BioCentury
ARTICLE | Clinical News

European Medicines Agency regulatory update

October 24, 2011 7:00 AM UTC

EMA's CHMP concluded that the benefit-risk balance of angiotensin receptor blockers (ARBs) is positive, and that evidence does not support an increased risk of cancer in patients on these drugs. CHMP conducted the review at the request of the Italian Medicines Agency following the publication of a meta-analysis in Lancet Oncology that suggested the drugs may be linked with a "modestly increased" risk of new cancer diagnosis (see BioCentury, July 19, 2010).

The committee said evidence from the meta-analysis was weak and noted several problems with the quality of the data. Specifically, patients in the trials were not followed up for long enough to clearly establish a link, and information on the risk of cancer prior to the start of treatment was lacking. CHMP said a review of large population-based studies and more complete meta-analyses without the same methodological problems did not show an increased risk of cancer. ...