For more information or confidential assistance
Call 516.741.5600

Benicar Side Effects

female patient with doctor Benicar is a drug that has been used to treat hypertension in the U.S. for more than a decade. It is classified as an angiotensin II receptor antagonist drug that works by blocking a substance in the body that leads to the tightening of blood vessels. Benicar is used to lower blood pressure and prevent narrowing of blood vessels that impedes blood flow. Also known by its generic name olmesartan, the drug has been shown to improve blood flow, which in turn reduces blood pressure to healthy levels.

Benicar has been approved by the FDA to treat patients as young as six who have been diagnosed with hypertension. It may be prescribed alone or in conjunction with other blood pressure-lowering medications. The drug is manufactured by the Japanese pharmaceutical company Daiichi Sankyo and was approved for use in the U.S. by the FDA in 2002.

Side effects of Benicar

Since its introduction to the U.S. market, Benicar has been linked to a number of common side effects, including:

  • Dizziness
  • Skin irritation and rash
  • Stomach pain
  • Back and muscle pain

Atypical side effects of the drug include:

  • Blood in urine
  • Ear and nasal congestion
  • Sneezing and runny nose
  • Sore throat and headache
  • Fever
  • Tightness in chest
  • Body aches or significant fatigue

The drug also has a black box warning for fetal toxicity. The FDA warns that taking olmesartan while pregnant could lead to serious injury of the fetus. Women are strongly advised not to take Benicar while pregnant and if they become pregnant while taking the drug, it should be discontinued immediately under a doctor’s supervision.

Benicar and gastrointestinal problems

One of the most serious Benicar side effects reported involves gastrointestinal problems that closely resemble Celiac disease. Celiac disease stems from a wheat allergy that usually requires a gluten-free diet to manage. Common symptoms of the condition include abdominal pain, diarrhea and drastic weight loss.

Despite experiencing symptoms comparable to Celiac disease, many patients experiencing these side effects from Benicar test negative for the condition. This leads to a diagnosis of sprue-like enteropathy, which only appears to be relieved when patients stop taking the hypertension drug. Unfortunately, many of these patients have required hospitalization to manage their symptoms, due to significant weight loss and dehydration.

Warnings by Mayo Clinic and FDA

In 2012, the Mayo Clinic published a study that showed a potential association between olmesartan and sprue-like enteropathy. Researchers looked at 22 patients taking olmesartan that also reported symptoms including chronic diarrhea, vomiting, intestinal inflammation, and weight loss. All of the patients were seen at the Mayo Clinic in Rochester, Minnesota, between August 1, 2008, and August 1, 2011. In all of these cases, Celiac disease was effectively ruled out and patients saw no relief from their symptoms by following a gluten-free diet. In fact, 14 of the patients had to be hospitalized for their symptoms.

Through their study, researchers determined that use of olmesartan could be directly related to sprue-like enteropathy. They also found that suspension of the drug could lead to full cessation of symptoms. Patients that stopped taking olmesartan also began to put weight back on that was lost while their condition was symptomatic.

The Mayo Clinic findings preceded a warning by the Food and Drug Administration (FDA) in July 2013, which involved changes to the packaging of olmesartan products, including Benicar, Benicar HCT, Tribenzor, Azor, and generic versions of the drug. The agency stated that use of olmesartan could lead to intestinal problems known as sprue-like enteropathy, which could require hospitalization for proper treatment. In addition, the FDA committed to continued evaluations of Benicar risks, while reserving its right to take further action in the future, if warranted.

Benicar litigation continues to mount

In the meantime, patients who have been injured unknowingly by Benicar have begun filing lawsuits against Daiichi Sankyo. Allegations include serious side effects like those listed above. Some patients did not begin experiencing their symptoms until months or even years after taking the drug. In addition, plaintiffs are stating that Daiichi Sankyo failed to provide proper warning about the side effects, leaving some patients vulnerable to potential injuries associated with Benicar use.

As the number of Benicar lawsuits continues to grow, federal cases have been coordinated into multidistrict litigation. Multidistrict litigation is often established when there are multiple cases involving common allegations against a single defendant. The purpose of an MDL is to coordinate early trial proceedings and reduce judicial burdens.

The MDL for Benicar lawsuits has been assigned to U.S. District Court for the District of New Jersey, where they are currently overseen by the Honorable Judge Robert Kugler. In April 2015, when the MDL was first established, 15 lawsuits from six states were transferred and the court was aware of 23 other tag-along cases. Plaintiffs in these complaints are all alleging use of olmesartan led to gastrointestinal injuries, such as sprue-like enteropathy and colitis.

The plaintiffs are seeking damages from the defendants, including:

  • Pain and suffering
  • Emotional distress
  • Medical expenses (past, present and future)
  • Lost wages

It is uncertain at this time how many cases will eventually join the Benicar MDL. In the meantime, those with lawsuits now pending are awaiting their day in court to pursue damages for their injuries, medical bills and other non-economic losses.