Estey Bomberger attorneys are reviewing potential lawsuits for individuals who have suffered severe and debilitating diarrhea and other stomach problems from Benicar, as well as Benicar HCT, Azor, and Tribenzor (all manufactured by Daiichi Sankyo).
What is Benicar?
Benicar (Olmesartan) is a drug to treat hypertension (high blood pressure), and reduce the risk of stroke and heart attack. Benicar is an angiotensin II receptor blocker (ARB), and is in the same class of drugs as Atacand, Avapro, Cozaar and Micardis. It may be prescribed alone or in combination with other antihypertensive agents. It is manufactured by Daiichi Sankyo Company and brought in $3.1 billion in worldwide sales in 2013. Its patent expires in 2016.
Benicar FDA Timeline
April 5, 2002: Benicar was approved by the FDA.
June 2010: The FDA announced it was reviewing data from two clinical trials (ROADMAP and ORIENT trials) in which Type 2 Diabetes patients taking Benicar had a higher rate of death from a cardiovascular cause compared to patients taking a placebo. At the time the FDA stated that they believed that the benefits of Benecar in patients with high blood pressure outweighed the potential risks.
July 2010: The FDA announced it would be conducting a review of the class of medications known as ARBs (Benecar is an ARB) after a recently published study suggested they may be associated with a small increased risk of cancer.
April 2011: The FDA announced that after reviewing the ROADMAP and ORIENT trials, they determined that the benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure according to the drug label. Daiichi Sankyo, the manufacturer of Benicar, agreed to work with the FDA to perform additional studies, as well as conduct additional analyses of completed clinical studies, to obtain additional information about the cardiovascular risks or benefits of Benicar in various clinical settings.
July 2013: The FDA warned that Benicar can cause intestinal problems known as sprue-like enteropathy. Along with their safety announcement, the FDA has approved changes to the labels of these drugs to include this concern.
July 2014: The FDA announced it had completed its safety review re cardiovascular risks (preveiously announced in June 2010 and April 2011) and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients. As a result, theirrecommendations for use of Benicar remained the same, but they said they would require information about some of the studies to be included in the drug labels. Patients were advised to discuss any questions they had with their health care professionals.
July 2015: As of July 15, 2015, the number of lawsuits consolidated for pretrial proceedings for MDL 2606 was 915, up from only 70 consolidated lawsuits as of June 15, 2015.