FDA Initial Review Finds 'Significant' Results in New Weight-Loss Drug

Diet pill Qnexa seems safe and effective, FDA reports.

ByABC News
July 12, 2010, 5:32 PM

July 13, 2010— -- An initial review has found the diet pill Qnexa to be safe and effective, according to a U.S. Food and Drug Administration report released this morning.

However, the FDA's look into two previous studies involving Qnexa found a high rate of participants who dropped out due to adverse effects. Some participants taking a high dose of the pill lost an average of 10 percent of their starting body weight.

According to the report, 18 percent of participants taking a high dose withdrew from trials after experiencing mild side effects such as tingling of the hands and feet, headache and constipation. And, around 40 percent of all participants either taking high or low doses of Qnexa did not complete the study for various reason.


"Until you get into the nitty gritty of why did those people take the drug for an entire year, I worry that there was some side effects in this group that were missed," said ABC News' Senior Health and Medical Editor, Dr. Richard Besser on Good Morning America.

The FDA will more thoroughly review Thursday the efficacy and safety of Qnexa, one of three new weight-loss drugs.

Experts hope Qnexa, and the other drugs, Lorcaserin and Contrave, will provide effective weight-loss without the dangerous side effects that doomed other drugs, such as Fen-phen, Meridia and Alli. Fen-phen was pulled from the market in 1997 after it was linked to a thickening of the heart valve. Meridia was pulled from the European drug market in 2009, and the FDA recently warned consumers about Alli's link to severe liver damage.

"It's shown a 10 to 15 percent weight-loss in patients, which is very impressive," said Dr. Ken Fujioka, director of the Scripps Clinic Center for Weight Management in San Diego. He is also on the advisory committee for Vivus, the company that makes Qnexa, as well as on the advisory committees for the companies that make Lorcascerin and Contrave.

"This drug isn't something new," said Besser. "It's a combination of two drugs that have been on the market for many years."

Qnexa contains the amphetamine phentermine -- one half the ingredients of the popular combination diet pill Fen-phen, ultimately pulled by its manufacturer Wyeth because of its link to heart damage.

Fujioka said although it proved dangerous in the combination, there were no safety issues with phentermine by itself.

According to Vivus, Inc., the company that makes Qnexa, phentermine helps suppress a person's appetite, while the other ingredient, the anti-convulsant topiramate, makes a person feel more satiated.

Some experts though, questioned the safety of a combination pill that appears to show striking similarities to previously recalled drugs.

"Whether any drug will become another Fen-phen is hard to predict," said Dr. Gerard Mullin, associate professor of medicine at the Johns Hopkins School of Medicine. "Every time we see a drug recalled, none were predictable, but it seems that similar classes of drugs can have inherent problems."