The Food and Drug Administration Tuesday approved Qsymia, a combination of the stimulant phentermine and the anti-seizure drug topiramate extended-release, to help obese and overweight people lose weight. But our medical advisers say the pill should be avoided because it can cause several serious side effects.
According to the evidence submitted to the FDA, Qsymia appears to help people drop a few pounds. In studies, obese and overweight people who took Qsymia for one year lost 3.5 to 9.4 kg more than those who took a placebo. But that small benefit is probably not worth the risks of birth defects, heart attacks, and strokes. In fact, two years ago the FDA rejected the drug, then called Qnexa, due to these concerns, and it is not clear why the FDA reversed course this time, since those side effects are still an issue.
The drug also carries a warning that it can increase heart rate and should not be used by people who have heart disease or have suffered a stroke. Due to the heart concern, Vivus, the manufacturer of Qsymia, is required to conduct a study to determine whether the drug poses a risk of major cardiovascular problems, including heart attack and stroke. Also too, pregnant women should not take Qsymia because it increases the risk of their children being born with a cleft lip or palate.
Qsymia will only be available through specially certified pharmacies under a Risk Evaluation and Mitigation Strategy, or REMS, which is intended to inform doctors and patients about the possibility of birth defects.
"The very idea that a post marketing risk evaluation strategy was a condition required by the FDA for approval of this combination drug product seems like putting the cart ahead of the horse," says Marvin Lipman, M.D., chief medical adviser for Consumer Reports. "Such a study may very well result in preventable mortality and morbidity, a high price to pay in exchange for a few pounds of flesh."
Qsymia contains several additional warnings, including that it can increase the risk of glaucoma, kidney stones, mood problems such as anxiety and depression, and suicidal behavior or thinking about suicide (ideation).
"This drug should only be used in the confines of a research trial in which consumers have been fully informed of its risks and benefits and, someone is responsible for the complications that occur. All the rest of us should wait until we know a lot more about its safety," says John Santa, M.D., director of the Consumer Reports Health Ratings Center.
Bottom Line: We recommend avoiding all weight-loss drugs and supplements. Their benefits are usually marginal. And even if they do help you to shed a few pounds, the side effects can be troublesome and even dangerous.
If you need to lose weight, increasing exercise and limiting portion size when it comes to food are better options.
How to control your weight [Consumer Reports]
Weight-loss drugs: Alli and Xenical (Orlistat): Slim benefits and embarrassing side effects [Consumer Reports]
Lose weight, stay active: Six small changes can help keep off pounds [Consumer Reports]
FDA approves weight-management drug Qsymia [FDA]
Panel recommends FDA approve weight loss drug Qnexa [Consumer Reports]
Note: This blog has been updated to reflect two corrections from "3.5 to 9.3 pounds" to "3.5 to 9.4 kg."