The European Medicines Agency said on Oct. 20 that it had completed a safety review seeking a possible link between angiotensin II receptor antagonists and increased cancer risk – and found none.
ARBs, which are used to treat hypertension, heart failure, diabetic nephropathy, and to reduce cardiovascular risk, have been authorized in the European Union since the 1990s.
The review was initiated at the request of the Italian Medicines Agency, the EMA said, following the June 2010 publication of a meta-analysis in the Lancet Oncology (doi:10.1016/S1470-2045(10)70106-6), which saw a 7% risk of new cancers, particularly lung cancers, among people taking ARBs. The authors of that study found the risk to be slightly lower – 6% – for people taking other types of heart medicines or no medicines.
The EMA said that it found aspects of the meta-analysis weak and noted "several problems with the quality of the data." Patients in the trials reviewed in the meta-analysis "were not followed-up for long enough to clearly establish a link between ARBs and cancer, information on the risk of cancer before start of treatment was lacking, and there was a possibility of publication bias," the EMA said in a news release.
The agency added that it had reviewed additional meta-analyses and population-based studies to confirm a lack of raised risk.
In a separate statement Oct. 20, EMA said that it had initiated a review of strontium ranelate–containing osteoporosis medicines, to better understand their risk-benefit profile.
The drugs are known to be associated with a raised risk of venous thromboembolism, and also drug rash with eosinophilia and systemic symptoms, or DRESS. Authors of a recent French study (Presse Med. 2011;40:e453-e62) concluded that the VTE risk might be reduced by adding a contraindication for patients with a history of VTE and by stopping treatment if a risk situation emerges. French authorities subsequently recommended restricting use of strontium ranelate to patients younger than 80 with high fracture risk who cannot take bisphosphanates.
EMA said that it would review these and other findings on the safety profile of strontium ranelate–containing medicines and decide whether the marketing authorizations for these medicines should be changed EU-wide.