It’s been 13 years since the FDA has approved a weight loss drug, but hope for “skinny in a pill” is raised once more. The FDA announced on Wednesday that the weight loss drug, Belviq, is safe for long-term weight loss in adults who are obese or overweight, with at least one medical complication related to excess weight.
In clinical trials, however, the drug offered only marginal weight loss results to study participants. Study participants lost an average of 3.7 percent of their starting body weight and a small fraction lost 5 percent – the amount required by the FDA to indicate effectiveness.
Qnexa, which was denied approval earlier this year due to potentially dangerous side effects, proved to be more effective on average – study participants lost 11 percent of starting body weight. Qnexa will be reevaluated in July.
The FDA reports that Belviq should be taken in conjunction with a diet and exercise plan and should not be taken for longer than three months if the patient has not seen any results (at least 5 percent loss of starting body weight.) Reported side effects include depression, migraines and memory lapses, however the panel of experts advising for or against the drug determined that the benefits outweigh the risks.
Many weight loss drugs have been up for approval over the last decade – however, the dangers of these drugs inhibited their approval. Xenical, was the last weight loss drug approved, but is known for the harsh side effect of leaky stools for only modest weight loss.
Experts say the biggest challenge in developing in a safe and effective weight loss drug is turning off the body’s desire for food, while still maintaining the desire to eat enough to sustain life.