Friday, June 24, 2011

ACTOS BLADDER CANCER - EU TO RULE ON ACTOS FATE BY EARLY JULY

The European Medicines Agency (EMA) has issued a press release on its website advising that the Committee for Medicinal Products for Human Use (CHMP) will finalise its review and make recommendations on the future use of pioglitazone containing medicines in July. The CHMP has been reviewing results from pharmacoepidemiological studies, non-clinical and clinical data and post-marketing reports on pioglitazone-containing medicines and the occurrence of bladder cancer.

The CHMP discussed the results of a recent retrospective cohort study carried out in France, and its potential impact on the use of these medicines across the whole EU at its meeting on 20-24 June 2011. The Committee considered that the French study strengthened the signal of a small increased risk of bladder cancer. However, it also found that the study had several methodological limitations, which limit the strength of evidence provided by these epidemiological data. These data will have to be evaluated in the context of the overall available data.

The CHMP has asked its Scientific Advisory Group on Diabetes/ Endocrinology (SAG-D/E) to discuss this issue in early July 2011 and to identify risk-minimisation measures for patients in clinical practice. The CHMP will discuss the recommendations of the SAG-D/E at its next meeting in July 2011 and give its final opinion on the benefits and risks of these medicines.