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Avandia Scare may make it tough for Rimonabant to clear FDA May 28, 2007 The recent scares raised by the diabetes drug Avandia, is likely to make matters tough for diet drug rimonabant (Acomplia / Zimulti), which will be tabled at FDA's Endocrinologic and Metabolic Drugs advisory panel on June 13 for its approval for sale in the U.S. According to Bear Stearns analysts, the safety concerns raised by the diabetes drug Avanida may increase the chances that the FDA will be more stringent in giving the go-ahead signal and is likely to seek additional data from the manufacturer of Rimonabant (Acomplia / Zimulti). What is more significant is the fact that Rimonabant (Acomplia / Zimulti) will have same the group of advisors that consider issues involving diabetes drugs like Avandia and they would never like to take make any major decision that quickly. With the recent advertisements about safety issues related with popular drugs like Aranesp, Epogen and Procrit have brought back the painful memories of the painkiller drug Vioxx, which was withdrawn from the market in 2004. Rimonabant, which is the first in a new class of drugs that operates by blocking CB-1 receptors in the brain, has been associated with depression and other psychotic side effects in clinical trails and similar side effects were felt in Europe too, where it has been on sale. However, in such scenario, it is likely that critiques of FDA will
build pressure on FDA to thoroughly examine the side effects of
Rimonabant (Acomplia / Zimulti). |
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