Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

FDA panel recommends keeping rosiglitazone

An advisory committee to the Food and Drugs Administration (FDA) has recommended that rosiglitazone (Avandia®) should remain on the market in America according to PharmaTimes. The recommendations made by the panel will be fully reviewed by the FDA before a final decision is made.

Despite this it is also worthwhile noting that the panel accepted that there was sufficient evidence associating rosiglitazone with an increased heart disease risk and that additional warnings needed to be added to the drug information advising that certain groups of patients should not take this drug.

Public Citizen, a consumer advocacy group in America, offered testimony at the panel advising that the drug be withdrawn from the market. They highlighted that there is "no evidence of any uniquely beneficial clinical outcome" but there is "growing evidence of unique risks".

Action: Rosiglitazone appears likely to remain on the market, at least for the time being, however it's place in therapy must now be considered to be a last option where all alternative oral options (including metformin, sulphonylureas and pioglitazone) have proved to be ineffective or poorly tolerated.

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