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 9.3 more pounds 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.