Ban urged on drug given to diabetics
Doctors are still prescribing a popular diabetes drug two months after a safety body recommended its withdrawal amid concerns the drug can increase the risk of heart attacks, it was revealed yesterday.
The British Medical Journal (BMJ) called for the immediate withdrawal of rosiglitazone, marketed as Avandia, saying the top-selling drug should never have been licensed.
An investigation found the Commission on Human Medicines advised an expert committee of the Medicines and Healthcare products Regulatory Agency in July to withdraw the drug as the “risks of rosiglitazone outweigh its benefits”. They said it “no longer has a place on the UK market”.
Rosiglitazone, which is manufactured by Glaxo SmithKline (GSK), was approved by the European Medicines Agency in 2000 to help lower blood sugar levels in patients with type 2 diabetes.
GSK said its “extensive research” showed the drug was “safe and effective when it is prescribed appropriately”.
But since its approval several studies have suggested the drug may lead to a small overall increase in the risk of heart attacks and the BMJ's investigations editor, Dr Deborah Cohen, said the European approval process was not rigorous enough.
She also raised concerns about the quality of the data used by GSK, the lack of publicly available trial results for independent scientific scrutiny, and failures to act swiftly on emerging safety fears.
The journal said doctors were advising that no new patients should start taking the drug and patients already using rosiglitazone should review their options. Those at higher risk of heart disease should be advised to stop taking it.