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FDA Investigating Possible Link Between Sibutramine and Cardiovascular Events
The FDA has issued an early communication regarding a possible increased risk for adverse cardiovascular events associated with sibutramine (Meridia), a prescription drug used to manage obesity.
A postmarketing study was conducted in some 10,000 obese patients with stable heart disease or type 2 diabetes plus another risk factor. Preliminary findings show more cardiovascular events occurred in patients who took sibutramine compared with placebo (11.4% vs. 10.0%).
Pending further data analysis, the FDA recommends following current labeling instructions to avoid the drug in patients with histories of coronary artery disease, congestive heart failure, arrhythmia, or stroke. In addition, the notice says, "healthcare professionals should continue to evaluate the benefits and risks of sibutramine, taking into account individual patient medical histories."
LINK(S):
FDA early communication (Free)
Sibutramine prescribing information (Free PDF)
Published in Physician's First Watch November 23, 2009
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