Product News and Recalls

As Benicar Lawsuits Top 1,000, Plaintiffs Ask: What Took So Long?

victims wonder why FDA action on Benicar took so longBenicar lawsuits consolidated in the New Jersey multidistrict litigation now exceed 1,000, and as more pour in, Benicar plaintiffs continue to ask: What took the U.S. Food and Drug Administration (FDA) so long to warn patients about the drug’s severe gastrointestinal side effects?

Daiichi Sankyo’s Benicar was approved by the FDA in 2002 to help treat patients with high blood pressure. It quickly became one of the country’s best-selling hypertension treatments, and has been prescribed to over 11 million patients in the United States. But in 2013, the FDA revealed that a search of its adverse event reporting database “found clear evidence of an association between [Benicar] and sprue-like enteropathy.” Sprue-like enteropathy is a complex of gastrointestinal problems, including severe and chronic diarrhea, vomiting, and weight loss. Accordingly, the agency requested that Benicar and other olmesartan-based drugs carry a warning about the gastrointestinal health risks they pose.

Plaintiffs who have filed Benicar lawsuits want to know why it took more than a decade for the FDA to recognize Benicar’s dangerous side effects. Judging by the number of cases now pending in the New Jersey Benicar multidistrict litigation, a substantial portion of Benicar users must have been experiencing gastrointestinal problems after taking the drug. Benicar lawsuits ask why these side effects were not picked up in post market surveillance by either the FDA or Daiichi Sankyo. Some Benicar lawsuits even allege that results from studies regarding Benicar’s gastrointestinal risks were provided to the FDA on a delayed basis.

Tell your doctor or physician about any medical side effects you are experiencing. If you or someone you know suffered from gastrointestinal problems after taking Benicar, contact the pharmaceutical attorneys at Lopez McHugh now for a free consultation. We can help determine whether a Benicar lawsuit is right for you.