Singapore, August 10, 2010: The MHRA has issued new guidlines on the safety of rosiglitazone  in the light of growing evidence of cardiovascular risk.

Healthcare professionals should ‘closely observe the current contraindications, warnings and precautions and monitoring requirements, and consider alternative treatments where appropriate’, according to the agency.

 
This guideline follows new evidence that raises concerns about an increased risk of cardiovascular adverse effects of rosiglitazone.

GPs are reminded that rosiglitazone must not be used in patients with current or previous heart failure, and in patients with acute coronary syndrome. It is not recommended in patients with ischaemic heart disease or peripheral arterial disease.

In addition, rosiglitazone and insulin should only be used together in exceptional cases, and under close supervision, the MHRA said. A European review of the drug was launched by the European Committee on Medicinal Products for Human Use (CHMP) on July 9 and the report should be filed by September.