Nearly two weeks after a popular cholesterol-lowering drug was pulled off the market for causing deadly muscle destruction, a consumer group charged that five similar medications have killed an additional 81 people.
Public Citizen petitioned the government to force manufacturers to give special warning brochures to the millions of Americans who take those medicines -- statins -- telling them to quit the pills at the first sign of muscle pain or weakness.
Statins dramatically lower cholesterol and reduce patients' risk of heart attacks.
"Most people taking these drugs aren't aware that they could sustain serious muscle damage and could even die," Dr. Sidney Wolfe of Public Citizen's Health Research Group said Monday.
"Serious muscle and kidney damage, and potentially death, may be averted only if the patients taking statins stop the drugs at the first sign of muscle pain or weakness," Wolfe wrote the Food and Drug Administration Monday.
The FDA disputed Wolfe's death count, saying its own investigation last year uncovered just 18 deaths that could be linked to the five statins on the U.S. market -- Lipitor, Mevacor, Pravachol, Zocor and Lescol.
But the agency will consider Wolfe's request for stiffer warnings.
Pfizer Inc. already has asked the FDA to approve a brochure written in layman's language that would accompany every bottle of the top-selling statin Lipitor, explaining the risk.
Wolfe's petition comes almost two weeks after one statin, Baycol, was pulled off the market when the FDA linked it to 31 U.S. deaths from a side effect called rhabdomyolysis. That's a rare but life-threatening condition in which muscle cells are destroyed. In severe cases, it leads to kidney failure.
Every statin has been linked to rare reports of a muscle side effect, and their labels carry that warning.
Wolfe analyzed FDA records to uncover 772 cases of rhabdomyolysis since 1997 among the six statins sold in this country. Half -- 387 cases -- were caused by Baycol alone, explaining why Bayer pulled it off the market.
But Wolfe said he found another 385 rhabdomyolysis cases among users of the other five statins still sold, including 81 deaths dating back to 1987, when the first of those drugs hit the market.
That's still a rare risk, considering 8 million Americans are estimated to use statins. But Wolfe argues that severe muscle destruction and death are preventable if patients are aware of the early warning signs.
He urged the FDA to put stronger warnings on the statins' labels, to write every U.S. physician telling them about the risk, and to mandate that every patient get a brochure with each bottle telling them to stop the pills and call a doctor if they suffer muscle symptoms.
A closer look at the FDA's reports shows duplicates and patients who actually died of other causes, leading federal health officials to link just 18 rhabdomyolysis deaths to statins during an investigation last year, said FDA's Dr. John Jenkins.
Merck & Co., maker of Zocor and Mevacor, says it provides Zocor users a layman's explanation of the muscle side effect on its Internet site.
Bristol-Myers Squibb is seeking to capitalize on Baycol's departure with full-page newspaper ads of Pravachol that mention the muscle risk, but company spokesmen didn't return calls seeking comment Monday.
Lescol-maker Novartis maintained the risk is small and that patients are appropriately warned.