European regulators say that the benefits of taking GlaxoSmithKline’s Avandia and Takeda’s Actos outweigh the risks for diabetes suffers but have recommended a label change for the former’s drug.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has completed a review looking at the two thiazolidinediones as part of its “continuous monitoring of the safety of medicines” but that process took on added significance in May when the drug class, but most specifically Avandia (rosiglitazone), was linked to the increased risk of ischaemic heart disease by a meta-analysis published in the New England Journal of Medicine. Information on the risk of bone fractures in women was also looked at.
Following that review, the agency has concluded that the benefits of medicines “continue to outweigh their risks in the approved indications”. However, it recommended changing the label on Avandia to include a warning that in patients with ischaemic heart disease, it should only be used after careful evaluation of each patient’s individual risk. In addition, the combination of rosiglitazone and insulin “should only be used in exceptional cases and under close supervision”.
No changes to the prescribing information for medicines containing Actos were considered necessary but the CHMP did note that it will review results of currently ongoing studies and also recommended that further research be performed “in order to increase the level of scientific knowledge on the two medicines.”
Alastair Benbow, vice president and European medical director of GSK said that the review shows that the EMEA “recognises the positive benefit risk of rosiglitazone in Europe and its importance in the treatment of patients with type 2 diabetes”. He added that the firm “is confident in the safety profile of rosiglitazone when used appropriately by physicians”, noting that GSK will continue to work with the agency on appropriate wording for the label.
The EMEA move follows a US Food and Drug Administration advisory committee’s recommendation in July that Avandia should stay on the market although the agency is currently considering whether to add a new warning to the label of Avandia and indeed Actos.