Here’s a little piece of friendly advice. If you’re waiting around for a diet pill to solve your weight problem, forget about it.
On Thursday, the Food and Drug Administration sent drugmaker Vivus what’s blandly called a “complete response letter,” detailing the shortcomings in the company’s application to sell a prescription diet pill called Qnexa.
The upshot is the agency isn’t going to approve Qnexa for a long time, if ever.
The once-a-day pill is a combination of phentermine, a stimulant and appetite suppressant, and topiramate, sold mainly to help control epilepsy seizures. While those drugs have risks, the side effects are pretty well understood at this point.
But are the risks worth the modest improvement in weight loss? That remains the big bugaboo for the field. It’s been tough for the makers of medicines to show they can help people lose just 5 percent of their weight.
Given the obesity epidemic in this country, millions of Americans might turn to a new diet pill for help. So even rare side effects could end up causing problems for a lot of people.
That’s one reason not to expect FDA — or doctors — to embrace any of these medicines anytime soon.