A proposed weight-loss drug that appears to raise the risk of suicidal thoughts shouldn’t be taken by people who are depressed, its manufacturer told federal health advisers Wednesday as they considered whether to recommend approval.
The Food and Drug Administration is expected to decide by July 27 whether to allow Sanofi-Aventis SA to sell the drug, called rimonabant, by prescription in the United States.
Study results that suggest the once-daily tablet raises the risk of suicidal thoughts and other symptoms of depression could lead to stern warnings on the medication if it is approved. Company officials appeared Wednesday open to such warnings, which could exclude its FDA-approved use in some patients.
“Who is the right patient to receive rimonabant? Not everybody,” Sanofi-Aventis’ Richard Gural told the panel of advisers. The drug is not appropriate for anyone with a history of depression or suicidal thoughts, or who has been diagnosed with depression or is currently taking antidepressant medication, he added.
FDA decision delayed
Sanofi-Aventis wants to sell the drug under the brand name Zimulti. Scrutiny of its psychiatric effects have delayed a final FDA decision on the medication: “Obviously, a big concern for us,” Dr. Eric Colman, deputy director of the FDA’s metabolic and endocrine drugs office, told the panelists.
The outside advisory committee was to make its recommendation on the drug late Wednesday. The agency isn’t required to follow the advice of its outside advisers but does so most of the time. The agency previously told the French company it would not approve the drug to help smokers quit.
Rimonabant blocks the same pleasure centers in the body activated when pot smokers get the munchies. Blocking the receptors leads to patients eating less and losing weight. Sanofi-Aventis also believes the drug decreases fat storage.
The prescription drug, when used in conjunction with a modest calorie diet and physical exercise, significantly decreases body weight and waist circumference in overweight or obese patients, according to Sanofi-Aventis. In year-long studies, patients on the drug lost roughly 14 pounds. Those given dummy pills lost only about 4 pounds. Patients regained weight when treatment was stopped after a year, the company said.
Drug can lead to psychiatric symptoms
What worries FDA reviewers is that the drug’s effect on the body’s cannabinoid receptors could lead to psychiatric symptoms, including anxiety, phobias, depression and post-traumatic stress disorders.
In studies, 26 percent of patients given Zimulti reported such a symptom, compared with 14 percent of those given sham treatment. Specifically, 9 percent of those treated with the drug reported symptoms of depression, compared with 5 percent given dummy pills.
And patients on the drug reported a two-fold increase in suicidal thoughts, compared to those on dummy pills. The company believes all those cases were associated with depression or other disorders and weren’t directly caused by its drug.
Sanofi-Aventis seeks to sell 20-milligram Zimulti tablets to the obese and to those who are overweight and have type 2 diabetes, high blood pressure or other conditions that put them at risk of cardiovascular disease.
Obesity rates have exploded in the past two decades. Today, nearly one in three American adults age 20 or older is obese, according to government data.
Generally, anyone with a body mass index, a ratio that takes into account height and weight, greater than 30 is considered obese. The overweight BMI range is 25 to 29.9. Normal is 18.5 to 24.9.
Rimonabant is sold under the brand name Acomplia in Europe.