What the FDA Says About Benicar

In 2002, the Federal Drug Administration (FDA) approved Benicar, also known as olmesartan medoxomil, for the treatment of high blood pressure. Doctors prescribe the drug to help prevent serious side effects from high blood pressure such as heart disease, stroke, and kidney failure. However, there are risks associated with Benicar, and over the past thirteen years the FDA has issued several Drug Safety Communications.

What We Know Now

When Benicar was first approved and for years after, patients and their doctors may have not known all of the potential side effects from this medication. Since 2002, the FDA has issued the following safety communications regarding this prescription blood pressure medication:

• June 2010: In its first safety communication regarding this drug, the FDA announced that it was investigating whether patients with Type 2 diabetes had a higher rate of cardiovascular death while taking this drug compared to patients with Type 2 diabetes who were taking a placebo.
• July 2010: Just a month after the first safety communication, the FDA announced that it was reviewing whether angiotensin receptor blockers (ARBs), such as Benicar, were associated with an increased risk of cancer.
• April 2011: This safety communication was a follow up to the June 2010 safety communication. In April 2011, the FDA announced that the benefits of Benicar continued to outweigh the potential risks. Additionally, the FDA announced that additional studies would be made to investigate the potential increased risk of cardiovascular death among patients with Type 2 diabetes.
• July 2013: More than a decade after approving Benicar, the FDA announced that the drug was associated with sprue-like enteropathy, a serious gastrointestinal condition with symptoms similar to those of uncontrolled celiac disease. Label changes were made to warn patients and health care professionals about the risk.
• June 2014: Recently, the FDA found no clear evidence of an increased risk of cardiovascular death among patients with Type 2 diabetes who were taking Benicar. However, the FDA did require a label change to notify patients and health care professionals about studies showing the potential for increased risks.

If you take Benicar or olmesartan medoxomil under any other name, then it is important to be aware of these risks. Please talk to your doctor about whether this medication is right for you.