Washington - The external reviewers of the U.S. Pharmacopoeia Drug Administration rejected the approval of Qnexa ® slimming majority. The safety concerns are greater than the benefits of the drug, which combines the active ingredients phentermine and topiramate.
Phentermine and topiramate have been approved in the U.S.. Phentermine was part of the popular slimming "fen-phen," which had to be taken off the market in 1997 because of other "fen-phen" drug fenfluramine may damage the heart valves. Topiramate is a proven anti-epileptic drug, one of whose side effects include weight loss.
On the efficacy of Qnexa, the experts had no doubts. It fell in the Phase III trials, the body weight by about 10 percent. But even if the two drugs are approved, this does not a priori safety concerns.
The FDA staff had called in advance several problems: increased heart rate phentermine, topiramate can interfere with concentration and memory, increase the risk of suicide and induce a metabolic acidosis and kidney stones. It is also suspected to be teratogenic.
These risks weighed for 10 experts more than the benefits of the drug, while six experts spoke out for approval. The FDA is not bound by the vote, and observers, it appears not impossible that it flouts the authority itself.
The decision will be announced in October. In September, the evaluators will have to vote on the antiobesity lorcaserin. For December, a meeting is scheduled for Contrave ®, which combines the active ingredients bupropion and naltrexone.
