Benicar Enteropathy Problems: Timeline

By Austin Kirk
Posted November 19, 2014

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Over the past decade, millions of people have used the hypertension drugs Benicar, Azor and Tribenzor, which all contain the active ingredient olmesartan.

Last year, the FDA required the Daiichi Sankyo and Forest Laboratories to add new warnings about the risk of serious and potentially life-threatening Benicar side effects, which may cause chronic diarrhea, weight loss and other sprue-like enteropathy problems to develop months or even years after first use of the drug.

While investigating potential Benicar lawsuits, Azor lawsuits and Tribenzor lawsuits for individuals throughout the United States who have experienced enteropathy problems, it appears clear that the drug makers knew or should have known about the link between Benicar and enteropathy for some time, yet withheld information from consumers and the medical community.

Time Line of Benicar Problems

The events and developments leading to the eventual FDA warnings in 2013 highlight a number of missed opportunities to provide information that could have prevented thousands of Benicar users from suffering severe gastrointestinal problems:

• April 2002: The FDA approves Daiichi Sankyo’s Benicar (olmesartan medoxomil) after only a small population, three-month clinical trial. Despite limited evidence establishing that it was safe or effect, the drug maker will push to introduce new drugs containing olmesartan and spend more than $1 billion on promotional advertising of Benicar between its approval and 2008.
• June 2003; The FDA approves Benicar HCT, a combination of Benicar and HCTZ.
• January 2006: Daiichi Sankyo, then Sankyo Pharma, Inc. received an FDA warning letter, complaining that the company was making misleading statements and unsubstantiated claims about Benicar safety and effectiveness.
• September 2007: FDA approves Azor, a combination drug that contains both Benicar and Norvasc. By this time, based on more than five years of data and information on Benicar use, it appears that the drug maker knew or should have known that the medication may be linked to a number of reports involving chronic diarrhea and unsuspected enteropathy. However, Azor was introduced without any new warnings about the risk of gastrointestinal problems.
• June 2010: The FDA warns that diabetics taking Benicar appear to face an increased risk of death.
• July 2010: The FDA approves Tribenzor, a fourth medication containing olmesartan, combining Benicar, HCTZ, and Norvasc. This completes the current “Benicar family” of drugs sold by Daiichi Sankyo, generating more than $1 billion in combined sales in 2010.
• March 2011: The Benicar ROADMAP post marketing study is published. The population of the study was likely too small to clarify and identify the risk of sprue-like enteropathy from Benicar.
• August 2012: A group of independent researchers published a report in the medical journal Mayo Clinic Proceedings, identifying at least 22 Benicar users treated at clinics in 17 different states who experienced chronic diarrhea, weight loss and other symptoms that doctors described as consistent with celiac disease. While celiac disease treatments were ineffective, the researchers noted that once the users stopped taking Benicar, their symptoms improved. The findings raised questions about how a manufacturer generating billions in sales was unable to identify the connection between Benicar and enteropathy problems among users of their drug.
• May 2013: A report published by the American Journal of Gastroenterology described cases involving patients with villous atrophy who tested negative for celiac disease, suggesting that the role of medications in the development of the problems should be investigated further, describing that some patients initially labeled as unclassified sprue were found to have villous atrophy associated with Benicar use.
• July 2013: The FDA issued a drug safety communication (PDF), providing the medical community with the first official warnings about the sprue-like enteropathy risk with Benicar, indicating that users may develop symptoms of severe gastrointestinal problems months or even years after first use of the medication. After reviewing available adverse event reports, which had been available to the drug makers for years, the FDA concluded that there is “clear evidence” of an association between olmesartan and enteropathy.
• November 2013: The FDA again warns Daiichi Sankyo that it is making unsubstantiated and misleading claims about Benicar efficacy and safety.
• June 2014: French researchers presented findings of a large study at the annual Digestive Disease Week, after examining data for more than 4.5 million patients from the French national health insurance plan. Researchers found that while there were 2.6 cases of hospitalization for intestinal malabsorption per 100,000 person years during the first year of Benicar use, that number jumped to 6.7 during the second year and 8.9 for those took the drug longer than two years. By comparison, the same issues for users of other ARB medications only were seen in 1.5 per 100,000 person years after two years, and for patients taking another type of hypertension drug known as ACE inhibitors, the number was 0.9 after the same time period. This provided strong evidence that Benicar enteropathy problems are unique to this family of olmesartan drugs.
• September 2014: The link between severe enteropathy and Benicar was further confirmed in a study published by the medical journal Alimentary Pharmacology and Therapeutics. Out of 36 cases of Benicar-associated enteropathy identified by the researchers, all but four of the cases resulted in villous atrophy, leaving users with long-term damage to the gastrointestinal tract that causes malnutrician, food intolerances and other digestive problems.
• October 2014: In a study published in the Journal of Clinical Pathology, researchers from Columbia University found that only hypertension drugs using the active ingredient olmesartan appear to be linked to cases of sprue-like enteropathy.

Benicar Sprue-Like Enteropathy Lawsuits

Based on mounting evidence about the link between Benicar, Benicar HCT, Azor, Tribenzor and severe enteropathy problems, users of these blood pressure medications who have been hospitalized with chronic diarrhea or suffered other gastrointestinal injury may be entitled to substantial compensation.

It appears that Daiichi Sankyo and Forest Laboratories knew or could have discovered the enteropathy risk with Benicar, yet failed to take steps to make certain that consumers and the medical community were aware of the potential for chronic diarrhea and villous atrophy. Rather than thoroughly testing their drug and evaluating post-marketing adverse event reports, the drug makers pushed to expand use and introduce more drugs with the same active ingredient.

As a result of the failure to warn about the potential side effects of Benicar, Azor and Tribenzor, many users have suffered from enteropathy for years without realizing that the problems may be caused by the medication. The chronic diarrhea and other symptoms of sprue-like enteropathy have left many of these users with permanent gastrointestinal damage known as villous atrophy, which is likely to cause them to experience complications for the rest of their lives.

The Benicar, Azor and Tribenzor lawyers at Saiontz & Kirk, P.A. are providing free consultations and claim evaluations for individuals throughout the United States who suspect that they or a loved one may have a case.

All enteropathy lawsuits are being pursued by our Benicar attorneys under a contingency fee agreement, which means that there are no fees unless a recovery is obtained either through a Benicar settlement or trial. To review a potential claim for yourself, a friend or family member, request a free case review.