FDA Rejects Yet Another Diet Drug: Qnexa

Another diet pill lost its battle for approval with the Food and Drug Administration this week. The FDA denied approval for the diet drug Qnexa, developed by Vivus, located in Mountain View, California. Overall, this is the third diet drug to receive a major setback from the FDA. Last week, the agency rejected the drug Lorcaserin for causing tumors in lab rats. As noted in a prior post, earlier in October, the drug Meridia was taken off the market.

A statement on the Vivus website says the FDA is seeking more safety information from the company about Qnexa, reports The New York Times. According to the company, the FDA wants more data on the drug's possible links to birth defects and heart problems. Vivus says it can provide the FDA with the necessary information in about six weeks.

A high incidence of heart risks also caused the FDA to force Meridia off the market. Back in 1997, the popular diet drug combo fen-phen was also pulled from the market after it was found to damage heart valves.

Unfortunately for those struggling with obesity, it is a common cause of heart trouble as well. As The Times reminds us, one third of Americans are described as obese. Obesity can lead to health issues such as cancer and diabetes, as well as heart risks.

The FDA is struggling to balance the risk of these diet drugs with their efficacy. A high heart risk is not worth the relatively minor weight loss that some of these drugs provide. However, this puts the agency in a quandary according to Morgan Downey, an advocate for obese people who also consults for pharmaceutical companies. “The FDA has gotten itself into a real knot,” Downey told The Times. “They can’t approve a very effective drug and they can’t approve a modest drug.”

According to The Times, there has been no new prescription diet pill approved since Roche’s Xenical in 1999. Xenical is currently the only drug approved for long-term use in managing weight.

Related Resources:

• FDA rejects second weight-loss drug in a week (MSNBC)
• Drugs and Medical Device Recalls (FindLaw)
• FDA Warning About Meridia Diet Drug (FindLaw's Common Law)