While diet drug Acomplia (rimonabant) doubles the risk of depression, its benefits "continue to outweigh its risks" for overweight and obese individuals who are not taking antidepressants, European drug regulators concluded on July 19th.
But in deciding to let Acomplia remain on the market in Europe, the regulators expressed concern that "too many patients are taking Acomplia at the same time as antidepressants," and issued a tougher warning to doctors to stop prescribing it to patients on antidepressants or suffering major depression.
The European Medicines Agency (EMEA) handed down their decision after reviewing safety data that led a U.S. FDA advisory panel last month to unanimously recommend against allowing rimonabant (also known as Zimulti) to be prescribed in the United States.
The EMEA's Committee for Medicinal Products for Human Use (CHMP) said it asked Sanofi-Aventis following the FDA advisory panel meeting in June 2007 to "submit all available information on the psychiatric side effects of Acomplia."
In assessing the data at its just concluded July meeting, the CHMP said it concluded "that the benefits of Acomplia continue to outweigh its risks, except in patients with ongoing major depression or taking antidepressants."
But it added that the risk of depression is approximately doubled in all overweight and obese patients taking rimonabant, and the risk may be further increased in patients with a past history of depression.
"This increased risk is of concern, since Acomplia is now being used in patients with a history of psychiatric events," the CHMP said. "In a small minority of cases, this could lead to suicidal ideation or even suicide attempts."
The EMEA said that while doctors were warned when rimonabant was approved a year ago that they " should not prescribe Acomplia in patients with uncontrolled serious psychiatric conditions such as major depression," the warning will now be upgraded.
The CHMP said it is now recommending " contraindicating Acomplia (rimonabant) from Sanofi-aventis, in patients with ongoing major depression or who are being treated with antidepressants, because of the risk of psychiatric side effects.
Additionally, the CHMP "recommended adding a warning that treatment with Acomplia should be stopped if a patient develops depression, as well as the inclusion of additional information on the psychiatric safety of Acomplia.
"Patients and their carers should be aware of the risk of depression in patients taking Acomplia," the CHMP added.
Acomplia is currently marketed in 13 European Union nations as well as in Argentina, Mexico and a handful of other countries.