The European Medicines Agency (EMEA) has finalised its review of the anti-obesity drug sibutramine and recommended the suspension of the marketing authorisations for the drug across Europe. The Committee for Medicinal Products for Human Use (CHMP) concluded that the risks associated with the use of sibutramine outweigh its benefits.
The review was initiated because 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 enrolled nearly 10,000 overweight and obese patients with known or high risk for cardiovascular disease. The trial was designed to determine the impact of weight loss with sibutramine on cardiovascular problems in these patients. Most of the patients in the SCOUT study would not normally have been prescribed sibutramine, as it is contra-indicated in patients with cardiovascular disease. Nevertheless the Committed considered that in clinical practice an increased risk can also apply to patients for whom sibutramine can be prescribed since obese and overweight patients are likely to be at risk of cardiovascular disease.
The Committee also noted that the data from available studies show that the weight loss achieved with sibutramine is modest and may not be maintained after stopping. The CHMP was therefore of the opinion that the benefit of sibutramine as a weight-loss aid do not outweigh the cardiovascular risks.
The suspension will remain in place until the company can provide data that are sufficient to allow the identification of a group of patients for whom sibutramine’s benefits clearly outweigh its risks. The Committee’s recommendation for the suspension of the marketing authorisations has been forwarded to the European Commission for the adoption of a decision.
The following recommendations are provided for healthcare professionals and patients:
• Doctors should stop prescribing sibutramine-containing medicines to obese or overweight patients. They should also review the treatment of patients currently treated with the medicine.
• Pharmacists should no longer dispense sibutramine-containing medicines.
• Patients who are taking a medicine containing sibutramine to help them to lose weight should make an appointment with their doctor at the next convenient time to discuss alternative measures to lose weight. Patients who wish to stop treatment before seeing their doctor can do so at any time.
• Patients who have any questions should speak to their doctor or pharmacist.
In the United States, the FDA has requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label stating that sibutramine is not to be used in patients with a history of cardiovascular disease, including (from source):
- History of coronary artery disease (e.g. heart attack, angina)
- History of stroke or transient ischemic attack (TIA)
- History of heart arrhythmias
- History of congestive heart failure
- History of peripheral arterial disease
- Uncontrolled hypertension (e.g. > 145/90 mmHg)
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