FDA Tentatively Approves Benicar Generic

The FDA has recently tentatively approved a generic form of Benicar. Benicar, or olmesartan medoxomil, is used to treat high blood pressure. The tentative approval comes just days before the three year anniversary of the FDA’s warning that Benicar may cause sprue-like enteropathy.

In July of 2013, the FDA announced that Benicar could cause severe, chronic diarrhea and extreme weight loss – symptoms of sprue-like enteropathy. The side effects may be so dangerous that hospitalization is benicar injury lawyerrequired. Often, these side effects begin after years of Benicar use. The tentative approval can become official after the patent on Benicar expires on October 25, 2016. The new generic, olmesartan medoxomil, will provide a cheaper alternative but may still cause some of the same problems as Benicar. Federal stipulations require all generic drugs to carry the same warning labels as their name brand counterparts. Thanks to the FDA’s 2013 Safety Communication regarding Benicar, the new generic will properly warn consumers of any possible side effects.

The FDA confirms a “clear” connection between intestinal problems and Benicar.

The FDA’s evaluation of Benicar found “clear evidence of an association between olmesartan and sprue-like enteropathy.” The agency found 23 serious cases in the FDA’s Adverse Event Reporting System (FAERS) of late-onset diarrhea with significant weight loss. All patients improved after discontinuing olmesartan. A similar Mayo Clinic study found sprue-like enteropathy associated with olmesartan in 22 cases. 18 of those cases showed recovery or improvement after discontinuation of olmesartan.

If you or your loved one has taken Benicar and suffered chronic diarrhea, extreme weight loss, vomiting, or malnutrition, you may have a claim eligible for compensation. Contact the Hollis Law Firm today at (800) 701-3672 for a free Benicar lawsuit review. All information shared with the Hollis Law Firm is confidential and obligation free.