Possible Benicar Death Risk Prompts FDA Review

U.S. drug regulators are investigating the blood pressure medicine <"http://www.yourlawyer.com/practice_areas/defective_drugs">Benicar (olmesartan) for a possible association with heart-related death. According to the Food & Drug Administration (FDA), patients taking Benicar in two clinical trials had a higher rate of heart-related death than those taking a placebo.

Benicar is in the class of drugs called angiotensin II receptor blockers (ARBs). In a notice posted on its Web site today, the FDA said that in order to evaluate the possible association with Benicar and increased cardiovascular-related death, it plans to review the primary data from the two trials and the total clinical trial data on Benicar.

The two studies in question, ROADMAP and ORIENT, are both long-term clinical trials. In ROADMAP, which involved 4,400 patients divided about evenly between those taking Benicar or placebo, there were 15 heart-related deaths in the drug group versus three on placebo. In ORIENT, which involved 557 patients, there were 10 heart deaths in the Benicar group compared with three on placebo.

The FDA believes the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks. The agency has not concluded that Benicar increases the risk of death. The FDA is reviewing this safety concern and will update the public when additional information is available.

For now, the FDA is advising that patients taking Benicar to continue doing so unless told to stop by their healthcare professional. Both patients and healthcare professionals are being encouraged to report any adverse events possibly associated with Benicar to the agency.

This entry was posted in Pharmaceuticals. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.