European regulatory body recommends suspension of rosiglitazoneBMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c5291 (Published 24 September 2010) Cite this as: BMJ 2010;341:c5291
- Deborah Cohen
The European Medicines Agency (EMA) has recommended the suspension of diabetes drug rosiglitazone (Avandia) made by GlaxoSmithKline (GSK) from the market in Europe.
A statement by the European Medicines Agency says they now believe the “benefits of rosiglitazone no longer outweigh its risks,” pointing to new studies that support an increased cardiovascular risk.
The suspension is pending adoption by the European Commission, but it is expected the drug—and other products containing it—will stop being available in the next few months.
By contrast, the US Food and Drug Administration (FDA) has recommended a package of measures to try to determine the safety of the drug and further restrict its use (BMJ 2010:341: c5287 doi=10.1136/bmj.c5287).
The Medicines and Healthcare Products Regulatory Agency is advising doctors to review all patients currently on rosiglitazone …