Finally, rosiglitazone (Avandia®) is no longer available in Europe.
In a previous post we discussed an article of The New York Times, which might help to explain why the FDA refuses its full withdrawal, although rosiglitazone is not better than pioglitazone, but causes more cardiovascular problems.
Yesterday, El País reported extensively on the ban, until Glaxo can "identify the group of patients in which the drug benefit exceeds the risks".
Avandia® sold 920 million Euros last year, and had arrived in 2006 to more than 2000 million. The question is: If the alert was given, and there are equally effective alternative medications, and safer, why was it still prescribed?
+ Info: - Spanish Agency for Drugs and Health Care Products (AEMPS):
Patient information note on the suspension of marketing of drugs containing rosiglitazone (Avandia ®, Avandamet ®, Avaglim ®)
Communication for professionals
- European Medicines Agency (EMA):
Press release: European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim
Questions and answers on the suspension of rosiglitazone-containing medicines (Avandia, Avandamet and Avaglim)
- In this blog:
GSK hid the rosiglitazone (Avandia) is associated with cardiovascular risk
GSK recibe una reprimenda de la FDA por ocultar datos sobre su antidiabético rosiglitazona (Avandia) (GSK receives a rebuke from the FDA for hiding data on its antidiabetic rosiglitazone Avandia)
Posted by Fernando Palacio
English version by Erika Céspedes