A diabetes drug taken by tens of thousands of people in Britain must be withdrawn from the market because it has been linked with heart problems, a drugs regulator has said.   Avandia should be withdrawn from the market over heart risks, drugs regulator warns.

The European Medicines Agency today recommended that the license for rosiglitazone, known as Avandia in Britain, should be suspended because the 'benefits no longer outweigh the risks'.
The drug was first licensed ten years ago and restrictions on its use have gradually been added as evidence mounted of links to heart problems.   A spokesman for the Agency said that sufficient evidence had now been accumulated to tip the balance against Avandia.
A parallel evaluation has been ongoing in America, where the Food and Drug Administration recommended that the drug stay on the market but with further restrictions.
A spokesman for the European Medicines Agency said the two organizations used the same data and came to the same conclusions about the risk of the drug but the FDA was not able to order its withdrawal.
It is estimated that patients taking Avandia were between 20 percent and 40 percent more likely to suffer heart failure, heart attacks or stroke.
One study had found patients on the drug were 14 per cent more likely to die if they were taking rosiglitazone than on a similar drug.
Patients were urged not to panic and to have their medicines reviewed by their doctor in a ‘timely manner.’
Last year there were 500,000 prescriptions dispensed for Avandia in England meaning around 50,000 patients were taking it. The recommendation from the Agency will be ratified by the European Commission.
Experts in Britain have questioned the regulatory process, licensing of drugs and monitoring of them once they are in use after the episode.
Prof Kent Woods, Chief Executive of the British regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said: “Patient safety is the top priority for the MHRA and we have been constantly monitoring the situation regarding rosiglitazone.
The “suspension means that clinicians should review all patients currently on rosiglitazone and take appropriate action, according to the individual clinical situation, to change to another suitable treatment.”
Meanwhile the European Medicines Agency has concluded its review of the swine flu vaccine Pandemrix after there were reports of narcolepsy among some people given the jab.
They found there was insufficient evidence to determine if there is a link or not and further research was needed.
Dr. Ellen Strahlman, GSK’s Chief Medical Officer, said: “Our primary concern continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the U.S. have all the information they need to help them understand how these regulatory decisions affect them and their patients.”
(Source: Daily Telegraph)