FDA Panel Says “No” to New Weight Loss Drug Combo

FOX 6 Good Day Alabama, 26 July 2010There were high hopes for the approval of a new weight loss pill called Qnexa.  Those hopes were dashed on July 16 when the FDA review panel voted 10 to 6 against it. The FDA could still approve the new drug against the panel's recommendation but it is unlikely.

Not Really New. Qnexa is not really a new drug. It's a combination of two approved drugs combined into one. Phentermine lowers the appetite and is already approved for weight loss. The other half of Qnexa is topiramate - a drug now approved to treat seizures.  Researchers discovered that topiramate increases satiety so people don't get hungry as quickly after a meal. Together, these two drugs can help people lose more weight than just diet and exercise alone.

FDA Weight Loss Requirements for Weight Loss Drugs:

  • The group getting the weight loss drug must lose an average of 5% more weight than the group getting the placebo (the sugar pill).
  • The group getting the weight loss drug must lose at least 5% of their beginning body weight over one year.

But drugs companies have to show that a new drug is also safe before the FDA will approve it. Some of the experts on the panel took issue with the short time period of the research.  The researchers studied the drug for one year. The weight loss was impressive - an average of 13% to 15%.  Those who voted "no" cited the short follow-up period and the possible side effects as the reasons for their vote:  

Possible Side Effects of Qnexa:

  • depression
  • anxiety
  • sleep disorders
  • attention
  • memory
  • language and other cognitive disorders
  • metabolic acidosis
  • increased heart rate
  • fetal malformation

The experts who voted for its approval stressed the need for an effective weight loss drug and that Qnexa helps increase weight loss more than the other drugs now available.

Be sure to talk with your doctor if you feel that you need some help from a weight loss drug. Your doctor can help you decide if a weight loss drug is right for you and, if so, which one will be the safest and most helpful. Here is a list of the major medications that the FDA has approved to help with weight loss. Diet and exercise are still very important. These drugs will not work well if you don't make some healthy changes to your diet and physical activity.

 Drugs Now Approved For Weight Loss:

  • Meridia (Sibutramine)
  • Adipex (Phentermine)
  • Xenical and Alli (Orlistat)

 These drugs also help people lose weight but the extra weight loss is usually modest - usually 5 to 7 pounds. Both Meridia and Adipex work by lowering your appetite. There are other appetite suppressants out on the market as well. Xenical works by blocking the absorption of about 1/3 of the fat you eat. One of the major side effects of Xenical is urgent diarrhea - particularly if they eat too much fat at one time. You can get Xenical at half strength over-the-counter as "Alli". I recommend that you let your doctor know if you decide to try it.

Remember, researchers study weight loss drugs in with people who are also on a diet and exercise program while on the drug. There are no magic bullets for weight loss - yet. Obesity experts tend to look at diet and exercise as an important first step in weight loss with diet drugs as an added help in losing weight and keeping it off.

Beth Kitchin, MS, RD
Assistant Professor, Nutrition Sciences
University of Alabama at Birmingham