Among Benicar side effects is perhaps the most serious and debilitating in the Benicar adverse event portfolio: sprue-like enteropathy - a nasty gastrointestinal condition that results in diarrhea, dehydration and weight loss, and in the most serious cases, chronic gastrointestinal issues that can become permanent long after the medication is stopped.As it is, various reports suggest and lawsuits have alleged that gastrointestinal symptoms can take months or even years to emerge. By then, it may be too late to mitigate the potential damage. Many plaintiffs wind up in the hospital suffering weight loss and other health issues.
Benicar (olmesartan) is a hypertension drug prescribed to rein in high blood pressure, a condition that affects millions of Americans. Benicar was granted market approval by the US Food and Drug Administration (FDA) April 5, 2002. Eleven years later, in July of 2013, the FDA was back with a mandate to update Benicar warnings to suggest patients have the potential to suffer symptoms of sprue-like enteropathy months or even years after first using the medication.
And it isn’t just an association, either - as some FDA warnings are peppered with disclaimers such as “potential risk” for a malady that “may cause” a problem. The latter disclaimer was deployed in the Benicar label change as well. However, the FDA also made reference to “clear evidence” of a link between gastrointestinal problems and use of Benicar.
That’s pretty strong language. But the reason for it is sound, in that high blood pressure is usually a chronic condition for which medication is an ongoing therapy. And plaintiffs, or their estates, are crying foul over the fact that a full decade went by between FDA approval of Benicar and the agency’s 2013 order of a label update suggesting “clear evidence” of the potentiality of sprue-like enteropathy linked to olmesartan.
Did this not come out in clinical trials? And were those trials insufficient in breadth to allow for sprue-like enteropathy to appear in trial participants, thereby sparing the wider population from such symptoms?
Severe diarrhea can be serious, especially in the elderly. The dehydration and gastrointestinal issues can lead to malnutrition and weight loss that can put a senior into the hospital. The prognosis can be dire.
Plaintiffs fault the principals involved with Benicar, Daiichi Sankyo and Forest Laboratories, for allegedly knowing about the link between Benicar and sprue-like enteropathy. Plaintiffs allege that Daiichi and Forest not only knew, but withheld information in order to maximize profits while putting the safety and health of consumers at risk.
It has been suggested by researchers that the chance for long-term or permanent gastrointestinal damage is heightened the longer Benicar is used. It has also been suggested that sprue-like enteropathy has been misdiagnosed as unclassified sprue or Celiac disease. This leaves patients continuing to ingest olmesartan for their high blood pressure, without realizing that Benicar may lay at the root of their Benicar Illness and Weight Loss - which again, could be permanent the longer the medication is used. Hypertension patients using Benicar to control their high blood pressure face the risk of villous atrophy.
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The current basket of cases has been consolidated before US District Judge Robert Kugler in the District of New Jersey. On May 20, Judge Kugler issued an Order for the creation of a plaintiff’s executive and steering committees. A leadership plan has also been approved. Bellwether cases will follow.
In the meantime, pundits expect the MDL will grow to hundreds or even thousands of cases over time. The case is In Re: Benicar (Olmesartan) Products Liability Litigation, Case No. 2606, in the US Judicial Panel on Multidistrict Litigation, District of New Jersey.