People with diabetes are still being prescribed a potentially dangerous drug two months after safety experts recommended it should be taken off the market.
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Rosiglitazone, which is sold under the name Avandia, should never have been licensed and ought to be withdrawn as it increases the risk of heart attack, said the British Medical Journal (BMJ) following an investigation into its regulation.
BBC One’s Panorama led an investigation into the drug, and found the Commission on Human Medicines said the “risks of rosiglitazone outweigh its benefits” and that it “no longer has a place in the UK market.”
In July the commission advised a committee of the Medicines and Healthcare products Regulatory Agency (MHRA) to withdraw GlaxoSmithKline’s (GSK) diabetes drug. It was approved in 2000 to help lower blood sugar levels for people with type 2 diabetes by the European Medicines Agency (EMA).
Since then several studies have suggested rosiglitazone may lead to a small overall rise in heart attack risk, despite GSK’s assertions that their “extensive research” proved it was “safe and effective when it is prescribed appropriately”.
Dr Deborah Cohen, the BMJ’s investigations editor, criticised the European approval process as insufficiently rigorous, and questioned the quality of GSK’s data, failures to respond quickly to safety fears and an absence of publicly available trial results that independent scientists could study.
The medical journal said doctors are recommending that patients taking rosiglitazone should consider other treatment, and those with a higher risk of heart attack should be advised to change drugs. No new patients should be prescribed the medication.
The Panorama investigation, called A Risk Worth Taking? will be broadcast on BBC One at 8.30pm on Monday.