Skip to main content

FDA Declines to Approve Third Diet Drug in Three Months for Safety Reasons

By February 3, 2011July 18th, 2019Dangerous Drugs

As a pharmaceutical liability attorney, I was very interested to read that the FDA has decided not to approve a drug proposed to help obese people lose weight. The New York Times reported Feb. 1 that the agency has turned down the drug Contrave (naltrexone and bupropion) until its manufacturer, Orexigen Pharmaceuticals, can complete studies showing that it doesn’t raise a risk of heart attacks. It follows on the heels of two similar FDA decisions for obesity drugs, lorcaserin and Qnexa, both of which were turned down for approval last year. It also follows the withdrawal of the diet drug Meredia (sibutramine) from the market after evidence showed an increased risk of heart attacks and strokes but only minimal effectiveness.
Contrave is a combination of two drugs that are already approved: naltrexone and bupropion. Naltrexone inhibits the brain’s acceptance of opioids and is used to treat alcoholism and sometimes drug addition. Bupropion is sold as an antidepressant under the name Wellbutrin, but as an anti-smoking drug under the name Zyban. It also works on brain chemistry. Critics have raised safety concerns including an increased risk of stroke and psychiatric side effects like mania, psychosis and suicidal thoughts, but it’s still on the market. In small and short clinical trials, Contrave elevated blood pressure slightly, leading to concerns about cardiovascular side effects like those of Meredia. An FDA advisory committee voted in December to approve the drug before further studies of its cardiovascular effects could be conducted, but the agency chose not to follow that nonbinding vote.
The Times article includes comments from several observers who feel this decision was overly cautious. But as a dangerous drug lawyer, I believe it’s always better to be cautious when people’s lives are at risk. Obesity already raises patients’ risk of heart attacks and other cardiovascular problems. A drug that raises that risk further would be unwise to give to that population – especially since a main medical goal of losing weight is to lower the risk of heart problems. The FDA didn’t comment on why it didn’t approve Contrave, but said it might start requiring cardiovascular studies for all obesity drugs. That policy is already in place for drugs treating diabetes, which also raises cardiovascular risks. The article notes that Contrave was only mildly effective at helping people lose weight, which calls into question whether the risks are worth the benefits.

Based in St. Louis and Belleville, Ill., Carey, Danis & Lowe has a special focus on representing people who were seriously injured by a prescription or over-the-counter medicine. We take drugs because we trust doctors and drug makers who recommend them, as well as FDA regulations. But when drug makers fail in their legal duty to ensure their products are safe, those products can sometimes seriously harm us instead. Our defective drug attorneys help people around the United States who were seriously hurt or lost a loved one because of an unsafe drug. When the drug maker knew or should have known it was selling something with safety problems, but failed to warn patients, victims can recover fair compensation for their injuries, physical pain and emotional suffering, as well as all of the medical costs of treating those injuries.
Carey, Danis & Lowe offers free, confidential case evaluations, so you can speak to us at no further risk or obligation. To set up a meeting, contact us through our website or call us toll-free at 1-877-678-3400.