Acomplia Anti-Obesity Drug Sales In Europe Suspended

Rimonbant’s rough ride may be nearly over: today, the European Medicines Agency (EMEA) announced that it has recommended suspension of the weight-loss drug, marketed as Acomplia in Europe [1]. According to an EMEA committee, the benefits of the drug “no longer outweigh its risks.” Sanofi-Aventis will "immediately" start talks with non-EU countries where the drug is available to have sales suspended there as well, the company said in a statement.

As previously reported the drug has known neurological and psychiatric side effects, including depression and "suicidal ideation," which are noted in the product labeling in Europe and were enough to persuade an FDA advisory committee in June 2007 that the drug should not be marketed in the US. In Europe, however, the drug has been available since June 2006, although the EMEA reconvened after one year to reassess the safety profile of the drug, ultimately leading to new contraindications for its use.

The European decision follows a recommendation from the London-based European Medicines Agency, which earlier Thursday said a study had revealed obese or overweight patients taking Acomplia were at approximately double the risk of developing psychiatric disorders than those taking a placebo.

The agency’s researchers also raised doubts over Acomplia’s effectiveness in clinical practice, saying this was "more limited than was expected on the basis of the clinical trials," because patients generally take it for only a short period.

The agency urged doctors to stop issuing new prescriptions for Acomplia and to review the treatment of patients already taking it.

Sanofi-Aventis said Acomplia has been marketed in 18 EU countries since 2006. The company said it is "committed to provide additional evidence for the re-evaluation of the benefit/risk profile of Acomplia," which is used to treat patients with diabetes and cardiovascular disease.

The drug was prescribed in addition to diet and exercise for the treatment of overweight patients with associated risk factors, the agency said in a statement.

==============================

Advertisement
Steps to Health Walking Program
The only program that is in use with over 200,000 patients. Reduce your blood sugars for less then 25 dollars and you don’t have to swallow anything. $24.95 with discounts for 2 or more…

https://www.rx4betterhealth.com/ccp51/cgi-bin/cp-app.cgi?pg=prod&ref=sthp&cat=sth&catstr=HOME:sth