FDA Requests Stronger Warning Label for Weight Loss Drug
by Jennifer Bunn, RNMeridia, a popular weight loss drug, must now come with a stronger warning on its label, following the results of the Scout trial, a study of 10,000 individuals taking Meridia (sibutramine) to manage their weight. The participants of the study all had type 2 diabetes or cardiovascular disease. The results of the Scout trial showed an increase in the risk of myocardial infarction (heart attack), stroke, and other cardiovascular problems.
Following the release of the results of the trial, Europe has banned the sales of medication containing sibutramine, including Meridia, one of the most popular. In the US, however, it has only been recommended that the drug be labeled with the stronger warning. Patients who have a history of the following conditions should not take Meridia or any other drugs containing sibutramine:
- Previous heart attack
- Previous stroke
- Heart arrhythmia
- Coronary artery disease
- Peripheral artery disease
- Uncontrolled hypertension (high blood pressure)
Meridia is prescribed for patients with a BMI of 30 or more, or a BMI of 27 with risk factors for cardiovascular disease.
Source: Europe Bans Meridia Diet Pill; FDA Strengthens Warning
