Some patients who have been injured by the use of Benicar have sued the manufacturer, Daiichi Sankyo because of pain and physical disability caused by the medication. The manufacturer of Benicar spent approximately $1 billion in aggressive promotions between the years 2002 and 2008, claiming that the medication was more effective and safer than other ARB type blood pressure medications.
Daiichi Sankyo was warned twice by the FDA, once in 2006 and once in 2013 for making misleading claims that were unsubstantiated regarding efficacy and for failing to fully disclose the risks.
Clinical trials for Benicar were conducted over a 3 month period. This was done despite the knowledge that a diagnosis of high blood pressure is usually a life-long condition and medications used to treat the disorder will be taken for many months or years. The GI threat may not have been identified in clinical trials prior to its approval in 2002 due to the shortness of the study period but a review of post marketing adverse event data showed that Daiichi Sankyo should have been aware of the trend and did not disclose any information.
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In 2012, the Mayo clinic issued a report showing a link between Benicar and patients with Celiac-like gastroenteropathy that was not treatable with traditional means. When Benicar was discontinued, some of the patients improved but some did not. Following the report, the FDA began requiring additional safety warnings on labeling of Benicar and other products containing olmesartan regarding the GI risk.
A number of patients have suffered for years with extreme pain and required hospitalization. Many of those have sued Daiichi Sankyo for their illness and injury. One patient who filed a lawsuit in Texas required hospitalization for over 100 days and required the placement of a feeding tube due to permanent injury of his gastrointestinal tract. Other lawsuits have been filed in Texas, New Jersey and other states and many more are expected.
Attorneys for the plaintiffs have accused the manufacturer of Benicar of aggressive promotion of an unsafe medication, making misleading claims regarding safety and efficacy and for a failure to clearly inform patients and physicians of the risks of taking the medication. Patients who have been injured by the use of Benicar may be eligible for actual damages (reimbursement for medical costs, loss of work, disability) and punitive damages (to punish Daiichi Sankyo).
A number of patients who were injured by taking Benicar have sued the manufacturer, Daiichi Sankyo Inc. Some patients have undergone years of treatment with extreme pain and physical debility. They may have been required to visit multiple physicians to seek relief from intestinal complaints and may have required treatment for other health conditions caused by the side effects of the medication such as nutrient malabsorption and weight loss. Some patients have also been hospitalized to treat complications and have had permanent injury or disability such as the failure of the digestive system, requiring a permanent feeding tube.
Benicar clinical trials were only performed for 3 months, even though most anti-hypertensives are prescribed for much longer than 6 months and may be given for years. In addition, independent reviews of adverse event data has shown that Daiichi Sankyo should have been aware of the increased GI complaint rate; however Daiichi failed to include this information in marketing material.
Daiichi Sankyo is reported to have spent approximately $1 billion in aggressive promotions claiming Benicar was superior to other ARBs with an increased safety and efficacy profile. The manufacturers of Benicar, Daiichi Sankyo have been warned twice by the FDA for making false or misleading claims about the medication indicating that claims were unsubstantiated and risks were not included in marketing materials.
Multiple lawsuits have been filed against Daiichi Sankyo for aggressive promotion, deceptive advertising, and failure to warn the medical community and patients about the increased risk of side effects and permanent injury. The company has been accused of placing profits above patient safety and many more lawsuits are expected.
Patients who have been injured by Benicar or other medications containing olmesartan may be eligible for actual damages (medical costs, permanent injury) and punitive damages (to punish the company).
The Food and Drug Administration approved Benicar, an angiotensin receptor blocker (ARB) used to treat high blood pressure in 2002. Benicar is the brand name for olmesartan medoxomil and is manufactured by Daiichi Sankyo, Inc., the US division of the Japanese pharmaceutical giant, Daiichi Sankyo Company, Limited.
Benicar is one of the top 100 selling drugs in the US, with over 11 million prescriptions written each year. It brought an estimated $3.1 billion in sales for Daiichi Sankyo, whose total revenue was reported at $11 billion for the year 2013. The global company, Daiichi Sankyo Co., Ltd. Is based in Tokyo and has operations in over 50 countries, including the US, offering pharmaceutical, medical, and agricultural products to a worldwide audience.
Olmesartan, the active ingredient in Benicar is also in combination blood pressure medications such as Benicar HCT (with a diuretic), Azor (with a calcium channel blocker), and Tribenzor (with both a diuretic and a calcium channel blocker). Benicar is used to treat high blood pressure and works by blocking the activity of angiotensin-II, a protein produced by the liver that is a potent vasoconstrictor. When Benicar blocks the angiotensin-II receptor, the blood vessels are allowed to relax. This decreases the pressure in the veins and allows the heart to work more efficiently.
Benicar, like all of the ARBs has a number of side effects, most of which are not severe but unlike other members this class, Benicar may cause the serious gastrointestinal condition known as “sprue-like enteropathy”. The severe side effects of Benicar caused by its GI activity include symptoms such as chronic, severe diarrhea, severe abdominal pain, nutrient malabsorption, and significant weight loss.
Because of the serious side effects of Benicar, many patients have filed lawsuits against Daiichi Sankyo for serious injury and more lawsuits filings are expected.
Benicar Side Effects
Benicar and medications containing olmesartan have a number of side effects. Like most medications, many of these side effects are mild to moderate but may have a negative impact on the patient’s quality of life. In other cases, however side effects are more severe and may be life-threatening.
The most common side effects of Benicar are:
- Rash and hair loss
- Nausea and vomiting
- Irregular heart beat and chest pain
- Swelling of the skin (angioedema)
- Liver or kidney impairment
Benicar may also cause a much more severe adverse reaction affecting the gastrointestinal tract. This side effect may be extremely painful and may cause permanent injury.
Benicar Gastrointestinal Disorder
Benicar, unlike other ARBs may cause a Celiac-like illness affecting the intestines. This condition is known as “sprue-like enteropathy” because it is has symptoms that are similar to Celiac disease which is also called “sprue”. Celiac patients can often be treated by dietary changes, usually the elimination of gluten from the diet. Patients with Benicar-related GI illness will not respond to Celiac treatments.
Symptoms of the sprue-like enteropathy may cause symptoms such as:
- Severe abdominal pain
- Chronic, severe diarrhea
- Nutrient malabsorption
- Significant weight loss
Some patients who get GI illness effects from Benicar may have to visit multiple physicians and may require hospitalization. Some patients have also had permanent injury to the GI system which has resulted in the inability to absorb nutrients, systemic body inflammation, and the need for placement of a feeding tube.
Benicar also has severe warning, known as a black-box warning regarding the potential for birth defects in women who take Benicar while pregnant. Benicar or products containing olmesartan should not be taken by pregnant women due to injury of death of the developing fetus.