Summary
A new study states that Bayer AG was too slow in withdrawing Baycol, a cholesterol-lowering medicine called a statin, from the market. Older people who are diabetic may develop a muscle disorder when they combine statins with fibrates. Fibrates, which lower triglycerides, can also be dangerous when taken alone. Dr. David Graham, Associate Director of Science in the FDA's Office of Drug Safety, told a Senate panel that Bextra and AstraZeneca PLC's statin drug Crestor are also unsafe. Muscle pain, weakness, fever, dark urine, nausea or vomiting, may be symptoms of a muscle disorder.
Original source:
http://www.canada.com/health/story.html?id=2d4c188b-d412-42c7-a225-3fab991a544e
Details
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New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the U.S. federal Food and Drug Administration to protect Americans from such risks.
- This time it's Baycol, a cholesterol-lowering medicine that Bayer AG withdrew in 2001 after some people who took it developed a severe and sometimes fatal muscle disorder.
- The study concludes that today's top-selling cholesterol-lowering drugs, called statins, are very safe, but could be risky when taken with other drugs called fibrates by older people with diabetes.
- It also reveals that fibrates alone can be dangerous.
- Its editors call for a new, independent office separate from the FDA to monitor drugs after they're on the market.
- Merck & Co. and the FDA have been accused of moving too slowly to stop sales of the arthritis drug Vioxx, which Merck withdrew in September after revealing it raised the risk of heart attacks and strokes.
- Some scientists claim that painkillers similar to Vioxx, especially Pfizer Inc.'s Bextra, also carry risks.
- On Thursday, Dr. David Graham, associate director of science in the FDA's office of drug safety, told a Senate panel that the FDA was incapable of protecting the public, and that dangerous drugs are being sold now.
- Crestor wasn't part of the new study that Graham and nine other government and private scientists published Monday because the drug was only approved in August 2003 and their study started in 2001, just after Bayer withdrew Baycol.
- They checked records from 11 large health insurance companies on more than 250,000 statin-users from 1998 to 2001.
- Statins lower LDL or "bad" cholesterol, and fibrates lower a different kind of fat in the blood, triglycerides.
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