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

FDA advise rosiglitazone reviews

The Food and Drugs Administration in America has issued a safety alert for rosiglitazone in response to cardiovascular safety concerns raised by the New England Journal of Medicine (NEJM).

As previously discussed, the meta-analysis in the NEJM revealed a statistically significant 43% increase in myocardial infarctions and a non-significant 64% increase in the risk of cardiovascular death in patients taking rosiglitazone when compared to controls (placebo or other hypoglycaemics).

The FDA are advising that patients who have heart disease, or who are at high risk of developing heart disease, should talk to their doctor about this new information and the treatment options.

Action: Clinicians should be aware of this evolving situation and be prepared to discuss the risks and benefits of the alternative treatment options with concerned patients.