Please login to the form below

Not currently logged in
Email:
Password:

Avandia label data revised in US

GlaxoSmithKline's diabetes drug Avandia is to have its label information revised in the US following recent regulatory restrictions

GlaxoSmithKline's (GSK) diabetes drug Avandia (rosiglitazone) is to have its label information revised in the US following recent regulatory restrictions.

Prescribing information and medication guides for all medicines that contain rosiglitazone will be updated with extra safety information and restrictions. Other affected medicines are GSK's Avandamet and Avandary.

The revisions follow the US Food and Drug Administration's (FDA) decision in September 2010 to place the marketing of Avandia in a restricted access programme, after the drug was linked to cardiovascular events. Marketing authorisation for the drug was suspended by the European Medicines Agency (EMA).

According to the FDA, product information has been updated to describe the risk of cardiovascular events. Labels will also state that rosiglitazone-containing drugs should only be used in patients who had already been prescribed the medicines before the restrictions were put in place, and in patients whose diabetes could not be controlled by other therapies and did not want to use pioglitazone-containing medicines.

Further to the label revisions, GSK is to establish a Risk Evaluation and Mitigation Strategy (REMS) programme to restrict the use of rosiglitazone. The FDA said it expects to approve the strategy by spring, 2011.

The FDA has also requested an independent re-evaluation of the cardiovascular safety study, RECORD, involving Avandia. GSK said it 'continues to work to meet the FDA's request'.

The FDA has futher information about the use of Avandia in the US.

8th February 2011

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
EY Life Sciences

Our global reach Against a backdrop of regulatory, digital, financial and global transformation, Life Sciences companies are finding integration and...

Latest intelligence

patients
Retaining reader value in plain language summaries of clinical studies
Balancing the risk of misinterpretation with the public’s ability to understand simplified plain-language summaries...
Can we talk about the ego-bias and chemicals influencing your target audience’s behaviour?
Over the Summer, the Page & Page team became fascinated by two books on this very subject. Two books from one author, Dean Burnett, an eminent neuroscientist, lecturing at Cardiff...
Paris
Making Europe a leader in bioscience: boosting trust and opening minds
A vision of Paris as Europe's leading hub for life sciences innovation...

Infographics