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WASHINGTON - A cholesterol-lowering drug taken by 700,000 Americans - Bayer's Pharmaceutical's Baycol - was pulled off the market Wednesday because of muscle destruction linked to 31 U.S. deaths and at least nine more fatalities abroad.
Baycol is one of an extraordinary popular family of drugs called statins that dramatically lower cholesterol and reduce patients' risk of heart attacks. Yet every statin has been linked to very rare reports of the muscle side effect called rhabdomyolysis.
The millions of Americans who take any of five other statins sold here should not panic, Food and Drug Administration physicians said.
Baycol has been linked to significantly more fatal cases than its competitors, said FDA's Dr. John Jenkins. So, he said, there are no plans to strengthen existing warnings or take other action against the other statins - Mevacor, Pravochol, Zocor, Lescol and Lipitor.
Still, people suffering muscle pain who take any of the statins should report it to their physicians, because they may need a lower dose or a change in medication, Jenkins said.
Baycol is the 12th prescription drug to have been taken off the U.S. market because of dangerous side effects since 1997. Some critics said many of those bans happened because FDA, under political pressure, had sped up drug approvals during the 1990s. Baycol was not a "fast track" drug. The agency spent 11 months reviewing it before approving it in 1997.
Rhabdomyolysis is a life-threatening condition in which muscle cells are destroyed and released into the bloodstream. It can cause severe muscle pain, most frequently in the calves and lower back - and occasionally is so severe that patients develop potentially fatal kidney damage.
Concern about Baycol has simmered for months, as British regulators banned a high dose of the drug and FDA officials debated similar steps, said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen.
Wednesday, working with FDA, Bayer announced it was stopping sales of Baycol, also called cerivastatin, in every country except Japan.
Bayer executives refused to say how many rhabdomyolsis victims they have counted worldwide. But in addition to the 31 American deaths, the FDA has reports of at least nine Baycol-related fatalities abroad.
FDA's Jenkins said he didn't know how many Baycol user have survived a rhabdomyolysis attack. But Wolfe said there have been hundreds of cases.
Baycol users should call their doctor about switching medications - and anyone who experiences muscle pain and is taking another cholesterol medicine called gemfibrozil should immediately stop the Baycol and report the pain to a doctor, FDA advised.
Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, fever, dark urine, nausea and vomiting.
Most at risk from Baycol are elderly patients, those who use higher doses, and anyone who used Baycol together with gemfibrozil. In 12 of the U.S. deaths, patients were taking both of the drugs together.
Bayer executives said they are continuing to sell Baycol in Japan because lower doses are sold there, and gemfibrozil is not on the Japanese market. Public Citizen's Wolfe said his group may write Japanese regulators to urge that Baycol's sale be stopped there, too.
Also, Wolfe said he is preparing to petition the FDA to strengthen warnings on all other statins, by requiring that every patient get a special brochure explaining the rhabdomyolysis risk.
"If people become aware early that they are developing this muscle disease, they can stop the drug" and recover, he said.
For more Baycol information, patients and doctors can contact Bayer at 1-800-758-9794 or the FDA at 1-888-INFO-FDA.
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