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IMB recalls weight-loss drug Reductil

The Irish Medicines Board has recalled all batches of Reductil 10mg capsules and Reductil 15mg capsules with immediate effect following new health warnings.

Doctors have been immediately requested to cease writing prescriptions for all weight-loss products containing sibutramine, the active ingredient in Reductil, while patients should discontinue treatment and consult their doctor or pharmacist.

The move is a result of the suspension of the marketing authorisations of all sibutramine-containing medicinal products in Ireland, following the recommendation issued by the European Medicines Agency (EMA).

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of sibutramine no longer outweigh its risks and that the marketing authorisations should be suspended across the EU.

Following assessment of the available information on the benefits and risks of sibutramine, the CHMP concluded that there was an increased risk of serious cardiovascular adverse events, such as stroke or myocardial infarction, with sibutramine in patients with cardiovascular disease.

The increased risk is also considered to be applicable to patients without known cardiovascular disease, given that obesity itself is a risk factor.

For further information visit www.imb.ie or www.ema.europa.eu.

Posted in Regulation on 22 January 2010
Tags: IMB