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Spangenberg Shibley & Liber LLP | Aug 31, 2015

Gastrointestinal Side Effects Of Benicar May Last A Lifetime

Daiichi Sankyo, manufacturer of the high blood pressure medication, is facing lawsuits from a number of victims who sustained serious and sometimes permanent damage to their gastrointestinal tract from the drug. Daiichi Sankyo spent more than $1 billion in the six years between 2002 and 2008 on an aggressive Benicar marketing campaign. During this marketing blitz, Sankyo repeatedly claimed Benicar was safe, as well as more effective than similar high blood pressure medications. Prior to receiving FDA approval and marketing the drug, clinical trials occurred for a period of only three months. Very soon after Benicar hit the drug market, there were reported adverse reactions to the drug, and it is clear that for several years now Daiichi Sankyo has been aware of the gastrointestinal disorders associated with its drug.

FDA Warns Benicar Manufacturer about Misleading Benicar Claims

Daiichi Sankyo has been warned by the FDA—once as far back as 2006—to stop making misleading and unsubstantiated claims related to Benicar. The FDA claimed the manufacturer had exaggerated the effectiveness of Benicar, while downplaying the side effects and risks. This has led to tragic consequences for many patients. In 2012, the Mayo Clinic reported a link between the active ingredient in Benicar—olmesartan—and sprue-like enteropathy. Patients who developed these gastrointestinal symptoms were advised to stop taking the drug.

Long Term Injuries from Benicar Use

Even when Benicar use is discontinued, many Benicar patients have suffered permanent injuries related to the drug, requiring multiple hospitalizations and leaving them with a life of chronic pain. One Texas patient spent over 100 days in the hospital due to Benicar-related symptoms and is now forced to use a feeding tube after his gastrointestinal tract suffered permanent damage. Use of Benicar can damage the walls of the intestines, causing a condition known as villous atrophy. This means the villi which line intestinal walls are damaged and are prevented from absorbing nutrients. When this occurs, the patient can suffer from malnutrition. In addition to severe diarrhea, patients taking Benicar have experienced malabsorption of nutrients, severe abdominal pain, significant weight loss (more than 100 pounds in some patients), chest pain, irregular heartbeat, nausea, vomiting, hair loss, kidney and liver issues.

$3.1 Billion in Benicar Revenues in 2013

Benicar became one of the top selling high blood pressure drugs soon after it was approved. With Benicar accounting for nearly a quarter of Daiichi Sankyo’s revenues, the drug brought in a staggering $3.1 billion for the company in 2013. In that same year, the FDA issued a drug safety alert for Benicar after reviewing data from a Mayo Clinic’s study. Prior to issuing that alert, the FDA received many adverse event reports from Benicar users who reported severe diarrhea and weight loss which in many cases required hospitalization. A significant number of those Benicar users developed severe, long-term intestinal damage. The Mayo Clinic results deemed some of the Benicar side effects “life-threatening.” As an example, one patient involved in the Benicar study lost 125 pounds, while others were placed on steroids in an attempt to control the inflammation in their intestinal tract.

American College of Gastroenterology Links Benicar to Sprue-Like Enteropathy

While there were only 22 patients involved in the initial Mayo Clinic Benicar paper, fourteen of those resulted in hospitalization. The Mayo Clinic doctors were not alone in their conclusions about Benicar and other related drugs such as Benicar HTC, Azor and Tribenzor. The American College of Gastroenterology linked another 40 cases of sprue-like enteropathy to Benicar use in October 2012. In April 2015, Daiichi Sankyo settled a U.S. Department of Justice Fales Claims Act case for $39 million regarding claims the company paid kickbacks to physicians who prescribed Benicar.

If you or a loved one suffered injury after taking the blood pressure drug Benicar, you may be able to seek compensation. If you would like to speak with one of our attorneys about your rights and legal options, contact our office right away by calling us at (877) 696-3303 or by filling out this form. It is in your best interests to act quickly. There is a time limit in each State for filing injury claims known as the statute of limitations. If a claim is not filed against the manufacturer, marketers, retailers and healthcare providers before the statute of limitations expires, an injured party will not be able to bring a claim against those liable for their injuries.