Cholesterol Drug Pulled off MarketAug 8, 2001 | NBC NEWS AND NEWS SERVICES Baycol, a cholesterol-lowering drug taken by 700,000 Americans, was pulled off the market Wednesday because of muscle destruction linked to at least 40 deaths around the world. But the Food and Drug Administration urged the millions of Americans who take any of the five other drugs known as statins not to panic.
EVERY STATIN has been linked to very rare reports of the muscle side effect called rhabdomyolysis, but Baycol — made by Bayer Pharmaceutical — has been linked to significantly more fatal cases than its competitors, said the FDA’s Dr. John Jenkins.
There are no plans to strengthen existing warnings or take other action against the other statins — Mevacor, Pravachol, Zocor, Lescol and Lipitor. Still, people suffering muscle pain who take any of those statins should report it to their physicians, because they may need a lower dose or a change in medication, Jenkins said.
Baycol users are advised to call their doctors about switching medications. Statins, which are taken by 8 million Americans, have revolutionized the treatment of high cholesterol. They have been shown to lower the risk of a heart attack by one-third.
“The overall benefit greatly outweighs the risks, as long as patients and their physicians are on the lookout for possible complicating issues of these drugs,” said Dr. Robert Bonow of Northwestern Memorial Hospital in Chicago.
Bayer executives refused to say how many rhabdomyolysis victims they have counted worldwide. But in addition to 31 deaths in the United States, the FDA has reports of at least nine Baycol-related fatalities abroad.
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 the condition is so severe that patients develop potentially fatal kidney failure.
Philip Ebel of North Carolina experienced the painful complication and was hospitalized for 10 days.
“I felt like I had been thrown out of a car, every muscle in my body hurt,” he recalled. “I think it was a very close call; I think they just caught it in time.”
In addition to muscle pain, symptoms of rhabdomyolysis include weakness, tenderness, fever, dark urine, nausea and vomiting.
Baycol is the 12th prescription drug taken off the U.S. market for dangerous side effects since 1997.
Some critics said many of those bans happened because the FDA, under political pressure, had sped up drug approvals during the 1990s. But Baycol was not a “fast-track” drug: The agency spent 11 months reviewing it before approving it in 1997.
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.
Bayer cooperated in the FDA action Wednesday, announcing it would stop sales of Baycol, also called cerivastatin, in every country except Japan.