Diabetes drug may soon be pulled
May 22nd 2007, 15:39
Avandia (rosiglitazone), the diabetes drug, may soon be pulled from markets around the world after a study discovered it increased the risk of heart attack by 45 per cent. America's drug regulator, the Food and Drug Administration (FDA), has issued an urgent safety alert, and is likely to follow up with a complete ban shortly.
Rosiglitazone is in a new family of drugs known as thiazolidinediones that lower blood glucose levels in people with type II diabetes. Another, Muraglitazar, never made it onto the market after it was also found to increase the risk of heart attacks.
As a result, development on a whole generation of thiazolidinediones was abandoned after they were found to be toxic in early-stage trials.
The only other thiazolidinedione that's still on the market is Pioglitazone, and the researchers who have uncovered safety issues about Avandia claim that it is far safer.
The new study, published online by the New England Journal of Medicine on May 21, examined 42 trials, and concluded that the drug increased the risk of heart attack by nearly 45 per cent and, of those, 64 per cent were likely to die from the attack.
The results are very bad news for the manufacturer, GlaxoSmithKline (GSK), whose shares tumbled by 8 per cent in the major markets. The drug is GSK's second biggest seller, with first quarter sales up 19 per cent to lb414m. It's reckoned that millions of people around the world take Avandia.
Other Bloggers discussing this:
- Healthcare and Pharma: 'So what's the truth about Avandia?'
- Prescription Access Litigation Project: 'GSK's Avandia and Heart Attacks - The Importance of Clinical Trial Registries and Real Post-Marketing Surveillance'
- Marijke: nurse turned writer: 'Oops, they've done it again - Avandia(r) in the news'
- usrbingeek's musings: 'Avandia Safety Alert'