The third diet drug under FDA review in 2010, Contrave, has failed tests for safety and effectiveness. Made by Orexigen Therapeutics, Contrave is a combination of the antidepressant drug bupropion (Wellbutrin) and the anti-addiction opioid drug naltrexone (Revia/Depade/Vivitrol).
The primary concern for the FDA was that patients taking Contrave lost just 4.2% more body weight than the placebo group in Orexigen’s clinical trials, just shy of the 5% benchmark set by FDA guidelines.
The FDA is also concerned, however, about the risk of cardiovascular problems associated with similar diet drugs like sibutramine (Meridia), which was recently taken off the market due to increased risk of heart attack and stroke.
FDA researchers were especially concerned that Orexigen intentionally enrolled very few clinical trial patients who were elderly or had previous heart problems. Such exclusion would make the drug look safer than it really is, since most drug-related heart attacks occur in these groups.
Contrave’s negative review comes just after the FDA’s October rejection of diet drugs Qnexa and Lorcaserin. Qnexa met the weight loss benchmark, but was deemed unsafe due to associated heart problems and birth defects. The FDA stopped the approval process for Lorcaserin after testing in rats produced cancerous tumors.
If you have suffered a heart attack, stroke, or other adverse effect from weight loss medication, please contact us today to get in touch with an experienced pharmaceutical injury attorney in your area. You may be entitled to money damages for your injury or illness.