- Prescribing Advice for GPs - https://www.prescriber.org.uk -

Sibutramine cardiovascular concerns

The European Medicines Agency (EMEA) has announced (PDF) that they will be conducting a safety review for sibutramine (Reductil®) after cardiovascular safety concerns were raised.

The Sibutramine Cardiovascular OUTcomes (SCOUT) trial involved approximately 10,000 patients who were overweight or obese and had risk factors for cardiovascular disease for example diabetes or dyslipidaemia. The study aimed to assess the efficacy of drug assisted weight loss using sibutramine on cardiovascular outcomes in this higher risk population.

The EMEA are reviewing data that indicate an increased risk of serious cardiovascular events, such as stroke or heart attack. In the meantime clinicians and patients are reminded to use sibutramine-containing medicines with caution, and only in accordance with the currently approved product information. It is noted that the patients recruited to the SCOUT study would have been contraindicated in the majority of cases.

Clinicians should refer to the Summary of Product Characteristics and be aware of the following:

Action: Clinicians should be aware of this review and use sibutramine cautiously until it is completed. Preferential use of orlistat, for the time being at least, would seem sensible.