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April 11, 2010 – FDA is alerting healthcare professionals that Sibutramine [Meridia] is contraindicated in patients with a history of cardiovascular disease because the drug increases their risk of heart attack and stroke. Sibutramine [Meridia] is used to manage obesity.
Based on this information, Sibutramine [Meridia] is now contraindicated in patients with a history of cardiovascular disease, including coronary artery disease, stroke or transient ischemic attack (TIA), cardiac arrhythmias, congestive heart failure, peripheral arterial disease, or uncontrolled hypertension. Healthcare professionals should regularly monitor the blood pressure and heart rate of patients using Sibutramine [Meridia] and discontinue the drug if there are sustained increases in these measurements.
They should also discontinue Sibutramine [Meridia] in patients who do not lose at least 5 percent of their baseline body weight within the first three to six months of treatment, because further treatment is not likely to be effective and exposes the patient to unnecessary risk. Patients using Sibutramine [Meridia] should talk with their healthcare professional about whether to continue using the drug.
It is noteworthy that the European Agency for Medicinal Products (EMEA) earlier this year already concluded that the risks of Sibutramine containing medicines, previously on the market in Europe as Reductil, Reduxade, and Zelium, are greater than their benefits and recommended the suspension of marketing authorisations for these medicines across the European Union. The Agency said that doctors should no longer prescribe, and pharmacists should no longer dispense the medicine.
This action in the European Union was taken based on the data from the Sibutramine Cardiovascular Outcome Trial (SCOUT) showed an increased risk of serious, non-fatal cardiovascular events, such as stroke or heart attack, with sibutramine compared with placebo. The SCOUT trial, in which nearly 10,000 patients were enrolled for up to six years, was designed to determine the impact of weight loss with sibutramine on cardiovascular problems in a large group of overweight and obese subjects with known or high risk for cardiovascular disease.
The American Food and Drug Agency (FDA), on the other hand, notified health care professionals that its review of additional data indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine. The decision come after the agency’s November 2009 Early Communication about an ongoing safety review of sibutramine, marketed as Meridia by Abbott, which has agreed to add the stronger warnings. Based on the serious nature of the review findings, the agency requested and the manufacturer – Abbott – agreed to add a new contraindication to the drug’s label stating that sibutramine is not to be used in patients with a history of cardiovascular disease, including a history of: coronary artery disease (eg, heart attack, angina), stroke or transient ischemic attack (TIA) heart arrhythmias, congestive heart failure, peripheral arterial disease; and uncontrolled hypertension.