Quoted from http://www.reuters.com/article/idUSTRE6841S320100905
UK wants GSK's Avandia pulled as EU reviews safety
Pharmacy staff holds a package of the diabetes drug Avandia in a pharmacy in Berlin, July 14, 2010.
Credit: Reuters/Thomas Peter
By Ben Hirschler and Kate Kelland
LONDON | Sun Sep 5, 2010 7:10pm EDT
LONDON (Reuters) - GlaxoSmithKline's diabetes drug Avandia should be pulled from sale because of concerns about heart risks, British drug regulators said on Monday 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."
Spokesman Stephen Hallworth said the MHRA 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 decentralised European body responsible for licensing Avandia in 2000 -- will hold an extraordinary expert meeting on September 8 to review the drug's safety before finalizing its position at its next scheduled meeting on September 20 to 23.
London-based EMA said the additional meeting was necessary because of the complexity of the data being assessed.
The British Medical Journal (BMJ) and some leading doctors attacked the tardy response, calling for Avandia to be pulled off the market immediately and saying it should never have been licensed in the first place.