Benicar was approved by the Food and Drug Administration in 2002 to help treat high blood pressure, and was aggressively marketed by its manufacturer, Daiichi Sankyo. The company claimed that Benicar was superior to other medications treating high blood pressure, but eleven years after its approval, the FDA warned consumers about serious side effects.
Many patients who took Benicar experienced a serious gastrointestinal condition known as sprue-like enteropathy. It is marked by intestinal problems that include severe, chronic diarrhea coupled with substantial weight loss, the severity of which can sometimes lead to extended hospitalization and lifelong complications.
Many patients that suffered from sprue-like enteropathy after taking Benicar were incorrectly diagnosed with Celiac disease – an allergy to gluten. This caused many patients to suffer from sprue-like enteropathy for years before realizing Benicar was to blame. Benicar has also been shown to cause an increased risk of heart disease, intestinal disease, and birth defects in pregnant women.
For patients who suffer from high blood pressure, management of this condition will last their lifetime. Despite this, the clinical trials that led to Benicar’s approval were only three months long, leaving many to conclude that the trials were not long enough to detect the increased risk of sprue-like enteropathy.
What Benicar lacked in clinical trial data, it made up for in advertising. Between 2002 and 2008, Sankyo reportedly spent $1 billion on advertising. However, this advertising was found to be false and misleading by the FDA who issued a warning letter to the company in 2013. The FDA stated the advertisement contained statistics from an “open-label, uncontrolled trial, which due to lack of placebo control or blinding, does not provide substantial evidence or substantial clinical experience to support the efficacy claims and presentations above.”
Benicar’s serious side effects caused patients to begin filing lawsuits against Sankyo beginning in 2014. Plaintiffs allege the company failed to warn doctors and patients of the risks associated with the drug. The lawsuits are in the very early stages, but it is anticipated more lawsuits will continue to be filed.