Though the FDA has not pulled Benicar from U.S. shelves, the federal agency has ordered that labels on the drugs be changed to reflect risks related to intestinal disorders. The FDA has also said the drug’s manufacturer must include information from two studies that revealed an increased risk of cardiovascular death among diabetics who took the drug in two clinical trials.
Via Price Benowitz LLP
A pair of independent studies of Benicar conducted in the U.S. led to the FDA warning last year. Mayo Clinic researchers sounded the first alarm regarding this suspicious connection between the drug and the pernicious gastrointestinal disease in June 2012, a year before the agency took action. Beginning in 2008, and for the next two years, Mayo researchers noted patients who presented with unusual gastrointestinal disease symptoms that mimicked similar side-effects to a different drug and which was also used to treat hypertension – which Benicar is designed to treat. Among the symptoms reported by the clinic were:
Tests revealed that these patients did not have the same active antibodies that were present in those who were taking the other drug. Eventually, Mayo researchers found the common link shared by 22 patients: Benicar. When the patients enrolled in the study discontinued use of the drug, their symptoms ceased to exist and they regained an average of 27 pounds over a 90 day period.
In 2012, researchers from the American College of Gastroenterology (ACG) revealed at a national conference that olmesartan (Benicar) had been linked to 40 of their test subjects who also displayed sprue-like enteropathy symptoms, much like those patients in the Mayo research. The ACG also reported favorable reversals, similar to those of the Mayo study, once their patients stopped taking Benicar. One researcher ominously reported at the symposium when summarizing the research that, “We believe it is the tip of the iceberg.”
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