14 DAY TRIAL // It should be better if we ate to live, but for some people, life isn't worth living without food, and a lot of it.
An American review addressing a Food and Drug Administration advisory panel found that the obesity pill boost suicidal thoughts or actions. "The 20-milligram dose of the drug, Zimulti, produced clinically significant weight loss over one year. With a low-calorie diet, the drug was shown to reduce body weight by approximately 5% relative to diet alone during trials of more than 6000 moderately overweight and obese subjects".
The chemical rimonabant is already marketed in 18 countries under the name of Acomplia.
The FDA final decision on rimonabant has been delayed several times due to concerns about depression. "We remain concerned about rimonabant's adverse event profile, specifically adverse psychiatric reactions," an FDA staff summary said. "Psychiatric problems represent the most common and worrisome rimonabant-induced adverse events. Depression was roughly twice as high for rimonabant patients compared with others who received a placebo," the reviewers said.
Drug's producer, Sanofi-Aventis, agreed on the findings, but also signaled that drug's benefits "clearly outweigh the defined risks that are manageable in clinical practice". Rimonabant stops the brain's food craving signals by silencing brain receptors linked to intense hunger after marijuana smoking. The drug is forecast to sell at over $3 billion annually.
It the first quarter of 2007, the drug generated sales of roughly $20 million, but approval for the US market would boom the numbers.
Outside sources will be asked to report assessments of the suicidal behavior, other psychiatric problems, neurological problems and seizures, before the drug's evaluation for approval. "Other weight-loss drugs - Roche AG's Xenical and Abbott Laboratories' Meridia - were approved even though higher rates of depression are noted on their labels," noted Karl Heinz Koch, an analyst from investment bank Vontobel.