FDA Approves Controversial Diet Drug Despite Warning of Suicide Risk

Contrave has terrible side effects, is expensive, includes a hidden antidepressant, and barely even works. So why did the FDA approve it? Action Alert!
The FDA approved two weight loss drugs in 2012, Qsymia and Belviq, but sales have been sluggish. This week FDA approved Contrave, even though the FDA initially denied approval to Contrave in 2011 due to health concerns—increased blood pressure and rapid pulse. Rather than addressing the safety issues, the manufacturer simply commissioned another study, which seems to have been enough for FDA to green-light the drug.
Contrave is the combination of two drugs: naltrexone, which is an opioid receptor antagonist used primarily in the management of alcohol and opioid dependence, and bupropion, an antidepressant (marketed as Wellbutrin). In other words, it is a repackaging of old drugs that have no direct link to appetite or eating. It carries the same black box warning as other antidepressants about the risk of causing suicidal thoughts. The black box warnings do not mention violence to others, although there is evidence of that too. Not to mention over-excitement and headaches.
Even with the threat of suicide and/or violence, not to mention the blood pressure and pulse dangers, it’s not as if this drug is a weight-loss powerhouse. From the evidence, it appears to be a dud. In clinical trials, non-diabetic patients taking Contrave lost only 4.1 percent more weight than those taking placebos. Only 42% of those getting Contrave lost more than 5% percent of their weight; in the placebo group, 17% lost the same amount. That means Contrave really worked to a small degree for only 25% of all patients. With this drug, a two-hundred-pound man would have lost only ten pounds over the course of a year. (Results from an earlier clinical trial that enrolled patients with type 2 diabetes showed that patients had an average loss of only 2% more weight with Contrave than with a placebo, and only worked on 18% of patients.)
Another weight-loss drug, rimonabant (known by the trade names Acomplia and Zimulti), also caused suicidal thinking and depression, even though it doesn’t contain antidepressants. In this case, the drug maker, the French company Sanofi SA, touted it as a possible “blockbuster” drug to treat obesity, with only mild side effects. In 2007 an FDA advisory panel urged the agency to reject rimonabant because of a significant increase in “suicidality” in patients. European regulators had approved the use of rimonabant prior to the FDA panel’s action, but sales were later suspended. It also spurred a class-action lawsuit from investors, who sued Sanofi for concealing clinical trials revealing the drug’s dangers. The lawsuit was settled this month for $40 million.
One in three Americans is obese, so naturally the drug companies see a potential bonanza. But obesity drugs have not made anything close to the “blockbuster” profits that manufacturers expected. The company that makes Qsymia is trying new tactics, such as direct-to-consumer advertising, and offering the first two weeks of pills for free.
The desperation to boost drug sales could also be why the FDA classified obesity as a disease in 2000, and the American Medical Association and the Obesity Society followed suit more recently. It could also be why vested interests are pushing legislation (the “Treat and Reduce Obesity Act”) to expand Medicare’s coverage of obesity drugs. Once insurance covers the major portion of the cost of the drugs, their sales are bound to increase. There is also a petition before the FDA to forbid supplements from making any weight loss reference, a petition that the agency hasn’t responded to but could at any time. If you haven’t done so already, write to the FDA and tell them not to ban weight loss supplements. Please take action immediately!

Although nutritional supplement companies cannot make claims to treat obesity now that it’s considered a disease, their labels can still refer to the promotion of normal amounts of weight loss. Terms like “suppresses appetite” or “increases satiety” are barely permissible, so long as it is made clear that the product is for ordinary weight loss and not for the treatment of obesity. For a review of supplements, please see LEF.org.
Natural approaches to weight management—nutrition, exercise, lifestyle changes, supplements—are safer and far more effective. But apparently our government would rather have a whole nation of potentially suicidal, FDA-drug-addicted zombies with high blood pressure, so long as Big Pharma is able to rake in the dollars.