UK regulator moots withdrawing GSK’s Avandia drug from UK market
06 Sep 2010
Citing concerns about heart risks, the UK drug regulator wants GlaxoSmithKline's (GSK) blockbuster diabetes drug Avandia to be pulled out from the market, ahead of European regulators meeting later this week to review the drug's safety.
In July 2010, the commission on Human Medicines had advised the UK regulator, the UK Medicines and Healthcare products Regulatory Agency (MHRA), to pull out GSK's diabetic drug Avandia from the market because the drug increased the risk of heart attacks in diabetic patients.
After an investigation into Avandia by the Commission on Human Medicines - an independent working group advising UK ministers, in July 2010 The British Medical Journal (BMJ) had advised the UK regulator, the UK Medicines and Healthcare products Regulatory Agency (MHRA), to pull out the drug from the market because it increased the risk of heart attacks in diabetic patients.
On 26 July MHRA sent a directive to all UK doctors advising them to consider alternative treatments, but stopped short of proscribing the drug despite the BMJ saying that the drug should not have been approved in the first place.
Ahead of the European regulators 8 September meeting to review the drug's safety, the MHRA today said that the side effects of the drug far outweighed the benefits and that it had no place in the UK market.
After months of investigation, the US Food and Drug Administration (FDA) advisory panel in July 2010 stopped short of removing Avandia from the US market, but imposed additional heart risk warnings. (See: FDA wants GSK to add more health warnings on diabetese drug Avandia)