Unanimous "No" to Rimonabant: Safety Not Demonstrated, FDA Advisory Panel Says

[Anna_Shvedova]

Еще одна новость переедания.

June 13, 2007 (updated June 14, 2007)Silver Spring, MD - In a blow to the drug maker and millions of overweight and obese Americans hoping for a new weight-loss medication, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee unanimously told Sanofi-Aventis to gather more detailed safety information about rimonabant over the long term, in larger patient numbers. All 14 members of the advisory committee agreed that rimonabant did not demonstrate the risk/benefit profile that would enable it to be approved for the indication sought: weight management in individuals with a body-mass index (BMI) of >30 kg/m2 or in individuals with a BMI of >27 kg/m2 when accompanied by at least one comorbid condition. Their concerns centered on a "clear" signal of increased risk of neurological and psychiatric side effects—seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients randomized to rimonabant.

Indeed, new analyses of the randomized controlled trials of rimonabant suggest that "suicidality"—ranging from suicidal thoughts to successful suicides—was 30% higher among subjects taking rimonabant.

"We don't have enough patients who are on this for a long enough period of time to know what's going to happen down the road, and we have enough concerns," panel member Dr Paul D Woolf (Crozer-Chester Medical Center, Upland, PA) summarized. "If the drug were going to cause a 30% weight loss we'd all be jumping up and down and throwing our hands in the air and saying this is marvelous, and we wouldn't be overly worried about the safety concerns. But . . . this drug seems to have the same efficacy as the other two approved [weight-loss] drugs."

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[Melnichenko]

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