Rosiglitazone in the UK: down but not outBMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c1849 (Published 07 April 2010) Cite this as: BMJ 2010;340:c1849
- Ike Iheanacho, editor, Drug and Therapeutics Bulletin
Go to the website of the Medicines and Healthcare products Regulatory Agency (MHRA; www.mhra.gov.uk) and you can find a statement released on 3 March 2010 about the drug rosiglitazone (Avandia). It’s essentially a brief summary of the view of the agency, and that of the European Medicines Agency (EMEA), on the safety of this diabetes medicine. Its presence and content, though, are a bit odd. The message is that EMEA completed a thorough review of the safety of the thiazolidinediones—the class from which the drug comes—in 2007, concluding that “the balance of risks and benefits of rosiglitazone remain favourable in its licensed indications.” Why does this conclusion need restating two-and-a-half years later?
First, a bit of background: rosiglitazone has been licensed in the European Union and marketed in the UK since July 2000. The licensed indications at launch included combination treatment …