Will Benicar be Recalled from the Market Due to the Risk of Sprue-Like Enteropathy and Chronic Diarrhea?
Information about the potential link between Benicar and chronic diarrhea problems known as sprue-like enteropathy first surfaced in July 2012, with the publication of a study in Mayo Clinic Proceedings.
Since then, the FDA issued warnings in July 2013, alerting doctors to the risk of sprue-like enteropathy and a number of Benicar lawsuits were filed on behalf of individuals nationwide.
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Complaints alleged the manufacturer failed to properly research the medication, disclose the potential side effects or remove Benicar from the market once information was discovered about the risk of chronic diarrhea and other symptoms consistent with celiac disease.
While serious questions have been raised about the apparent decision by the drug maker to put their desire for profits before patient safety, there are no indications at this time that a Benicar recall is likely to be issued.
Several studies have found an association between Benicar and sprue-like enteropathy. It appears that information about this risk was known to the drug maker for some time before it was reported by independent researchers.
Although warnings have been added to the medication, many lawsuits still allege that the drug maker is not doing enough to ensure consumers and the medical community are aware that diarrhea symptoms may be caused by Benicar.
However, it is very unlikely that Benicar will be taken off the market due to the risk of spue-like enteropathy.
Rather, stronger warnings may be required or additional steps may be taken to ensure information is provided with all prescriptions directing patients to contact their medical provider if they experience diarrhea or other side effects.
The FDA safety announcement issued in July 2013 indicates that the agency is continuing to evaluate the safety of Benicar and will communicate any additional information as it becomes available.
The agency has provided no indication that it is considering any regulatory action that would result in a recall of Benicar, but consumers and medical providers have been urged to report any adverse events involving problems with Benicar to the FDA MedWatch program.
Consumers have been advised not to stop taking their blood pressure medication without first discussing it with their doctor, as failure to appropriately treat high blood pressure could result in strokes, heart attacks, kidney failure or other serious harm.