GLAXOSMITHKLINE’S diabetes drug Avandia should be pulled from sale because of concerns about heart risks, British drug regulators said yesterday ahead of a special European meeting on the drug’s safety.
The strong line from safety experts in the drugmaker’s home market is a fresh blow to a medicine that was once Glaxo’s second biggest seller but has become a liability since being linked to increased heart attack risk in 2007.
The Medicines and Healthcare products Regulatory Agency (MHRA) said it believed the risks of Avandia, known generically as rosiglitazone, outweighed its benefits and that “it no longer has a place on the UK market”.
Stephen Hallworth, a spokesman for the MHRA, said the regulator had put forward its position “robustly” to the European Medicines Agency (EMA) and would highlight its concerns again at a special meeting on the drug’s future this week.
The EMA – the European body responsible for licensing Avandia in 2000 – will hold an extraordinary expert meeting on 8 September to review the drug’s safety.
City A.M. Reporter