In July 2013, the Food and Drug Administration issued a drug safety alert for Benicar(olmesartan medoxomil), the medicine developed to help with high blood pressure and reduce the risk of serious medical problems. The alert came as a result of findings by the Mayo Clinic that Benicar and similar drugs like HCT, Azor, and Tribenzor were found to cause severe problems like sprue-like eneropathy and villous atrophy.
Symptoms of enteropathy severe, chronic diarrhea with substantial weight loss whereas villous atrophy damages the ability of the intestines to absorb nutrients. The enteropathy in particular may not develop for months or years after taking these drugs. In the study done by the Mayo Clinic involving 22 patients, 14 of them had to be hospitalized for these symptoms. One of the patients even lost 125 pounds.
The FDA ordered these new side effects be added to drug labels but the product had been on the market for a long period of time by then. “The FDA’s evaluation found clear evidence of an association between olmesartan and sprue-like enteropathy. If patients taking olmesartan develop these symptoms and no other cause is found, the drug should be discontinued and therapy with another antihypersensitive started,” the agency stated. The FDA considered these side effects life threatening in its report.
Benicar has also been found to damage the walls of the intestines. This erosion of the walls results in malnourishment. Stopping use of the drug allows patients to regain lost weight and lessen other symptoms.
High blood pressure affects nearly 67 million Americans, who are the target audience for this medication. In 2012, 1.9 million patients filed prescriptions for Benicar and other olmesartan-based medicines in 2012. The parent company for this drug, Forest Laboratories Inc., has $140 million of product liability insurance coverage, and many lawsuits have already been filed as a result of the Mayo Clinic and FDA findings.
Other side effects that have been discovered post market for Benicar include Angioedema (swelling of the skin), vomiting, irregular heartbeat, abdominal pain, nausea, chest pain, arthritis, rash, kidney problems, liver impairment, and hair loss. It is also strongly warned for women who become pregnant to stop use immediately because of the possibility of injury or death to the fetus.