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Image 1: Reductil 15mg. |
The Irish Medicines Board (IMB) has today issued a statement recalling Reductil (Sibitramine) from the Irish market. In line with the European Medicines Agency (EMA) recommendation, the IMB have concluded that the risks of sibutramine-containing medicines outweigh their benefits.
The decision comes on the back of recent results from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial, which showed an increased risk of serious cardiovascular events such as heart attack or stroke in patients with cardiovascular disease treated with this medicine. As obesity is a risk factor for cardiovascular disease, the risk is also considered to be applicable to all patients using the drug.