Temporary marketing suspension of Reductil (sibutramine) in Croatia
22.01.2010
The European Medicines Agency (EMA) released a public statement on 21 January 2010, recommending the suspension from the European Union markets of the medicinal product Reductil, which contains sibutramine as the active substance, due to unfavourable benefit/risk ratio.
The medicinal product Reductil was authorised as an auxiliary, with dieting and physical exercising being the primary, treatment for obesity in:
- patients with a diet-induced obesity (DIO) whose Body Mass Index (BMI) is 30kg/m2 or higher;
- patients with a diet-induced obesity (DIO) whose Body Mass Index (BMI) is 27 kg/m2 or higher, who have other risk factors such as type 2 diabetes or dyslipidemia.
The new data from the Sibutramine Cardiovascular OUTcomes (SCOUT) study, aimed at investigating the effects of the sibutramine treatment on the cardiovascular system of overweight and obese patients (with a known cardiovascular disease and higher risk of cardiovascular disease), indicate an increased risk of developing serious cardiovascular incidents, such as a stroke or heart attack in patients treated with Reductil in comparison with patients receiving placebo. In the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, based on the available data on safety and efficacy of the medinical product Reductil, the risk outweighs the benefit and therefore their recommendation is to recall the medicinal product in question.
Based on the EMA's decision, the Agency for Medicinal Products and Medical Devices (the Agency) has issued the following recommendations:
- Physicians may no longer prescribe Reductil, and must consider other methods of treating patients previously treated with Reductil;
- Pharmacists may no longer dispense Reductil, and the patients previously using Reductil should be refered to a physician for an examination;
- Patients who have theretofore been using Reductil should now contact their physician in order to consider other treatment possibilities, including dieting and physical exercise. Should they wish to do so, patients may stop the Reductil treatment on their own initiative even before their medical examination.
The Agency, in cooperation with the marketing authorisation holder for the medicinal product Reductil (Abbott Laboratories d.o.o., Zagreb), organised the recall of Reductil from the Croatian market. All healthcare professionals participating in prescribing and dispensing of Reductil will be receiving a letter with the latest information on the safety of this medicinal product.
You can find the Dear Healthcare Professional letter here. (available in Croatian language)
The EMA statement can be found at the following link:
http://www.ema.europa.eu/pdfs/human/referral/sibutramine/3940810en.pdf
