Summary
The consumer watchdog group Public Citizen said it demands federal regulators to order the painkillers Bextra and Celebrex removed from U.S. pharmacies. The two drugs are currently being reviewed after recent studies showed they might lead to heart attacks. Makers of a similar drug Vioxx voluntarily stopped selling their pills late last year.
Original source:
http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=7411092
Details
In a formal petition to the U.S. Food and Drug Administration, Public Citizen said the two drugs' potential to cause heart attacks and strokes outweighed any possible benefit.
The letter, a copy of which was obtained by Reuters, is the latest action following a series of warnings over heart problems connected to both prescription and over-the-counter painkillers.
Merck Inc. pulled its arthritis drug, Vioxx, from the market in September after a study showed its doubled the risk of heart attack and stroke.
Last month, the National Institutes of Health halted two studies involving Celebrex and naproxen, a nonprescription painkiller sold as a generic and under several brand names, including Bayer AG's Aleve and Roche AG's Naprosyn.
Pfizer has kept Celebrex on the market but agreed to suspend consumer advertising.
It also placed a note on Bextra warning of increased risk in patients who have just had heart bypass surgery.
The FDA has called on doctors to limit prescribing of Celebrex and Bextra, and an FDA advisory panel of outside experts plans to meet for an unusual 3-day meeting to discuss the entire class of drugs.
In its letter sent Monday, Public Citizen said Pfizer's drugs have not been proven any safer than older non-steroidal, anti-inflammatory painkillers, known as NSAIDs, like aspirin or naproxen.
Public Citizen researchers analyzed results from 14 randomized trials involving all drugs in the class that includes Celebrex and Bextra -- known as Cox-2 inhibitors.
Arcoxia is approved in the European Union, but the FDA rejected the experimental
drug in October, requesting more data.
Novartis pulled its application for EU approval in November, saying it would provide more data, and has said it is working to get the drug approved in the United States.
About the author: Mike Adams is a natural health researcher, author and award-winning journalist with a strong interest in personal health, the environment and the power of nature to help us all heal He has authored more than 1,800 articles and dozens of reports, guides and interviews on natural health topics, and he has authored and published several downloadable personal preparedness courses including a downloadable course focused on safety and self defense. Adams is an honest, independent journalist and accepts no money or commissions on the third-party products he writes about or the companies he promotes. In 2010, Adams created TV.NaturalNews.com, a natural living video sharing site featuring thousands of user videos on foods, fitness, green living and more. He also founded an environmentally-friendly online retailer called BetterLifeGoods.com that uses retail profits to help support consumer advocacy programs. He's also a noted pioneer in the email marketing software industry, having been the first to launch an HTML email newsletter technology that has grown to become a standard in the industry. Adams is currently the executive director of the Consumer Wellness Center, a 501(c)3 non-profit, and pursues hobbies such as martial arts, Capoeira, nature macrophotography and organic gardening.
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Thursday, February 03, 2005
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