Lawsuits are mounting against drug maker, Daiichi Sankyo Inc., over claims that blood pressure medication, Benicar (olmesartan medoxomil), led to significant adverse reactions, including severe and chronic diarrhea, sprue-like enteropathy, weight loss, malnutrition, and intestinal atrophy.
Forest Laboratories Inc., which allegedly marketed Benicar with Daiichi; Daiichi Sankyo Co. Ltd., Daiichi’s Japanese parent company; and other Daiichi entities, has also been named in the lawsuits.
Benicar Injury Lawsuits Mounting
To date, three lawsuits have been brought over Benicar and have been moved to federal court. Additional lawsuits are expected to be filed by the end of this week. The lawsuits allege that Daiichi created Benicar in a defective way and neglected to advise consumers that the medication could lead to:
- chronic diarrhea
- weight loss
In one alleged case, a patient required hospitalization for more than 100 days in a four-year period following his having taken Benicar. The man is now being fed by tube, suffered a compression fracture in is back, and developed cataracts in both of his eyes, either due to his having taken Benicar or for diarrhea-related treatments, according to the complaint, wrote Law360.
Federal Regulators Call for Benicar Label Changes Over Intestinal Injuries
In July, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication indicating that it approved label changes that would include intestinal problems—sprue-like enteropathy—that are tied to the blood pressure medication olmesartan medoxomil, which is sold under the names Benicar, Benicar HCT, Azor, and Tribenzor, as well as generic options,
Sprue-like enteropathy causes severe and chronic diarrhea with substantial weight loss and may take months, even years to develop and may require hospitalization. The FDA warns that people who take Benicar who develop these severe intestinal issues with no other cause, should discontinue taking the medication and continue therapy with another anti-hypertensive drug. In patients suffering from sprue-like enteropathy symptoms, discontinuation of Benicar led to clinical improvement of those symptoms.
Benicar is an angiotensin II receptor blocker (ARB) that received FDA approval for the treatment of high blood pressure, either alone or in collaboration with other antihypertensive agents. Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan.
As of July, the agency identified 23 serious patient cases of sprue-like enteropathy in users of Benicar in its adverse event reporting system, according to Law360, which noted that 1.9 million people have filled a prescription for Benicar in 2012.
Many of the patients reporting intestinal injury after taking Benicar had been diagnosed with celiac disease following small intestine biopsies, according to The New York Times/Well blog. Celiac disease is an allergic-like response to the protein, gluten. Biopsies revealed the same injury to that part of the gut mucosa seen in celiac disease, known as celiac sprue. The condition causes destruction to the absorption layer of the gut mucosa, which leads to malabsorption and diarrhea. The difference between celiac disease and the responses seen in people taking Benicar is that Benicar patients do not respond to a gluten-free diet, which is the traditional celiac disease treatment.
Senior FDA Regulator Reveals Cancer Links in ARBs
In 2013, a senior regulator at the U.S. Food and Drug Administration (FDA) sought increased warnings on drugs in the ARB class, according to a prior report by The Wall Street Journal. According to FDA official Thomas A. Marciniak, and other physicians outside of the agency, ARBs may be associated with increased rates of cancer. Dr. Marciniak specialized in cancer while he was a resident at the Mayo Clinic. Before joining the FDA, he spent 10 years at the National Cancer Institute.
A 2010 study published in Lancet Oncology, based on research conducted at University Hospitals in Cleveland, reviewed five studies involving 68,402 patients. The research revealed that, when compared to people not treated with an ARB, individuals taking an ARB experienced an 11 percent increased risk of new cancer overall, and a 25 percent increased risk of new lung cancer.
Although the FDA approved the drugs, indicating that its analysis did not find an increase in cancer risks, Dr. Marciniak did not agree. The FDA conducted a meta-analysis, which means it combined a number of studies so that it could review more patients and increase statistical power. This method was used to locate potential ARB side effects; however, if the original studies contain flaws, then the meta-analysis would compound those flaws. Dr. Marciniak also warned others at the FDA that utilizing results tabulated by companies would likely lead to unreliable results, writing, “Garbage in, garbage out.” Dr. Marciniak also wrote, in an internal analysis that The Wall Street Journal viewed, that the FDA meta-analysis did not take into account cases of “lung carcinomas,” as lung cancers, which they, in fact, are.
Dr. Marciniak, following the FDA’s dismissal of ARB cancer concerns, went through the raw data on the drug studies, by patient. By March 2013, he found a 24 percent increase in cancer in ARB patients, which he concluded was statistically significant. In fact, in 10 of the 11 studies he reviewed, he found that there were more lung cancer cases in ARB-treated patients than in patients not taking the drugs. “The FDA needs to inform patients and physicians about the ARB lung-cancer risks. The FDA must act now,” he wrote in a memo to senior FDA officials, The Wall Street Journal reported. The FDA disagreed; however, others agree. “I have no doubt that ARBs increase cancer risk,” Dr. Sipahi, an author of the 2010 study, told The Wall Street Journal. Renowned Cleveland Clinic cardiologist Steven Nissen, also said that the FDA “has a huge advantage over academic researchers, of having access to patient-level data” that it hasn’t fully reviewed. “Until I see such a rigorous analysis, I remain concerned about the ARB cancer problems.”
Although Dr. Marciniak’s analysis did not include trial data on all ARB drugs, including Benicar, he did conclude “that the increased incidence of lung cancers with ARB use is likely a class effect of ARBs” and that it would be “inappropriate” to classify specific ARBs as being safe because of the “lack of adequate studies.”
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