A popular drug used to tackle obesity and metabolic disorders has been banned after worrying reports of mental and psychiatric side-effects. Doctors have been advised not to prescribe the drug known as rimonabant, which has a brand name of Acomplia. Psychiatric disorders and suicide are just some of the reported problems users have faced when on the medication.
The problem was made public yesterday, after the European Medicines Evaluation Agency strongly recommended the drug be withdrawn from use in overweight and obese patients, following evidence of sleep disorders, aggression, anxiety and depression. The drug has not affected all patients that are prescribed it, but as yet there have not been sufficient trials to identify who is more at risk. The EMEA have therefore said marketing of Rimonabant should discontinue.
In addition, the Medicines and Healthcare products Regulatory Agency (MHRA), who monitor drug safety in the UK, have asked doctors not to issue any new prescriptions for the drug.
Approximately 97,000 patients in the UK have used Accomplia, and currently there are 20,000 users of the drug. The new findings do not mean patients should stop taking the drug immediately, but they should consult their doctor.
Acomplia has been available on the NHS since June. The report summarises concerns that were raised a significant time ago. In fact, back in 2007 the EMEA suggested it may be unsuitable for those already on anti-depressants. Information collated from trials carried out by the maker, sanofi-aventis, highlight the fact that patients taking Acomplia are twice as likely to develop a psychiatric disorder compared to those who were taking a placebo. Of the 36,000 patients that were trialling the drug between June and August, five of them committed suicide. This is compared to just one suicide within those taking the placebo. The risks involved in taking the medication are much higher than originally thought, while the effectiveness of the drug has decreased, due to patients ending the treatment after a short period.
The EMEA have therefore ruled that the dangerous risks posed by taking Acomplia far outweigh the benefits.
The EU authorised use of Acomplia in June 2006, to be taken in conjunction with diet and healthy eating to tackle obesity. The EMEA concludes it has been “moderately effective”.
The manufacturer, Sanofi-aventis, have advised they will ”comply with the European authorities’ request to temporarily suspend the marketing authorisation of Acomplia in obese and overweight patients”. However, they will continue to carry out clinical trials in order to collate more sufficient reuslts as they feel the drug has “significant benefits” for overweight and obese people.
