MEDDESKTOP

Friday, August 24, 2007

West Nile Virus rampant in Canadian Prairies

The number of cases of West Nile virus on the Prairies has exploded. And some experts are warning the worst is yet to come.The latest figures show at least 386 Canadians have been infected. In Manitoba, the number of cases has doubled to 213. That's almost twice as many as the figures for the entire country last year.Of the new cases in Manitoba, 18 were identified by Canadian Blood Services routine screening. The donated blood units were discarded as planned.Two West Nile virus-related deaths were reported in Manitoba earlier this month; West Nile was the likely cause of death in one of the cases and is suspected in the other.Many of the cases begin identified now were like contracted weeks ago. Peak exposure to west Nile is late July to mid-August and the infection can take up to three weeks to surface.

West Nile Virus rampant in Canadian Prairies

FDA Approves Updated Warfarin (Coumadin) Prescribing Information

The U.S. Food and Drug Administration announced today the approval of updated labeling for the widely used blood-thinning drug, Coumadin, to explain that people's genetic makeup may influence how they respond to the drug.

Manufacturers of warfarin, the generic version of Coumadin, are to add similar information to their products' labeling, FDA said.

The labeling change highlights the opportunity for healthcare providers to use genetic tests to improve their initial estimate of what is a reasonable warfarin dose for individual patients. Testing may help optimize the use of warfarin and lower the risk of bleeding complications from the drug.

These labeling updates are based on an analysis of recent studies that found people respond to the drug differently based, in part, on whether they have variations of certain genes.

FDA estimates that 2 million persons start taking warfarin in the United States every year to prevent blood clots, heart attacks and stroke. Warfarin is a difficult drug to use because the optimal dose varies and depends on many risk factors including a patient's diet, age, and the use of other medications.

Patients who take a dose larger than they can tolerate are at risk of life-threatening bleeding. Those who receive too low a dose are at risk of equally dangerous blood clots. Dosing is particularly important at the beginning of therapy, when problems in adjusting the dose can lead to complications such as bleeding.

Warfarin is the second most common drug – after insulin –implicated in emergency room visits for adverse drug events.

Physicians and other health care professionals who prescribe warfarin regularly check to see if the drug is working properly by ordering a test called the PT or prothrombin time that evaluates the blood's ability to clot properly. The results are measured in seconds and compared with the expected value in healthy people, known as the International Normalized Ratio or INR.

"Today's approved labeling change is one step in our commitment to personalized medicine. By using modern science to get the right drug in the right dose for the right patient, FDA will further enhance the safety and effectiveness of the medicines Americans depend on," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D.

The FDA's "personalized medicine" initiative makes use of pharmacogenomics—the science that predicts a response to drugs based upon a person's genetic makeup. This effort supports the personalized health program spearheaded by Health and Human Services Secretary Mike Leavitt.

A person's genes "encode" enzymes and differences in the sequence of a gene can cause differences in enzyme activity or sensitivity. That is why different people process the same drug differently.

One-third of patients receiving warfarin metabolize it quite differently than expected. Research has shown that some of the unexpected response to warfarin depends on a patient's variants of the genes CYP2C9 and VKORC1.

"Although genetic testing can currently identify who has these genetic variants, more studies are needed to explore the precise starting dose for these patients," said Larry Lesko, Ph.D., director of the FDA's Office of Clinical Pharmacology. "FDA has been working with other government agencies and organizations to develop such studies under the auspices of our three-year-old Critical Path Initiative, which addresses the challenges of moving promising medical products from discovery to patient use."

FDA's Critical Path Initiative has funded a research project with the University of Utah and the Critical Path Institute of Tucson, Ariz., to develop genetically based instructions for warfarin dosing. The Initiative has also facilitated meetings and planning with the National Heart, Lung and Blood Institute for a clinical trial that will study warfarin dosing based on genetic test information and is helping to pay for another clinical study being conducted by Harvard Partners that will derive personalized warfarin dosing algorithms for patients new to the drug.

The dosage and administration of warfarin must be individualized for each patient according to the particular patient's PT/INR response to the drug. The specific dose recommendations are described in the warfarin product labeling, along with the new information regarding the impact of genetic information upon the initial dose and the response to warfarin. Ongoing warfarin therapy should be guided by continued INR monitoring.

Bristol-Myers Squibb Co. of Princeton, N.J., is the manufacturer of Coumadin.

For more information see New Labeling Information for Warfarin.

FDA defines SPF, "sunburn protection factor" not "sun protection factor"

FDA Proposes New Rule for Sunscreen Products Highlights Include New UVA Rating System, Sun Warning Information
Scroll down for FDA Proposal and links.
The proposal when finalized, the proposed regulation would amend the existing OTC sunscreen rule published in 1999 that established regulations related to UVB light and mandated that OTC UVB sunscreen products be labeled with a SPF. FDA also is amending its existing 1999 rule to increase the SPF from SPF30+ to SPF50+. Previously, FDA had recognized SPF values up to 30+. Under the proposed amendment, the range would be SPF2 to SPF50+. SPF50 provides more UVB protection than lower SPF values. Additionally, the proposed rule:

revises the existing SPF (UVB) testing procedures;
allows new combinations of active ingredients; and
asks for comments on the issue of nanoparticles.

he new proposal
Consumers have 90 days in which to comment on the new proposed standards.

Manufacturers will be given 12 months to comply to the new standards once they come into force, so consumers should not expect to see the new labeling before then.
Besides this, the term "sun protection factor" will have to be replaced by the term "sunburn protection factor." in order to avoid the misconception of a user of being absolutely invincible against the sun and the ensuing false sense of security.

A dermatologist who specializes in skin cancer who practises St Petersburg in Florida, Dr James Spencer, told the New York Times the new standards are good news for consumers:

"Now when you go to the drugstore and buy sunscreen, you will finally know what you are getting."

Dr Perry Robins, President of the Skin Cancer Foundation (sponsored among others by the cosmetics industry) also welcomed the news, saying that over 90 per cent of skin cancers are caused by sun exposure and:

"We now know that UVA plays a very direct role in skin cancer comparable to that of UVB. Therefore, introducing a UVA test method will enable consumers to know how well the product protects against UVA rays as well as UVB rays."

Skin cancer is cancer that forms in the tissues of the skin. There are mainly two types, both of which usually result from exposure to sunlight. One type of cancer is when the cells that form pigment become cancerous, this is called melanoma. The other type of skin cancer develops in cells that do not form pigment and there are two types of these cells: basal (small and round cells in the base of the outer layer of skin) and squamous (flat cells on the surface of the skin).

Skin cancer is the most common form of cancer in the United States. More than 1 million new cases are diagnosed every year.

FDA Release.
FDA Proposes New Rule for Sunscreen Products Highlights Include New UVA Rating System, Sun Warning Information

The U.S. Food and Drug Administration today proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter (OTC) sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection.

"For more than 30 years, consumers have been able to identify the level of UVB protection provided by sunscreens using only sunburn protection factor or SPF values," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "Under today's proposal, consumers will also now know the level of UVA protection in sunscreens, which will help them make informed decisions about protecting themselves and their children against the harmful effects of the sun."

Sunlight is composed of the visible light that we can see, and ultraviolet (UV) light that we can not. There are two types of UV light, UVA and UVB. UVA light is responsible for tanning and UVB for sunburn. Both can damage the skin and increase the risk of skin cancer.

The proposed regulation creates a consumer-friendly rating system for UVA products designed to help consumers identify the level of UVA protection offered by a product. The FDA proposal provides a ratings system for UVA sunscreen products on a scale of one to four stars. One star would represent low UVA protection, two stars would represent medium protection, three stars would represent high protection, and four stars would represent the highest UVA protection available in an OTC sunscreen product. If a sunscreen product does not provide at least a low level (one star) of protection, FDA is proposing to require that the product bear a "no UVA protection" marking on the front label near the SPF value.

Ratings would be derived from two tests the FDA proposes to assess the effectiveness of sunscreens in providing protection against UVA light. The first test measures a product's ability to reduce the amount of UVA radiation that passes through it. The second test measures a product's ability to prevent tanning. This test is nearly identical to the SPF test used to determine the effectiveness of UVB sunscreen products.

In addition, a "Warnings" statement in the "Drug Facts" box will be required of all sunscreen product manufacturers. The warning will say: "UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen." The warning is intended to increase awareness that sunscreens are only one part of a sun protection program.

"Many consumers incorrectly believe that the only way to protect themselves from skin damage caused by the sun is to apply sunscreens," said Douglas Throckmorton, M.D., deputy director of FDA's Center for Drug Evaluation and Research. "The labeling being proposed today strengthens the existing labeling for sunscreens by educating consumers on the added importance of limiting their time in the sun and wearing protective clothing as part of a sun protection regimen."

When finalized, the proposed regulation would amend the existing OTC sunscreen rule published in 1999 that established regulations related to UVB light and mandated that OTC UVB sunscreen products be labeled with a SPF. FDA also is amending its existing 1999 rule to increase the SPF from SPF30+ to SPF50+. Previously, FDA had recognized SPF values up to 30+. Under the proposed amendment, the range would be SPF2 to SPF50+. SPF50 provides more UVB protection than lower SPF values. Additionally, the proposed rule:

revises the existing SPF (UVB) testing procedures;
allows new combinations of active ingredients; and
asks for comments on the issue of nanoparticles.

FDA is accepting comments on the new rule for 90 days until November 26, 2007. Comments must be identified with Docket No. 1978N-0038 and can be submitted electronically or in written form. Electronic submissions can be submitted at the following Web sites:

Federal eRulemaking Portal: www.regulations.gov
FDA Web site: www.fda.gov/dockets/ecomments

Wednesday, August 22, 2007

Health warning to Seniors, you might be out of Medicare Advantage

WASHINGTON, D.C. · August 03, 2007 / PRNewswire / – Three million seniors could lose their Medicare Advantage coverage, while millions more would face benefit cuts and higher out-of-pocket health care costs under legislation passed today by the U.S. House of Representatives.

Noting that 49 percent of Medicare Advantage beneficiaries have incomes of less than $20,000 per year, Karen Ignagni, President and CEO of America's Health Insurance Plans (AHIP), said the legislation would have a devastating impact on seniors' health security.

"The House bill shreds the safety net for millions of seniors who depend on Medicare Advantage," said Ignagni.

In testimony before the Ways and Means Committee last week, Peter Orszag, Director of the non-partisan Congressional Budget Office, said that Medicare Advantage enrollment would fall by 33 percent under the legislation passed today by the House.

A study from an independent researcher and former senior health care official in the Clinton Administration, Ken Thorpe, estimates that the proposed cuts would result in 3.2 million seniors losing their Medicare Advantage coverage and that Medicare Advantage would no longer be available to seniors in 22 states. Seniors in these states would have to enroll in the fee-for-service Medicare program, where they would likely receive fewer benefits and pay higher out-of-pocket costs than they do in Medicare Advantage.

AHIP also reiterated its support for strengthening the State Children's Health Insurance Program (SCHIP), which is a key element of AHIP's comprehensive proposal to cover the uninsured. AHIP has run advertisements in support of raising tobacco taxes to finance SCHIP and joined with a diverse group of national organizations to promote the program through the Health Coverage Coalition for the Uninsured.

America's Health Insurance Plans –
Providing Health Benefits to More Than 200 Million Americans

Contact Info

Mohit Ghose
(202) 778-8494

Saturday, August 18, 2007

FDA Warns on Codeine Use by Nursing Mothers

FDA Alert [8/17/2007]: FDA has important new information about a very rare, but serious, side effect in nursing infants whose mothers are taking codeine and are ultra-rapid metabolizers of codeine. These babies may be at increased risk for morphine overdose.

When physicians prescribe codeine-containing drugs to nursing women, they should inform their patients about the potential risks and the signs of morphine overdose. Nursing women taking codeine need to carefully watch their infants for signs of morphine overdose and seek medical attention immediately if the infant develops increased sleepiness (more than usual), difficulty breastfeeding or breathing, or decreased tone (limpness). Nursing mothers may also experience overdose symptoms such as extreme sleepiness, confusion, shallow breathing or severe constipation. When prescribing codeine to nursing mothers, physicians should choose the lowest effective dose for the shortest period of time and should closely monitor mother-infant pairs.

Drug metabolism is a complex process involving multiple genetic, environmental and physiologic factors. Limited evidence suggests that individuals who are ultra-rapid metabolizers (those with a specific CYP2D6 genotype) may convert codeine to its active metabolite, morphine, more rapidly and completely than other people. In nursing mothers, this metabolism can result in higher than expected serum and breast milk morphine levels. One published case report of an infant death raises concern that nursing babies may be at increased risk of morphine overdose if their mothers are taking codeine and are ultra-rapid metabolizers of the drug.
FDA News on Codeine use.

Friday, August 17, 2007

Turn your leftover IVF embryos into personalized stem-cell lines.

A biotech company offers to turn unused IVF embryos into personalized stem-cell lines.

Couples who have had children via in vitro fertilization are often left with extra embryos--and the rather difficult decision of what to do with them. Embryos can be donated to research or to other couples, destroyed, or left languishing in frozen storage. But now a California-based biotech startup is offering a new option: to use these embryos to create personalized stem-cell lines for couples or their families.

TR Blog: A New Use for Your Leftover Embryos

Thursday, August 16, 2007

Toy recalls in Japan too by Tomy

Update;

The mattel.com site does not seem to support Firefox properly. IE works fine. I have provided individual links below.

What do you do if you suspect you have a recalled toy?

The first step is for consumers to determine if they have a toy that has been affected by the recall. To do so, they can visit www.service.mattel.com (Check links Below)where they will find a complete list of each toy recalled, including color photos and toy model numbers. You can locate toy model numbers on the bottom of most recalled toys. You also can compare the images.

From there, you are prompted to fill out a form and Mattel will send them (via email or to a postal address) a color brochure with photos and toy numbers of every affected product, as well as a pre-paid mailing label for return of the products.

Once Mattel receives a consumer’s returned, affected products, Mattel will send the consumer a voucher for each affected product for the product’s original value. Vouchers may be used at most national retailers and are good toward any Mattel or Fisher-Price manufactured product.

Direct links by type of recall
Mattel Playsets with Magnet Hazard Recall
Barbie® Doll and Tanner™ Magnet Hazard Recall
Pixar Cars Sarge Lead Paint Hazard Recall
Fisher-Price Toys with Lead Paint Hazard Recall

For People without Internet access (Please inform you neighbors), or for those preferring phone support, they may call the following hotlines dedicated to the different product recalls:

“CARS” Sarge character diecast vehicle Recall Hotline: 1-800-916-4997
Fisher-Price Toy Lead Paint Recall Hotline: 1-800-916-4498
Magnet Hazard Recall Hotline: 1-888-597-6597

TOKYO, Aug 16 (Reuters) - Japanese toy maker Tomy Co. (7867.T: Quote, Profile, Research) said on Thursday it will voluntarily recall Mattel Inc. (MAT.N: Quote, Profile, Research) die-cast cars following the U.S. toy giant's massive recall of toys made in China due to lead paint.

Tomy officials were not immediately available for comment, but in a statement posted on its Web site, Tomy said its subsidiary will recall "Sarge" die-cast toy cars it imported and sold in Japan since March 1 this year.

Jiji news agency reported 2,730 Matchbox cars will be recalled.

Tomy said it has not received any reports of health hazards from customers.

Mattel, the world's largest toy maker, has recalled millions of toys made in China due to lead paint and hazards from small, powerful magnets that can be swallowed and cause injury.

Reuters News