Three diet drug makers will be looking for a second review from the U.S. Food and Drug Administration in an effort to get approval for their weight-loss pills.
The Associated Press reported that the FDA rejected three prescription diet pills in the last three years and it has raised concerns as to whether any weight-loss drug can actually win approval in the United States.
According to The AP, it has been 13 years since the FDA approved a new prescription weight-loss drug.
Here are the three drugs that are seeking a second review as reported by The AP:
1. Qnexa is a combination of two prescription drugs Phentermine and Topiramate. For years, Phentermine has been used to fight obesity. Topiramate has been used as an anti-convulsant as with epilepsy patients. Topiramate is sold by Johnson & Johnson as Topamax, which is said to make patients feel more satisfied. The AP said that the FDA rejected the drug in October 2010, expressing concerns about higher heart rate and birth defects in women who become pregnant. A panel of advisers to the FDA this week, recommended Qnexa's approval if Vivus Inc., from California, conduct a follow-up study to ensure the drug doesn't cause heart problems.
2. Contrave is also a mixture of two already existing medications and is created by Orexigen Therapeutics Inc., a pharmaceutical company based out of California. The pill has a mixture of the antidepressant ingredient in Wellbutrin and the anti-smoking drug bupropion. With Contrave, the FDA is also worried about heart safety concerns and is requiring that the company conduct a 10,000-patient study of cardiovascular health. The study should be done by 2014, according to The AP.
3. Lorcaserin is a new diet pill that is being manufactured by Arena Pharmaceuticals, which is also California based. This appetite suppressant adjusts the chemicals in the brain and helps to reduce hunger. It uses a new type of ingredient to stimulate serotonin receptors located in the hypothalamus, and controls appetite, according to its Web site. The AP reported that Lorcaserin has faced the most severe safety questions from FDA and that the drug was rejected in 2010. This was after concerns were raised about cancerous tumors seen in rats given the drug.