleaning procedures for frequently touched surfaces and surfaces that come into direct contact with people's skin.

CDC has published more facts about MRSA and it never huts to learn;

• What type of infection does MRSA cause?

• How is MRSA transmitted?

• In what settings do MRSA skin infections occur?

• How do I protect myself from MRSA?

• Should schools close because of a MRSA infection?

• Should the school be closed to be cleaned or disinfected when an MRSA infection occurs?

• Should the entire school community be notified of every MRSA infection?

• Should the school be notified that my child has an MRSA infection?

• Should students with MRSA skin infections be excluded from attending school?

• I have an MRSA skin infection. How do I prevent spreading it to others?

Tags: MRSA, Staphylococcus, Staph, CDC

Trasylol trial halted Bayer and FDA Informs Physicians

Update to previous post on Trasylol (Aprotinin). Includes information from BART study.
Leverkusen, Germany and West Haven, CT, USA, October 25, 2007 – Today Bayer announced new guidance to physicians and health care providers regarding the use of Trasylol^® (aprotinin injection) in patients at an increased risk of blood loss and blood transfusion undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB).

The company did so after being notified that the BART Executive Committee had halted the Canadian-based trial – a randomized, controlled trial being conducted in high-risk cardiac surgery patients. This followed a letter from the BART Data Safety Monitoring Board informing the Committee that a planned periodic data analysis indicated reduced bleeding but also an increase in all-cause mortality (that almost reached conventional statistical significance for 30-day mortality) for patients in the aprotinin treatment arm compared to patients who received either aminocaproic acid or tranexamic acid. Data have not, as yet, been shared with Bayer.

Bayer immediately informed the U.S. Food and Drug Administration (FDA), Health Canada and other health authorities around the world.

Bayer has also been informed that data will now be collected from all centers throughout Canada and data analysis will be undertaken by those conducting the BART study – a process that is expected to take between four and eight weeks. Consequently no further evaluation either by Bayer or by regulatory authorities can take place until additional information becomes available from the BART investigators.

Guidance from Bayer includes a recommendation that physicians use Trasylol only in accordance with approved product labeling. Trasylol is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.

Additionally, when deciding to prescribe Trasylol, physicians should also take into consideration that the BART Trial has been halted due to an increase in all-cause mortality in patients in the aprotinin treatment arm compared to patients who received either aminocaproic acid or tranexamic acid.

Patient safety remains Bayer’s primary concern. Bayer believes Trasylol remains a safe and effective treatment option for physicians. Bayer will continue to work closely with medical experts, the FDA and health authorities in countries where Trasylol is marketed to re-evaluate the overall risk-benefit of the product and will evaluate the need for a label change and/or other actions as additional data and analyses become available from the BART trial.

Bayer has posted information regarding this issue on its websites www.trasylol.com, www.pharma.bayer.com, www.bayerscheringpharma.de/trasyslol/en, www.bayerhealthcare.com/trasylol/en. Subsequently, in consultation with the FDA and other health authorities, the Company will issue a letter to health care providers who use Trasylol such as cardiothoracic surgeons, anesthesiologists and hospital pharmacists. Bayer has also been informed that the FDA plans to communicate with the public on this issue

Tags: Aprotinin, Trasylol, drug trial, Bayer, FDA, CABG, BART

Bell's Whitefish Pate Recalled

FOR IMMEDIATE RELEASE -- October 25, 2007 -- Bell's Fishery of Mackinaw City is recalling all of its packages of Bell's Whitefish Pate because they contain undeclared egg, soy, and milk products. People who have allergies to egg, soy or milk products run the risk of a serious or life-threatening allergic reaction if they consume these products.

The recalled Bell's Whitefish Pate was sold in Michigan at Bell's Fishery located at 229 S Huron St. in Mackinac City, and Biindigen Gas Station located at 2169 US 31 North, in Petoskey.
The product comes in an 8 ounce or 16 ounce plastic container marked with lot #100607, expiration date 10-20-07, or lot # 100807, expiration date 10-28-07.
No Illnesses have been reported to date in connection with this problem.
The recall was initiated after it was discovered that the product was distributed in packaging that did not reveal the presence of egg, soy, and milk as ingredients in the Bell's Whitefish Pate.
Production of the product has been suspended until FDA and Bell's Fishery is certain that the labeling problem has been corrected.

Consumers who have purchased the Pate are encouraged to return the product to
the place of purchase for a full refund. Consumers with questions may contact Bell's Fishery at 1-231-436-7821.

Tags: Bell's Whitefish Pate, food recall, FDA

Ongoing Safety Review on Aprotinin Injection (marketed as Trasylol)

On October 19, 2007, FDA was notified of the Data Safety Monitoring Board’s (DSMB) recommendation to stop patient enrollment in the aprotinin (marketed as Trasylol by Bayer, Inc.) treatment group arm of the: Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study. The preliminary findings suggest that, compared to the antifibrinolytic drugs, epsilon-aminocaproic acid and tranexamic acid, aprotinin increases the risk of death.

The BART study was designed to test the hypothesis that aprotinin was superior to epsilon-aminocaproic acid and tranexamic acid in decreasing the occurrence of massive bleeding associated with cardiac surgery. The study had planned to enroll approximately 3,000 adult Canadian patients who were to undergo various types of cardiac surgery that placed them at high risk for bleeding.

Information from the interim analyses performed by the DSMB is limited, but FDA has been informed that:

• the 30- day mortality in the aprotinin group nearly had reached conventional statistical significance at the interim analysis, when compared to either epsilon-aminocaproic acid or tranexamic acid;

• a trend toward increased mortality in the aprotinin group had been observed throughout the study;

• the use of aprotinin was associated with less serious bleeding than either of the comparator drugs; however, more deaths due to hemorrhage had been observed among patients receiving aprotinin;

• the DSMB concluded that continued enrollment of patients into the aprotinin group was unlikely to significantly change the study findings.

Additional data collection and analyses must be performed to more thoroughly assess the findings from the BART study. However, these preliminary data support the findings from observational studies that also suggested increased risks for mortality when aprotinin was compared to other antifibrinolytic drugs. These observational studies were discussed at a September 12, 2007, joint meeting of the Cardiovascular and Renal Drugs and Drug Safety and Risk Management Advisory Committees.

In light of the preliminary BART study findings, FDA anticipates re-evaluation of the overall risks and benefits of Trasylol. This re-evaluation may result in the need to revise the labeling or other regulatory actions. Until this process has been completed, healthcare providers who are considering use of Trasylol should be aware of the risks and benefits described in the labeling for Trasylol and the accumulating data suggesting Trasylol administration increases the risk for death compared to other antifibrinolytic drugs.

Trasylol is currently approved for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft (CABG) surgery who are at an increased risk for blood loss and blood transfusion.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA will work with the sponsor of the BART study and the manufacturer of Trasylol to fully evaluate the risks and benefits associated with the use of Trasylol. As soon as this process is complete, FDA will communicate the conclusions and recommendations to the public.

The FDA urges healthcare professionals to promptly report serious and unexpected adverse reactions associated with Trasylol to Bayer or to the FDA MedWatch reporting program, as described below.

• online at www.fda.gov/medwatch/report.htm
• by returning the postage-paid FDA form 3500 (available in PDF format at www.fda.gov/medwatch/getforms.htm) to 5600 Fishers Lane, Rockville, MD 20852-9787
• faxing the form to 1-800-FDA-0178
• by phone at 1-800-332-1088

Tags: aprotinin, Trasylol, antifibrinolytics, antifibrinolytic drugs, epsilon-aminocaproic acid, tranexamic acid, DSMB, BART study findings, FDA, healthcare

Ixempra Approved by FDA for Advanced Breast Cancer Patients

The U.S. Food and Drug Administration has approved Ixempra (ixabepilone), a new anti-cancer treatment, for use in patients with metastatic or locally advanced breast cancer who have not responded to certain other cancer drugs. The FDA evaluated Ixempra under priority review, completing its assessment of the drug's safety and effectiveness in six months.

"This approval is important because it provides certain patients with a new chemotherapy option in instances where other drugs have failed," said Douglas C. Throckmorton, M.D., deputy director of the FDA's Center for Drug Evaluation and Research. "FDA is working every day to support the development of safe and effective new therapies that benefit patients in need."

Ixempra was approved for use in combination with another cancer drug, capecitabine, in patients who no longer benefit from two other chemotherapy treatments. These prior treatments included an anthracycline (such as doxorubicin or epirubicin) and a taxane (such as paclitaxel or docetaxel).

Ixempra was also approved for use alone in patients who no longer benefit from an anthracycline, a taxane and capecitabine. According to the American Cancer Society, about 180,000 new cases of breast cancer are diagnosed each year in the United States. Metastatic breast cancer is the most advanced stage of breast cancer and has the potential to spread to almost any region of the body.

Ixempra has been shown to bind to cancer cell microtubules, which are structures within cells that help to support and shape them. Microtubules also play a role in cell division. The safety and efficacy of Ixempra in combination with capecitabine were evaluated in 752 patients in a randomized clinical trial comparing the combination to capecitabine alone. This combination therapy demonstrated improvements in delaying cancer progression or death compared to capecitabine alone.

The safety and efficacy of Ixempra administered alone were evaluated in a study of 126 patients. Clinically significant tumor shrinkage occurred in 12 percent of the patients. Ixempra's significant side effects included peripheral neuropathy (numbness, tingling or burning in the hands or feet) and bone marrow suppression. Other commonly observed toxicities included constipation, nausea, vomiting, muscle paint, joint pain, fatigue and general weakness.

Women taking Ixempra should avoid taking drugs that are strong inhibitors of CYP3A4, one of the enzymes that metabolizes Ixempra. Ixempra should not be taken by women who have had severe allergic reactions to drugs that contain Cremophor or its derivatives, or by women who have baseline bone marrow suppression determined by low white blood cell or platelet count.

The combination of Ixempra and capecitabine should not be given to patients with moderate or severe liver impairment due to the increased risk of toxicity and death. Ixempra is administered by intravenous infusion. It is distributed by Bristol-Meyers Squibb Company, Princeton, New Jersey

Tags: Ixempra, Cremophor, CYP3A4, Microtubules, Metastatic breast cancer, breast cancer, anthracycline, taxane, capecitabine, ixabepilone, American Cancer Society

Broccoli May Help to Prevent Skin Cancer

Researchers say that an extract made from broccoli sprouts may prevent skin cancer when applied directly to the skin. VOA's Jessica Berman reports scientists say broccoli contains a chemical that stimulates the body's natural anti-cancer ability.
According to scientists, broccoli contains a chemical called sulphoraphane, which activates cancer-fighting enzymes inside cells. Researchers say the richest source of sulphoraphane is contained in sprouts.

In a demonstration of the plant's anti-cancer properties, investigators smeared broccoli sprout extract on the skin of six volunteers for three days, and then exposed them to high doses of ultraviolet radiation, which is the leading cause of skin cancer.

They found there was an average 37 percent less redness and sunburn in the patches covered by broccoli extract. Redness and sunburn are an indication of skin damage that could lead to cancer.

The results of the study are published in the journal Proceedings of the National Academy of Sciences.

Paul Talalay is a Johns Hopkins University molecular pharmacologist and the author of the study. Talalay says sunscreen conferred no protection against the UV rays, but he says that does not mean people should stop using it.

"We want to avoid under all circumstances people doing weird things like making broccoli sprout soup and applying to their skin and thinking that they will be protected against the sun," he said. "They will have not have any protection whatsoever, because it's a totally different mechanism and one cannot possibly substitute for the other."

Applied as a thick cream, sunscreen protects the skin by deflecting the sun's harmful rays. But it must be constantly reapplied to remain effective.
VOA article

Tags: Skin Cancer, sulphoraphane, broccoli, sprouts, Johns Hopkins University

FDA Approves Generic Alzheimer's and Parkinson's desease Drug

BANGALORE (Thomson Financial) - Sun Pharmaceutical Ltd said the US Food and Drug Administration has approved its application to market its generic version of Novartis' Exelon capsules.

It is primarily used for treating Alzheimer's and Parkinson's diseases. In a filing to the Bombay Stock Exchange, the firm informed that the USFDA had granted the final approval for its Abbreviated New Drug Application (ANDA) to market the generic version of Novartis Exelon capsules.

The generic version of rivastgmine tartrate capsules (Exelon) comes in four strengths, 1.5 mg (base), 3 mg (base), 4.5 mg (base) and 6 mg (base). Rivastgmine tartrate is indicated for the treatment of mild to moderate dementia of the Alzheimer's type and for the treatment of mild to moderate dementia associated with Parkinson's diseas

The Mumbai-based company said in view of the ongoing litigation with Novartis on this product, it is evaluating all its launch options. Sun Pharma said it shares a 180-day marketing exclusivity.

Tags: Novartis' Exelon, generic Exelon, Sun Pharmaceutical, Rivastgmine tartrate, alzheimer, Parkinson's disease, dementia

H5N1 bird flu Shots

Deployed military troops, emergency workers, pregnant women and children will be among the first to get scarce vaccinations if a pandemic strain of flu breaks out, U.S. officials said.

A long-awaited report to be issued on Tuesday lays out who would be first in line to get vaccinated against H5N1 bird flu or any other strain of pandemic influenza.

The Health and Human Services report proposes creating four categories of people, and vaccinating the top tier of each category first. The categories are homeland and national security, critical infrastructure, health and community support services and the general population.

"Certain military personnel like deployed forces would get vaccinated before certain other military personnel," HHS science adviser William Raub said in a telephone interview.

Virtually all health experts agree that the world is overdue for a pandemic of some sort of influenza.

No one can predict when one might come, how bad it would be or which strain of influenza virus may be responsible. But the H5N1 bird flu virus that has infected 331 people since 2003, killing 203 of them, is the current chief candidate.

Companies are working to make a vaccine against H5N1 but the process takes months and it is not clear if vaccines formulated to match the current strain would protect well against whatever mutated version emerges to cause a pandemic.
Reuters Article
US Government Pandemic Flu site

Tags: H5N1 bird flu, H5N1 bird flu shots, vaccine, pandemic influenza

Health Insurance and November 2008 elections

Health insurance problems driving US health care and medicines to be most expensive in the world, and with 47 million people in the United States without any health insurance, the U.S. presidential candidates' plans to close that gap are coming under scrutiny by voters before the November 2008 election. Reuters has published some health care proposals from leading candidates.
Go make your own analysis.

Tags: health insurance, US health care, November 2008 election, health care proposal

You might be able to eat that Bacon, Merck is seeking Approval to sell a Cholesterol-lowering Drug without a Prescription.

WASHINGTON -(Dow Jones)- Merck & Co. (MRK) is pushing forward with another bid to seek Food and Drug Administration approval to sell a cholesterol-lowering drug without a prescription.

The FDA said Monday it would convene a joint advisory panel meeting to consider the proposal on Dec. 13. Specifically, Merck is asking the FDA to sell switch a 20 milligram dose of Mevacor from prescription to over-the-counter status. Mevacor was approved as a prescription drug in 1987.

In January 2005 another FDA panel rejected a bid by Merck and then partner Johnson & Johnson (JNJ) to sell Mevacor without a prescription. The panel was concerned consumers wouldn't correctly use the drug and suggested the FDA needed to establish a "behind-the-counter" system where a drug could be dispensed by a pharmacist who could make sure consumers fit the criteria to use the drug.

The FDA is considering establishing such a behind-the-counter drug system and is holding a Nov. 14 public meeting on the issue. However, establishing a new system will require the FDA to establish new rules through the federal rule- making system, a process that takes several months to years to complete.

Ron Rogers, a Merck spokesman, confirmed the company is trying again to switch Mevacor from prescription to over-the-counter status, but this time without Johnson & Johnson as a partner. He said the company is in discussions with several potential partners to sell Mevacor without a prescription.

The FDA has allowed the switch of some types of drugs including products used to treat heartburn and to treat certain vaginal infections.

However, the FDA panel that considered Mevacor in 2005 said they were concerned if Mevacor were widely made available to consumers, that many of them would incorrectly use the medication, based on data submitted by the companies. There were also concerns that people who shouldn't use the drug, such as those with liver disease or women who might become pregnant, might do so.

Rogers said the company will be submitting additional data to address some of the concerns raised at the last FDA panel meeting.

"We are optimistic and hopeful we'll be successful this time," Rogers said.

Merck made a similar proposal to sell a 10 milligram dose of Mevacor without a prescription, but the FDA rejected that plan in 2000 and said the companies needed to submit more data about consumer use.

- By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com.

  (END) Dow Jones Newswires
 10-22-07 1408ET
 Copyright (c) 2007 Dow Jones & Company, Inc.

Tags: Over the counter Drugs, FDA, Merck, Mevacor

MRSA and STAPH, what are these?

On Friday, Dr. Jacqueline Eghrari-Sabet from Family Allergy & Asthma Care held an online chat on nbc4.com Washington, to discuss MRSA and other staph infections. The transcript of the chat is available at the link below.
I learned a lot by following the transcript. I hope NBC4.COM will give us pod casts of such interviews so that more people could benefit by not only having to read online. Podcast could be down loaded to personal music players such as iPod and listened later.
Thank you NBC4
Dr. Answers MRSA Questions During Online Chat

Tags: health, disease outbreak, STAPH, MRSA, iPod, Podcast

Middle School Birth Control or Access to Prescription Contraceptives.by Minors

I don't think I was worried about birth control when I was at middle school. Two things that I can remember were on my mind was to be the best of the class and be a part of schools football (soccer) team. I think I looked at those beautiful girls at school and else where, infatuation lead day dreaming but sex was not in my mind when I was 11.
In any case, I do not agree with the King Middle School, Portland school board’s decision to let the independently operated clinic at her school provide students access to prescription contraceptives.
They are just too small to know what is best for them. Another reason that I don't like it is keeping the information away from parents. There might be exceptions but any parent know what is best for their children and it might help families to keep things open. If parents and doctors decide that there is a need for such things as contraceptives that might be a different story.
I hope this decision don't send out signals to people indicating it is OK for minors to have sex.
In any case people should be informed and following are some links providing information. After reading those you might have a different idea about this issue.

Not All Are Pleased at Plan to Offer Birth Control at Maine Middle School: NY Times
Parents, remember teen years Alternative view at Boston Herald

Update; this link was in a comment left for this article. I thought it was very good ling and I learn somethings new today and I was convinced once again that we live in a great country.

Tags: King Middle School, contraceptive, prescription contraceptives, Birth Control

How Long Would Frozen Food Last?.

Everyone stuffs their freezers with food to be used later. We know some will escape the hands that search for packages and get left behind.
Is it safe to eat those food or how long those food is safe to use? Are there any guide lines?
I did know the answers either, but people at DIY Kits' DIY Basics gives some pointers. The most important for me was the following;

The Time Periods for Frozen food!

Properly prepared and packaged food should last for several months.

Fruits and Vegetables: 8-12 Months
Poultry: 6-9 Months
Fish: 3-6 Months
Ground Meat: 3-4 Months
Cured or Processed Meat: 1-2 Months

Tags: Fruits and Vegetables, Poultry, Fish, meat, frozen, frozen food, DIY

Labels for CialiLabels for Cialis, Levitra and Viagra to be Revised to Display Potential Risk of Hearing Loss,

The U.S. Food and Drug Administration has approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis, Levitra, and Viagra, to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing.

In addition, the FDA plans to require the same changes in labeling for the drug Revatio, also a member of this drug class known as phosphodiesterase type 5 (PDE5) inhibitors. Revatio is used to treat pulmonary arterial hypertension (PAH). PAH is a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle and often leads to right heart failure and death.

The FDA asked manufacturers of these drugs to revise product labeling after a very small number of patients taking the PDE5 inhibitors reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.

“Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.

Patients taking Cialis, Levitra, or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention. Those using Revatio should continue taking their medication but should contact their health care provider for further evaluation. Because Revatio is used to treat a potentially life-threatening condition, the FDA does not recommend patients abruptly stop taking this medication but should consult their physician if they experience sudden problems with their hearing.

A case report in the April 2007 issue of the Journal of Laryngology & Otology involving sudden hearing loss in a man taking Viagra prompted the FDA to search the FDA’s Adverse Events Reporting System for instances of hearing loss and PDE5 inhibitors. The FDA found a total of 29 post marketing reports of sudden hearing loss, both with and without accompanying ringing in the ears, vertigo, or dizziness. In most of the cases, the hearing loss involved one ear. The hearing loss was either a partial or complete loss of usual hearing. In approximately one third of cases, the event was temporary. In the remainder, the hearing loss was ongoing at the time of the report or the final outcome was not described.

Although no causal relationship has been demonstrated, the strong relationship between the use of these drugs and sudden hearing loss in these cases warrants revisions to the product labeling for this drug class.

Product Web sites, marketing and educational materials, and advertisements for PDE5 inhibitors will reflect the revised product labeling. The label revisions can be viewed at: www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm.

For more information:
http://www.fda.gov/cder/drug/infopage/ed_drugs/QA.htm

Tags: Cialis, Levitra, Viagra, PDE5, phosphodiesterase, hearing loss, Revatio, FDA

Safe Sources of Puffer Fish, from FDA (Fuku from Fugu, Fugu happiness)

The U.S. Food and Drug Administration today released consumer and industry advisories regarding safe sources of puffer fish. Many puffer fish, also known as fugu, bok, blowfish, globefish, swellfish, balloonfish, or sea squab, contain deadly toxins that affect the central nervous system, if consumed.

Puffer fish can be safely consumed when special care is taken to ensure that the fish caught are free of toxins, or when they are processed to eliminate the toxins.

"Over the past year, several illnesses have been linked to puffer fish improperly processed and illegally imported into the United States," said Robert Brackett, Ph.D., director of the FDA's Center for Food Safety and Applied Nutrition. "If restaurateurs, retailers, and consumers follow the advice the FDA is providing, puffer fish can be safely enjoyed."

The only safe sources for imported puffer fish are fish that have been processed and prepared by specially trained and certified fish cutters in the city of Shimonoseki, Japan. Additionally, puffer fish caught in the mid-Atlantic coastal waters of the United States, typically between Virginia and New York, are safe to consume. Puffer fish from all other sources can either naturally contain deadly toxins or become toxic because of environmental factors and therefore are not considered safe.

Symptoms of ingesting the toxins found in puffer fish include tingling around the lips and in the extremities followed by problems speaking, loss of balance, muscle weakness and paralysis, vomiting, and diarrhea. In extreme cases, there may be respiratory paralysis that can lead to death.

Consumers should ask about the origin of the fish before ordering or buying. In cases where the source is uncertain or unknown, consumers should not eat the puffer fish.

Establishments that serve or sell puffer fish, including restaurants and fish markets, should obtain the product from a known safe source.

FDA officials are working with state and local health officials, along with food safety organizations, to raise awareness about the industry advisory to restaurants, fish markets, and food stores.

Consumer Advisory: Only Eat Puffer Fish from Known Safe Sources
www.cfsan.fda.gov/~dms/adpuffer.html

Industry Advisory on Puffer Fish
www.cfsan.fda.gov/~dms/ad2puff.html

Tags: fugu, bok, blowfish, globefish, swellfish, balloonfish, sea squab, puffer fish, Shimonoseki, Fuku

Poison Kisses With Bad Lead Tainted Lipsticks

It seems Toys made in China aren’t the only products laced with dangerous heavy metals: lipstick manufactured in the United States and used daily by millions of American women also contains surprisingly high levels of lead, according to new product tests released by the Campaign for Safe Cosmetics.

According to The Campaign for Safe Cosmetics;

Boston – Toys made in China aren’t the only products laced with dangerous heavy metals: lipstick manufactured in the United States and used daily by millions of American women also contains surprisingly high levels of lead, according to new product tests released today by the Campaign for Safe Cosmetics. The lead tests were conducted by an independent laboratory over the month of September on red lipsticks bought in Boston, Hartford, Conn., San Francisco and Minneapolis. Top findings include:

More than half of 33 brand-name lipsticks tested (61 percent) contained detectable levels of lead, with levels ranging from 0.03 to 0.65 parts per million (ppm). None of these lipsticks listed lead as an ingredient.

One-third of the tested lipsticks exceeded the U.S. Food and Drug Administration’s 0.1 ppm limit for lead in candy – a standard established to protect children from directly ingesting lead. Lipstick products, like candy, are directly ingested into the body. Nevertheless, the FDA has not set a limit for lead in lipstick, which fits with the disturbing absence of FDA regulatory oversight and enforcement capacity for the $50 billion personal care products industry.

The good news is that the tests show it is possible to make lipstick without lead: 39 percent of lipsticks tested had no detectable levels of lead, and cost doesn’t seem to be a factor. Some less expensive brands such as Revlon ($7.49) had no detectable levels of lead, while the more expensive Dior Addict brand ($24.50) had higher levels than some other brands.

Among the top brands testing positive for lead were:
-L’Oreal Colour Riche “True Red” – 0.65 ppm
-L’Oreal Colour Riche “Classic Wine” – 0.58 ppm
-Cover Girl Incredifull Lipcolor “Maximum Red” – 0.56 ppm
-Dior Addict “Positive Red” – 0.21 ppm

(The Campaign for Safe Cosmetics is a coalition of women’s, public health, labor, environmental health and consumer-rights groups. Our goal is to protect the health of consumers and workers by requiring the health and beauty industry to phase out the use of chemicals linked to cancer, birth defects and other health problems, and replace them with safer alternatives.)

Read the complete news release at The Campaign for Safe Cosmetics

Tags: The Campaign for Safe Cosmetics, Cosmetic recall, lipstick, lead in lipstick, Cover Girl Incredifull Lipcolor, L’Oreal Colour Riche, L’Oreal Colour Riche

Children's HealthCare heats up Capitol Hill

Democrats are not predicting victory in the main event in Congress this week - their push to override President Bush’s veto of a children’s health care bill. But they believe they’re winning nonetheless.

Even though Republicans expect to narrowly sustain President Bush’s veto in a vote set for Thursday, Democrats say they have managed to put Republicans back on their heels, scrambling to explain their opposition to a popular health program.

“This is a defining moment for the Republican Party, in my opinion,” Representative Steny H. Hoyer of Maryland, the majority leader, said on “Fox News Sunday.” “They’re going to say whether they are, in fact, a compassionate community, or whether they’re going to unthinkingly follow the dictates of their party and their president against the program that the overwhelming majority of their constituents are for.”

Read more at the Newyork Times

Tags: HealthCare, Children's HealthCare, children’s health care bill

Soy Milk Chocolate Bars Recalled

FOR IMMEDIATE RELEASE -- Elizabeth, NJ -- October 10, 2007 -- Vintage Chocolates Inc. of Elizabeth, New Jersey is recalling 4,455 bars of soy milk chocolate, because it may contains undeclared traces of milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this soy milk chocolate bar.

The Soy Milk chocolate bar was distributed in the following states: New York, New Jersey , Pennsylvania, Connecticut, New Hampshire, Massachusetts, Vermont, Wisconsin., New Mexico, Virginia, Washington, Oregon, California, Michigan, Ohio. This product was available through retail stores and chain stores and through our web site: echocolates.com.

The bar is presented in a beige cardboard package of 3.5 oz, depicting tree with a green band on top stating "43% Soy milk or 38% Soy milk". On the back of the package one would find; the following information:

UPC: 797148000398.

There is one incident involving a child who developed rashes that has been confirmed to date.

This incident triggered an analysis of the formulation, and product analysis to determine the origin of the problem. We think the traces of milk came from a cross contamination issue during processing. We are currently designing a new process to specifically tackle this problem.

Consumers who have purchased The Vintage Plantation Soy milk bars are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at: 1-800-207-7058.

Tags: Vintage Chocolates, soy milk chocolate, echocolates, chocolate recall

FDA Commissioner Meets with Chinese Minister of Health and Discusses how they can work together to beat disease, ensure safe food, effective drugs

Food and Drug Administration Commissioner Andrew C. von Eschenbach, M.D., met this week with leading officials in China, as part of a series of negotiations launched by Health and Human Services Secretary Mike Leavitt with Chinese counterparts on the safety of food, feed, drugs and medical devices.

The latest meeting provided another opportunity for high-ranking experts from both governments to exchange views and information about their respective efforts to protect and promote the health of their citizens.

Dr. von Eschenbach met with Dr. Zhu Chen, minister of health of the People’s Republic of China, Commissioner of China’s State Food and Drug Administration, Shao Mingli, and Vice Minister Chuanzhong Wei of the Chinese General Administration of Quality, Supervision, Inspection and Quarantine.

“Our discussions were very productive,” said Dr. von Eschenbach. “Minister Chen, Commissioner Shao and Vice Minister Wei are distinguished leaders, who are, like me, dedicated to enhancing the health of the men, women, and children we each serve, and to protecting the safety of our food supply and chain of medical and pharmaceutical products. We are all deeply committed to enhancing the health of the publics we serve.”

During the meeting, both sides framed their discussion in the context of global medical research and public health concerns, all of which the activities of their respective organizations affect.

Tags: FDA, China, USA, food safety, feed safety, drug safety, medical devices safety

ConAgra Foods Recalls All Banquet Pot Pies and Store Brand Pot Pies

ConAgra Foods Inc. recalled all its Banquet pot pies and store brand varieties Thursday after the products were linked to a nationwide salmonella outbreak. Salmonella sickens about 40,000 people a year in the U.S. and kills about 600. Most of the deaths are among people with weaker immune systems such as the elderly or very young. Salmonella poisoning can cause diarrhea, fever, dehydration, abdominal pain and vomiting. Most cases are caused by undercooked eggs and chicken.

The recall includes all Banquet pot pie varieties, including poultry and beef. The store brand not-ready-to-eat pot pie products include all varieties under the following brand names:

    --  Albertson's (sold at Albertson's);

--  Hill Country Fare (sold at HEB);

--  Food Lion (sold at Food Lion);

--  Great Value (sold at Wal-Mart);

--  Kirkwood (sold at Aldi);

--  Kroger (sold at Kroger);

--  Meijer (sold at Meijer);

--  Western Family (now discontinued; previously sold at a variety
    of small retailers)
Consumers with questions about Banquet or store brand pot pies may
call 1-866-484-8671. For more information on food safety,
consumers may reference IFIC.org.

The company included beef pot pies in the recall after initially saying only the chicken and turkey pot pies should not be eaten. ConAgra issued a consumer alert Tuesday and asked stores nationwide to stop selling the poultry pot pies, but the company stopped short of a recall until Thursday evening.

Recall information.

Tags: food recall, conagra, potpie recall, IFIC

Infant Cold and caugh medicines recalled

I do not take over the counter medicines that most of the people are used to take. The advertisements on TV make it look like that you have to have cold medicines and the likes of Tylenol to get through the day. But I have not come to need of such things. I am able to continue with little discomfort through day to day life and cold bouts. I am against any child being given these kind of medicines. But I am not an expert, I just know what works for me. I do take my vitamins.
Here is a news post from New York Times;
WASHINGTON, Oct. 11 — Major makers of over-the-counter infant cough and cold medicines announced Thursday that they were withdrawing their products from the market for fear that they could be misused. (Really?)
The withdrawal comes two weeks after safety reviewers within the Food and Drug Administration urged the agency to consider an outright ban of over-the-counter cough and cold products for children under 6. Even the industry’s main trade group, the Consumer Healthcare Products Association, recommended two weeks ago that the products not be used in infants.
continued to sell cough and cold products labeled for infants. Last week, Representative Despite the recommendation, giant drug makers like Johnson & Johnson, Wyeth and NovartisHenry A. Waxman, the California Democrat who is chairman of the House Committee on Oversight and Government Reform, sent a letter to the industry’s trade association asking why the products were still being sold.

Tags: infant cough and cold medicines, Drug recall, Healthcare

Social Networking Hits Medical and Health Care Field!

Social networking hits medical and health care field!
LAKE WORTH, Fla., Oct. 9 /PRNewswire/ -- Let's face it: If you're in the medical or health care field, your job is extremely demanding, perhaps even all-consuming. Finding a way to connect socially with others in your industry is tough, as is catching up on the latest industry news or exploring fresh career options. You simply lack the free time -- which is
why the award-winning AbsolutelyHealthCare.com (http://www.healthjobsusa.com), the largest niche health care and medical job board in America, has launched MedicalMingle.com
(http://www.medicalmingle.com).
MedicalMingle.com is a social network and virtual community where people working in or studying to enter the health care and medical fields can make friends, discuss various topics, look for jobs and job-related resources, post a resume, obtain industry news and
free professional publications, go shopping, and even date -- all without a
membership fee.
"While Absolutely Health Care serves as an excellent career-centric resource for those pursuing the medical and health care trades, we've recognized a real need for a general networking Web site for this industry," said Ken Levinson, founder of Absolutely Health Care, MedicalMingle.com's primary sponsor.
"With more of a social slant to this site, MedicalMingle.com is simply a fun -- and free -- place to go online if you're seeking to connect with others in your industry, interact either socially or professionally, and learn about what's happening in health care today. What's more, you can even use this site as a springboard for online activities like Internet dating, researching a trip, or shopping."
MedicalMingle.com is powered by ONEsite Inc.'s social network software, which offers members an efficient, secure setting in which to blog, post photos and videos, as well as create and control their own sites. One glance of MedicalMingle.com, and you'll notice a community of members who've already jumped at the opportunity to establish -- or expand --
meaningful relationships.
"There's a very positive vibe at MedicalMingle.com, which is why it's catching on and new members are joining daily," Levinson says. "Significant exchange on the blogs and message boards shows we're fostering a supportive network of talented, intelligent and interesting people."

Tags: medical and health care, medicalmingle