Get Email Updates from Google
Anti-obesity Drug Suspended Due to Psychiatric Risks
An anti-obesity drug that has been successful at aiding weight loss in morbidly obese patients is being retracted due to evidence that it poses a psychiatric risk. The European drugs watchdog is recommending doctors to stop prescribing the anti-obesity drug rimonabant, (aka Acomplia). The European Medicines Agency has stated that it believes there to be serious risks of psychiatric disorders developing as a side effect of the drug. There is no way to determine who is at risk, and who is not, therefore the recommendation is for the drug to be withdrawn completely. It is advisable that people taking Acomplia should speak to their GP as soon as possible, although they do not need to immediately stop taking the drug.
Approximately 97,000 obese or overweight people in the UK have been prescribed rimonabant. The drug is prescribed with a diet and exercise regime. Currently about 20,000 are on the drug. It was only approved in June of 2008 for use by the NHS.
The concerns are not new however, as trails suggested that it could cause depression and even suicide. In July last year, the EMEA warned it may be unsafe for patients who are also taking anti-depressants. GP’s were also warned not to prescribe it to patients with a history of depression.
Recent studies have indicated that the risks are much higher than previously thought with around double the risk of psychiatric disorders in obese or overweight patients taking rimonabant compared to those taking a placebo. Between June and August 2008, there were five suicides among patients taking part in a trial who were on the drug, compared with one among those taking a placebo. These were seen in a total of around 36,000 patients.
“Prescribers should not issue any prescriptions for Acomplia [rimonabant] and should review the treatment of patients currently taking the medicine. Patients who are currently taking Acomplia should consult their doctor or pharmacist at a convenient time to discuss their treatment. There is no need for patients to stop treatment with Acomplia immediately, but patients who wish to stop can do so at any time.” EMEA statement.
In a statement, Sanofi-Aventis said it would comply with the EMEA’s decision, but that it believed rimonabant would remain “an important therapeutic answer to a highly prevalent and increasing unmet medical need”.
“My patients were doing very well on it, and they will now have to stop and come off it. Patient safety must be foremost, but I always thought that if you ruled out the patients with depression, you ruled out the problem with the drug.” Dr Colin Waine, chairman of the National Obesity Forum.
Some doctors still believe that the risks of temporary mental disorders is acceptable considering the serious ill effects of long term obesity, i.e. heart disease, stroke, diabetes and increased risk of cancer, plus the fact that many morbidly obese patients suffer from depression also. However, this latest research, showing that there is a real risk that the drug can lead to severe cases of depression, and suicide, would suggest that the risk factors are no longer acceptable.
Unfortunately there is no safe way for the morbidly obese to lose weight, as invasive measures such as stomach stapling and gastric band surgery both have known risks associated with major surgery. The long term solution is improved education in schools, with physical education classes emphasised from a younger age. Many people feel that physical training should be brought back into schools, as traditional “old school” fitness training is often the most effective means of getting people fit, and teaching people how to stay fit.
News source: http://www.emea.europa.eu/humandocs/PDFs/EPAR/acomplia/53777708en.pdf
Tweet Me!Recommended Reading
• Diet Pill Approved By NHS Although There Are Health Risks
• Too many people are being diagnosed with depression
• Alli Slimming Pill May Cause Liver Damage
• Obesity Diet Pill to be Available over the Counter in the UK
• New Skin Cancer Drug Could Cure Cancer
