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Obesity drug withdrawn
[Posted: Thu 23/10/2008 by Niall Hunter, Editor www.irishhealth.com]
An anti-obesity drug that suppresses appetite has been taken off the Irish market following concerns about its psychiatric side-effects.
The Irish Medicines Board said today that in line with a recommendation from the European Medicines Agency, Acomplia, (rimonabant), marketed by Sanofi-Aventis, will no longer be available on the Irish market.
It said the benefits of the drug were no longer felt to outweigh the risks.
Meanwhile, a leading medical obesity expert, Dr Donal O'Shea, has told irishhealth.com that patients should not be unduly concerned following the withdrawal of the drug.
Dr Joan Gilvarry of the Irish Medicines Board (IMB) said following assessment of the most recent data on Acomplia, an increased risk of psychiatric disorders for patient was confirmed.
She said a precautionary measure to protect patient health, this product will no longer be available.
"In Ireland, there are a relatively small number of patients on this product for whom alternative treatments are available. Patients currently taking Acomplia should stop their treatment and visit their GP at their convenience for further advice."
The IMB said no further prescriptions for Acomplia should be prescribed or dispensed by doctors and pharmacists.
Acomplia is a prescription-only medicine which is used as an adjunct to diet and exercise in the treatment of obesity in adult patients and overweight patients with other risk factors such as diabetes and high cholesterol.
It has been approved for use throughout the EU since 2006, and, according to the IMB, at that time the potential for psychiatric side effects were identified.
Since Acomplia was introduced, there have been reports of side effects associated with taking the drug, including severe depression.
The European Medicines Agency said an increasing number of cases of serious psychiatric disorders have been reported with the drug, including suicide cases.
Warnings about side effects have been included in the product information of the drug since it was first launched and have been continuously updated and strengthened over time to include new warnings and contraindications in line with emerging data, the Medicines Board said.
Dr O'Shea, consultant endocrinologist at St Columcille's and St Vincent's Hospitals in Dublin, told irishhealth.com that Acomplia was unique among obesity drugs in that it worked on the cannabinoid receptors in the brain to reduce appetite.
He said, however, patients should not have major problems in ceasing to take the drug."It is not like, for example, stopping an antihypertensive drug where there would be a risk of blood pressure rising."
Dr O'Shea said, however, that patients who have been taking Acomplia shoiuld consult the clinician who prescribed them the medication, who could advise them on their future weight management.
He said a number of patients attending his obesity clinic were taking Acomplia.
Dr O'Shea said the drug had been effective in a select group of patients but concerns had been flagged in the past about the possible psychiatric effects of the medication.
He said possible alternatives to Acomplia would be other anti-obesity drugs such as Reductil or Xenical, which worked in different ways.
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