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The FDA has initiated a safety review into the side effects of Benicar, a blood pressure medication that recent studies suggest may increase the risk of death in some patients.
On June 11, the FDA announced that it was conducting an ongoing safety review of Benicar side effects to evaluate data from two clinical trials that determined the drug may cause an increase in the risk of death due to heart problems in patients with type 2 diabetes. During the two studies, 25 subjects died due to cardiovascular death while taking Benicar.
Benicar (olmestartan), was developed by Daiichi Sankyo, and was approved for the treatment of high blood pressure by the FDA in 2002. In 2008, sales for Benicar totaled more than $455 million.
The studies under review by the federal drug regulators include a 4,447-patient Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP) and a 566-patient Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial (ORIENT). In the ROADMAP study, 15 people died due to cardiovascular death while taking Benicar, compared to 3 taking a placebo. During the ORIENT trial, 10 people died due to heart problems while on Benicar, compared to three from the group taking a placebo.
In both studies, patients with type 2 diabetes were given the drug to see if it would stave off the effects of kidney disease. These are the only two studies so far that have shown a link between Benicar and heart attacks, strokes and sudden death, according to FDA.
Benicar belongs to a class of drugs known as angiotensin-receptor blockers, or ARBs, which are used to treat high blood pressure, heart problems and kidney disease caused by diabetes. In an another study published Monday in the medical journal Lancet Oncology, researchers have linked ARBs with a “modest” increase in the risk of cancer.
Researchers looked at data on 60,000 patients, and determined that use of ARBs, like Benicar, were linked to a 1% increase in the risk a number of forms of cancer, including lung, prostate and breast cancer. The researchers said that due to the limited data and results, more studies were necessary before ARB and Benicar cancer risk could be quantified.
The FDA notes that currently, the agency has made no conclusion that Benicar carries an increased risk of death, and said in its safety review announcement that FDA still believes the benefits of Benicar outweigh any potential known risks.
The agency urged healthcare professionals prescribing Benicar and patients taking the drug to report any adverse events or side effects to the FDA Medwatch Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm.