Patients who took a Sanofi-Aventis SA obesity drug in clinical trials were more likely to report suicidal thoughts or actions than others who got a placebo, U.S. drug reviewers said in an analysis released on Monday.
Food and Drug Administration staff also said the 20-milligram dose of the drug, Zimulti, produced clinically significant weight loss. An advisory panel will consider on Wednesday if the drug should be approved for sale in the United States.
Known generically as rimonabant, the drug already is sold in 18 countries under the name Acomplia.
FDA statisticians said the incidence of suicidal thoughts and behavior “was higher for 20-milligram rimonabant compared to placebo. Similarly, the incidence of psychiatric adverse events, neurological adverse events and seizures were consistently higher for rimonabant.”
Sanofi, in a separate summary, said more Zimulti patients reported suicidal thoughts but added the drug’s benefits “clearly outweigh the defined risks that are manageable in clinical practice.”
The FDA staff and Sanofi summaries were posted on the agency Web site.
