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Benicar labelManufactured by Daiichi Sankyo, Inc., Benicar is approved to treat hypertension (high blood pressure). Nearly one out of every three Americans suffers from this ailment, which if left unchecked can lead to heart attacks, stroke and serious kidney problems.

Olmesartan is a type of angiotensin receptor blocker that functions by relaxing blood vessels. This in turn keeps vessels from constricting, thus improving circulation. The drug is classified as pregnancy category D, indicating it increases risk of fetal and neonatal death. Besides pregnant women, Benicar is not indicated for patients with gallbladder dysfunction or a history of liver problems.

Benicar may be taken alone, or in conjunction with other antihypertensive agents to help control hypertension in adult patients and children ages 6 and older. Benicar HCT, Azor and Tribenzor also contain olmesartan, which has been linked to severe gastrointestinal side effects.

In 2013, the FDA issued a warning about the risk of sprue-like enteropathy – a condition whose symptoms often mimic Celiac disease – in relation to olmesartan exposure. Accordingly, the agency mandated that all products containing olmesartan update their labels to reflect this risk.

Benicar side effects

Treatment with Benicar is generally well-tolerated by most patients, but like any prescription drug, it carries risks of adverse side effects.

Less serious side effects associated with Benicar include:

  • Weakness
  • Muscle or joint pain
  • Nausea
  • Diarrhea
  • Dizziness
  • Stomach pain
  • Rash
  • Hair loss
  • Itchy skin

Patients who experience the following Benicar side effects are urged to seek immediate medical attention:

  • Chest pain
  • Feeling that you might pass out
  • Irregular heart beat
  • Tachycardia
  • Severe vertigo
  • Swelling in the feet or hands (peripheral edema)
  • Problems urinating
  • Persistent diarrhea
  • Myalgia
  • Sudden weight loss

Gastrointestinal problems and Benicar

Since its introduction to the market in 2002, Benicar has become a top-selling drug for Daiichi Sankyo, Inc., with more than 10 million prescriptions dispensed in the United States alone. However, the Japanese-based company is now facing claims by patients who have suffered debilitating gastrointestinal complications, including chronic diarrhea, abdominal pain, extreme weight loss, dehydration and malnutrition.

Since these symptoms are also suggestive of Celiac disease, some patients were misdiagnosed, leading to delayed treatment.

Thanks to pivotal research by Dr. James Murray of the Mayo Clinic, who made the first connection between Benicar and sprue-like enteropathy, medical professionals and the FDA learned of this potential side effect. During his research, Murray found that nearly two-thirds of his 22 patients taking Benicar required hospitalization due to the gravity of their symptoms. All reported dramatic weight loss, with one patient dropping 125 pounds.

Researchers determined that GI problems didn’t always manifest right away, but could start weeks or months after taking olmesartan. Fortunately, most symptoms resolved spontaneously once the drug was discontinued.

Dr. Murray’s team also found that sprue-like enteropathy was solely linked to olmesartan exposure, as patients takin other angiotensin receptor blockers experienced no gastrointestinal effects. The FDA cautions that some patients on olmesartan have shown evidence of villous atrophy, a form a permanent intestinal damage. This basically causes the intestinal lining to atrophy, and can also lead to severe inflammation of the mucous lining.

Signs of sprue-like enteropathy

Patients are advised to look out for symptoms of sprue-like enteropathy, including:

  • Unexplained weight loss
  • Diarrhea
  • Chronic nausea
  • Vomiting
  • Malabsorption of nutrients
  • Dehydration
  • Inflammation of the colon (colitis)

Prior to the 2013 FDA warning and subsequent label change, Benicar patients had no knowledge of this latent GI risk. This serious oversight has left some users with serious health complications, especially those who were diagnosed with villous atrophy. In extreme cases, this intestinal degeneration can allow undigested food to pass into bloodstream, sparking an immune system response. Early detection is key to help prevent long-term complications.

Litigation ensues on heels of FDA Benicar warning

Early 2014 saw the first wave of Benicar lawsuits alleging Daiichi Sankyo and Forest Laboratories designed, manufactured and promoted a dangerous drug without adequate warnings. Many of the plaintiffs detailed multiple ER visits, extended hospital stays and the need for ongoing medical monitoring after taking Benicar. One claimant who suffered intestinal damage as an alleged result of the blood pressure drug must now use a feeding tube.

The complaints also contend that the defendants were aware of gastrointestinal side effects before the FDA communication, but continued to promote Benicar in a misleading manner to minimize references to potential health risks.

In April of 2015, the Judicial Panel on Multidistrict Litigation (JPML) decided to coordinate suits before Judge Robert Kugler in the District of New Jersey. The transfer order included 15 claims, with more than 20 potential tag-along actions. All of the cases allege serious gastrointestinal injury from Benicar, and call to question the marketing and labeling of the product. The purpose of centralizing individual claims before one judge is to help avoid inconsistent pretrial rulings and allow both parties to share in the discovery process and hopefully facilitate a more speedy resolution.

Benicar multidistrict litigation (MDL 2606) is expected to grow substantially over the next year, as more injured patients seek legal counsel to protect their interests. Individuals who believe they have a potential claim for damages against Daiichi Sankyo may still file suit, but statutes of limitations do apply to all personal injury cases.

  1. FDA, Olmesartan (marketed as Benicar) Information

  2., FDA Adds GI Warning to Benicar Label,

  3., What is Benicar?

  4. PubMed, (Mayo Clinic) Severe sprue like enteropathy associated with olmesartan.