Regulator suspends licence for rosiglitazone
By Nigel Praities
The MHRA has advised all patients taking rosiglitazone to consult their GP about alternative treatment, after the licence for the controversial diabetes drug was suspended.
The European Medicines Agency's decision to recommend rosiglitazone's suspension came after an analysis by its Committee on Medicinal Products for Human Use showed that overall there was an increased risk of heart attacks and strokes with the thiazolidinedione.
The committee recommended the suspension of the marketing authorisation for rosiglitazone because the benefits of the treatment 'no longer outweigh the risks'.
The recommendation has now been forwarded to the European Commission for a legally binding decision but all products containing rosiglitazone will stop being available in Europe within the next few months.
The Medicines and Healthcare products Regulatory Agency (MHRA) is advising GPs to call patients taking rosiglitazone in for consultations in order to reduce patient anxiety. Patients who are concerned are being advised not to stop their treatment but to contact their GPs.
MHRA chief executive Professor Kent Woods said: 'Today's 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.'
'Prescribers should review the treatment of diabetic patients currently taking Avandia. The chairman of the Commission on Human Medicines is sending a letter with advice to healthcare professionals, through the Department of Health's Central Alerting System,' the MHRA added.
There have been calls in the US to take rosiglitazone off the market. But after a tense two day meeting in July the US Food and Drug Administration ruled the drug should retain its licence but be subject to tighter restrictions.
Ellen Strahlman, chief medical officer at manufacturer GlaxoSmithKline, said that the company still considered that rosiglitazone was a safe and effective treatment 'when used appropriately'.
'GSK is working closely with the regulatory authorities and healthcare professionals to implement the changes,' she said.The licence for the controversial diabetes drug rosiglitazone has been suspended The licence for the controversial diabetes drug rosiglitazone has been suspended