Benicar is the brand name of the generic drug olmesartan, created by Japanese pharmaceutical company Daiichi Sankyo. It was approved by the U.S. Food and Drug Administration (FDA) in 2002 to treat high blood pressure, also known as hypertension. As more evidence has accumulated since then about the side effects, patients harmed by the drug have filed lawsuits.
The plaintiffs in these cases claim that Daiichi Sankyo knew about some serious risks of taking Benicar, and didn’t warn patients about them. Many patients have developed severe gastrointestinal conditions with symptoms and complications similar to those seen in people with celiac disease, intolerance to gluten. If you have struggled because of taking Benicar, find out how you can join lawsuits against the manufacturer.
What is Benicar?
Benicar, or olmesartan, is a type of drug called an angiotensin II receptor blocker (ARB). Daiichi Sankyo developed the drug, but since the patent has run out, generic versions have been made available by other companies. The FDA approved Benicar in 2002 to treat hypertension in adults and children older than six years. In addition to Benicar, there are medications like Tribenzor and Azor, which contain olmesartan in combination with other drugs.
While Benicar can be taken alone or in combination, it was also supposed to be used in conjunction with healthy lifestyle changes. High blood pressure can lead to serious complications like heart disease, kidney failure and strokes. Lowering blood pressure with a healthy diet, exercise and medications like Benicar can help reduce the risk of having these life-threatening complications.
Side Effects and Black Box Warning
As with all medications, Benicar’s benefits have to be weighed against its risks and side effects. For some people the drug is effective at lowering blood pressure without causing too many side effects. For others those side effects can be severe and debilitating. Some patients have filed Benicar lawsuits because of these more serious complications.
Many people will experience mild side effects with olmesartan, like dizziness and lightheadedness, but these usually go away as the body adjusts to the drug. More serious is the possibility that it may interfere with fetal development in pregnant women. This risk is serious enough that the FDA has required that Benicar carry a black box warning stating that women who are or may become pregnant should not use the drug. It has been shown to cause serious fetal health problems and even death.
Gastrointestinal Side Effects and FDA Warning
While most side effects that come along with Benicar are mild, some people have experienced very serious, severe, and sometimes debilitating gastrointestinal side effects. These include severe diarrhea, which can lead to complications like dehydration, weight loss, and malnutrition. Although Benicar has been on the market since 2002, it was only in 2013 that the FDA warned about the serious gastrointestinal side effects.
The packaging for any medication with olmesartan now carries a warning about these side effects, but it was too late for too many patients. Many of these have decided to start lawsuits because of the serious symptoms they experienced while taking Benicar. The FDA found the connection between the drug and the side effects after seeing a number of reports about it in the agency’s adverse event reporting system. Plaintiffs in lawsuits believe that Daiichi Sankyo should have known about these risks and if they did, should have warned the public about them.
The collection of gastrointestinal symptoms that some patients have experienced, and which have led to numerous Benicar lawsuits, is called sprue-like enteropathy. According to the warning released by the FDA in 2013, the symptoms of this condition include severe and chronic diarrhea followed by significant weight loss. The condition may not develop right away after taking a drug with olmesartan, but may begin only months or even years after taking it. For some patients the symptoms are severe enough to require hospitalization.
According to the FDA, the adverse events reporting system identified at least 23 cases of severe enteropathy and connected them to olmesartan. More evidence for the connection came from a 2012 study published by the Mayo clinic, which detailed the experiences of 22 patients on olmesartan who developed severe diarrhea and lost weight.
Some of the patients who had these symptoms also developed a condition called villous atrophy, a complication often associated with celiac disease. This occurs when the villi in the small intestines are damaged. The villi are the structures in the intestines responsible for absorbing nutrients. When they become damaged the result may be malnutrition.
Patients who have experienced the symptoms of sprue-like enteropathy while taking Benicar are advised by the FDA to discontinue use of the drug and to be given another medication for treating high blood pressure. For some patients, though, the realization that there was a problem caused by the medication came too late, after experiencing months of debilitating symptoms and dangerous weight loss and malnutrition. Many of these patients have decided to file Benicar lawsuits against Daiichi Sankyo.
Plaintiffs and their lawyers have claimed that the drug company knew about the problems with Benicar long before the FDA issued the 2013 warning. The U.S. Department of Justice thought so too and charged Daiichi Sankyo under the False Claims Act, stating that the company misrepresented the safety of Benicar and made misleading claims about its safety and effectiveness. The case was settled for $39 million.
There are now over 1,000 lawsuits pending against Daiichi Sankyo, and more are expected to be filed in the future. The people filing suits have suffered from severe weight loss, poor nutrition, and all the health complications that followed as well as steep medical expenses. They want the drug company to pay for misleading the public and failing to warn doctors and patients about the serious risks of taking Benicar. If you have taken Benicar and you experienced some of these debilitating gastrointestinal conditions, you have time to be a part of the lawsuits against Daiichi Sankyo. Speak with a lawyer to discover your legal options.