New advice on rosiglitazone use
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a new warning over the use of rosiglitazone (Avandia) for the treatment of type-2 diabetes, as evidence grows of cardiovascular risk.
The latest research adds to the existing evidence and points towards an increased cardiovascular risk with rosiglitazone compared with both placebo and with pioglitazone.
Healthcare professionals should “closely observe the current contraindications, warnings and precautions and monitoring requirements, and consider alternative treatments and consider alternative treatments where appropriate,” says the MHRA.
Rosiglitazone should not be used in patients with current or previous heart failure and in patients with acute coronary syndrome.
The MHRA also advises against using it in patients with ischaemic heart disease or peripheral arterial disease, and warns that rosiglitazone and insulin should only be used together in exceptional cases and under close supervision.
A Europe-wide review of available data on the risks and benefits of rosiglitazone by the European Committee for Medicinal Products for Human Use (CHMP) is currently underway and is expected to be completed by September 2010.
NICE guidance on the use of newer agents for type-2 diabetes recommends that when selecting a thiazolidinedione (pioglitazone, rosiglitazone), healthcare professionals take into account up-to-date advice from the relevant regulatory bodies, such as the European Medicines Agency and the MHRA, cost, safety and prescribing issues.
10 August 2010
This page was last updated: 11 August 2010