[Suspension of the commercialization of sibutramine and rosiglitazone in Europe].
The European Medicines Agency (EMA) recommended the suspension of the marketing authorisations for sibutramine, a centrally-acting anti-obesity agent, and of rosiglitazone, an oral glucose-lowering compound of the thiazolidinedione family. This decision was taken because of a possible increased cardiovascular risk, mainly ischaemic heart disease, associated with the use of sibutramine or rosiglitazone in patients with pathologies prone to develop cardiovascular complications. The conclusion was that the benefits no longer outweigh the risks. The present paper summarizes the up- and -down history of these two pharmacological compounds, analyzes the data that resulted in such a decision and briefly discusses the future implications regarding the pharmacotherapy of cardiometabolic diseases.
Université de Liège, Service de Diabétologie, Nutrition et Maladies métaboliques, Departement de Medecine, CHU de Liège, Belgique.
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Scheen
D001067:Appetite Depressants / Q000009:adverse effects; D003503:Cyclobutanes / Q000009:adverse effects*; D005060:Europe; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects; D011358:Product Surveillance, Postmarketing; D000077154:Rosiglitazone; D056737:Safety-Based Drug Withdrawals; D045162:Thiazolidinediones / Q000009:adverse effects*
D001067:Appetite Depressants; D003503:Cyclobutanes; D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone; C058254:sibutramine