Pharmaceutical News - January 2010
Suspension for Anti-Obesity Drug Reductil
Posted by Pharmaceutical International's Drug Development Correspondent on 22/01/2010 - 00:00:00
The European Medicines Agency (EMA) has called for anti-obesity drug Reductil - the brand name for sibutramine - to be made unavailable to patients based on concerns over the side effects it could produce. Appetite suppression medication sibutramine has been linked both to strokes and to heart attacks and, so, should neither be prescribed by GPs nor issued out by pharmacists, the medical body said in a report.
Those prescribed this drug are advised to make contact with their GP to discuss other anti-obesity options, but are reassured that ceasing their intake of it in the interim is harmless.
Reductil Suspension
"The [sibutramine/Reductil] suspension will remain in place until the company [Abbott Laboratories] can provide data...sufficient to allow the identification of a group of patients for whom sibutramine's benefits clearly outweigh its risks", EMA said.
Reductil was the subject of a six-year-long trial in which 10,000 patients participated. While no data has yet emerged in terms of specific results, the European Medicines Agency stressed that strokes and heart attacks were more frequent where Reductil patients were concerned, than in the case of patients taking a placebo. What's more, the decrease in weight produced by the drug didn't measure up to the mock-drug.
Anti-Obesity Treatment
More than one billion people around the world are considered obese or overweight. Of the anti-obesity prescriptions issued by UK doctors in 2009, in excess of 300,000 were for Reductil. The anti-obesity treatment drug is usually issued in 10mg strength and taken once a day by patients. In some instances where 10mg has been insufficient, the dose has been boosted to 15mg.
When taken, Reductil intercepts and adjusts messages sent to the brain relating to food consumption desires.
"Evidence suggests that there is an increased risk of non-fatal heart attacks and strokes with this medicine that outweigh the benefits of weight loss, which is modest and may not be sustained in the long term after stopping treatment", Medicines and Healthcare Products Regulatory Agency Doctor June Raine said. "Prescribers are advised not to issue any new prescriptions and to review the treatment of patients taking the drug."
"We believe there are many patients who benefit from sibutramine and respectfully disagree with the... recommendation to suspend the medicine", Abbott Laboratories representative Eugene Sun commented, adding: "However, we will act promptly to comply with the committee's recommendation."
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