The latest news on the miracle weight loss drug, Acomplia

Today, the European Medicines Agency (EMEA) issued an announcement recommending the suspension of marketing authorization for Acomplia (rimonabant) jusacross the entire European Union. The Agency’s Committee for Medicinal Products for Human Use completed its review of the evidence on the drug’s effectiveness and safety, specifically psychiatric adverse reactions, at the request of the European Commission. It concluded that the benefits of Acomplia do not outweigh its risks and that sales should be suspended throughout Europe.

The Committee found that post-market data and ongoing clinical trial evidence have revealed that serious psychiatric disorders appear more common than shown in the clinical trials used in the initial trials for drug approval. “Since the medicine has been on the market, an increasing number of cases of serious psychiatric disorders, including suicide, have been reported,” the Committee review concluded. “In addition, between June and August 2008, five cases of suicide were reported in patients taking Acomplia in ongoing studies, compared with one case in patients taking placebo.” These experts believed that the psychiatric side effects couldn’t effectively be addressed by any measures attempting to protect consumers.

“In addition, the CHMP noted, that the effectiveness of Acomplia in clinical practice is more limited than was expected on the basis of the clinical trials, because available data indicate that patients generally take Acomplia only for a short period.” The accompanying FAQ added: “There is also no evidence that Acomplia prevents cardiovascular disease.”

The EMEA advised healthcare providers to cease writing prescriptions for Acomplia and to review the care of all of their patients currently taking the medicine. People taking the medication were advised to consult their doctor.

The lifting of this suspension is dependent on the pharmaceutical company resolving the issues identified by the EMEA.

Back in December of 2006, the media was reporting in lockstep that Acomplia was a “miracle pill” that would block food cravings (working like on pot munchies) and make fat people lose weight. Eating is out of control in fat people, according to one of the diet doctors who’d participated in the pharmaceutical company’s trials. The American public was told the side effects were mild…

JFS was like the only source giving a different viewpoint and urging caution. Taking a critical look at the clinical trial evidence conducted seeking FDA approval, the research was found to be considerably flawed. The actual benefits demonstrated were short-term and far less impressive, and the potential adverse effects of blocking cannabinoid-1 receptors in the neurological and reproductive system were more worrisome, than the public was hearing.

The FDA put Acomplia on the slow track for approval due to concerns over its efficacy and safety, and then in June 2007, the FDA advisory panel failed to recommend it for approval and Sanofi withdrew its FDA application for Acomplia. By withdrawing the application, the pharmaceutical company avoided outright FDA rejection of the drug, leaving it able to modify the application and try again, presenting it as a treatment for something else, such as diabetes, JFS explained.

Sure enough, by November 2007, Acomplia was being promoted as a potential treatment for diabetes, heart disease and metabolic syndrome. JFS then reviewed for you the Acomplia story behind efforts to get FDA approval and took a critical look at the four international clinical trials on Acomplia: the RIOs (Rimonabant In Obesity) — RIO-North America, RIO-Europe, RIO-Lipids and RIO-Diabetes, paying special attention to its efficacy for diabetes.

All of the RIO trials shared similar design and methodological weaknesses, examined here. Understanding them helps to explain why expert reviews — including by the American Heart Association, Cochrane, FDA, and Europe Medicines Agency — have concluded that the studies likely underestimate the adverse effects and overstate the benefits. [As the trials actually revealed, half of the patients who withdrew from the study needing anti-depressants weren't followed by the authors; and psychiatric and neurological side effects among the remaining study populations were significant and far more prevalent than indicated by looking just at suicides.] JFS also examined the most comprehensive review of the adverse reactions seen in the preclinical and clinical evidence on Acomplia, done by the FDA Endocrinologic and Metabolic Drugs Advisory Committee. The FDA committee report had included additional safety and adverse event report information on the ongoing trials not yet published.

Today’s EMEA announcement concurred with the FDA, which to date has also refused to approve the drug here. As we’ve seen, metabo and diabetes is the up and coming focus of public health campaigns. Today, Bloomberg also reported that Sanofi-Aventis has been trying to refashion Acomplia as a treatment for type 2 diabetes. That makes it doubly important for consumers and healthcare professionals to understand what makes a fair test. Turning to the soundest evidence, rather than media marketing, will help you make the most informed healthcare decisions.