Popular High Blood Pressure Drug Could Be Tip of the Litigation Iceberg

Camden, NJIf there is one certainty about the pharmaceutical industry, it is that Big Pharma is never boring. And at the risk of appearing insensitive about the alleged harms from prescription medications suffered by innocent patients, the fact remains that Americans are hearing about an increasing number of long-approved drugs having seemingly new and unforeseen side effects that negatively impact a patient. Such is the case with Benicar, a drug indicated for hypertension and the lowering of high blood pressure. And to be sure, we are starting to see headlines that scream “Benicar Lawsuits Filed Alleging Illness and Weight Loss.”

Benicar (olmesartan) has proven to be a very popular medication for the mitigation and management of high blood pressure, a common malady amongst Americans. According to one Benicar HCT lawsuit, there were no fewer than 1.9 million prescriptions written for olmesartan or similar drugs that contain olmesartan, such as Azor and Tribenzor, in 2012.

Benicar, manufactured by Daiichi Sankyo Inc. and marketed in the US by Forest Laboratories Inc., was granted approval by the US Food and Drug Administration (FDA) in April 2002. Eleven years later, the FDA would be back in July 2013 to issue a warning about Benicar and to mandate its manufacturer and marketing partners to include a warning for sprue-like enteropathy, a condition characterized by severe and chronic diarrhea and weight loss.

The FDA was reacting to a study concluded one year earlier and conducted by the Mayo Clinic on participants over a three-year period from 2008 to 2011. Based on the results and conclusions of that study, together with reports from its own Adverse Event Reporting System (AERS), the FDA concluded that there was “clear evidence of an association between olmesartan and sprue-like enteropathy.” Thus the label changes.

Where was the reference to sprue-like enteropathy prior to 2013?

Here’s the thing about Benicar HCT, as well as Azor and Tribenzor that all contain olmesartan: symptoms can take months or even years to appear. All this time, patients taking Benicar in good faith in order to manage high blood pressure with the blessing of their respective physicians would have no idea that a potentially nasty condition could be lurking deep within them, readying for an explosion of diarrhea and unexplained weight loss. Such benicar side effects can and have also been misdiagnosed as celiac disease.

And yet, according to the Boston-based advocacy group CenterWatch, Benicar olmesartan was approved in 2002 based on seven placebo-controlled clinical trials involving 3,275 participants in total, with various doses of Benicar administered over a period from six to 12 weeks. The only notable side effect was the potential for dizziness.

And now, this…

Were study participants monitored beyond the 12-week window for persisting Benicar side effects before Benicar olmesartan was approved? The Mayo Clinic study found that of the 22 study participants, fortunes improved for 18 of them after Benicar was stopped. But that suggests that for the other four participants, the aftereffects of Benicar did not.

Little surprise then, given the FDA’s recent stance and a lack of any reference to sprue-like enteropathy before July 2013, that lawsuits are starting to come in. Seven months after the FDA issued its warning, plaintiff George Williams filed his Benicar defective products lawsuit in New Jersey. According to court documents, Williams had been hospitalized in excess of 100 days over a period of four years due to adverse reactions allegedly due to Benicar. The plaintiff alleges in his lawsuit, filed in February of this year, that he is forced to use a feeding tube for nourishment, has developed cataracts in both eyes and has suffered a compression fracture of his back - all allegedly due to Benicar or treatments he has received in order to combat his diarrhea.

Other Benicar lawsuits allege similar symptoms and harms.

Little wonder then that we can expect to see “Benicar Lawsuits Filed Alleging Illness and Weight Loss” screaming from the headlines for the months and years to come. Legal pundits hold that lawsuits such as these could be the tip of the iceberg. The lawsuit is Williams et al. v. Daiichi Sankyo Inc. et al., case number 1:14-cv-00863 in the US District Court for the District of New Jersey.