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FDA reported possible link between sibutramine, adverse CV events
Agency, manufacturer agreed to add new contraindication for patients with history of CVD.
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The FDA has notified health care professionals that a review of additional data on sibutramine indicated an increased risk for MI and stroke in patients with a history of CVD.
Based on the review findings, the FDA requested and sibutramine (Meridia) manufacturer, Abbott, agreed to add a new contraindication to the drug label that states sibutramine should not be used in patients with a history of CVD, including history of CAD, stroke or transient ischemic attack, heart arrhythmias, congestive HF, peripheral arterial disease and uncontrolled hypertension.
In November, the FDA released early communication about an ongoing safety review of sibutramine. The agency examined cardiac events that occurred in the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk for CVD Trial (SCOUT). The study compared weight loss plus sibutramine with weight loss plus standard medical care in about 10,000 overweight/obese individuals with a history of heart disease and type 2 diabetes. Adverse CV events occurred in 11.4% of patients assigned sibutramine vs. 10% in patients assigned placebo, signaling a “higher than expected” difference, according an FDA statement.
The FDA encouraged health care professionals to discuss use of sibutramine with their patients and determine if continued use is appropriate.