Benicar is a drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of high blood pressure. It is made by drug company Daiichi Sankyo and was first approved in 2002. Over the next few years, more studies and trials using the drug found that it can cause some very serious gastrointestinal side effects.
Lawsuits have been filed against Benicar’s manufacturers, claiming that they did not adequately warn patients and doctors about the dangers. The gastrointestinal conditions that some patients have experienced led to very serious complications like severe weight loss, malnutrition, chronic diarrhea, and damage to the intestines. If you have taken Benicar and suffered these side effects, you may have a case that could net you the money you need for further medical treatment and to get your life back on track.
Uses for Benicar
Benicar is the brand name for the generic drug olmesartan medoxomil. It was first developed by Daiichi Sankyo, but has since been made by more than one manufacturer. It is used for the treatment of hypertension, or high blood pressure, in adults and children over the age of six. Benicar belongs to a class of drugs called antiotensin II receptor blocker, or ARB, all of which treat high blood pressure.
Benicar can be used alone or in combination with other drugs. After it was first developed, tested, and approved, more drugs with olmesartan came onto the market, in combination. These included Azor and Tribenzor. Benicar has been useful in lowering high blood pressure, which if left untreated can cause serious damage in the body, ultimately leading to a heart attack, stroke, kidney failure, and other major and life-threatening health problems.
When Benicar and similar ABR drugs are prescribed to patients they are typically expected to be used in combination with lifestyle changes. Losing weight, eating a better diet, exercising more, quitting smoking, and drinking less alcohol can all help to reduce blood pressure. Taking a drug like Benicar along with lifestyle changes can significantly improve high blood pressure and reduce the risks of further health complications.
How Benicar Works
As an ABR, Benicar works as a vasodilator. It causes blood vessels to dilate, or open up wider so that blood can flow more freely. This lowers blood pressure. The way Benicar does this is by blocking a natural chemical in the body called angiotensin II. This substance causes blood vessels to constrict and get smaller, which has the effect of increasing blood pressure. Angiotensin II also acts to release more sodium and into the blood stream, increasing its volume and further increasing blood pressure. By blocking both effects of this natural substance, Benicar reduces blood pressure throughout the body.
Precautions for Benicar
Although Benicar has helped many people lower their blood pressure safely, there are many precautions and unintended consequences of taking the medication. Precautions include telling the prescribing doctor or pharmacist if you are allergic to ARBs, if you have diabetes and take a medication for it, if you have ever had kidney failure, liver failure, or heart disease, or if you are breastfeeding.
Other precautions include the warning that Benicar can make you feel dizzy and lightheaded and that you should be careful when getting up from bed or a seated position. If you are taking the medication and experience vomiting, diarrhea, or don’t drink enough fluids, you can get lightheaded and faint.
Side Effects and Black Box Warning
Some common side effects of taking Benicar include getting dizzy or lightheaded, but these usually diminish after taking the drug for a certain period of time. More serious side effects, which should be reported to a doctor immediately, include swelling in the face, mouth, eyes, hands, ankles, or feet, difficulty breathing and swallowing, hoarseness, severe diarrhea, and weight loss.
Benicar also comes with a black box warning, a special warning required by the FDA when a medication presents a very serious health risk. The warning states that Benicar should not be taken by a woman who may be pregnant or who may become pregnant. Drugs that impact angiotensin II can cause serious health problems in a fetus and may even lead to the death of a fetus, especially during the last six months of a pregnancy.
Gastrointestinal Side Effects
Benicar has been a popular drug since it came on the market in 2002. In 2012, according to the FDA, over ten million prescriptions were written for this medication. Unfortunately, research has since found that Benicar can cause serious gastrointestinal issues in some patients. The FDA released a new safety warning regarding this finding in 2013. The statement said that Benicar and other drugs containing olmesartan medoxomil may cause a condition called sprue-like enteropathy. Since the warning was released, packaging for Benicar had to include this information.
Sprue-like enteropathy is a gastrointestinal condition with symptoms that include chronic and severe diarrhea with significant weight loss, sometimes leading to hospitalization. The symptoms are similar to those seen with celiac disease, intolerance to the protein gluten. This has been found to develop in some patients taking Benicar, even many months or years after first starting on the medication. If no other cause for such symptoms can be found, the FDA recommends that Benicar use be discontinued and that the patient be given another type of blood pressure medication.
The FDA discovered the connection between sprue-like enteropathy and Benicar after investigating several reports in their Adverse Event Reporting System. This is a database of all reports of side effects and adverse events occurring with approved medications. They found several serious reports of the condition. These findings were backed up by several studies that found the same connection between the medication and the gastrointestinal condition.
Once the truth about Benicar and srpue-like enteropathy came to light, the FDA issued a warning to Daiichi Sankyo that the drug company was making unsafe and misleading claims about the medication and how safe it was to take. The company eventually settled with the U.S. Department of Justice to the amount of $39 million. The company had been charged under the False Claims Act.
Since then many lawsuits have been filed against the company by individuals and state attorneys general. They now number over 1,000 and are still climbing. Some of the individuals cite experiences of having diarrhea between ten and twenty times a day, losing up to 100 pounds, and becoming severely malnourished while on Benicar.
The number of lawsuits against Daiichi Sankyo is expected to eventually climb to three to four thousand. They are expected to begin going to trial in late 2016, but lawyers on both sides have millions of pages of documents to go through. It could be a long haul to make a case against the drug company and to get a settlement. If you experienced some of these serious gastrointestinal issues while taking Benicar, you could be a part of these suits and any future settlements.