Benicar Side Effects for Diabetics Linked to Risk of Death
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.
4 comments
My son Chris DeRemer has taken Benicar for two years. He has type II diabetes, he was just diagnosed with Lung Cancer at age 34. Until than he had no other health problems. We llive in New Jersey. Is there someone out there who can help my family?
went to er 7/12/2010, feeling lightheaded off balance just plan crappy.. dr. took me off benicar due to vertigo .. been on the drug for about a year i think without checking. also had heart palpatations at night very scary.. hopefully ill feel better soon
I was on Benicar more or less one year. I was never diagnosed of cardiovascular disease before using it not until after less than a month using it, I went to see my cardiologist because I developed shortness of breath, wheezing, chest pain, unexplained head/neck , sore throat. I had an abnormal EKG and diagnosed of ischemia and cardiovascular disease and ended up with angioplasty with stent and esophageal surgery.
I was on Benicar for one week. First I developed alarming rectal bleeding, and a rash on the back of my right hand that looked like I had been scalded. Dermatitis herpetiformis?