FDA NEWS RELEASE
For Immediate Release: March
19, 2010
Media Inquiries: Elaine Gansz Bobo,
301-796-7567; elaine.bobo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Warns about Increased Risk of Muscle
Injury with Zocor (Simvastatin).
Highest approved dose of cholesterol-lowering medication could cause
harm to muscles
The U.S. Food and Drug Administration today warned patients and
healthcare providers about the potential for increased risk of muscle
injury from the cholesterol-lowering medication Zocor (simvastatin) 80
mg. Although muscle injury (called myopathy) is a known side effect with
all statins, today’s warning highlights the greater risk of developing
muscle injury, including rhabdomyolysis, for patients when they are
prescribed and use higher doses of this drug. Rhabdomyolysis is the most
serious form of myopathy and can lead to severe kidney damage, kidney
failure, and sometimes death.
“Review of simvastatin is part of an ongoing FDA effort to evaluate
the risk of statin-associated muscle injury and to provide that
information to the public as it becomes available,” said Eric Colman,
M.D., Deputy Director of FDA’s Division of Metabolism and
Endocrinology Products (DMEP). “It’s important for patients and
healthcare professionals to consider all the potential risks and known
benefits of any drug before deciding on any one therapy or dose of
therapy.”
Simvastatin is sold as a single-ingredient generic medication and as
the brand-name Zocor. It also is sold in combination with ezetimibe as
Vytorin, and in combination with niacin as Simcor.
FDA’s review of new information on the risk of muscle injury is
derived from clinical trials, observational studies, adverse event
reports, and prescription use data. The agency also is reviewing data
from the SEARCH (Study of the Effectiveness of Additional Reductions in
Cholesterol and Homocysteine) trial, which evaluated major
cardiovascular events, such as heart attack, revascularization and
cardiovascular death, in patients taking 80 mg compared to 20 mg of
simvastatin. SEARCH also included data on muscle injury in patients
taking simvastatin.
FDA is committed to informing the public about its ongoing safety
review of drugs and will update the public as soon as the review of
simvastatin is complete.
For further information on this safety issue:
Ongoing
Safety Review of High-dose Zocor (simvastatin) and Increased Risk of
Muscle Injury
Previous
FDA safety communications on the increased risk of muscle injury with
simvastatin in patients who concurrently take other medications
