[e-drug] Non-cerevastatin rhabdomyolysis deaths and cases

[Sidney Wolfe <swolfe@citizen.org>]

E-drug: Non-cerevastatin rhabdomyolysis deaths and cases
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WASHINGTON, D.C. - The U.S. Food and Drug Administration
(FDA) should strongly warn doctors and patients about the potential
for a class of cholesterol-lowering drugs known as "statins" to
cause potentially life-threatening muscle damage, Public Citizen said
today.
 
In a petition filed with the FDA, Public Citizen noted 385 FDA
reports from October 1997 to December 2000 of patients taking
statins who had sustained muscle damage (rhabdomyolysis)
associated with the drug, most of whom were hospitalized.
Included were 52 people who died from statin-related muscle
damage during that time, records show. A total of 81 people have
died from statin-related rhabdomyolysis since the time the drugs
first were marketed in 1987. Those reports don't include deaths
and injuries associated with Baycol, a cholesterol-lowering drug
recently pulled from the market. Increased awareness of the early
symptoms of muscle damage and stopping the use of the statins
will prevent the progression of the adverse reaction to
hospitalization and death.
 
The drugs that should be subject to increased warnings include
Liptor, Lescol, Mevacor, Pravachol and Zocor, the petition says. The
FDA should add a "black box" warning to the professional package
insert - a warning that is in bold type and surrounded by a black
box to make it stand out. Also, the agency should require additional
warnings in bold type be added to these products' package inserts,
the petition says. The FDA also should require that an
FDA-approved medication guide be distributed to patients filling
statin prescriptions, advising them to immediately stop using the
drug if they experience muscle pain, tenderness, weakness or
tiredness. Finally, drug companies should be required to send "Dear
Doctor" letters to all U.S. physicians about the risk of muscle
damage due to statins. 
 
"Labeling on statins is inconsistent and dangerously inadequate,"
said Dr. Sidney M. Wolfe, director of Public Citizen's Health
Research Group, which filed the petition. "Most people taking these
drugs aren't aware that they could sustain serious muscle damage
and could even die from taking these drugs."

The warnings are particularly necessary in light of the recent release
of a government report recommending that 23 million more people
take cholesterol-lowering drugs -- triple the current number. A copy
of the petition is available at
www.citizen.org/hrg/publications/1588.htm

Sidney M.Wolfe M.D.
Director, Public Citizen's Health Research Group
1600 20th St. NW, Washington, DC. 20009
202 588-7735  fax 588-7796
e-mail swolfe@citizen.org
Web site: www.citizen.org/hrg


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