An internal struggle within the U.S. Food and Drug Administration (FDA) over Benicar is drawing attention and criticism as new Benicar lawsuits are filed over celiac disease symptoms allegedly caused by the drug.
In 2010, the FDA announced that it was reviewing the safety of Benicar over concerns related to heart disease in diabetics taking the drug. The followup announcement by the FDA came out in June, indicating that the drug was not associated with an increased risk of heart problems.
However, the study’s lead author, Dr. David Graham, actually contacted Forbes Magazine, resulting in an article critical of the FDA’s interpretation of his study. Graham asserted that the study did find an increased risk of heart problems in diabetics using the drug.
This comes as Benicar is already under intense legal scrutiny over allegations that the drug could cause celiac disease symptoms that had frustrated patients for years.
On the celiac disease symptoms front, the FDA has taken more drastic action. In July, the FDA issued a drug safety communication that Benicar could cause symptoms that mimic celiac disease and Irritable Bowel Syndrome (IBS), a constellation of symptoms called sprue-like enteropathy.
Celiac disease symptoms are painful, debilitating, and potentially embarrassing, including painful chronic diarrhea. The FDA’s statement came in response to a study published two years earlier in the peer-reviewed medical journal Mayo Clinic Proceedings, and mandated changes to the drug’s labeling to warn patients of this risk.
For many taking Benicar, the FDA’s statement was the first time they, and even their physicians, had heard that Benicar could cause sprue-like enteropathy. Allegedly, many patients had been suffering from painful debilitating symptoms of Celiac disease.
The group of disorders that includes Celiac disease and IBS do not have a perfect clinical test. Instead, patients are told to change their diet and see if symptoms like chronic diarrhea stop. In the case of celiac disease, completely avoiding gluten can more-or-less control the illness.
However, some diseases in this family are even more poorly understood, so when there is not a clear cause of the symptoms, patients could suffer indefinitely. Allegedly, some patients have suffered from sprue-like enteropathy for years before learning that Benicar could have been the cause of their symptoms.
A class action lawsuit investigation has been launched to explore the possibility of Benicar lawsuits over the alleged link between Benicar and spue-like enteropathy.
Such a Benicar lawsuit could allege that the makers of the drug were aware — or should have been aware, as they are legally obligated to monitor postmarket reports for signs of problems — of the potential link between Benicar and sprue-like enteropathy. Such a Benicar lawsuit could further allege that drug makers did not act quickly or properly to protect patients from this risk, leading to years of suffering.
In general, Benicar lawsuits are filed individually by each plaintiff and are not class actions.
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