The U.S. Food and Drug Administration (FDA) approved Benicar in 2002 to treat high blood pressure, also known as hypertension. Benicar was developed and first manufactured by the Japanese company called Daiichi Sankyo. Since it came on the market Benicar has been found to increase the risk of serious gastrointestinal conditions in some of the patients using it.
Although the more common Benicar side effects are much less severe, the possibility of developing these serious gastrointestinal conditions cannot be taken lightly. Nor can the fact that Daiichi Sankyo actively promoted as safe, a drug it knew to have these potential side effects. Lawsuits have cost the company money because individuals have been harmed by Benicar. If you were hurt by this medication, you too may have made a case against Daiichi Sankyo for hiding these side effects.
What is Benicar?
Benicar treats hypertension in adults and in children as long as they are older than six. The generic name for the medication is olmesartan medoxomil. As a treatment for high blood pressure, Benicar is in the class of drugs called angiotensin II receptor blockers. These drugs lower blood pressure by dilating blood vessels. This opens them up more widely so that blood can flow more freely. The result is a drop in blood pressure.
Although Daiichi Sankyo first created Benicar, generic versions of olmesartan are now made by other companies. Blood pressure medications like olmesartan are important because although lifestyle changes can treat hypertension, for many people eating better, exercising, and reducing stress just aren’t enough. Without additional support to lower blood pressure, these people are at risk for stroke, a heart attack, kidney failure, and other health problems. While Benicar is effective as a tool for lowering blood pressure, it also comes with side effects, some of which are very serious.
Gastrointestinal Side Effects
Of all the Benicar side effects that are possible in people taking the medication, gastrointestinal are the most severe and serious and have the potential to cause a number of further complications. Unfortunately for patients who had been taking Benicar for years, the warnings about serious gastrointestinal side effects did not come out until 2013, more than ten years after the medication was initially approved.
The FDA issued the warning in 2013 that Benicar and other olmesartan drugs could cause something called sprue-like enteropathy. Packaging for olmesartan products now carry this warning, but for more than a decade patients were exposed to the risk without knowledge and without being able to make an informed decision about risks and benefits.
The discovery that Benicar could cause gastrointestinal conditions came from the FDA’s adverse events reporting system. This is a system through which the agency collects individual cases of adverse reactions and side effects caused by medications. The agency found several reports of sprue-like enteropathy and simultaneous studies confirmed there was a link between this condition and olmesartan.
What is Sprue-Like Enteropathy?
Sprue-like enteropathy is a gastrointestinal condition that can be triggered by medications like Benicar. Although not many patients will experience it, those who do, have to cope with a very serious and often severe health problem. Case studies and research have found that Benicar may trigger this condition a few months after using the drug, or not until years later.
The symptoms of sprue-like enteropathy are severe and chronic diarrhea, followed by significant and dangerous weight loss. The condition can be severe enough to require hospitalization. It is possible to die from sprue-like enteropathy if it is left untreated. The symptoms of this condition mimic those of celiac disease, but if discontinuing Benicar helps, they can be attributed to the drug and not a separate condition.
One possible complication of sprue-like enteropathy is villous atrophy. This is also something that can result from celiac disease. Villous atrophy occurs when the lining of the small intestines become damaged. The villi, which are found on the lining, absorb nutrients from food. The damage results in an inability to absorb nutrients, which in turn leads to malnutrition. This can be very serious if not treated.
Other Benicar Side Effects
Luckily for most patients taking Benicar or other olmesartan products, the more common side effects are less severe than olmesartan. Most commonly people experience a little dizziness or a feeling of being lightheaded. These symptoms usually diminish and completely disappear with time.
Another potential side effect is related to pregnancy. Women who are pregnant or who might become pregnant while using it should not take Benicar. Olmesartan and other angiotensin II receptor blockers cause complications to the fetus and can even lead to its death. The FDA included a special warning on Benicar to make sure that patients are well aware of the risks to unborn babies.
Side Effect Lawsuits
It took several years for the discovery of the connection between Benicar and sprue-like enteropathy to come to light, but once it did, Daiichi Sankyo was in trouble. When the FDA realized what the risk was, it issued the public warning, but also sent a warning to the drug maker. It warned the company that it had been advertising and marketing a drug as safe without warning about the risk of gastrointestinal issues.
The evidence of this misrepresentation of Benicar was strong enough for the U.S. Department of Justice to get involved. Daiichi Sankyo settled with the Department to the tune of $39 million after being charged with violating the federal False Claims Act.
It wasn’t just the federal government that felt Daiichi Sankyo had acted wrongly in the case of Benicar. Thousands of lawsuits have been filed by individuals who developed sprue-like enteropathy. These plaintiffs are prepared to argue that the company failed to adequately warn them of the risks of using their olmesartan blood pressure medication. The trials are set to begin in late 2016 and plaintiffs and their lawyers are hopeful that they have the evidence to prove Daiichi Sankyo’s wrongdoing and to get settlement funds to make up for the pain and suffering caused by Benicar.