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Sibutramine Use Contraindicated in Patients With History of CVD, Says FDA
Agency Continues to Assess Increased Heart Attack, Stroke Risks Linked to Weight-loss Drug
By News Staff
European Union Bans Use of All Anti-obesity Drugs Containing Sibutramine
According to the Committee for Medicinal Products for Human Use, doctors should no longer prescribe, and pharmacists should no longer dispense, products containing sibutramine.
Abbott Laboratories, which manufactures and distributes sibutramine under the brand names Ectiva, Raductil, Reductil and Sibutral in Europe, said in a Jan. 21 press release that despite its belief that "sibutramine has a positive benefit/risk profile when used appropriately in the approved patient population," the company would suspend its marketing of these products.
"We believe there are many patients who benefit from sibutramine and respectfully disagree with the committee's opinion and the recommendation to suspend the medicine," said Eugene Sun, M.D., Abbott's VP of global pharmaceutical research and development. "However, we will act promptly to comply with the committee's recommendation."
The marketing authorization for all medications containing sibutramine has been suspended in more than two dozen European countries, including France, Germany, Spain and the United Kingdom.
- coronary artery disease (myocardial infarction, angina);
- stroke or transient ischemic attack;
- heart arrhythmias;
- congestive heart failure;
- peripheral arterial disease; or
- uncontrolled hypertension.
According to FDA officials, physicians should regularly monitor the blood pressure and heart rate of patients using sibutramine. If sustained increases in blood pressure and/or heart rate are observed, use of the drug should be discontinued.
The FDA also said the weight-loss medication should be discontinued in patients who do not lose at least 5 percent of their baseline weight within the first three to six months of treatment because continued use is unlikely to be effective and exposes patients to unnecessary risk.
In a study of 10,000 people, cardiovascular events occurred in 11.4 percent of patients using sibutramine compared with 10 percent of patients taking a placebo. The FDA said the difference was higher than expected and indicated that sibutramine was associated with an increased cardiovascular risk. Furthermore, the increased risk for cardiovascular events with sibutramine occurred only in patients with a history of cardiovascular disease.
After the FDA completes its review of additional safety data -- which is expected to be submitted to the FDA by Abbott in March 2010 -- and other relevant information related to sibutramine's potential benefits and risks, the agency will convene an open public advisory committee meeting to discuss the drug's benefit/risk profile and determine if additional regulatory actions should be taken.
FDA, Manufacturers Advise Physicians of Actions Involving Various Drugs
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