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Acomplia Only a Loser for Sanofi-Aventis

Jun 4, 2008 | Parker Waichman LLP Five lives have been claimed and 720 adverse drug reactions have occurred in Britain since the launch of France’s Sanofi-Aventis SA's weight-loss drug, Acomplia, two years ago; this, according to a posting on the United Kingdom’s drug regulator’s Website this week.  Acomplia—known generically as rimonabant—had been slated to be a multi-billion dollar seller; however, following its rejection in the United States by a panel of US Food and Drug Administration (FDA) experts a year ago, its success has faltered.  The team of US experts claimed the drug increased the number of psychiatric events, such as depression and suicidal ideation.  Acomplia posted sales of 79 million Euros in 2007.

Acomplia is a new type of anti-obesity drug that blocks certain brain receptors that regulate appetite.  In a 2006 study, Acomplia emerged as a promising diabetes treatment when patients who took Acomplia for a year reported improved blood sugar and cholesterol control in conjunction with moderate weight loss.  A more recent study of Acomplia in obese heart patients revealed that nearly half—40 percent—of those patients studied developed psychiatric problems.  Another study published last month raised concerns about using drugs such as Acomplia in children.

Despite this, Acomplia remains on shelves in the European Union with strengthened safety warnings and cannot be prescribed to patients suffering from depression.  According to the Medicines and Healthcare Products Regulatory Agency's (MHRA) website there has been one case of suicide in the period up to May 9, 2008, and two suicide attempts.  A Sanofi spokeswoman said most of the five reported fatalities occurred before 2008 and that the report referred to the aggregated total of adverse reactions recorded in reports received by the MHRA since 2006.  The other four deaths related to two cases of fatal heart attack, one sudden death, and one case of infectious disease.

Meanwhile, Merck &Company in the US is developing a similar drug—taranabant—which is in late-stage development and is also showing promise of enabling weight loss; however, studies have linked taranabant to increased psychiatric side effects such as those exhibited in Acomplia.

Merck has been in the news most recently after agreeing to pay $58 million to Massachusetts, 28 other states, and the District of Columbia, to settle lawsuits that claim Merck allegedly used deceptive marketing to promote its popular painkiller Vioxx.

Vioxx is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) and works by reducing substances that cause inflammation, pain, and fever.  A three-year study aimed at showing that Vioxx—at a 25-milligram dose—prevents recurrence of polyps in the colon and rectum was ceased when Merck discovered a higher heart risk compared to patients taking placebos.  Prior to the Vioxx withdrawal, the FDA announced that patients taking Vioxx had a 50 percent greater chance of heart attack and sudden cardiac death and patients taking the highest recommended daily dosage of Vioxx had three times the risk of heart attack and sudden cardiac death as those not taking standard painkillers.  Merck pulled Vioxx from the market on September 30, 2004 after acknowledging that Vioxx could significantly increase the risk of heart attacks.

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