Benicar Enteropathy Problems: Timeline

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Benicar Enteropathy Problems: Timeline

Austin Kirk

November 19th, 2014by Austin Kirk

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

Last year, the FDA required the Daiichi Sankyo and Forest Laboratories to join new warnings about the risk of weighty and potentially life-threatening Benicar faction effects, which may cause chronic diarrhea, ponderosity loss and other sprue-like enteropathy problems to advance in successive months or even years after first use of the drug.

While investigating possible Benicar lawsuits, Azor lawsuits and Tribenzor lawsuits as far as concerns individuals throughout the United States who be obliged experienced enteropathy problems, it appears unblemished that the drug makers knew or should esteem known about the link between Benicar and enteropathy with respect to some time, yet withheld information from consumers and the healing community.

Time Line of Benicar Problems

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

April 2002: The FDA approves Daiichi Sankyo’s Benicar (olmesartan medoxomil) subsequent only a small population, three-month clinical endeavor. Despite limited evidence establishing that it was sure or effect, the drug maker will push to introduce new drugs containing olmesartan and part with more than $1 billion on promotional advertising of Benicar betwixt its approval and 2008.

June 2003; The FDA approves Benicar HCT, a combination of Benicar and HCTZ.

January 2006: Daiichi Sankyo, in that case Sankyo Pharma, Inc. received an FDA admonitory letter, complaining that the company was structure misleading statements and unsubstantiated claims nearly Benicar safety and effectiveness.

September 2007: FDA approves Azor, a union drug that contains both Benicar and Norvasc. By this time, based on more than five years of premises and information on Benicar use, it appears that the unsalable article maker knew or should have known that the medication may subsist linked to a number of reports involving inveterate diarrhea and unsuspected enteropathy. However, Azor was introduced out of any new warnings about the danger of gastrointestinal problems.

June 2010: The FDA warns that diabetics seizing Benicar appear to face an increased danger 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 ~ means of Daiichi Sankyo, generating more than $1 billion in combined sales in 2010.

March 2011: The Benicar ROADMAP intelligencer marketing study is published. The number of people of the study was likely too small to clarify and identify the danger of sprue-like enteropathy from Benicar.

August 2012: A assemblage of independent researchers published a statement in the medical journal Mayo Clinic Proceedings, identifying at minutest 22 Benicar users treated at clinics in 17 diverging states who experienced chronic diarrhea, measure loss and other symptoms that doctors described of the same kind with consistent with celiac disease. While celiac indisposition treatments were ineffective, the researchers illustrious that once the users stopped anger Benicar, their symptoms improved. The tools and materials raised questions about how a manufacturer generating billions in sales was powerless to identify the connection between Benicar and enteropathy problems mixed 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 as antidote to celiac disease, suggesting that the role of medications in the development of the problems should be investigated more remote, describing that some patients initially labeled for example unclassified sprue were found to be favored with villous atrophy associated with Benicar application.

July 2013: The FDA issued a deaden with narcotics safety communication (PDF), providing the therapeutic community with the first official warnings approximately the sprue-like enteropathy risk through Benicar, indicating that users may make known symptoms of severe gastrointestinal problems months or flat years after first use of the medication. After reviewing suitable adverse event reports, which had been advantageous to the drug makers for years, the FDA concluded that in that place is “clear evidence” of an association between olmesartan and enteropathy.

November 2013: The FDA once more warns Daiichi Sankyo that it is fabrication unsubstantiated and misleading claims about Benicar vigor and safety.

June 2014: French researchers presented tools and materials of a large study at the occurring every year Digestive Disease Week, after examining data for more than 4.5 very great number patients from the French national soundness insurance plan. Researchers found that while there were 2.6 cases of hospitalization during the term of intestinal malabsorption per 100,000 character years during the first year of Benicar use, that number jumped to 6.7 for the period of the second year and 8.9 in spite of those took the drug longer than pair years. By comparison, the same issues despite users of other ARB medications merely were seen in 1.5 through 100,000 person years after sum of ~ units years, and for patients taking one more type of hypertension drug known while ACE inhibitors, the number was 0.9 in the rear of the same time period. This granted strong evidence that Benicar enteropathy problems are unmatched to this family of olmesartan drugs.

September 2014: The fasten between severe enteropathy and Benicar was more distant confirmed in a study published ~ means of the medical journal Alimentary Pharmacology and Therapeutics. Out of 36 cases of Benicar-associated enteropathy identified ~ the agency of the researchers, all but four of the cases resulted in villous gradual wasting, leaving users with long-term loss to the gastrointestinal tract that causes malnutrician, sustenance intolerances and other digestive problems.

October 2014: In a study published in the Journal of Clinical Pathology, researchers from Columbia University place that only hypertension drugs using the stirring ingredient olmesartan appear to be linked to cases of sprue-like enteropathy.

Benicar Sprue-Like Enteropathy Lawsuits

Based in successi~ mounting evidence about the link betwixt Benicar, Benicar HCT, Azor, Tribenzor and serious enteropathy problems, users of these posterity pressure medications who have been hospitalized through chronic diarrhea or suffered other gastrointestinal mischief may be entitled to substantial reparation.

It appears that Daiichi Sankyo and Forest Laboratories knew or could receive discovered the enteropathy risk with Benicar, over and above failed to take steps to operate certain that consumers and the healing community were aware of the potential for chronic diarrhea and villous emaciation . Rather than thoroughly testing their physic and evaluating post-marketing adverse affair reports, the drug makers pushed to dilate use and introduce more drugs through the same active ingredient.

As a conclusion of the failure to warn concerning the potential side effects of Benicar, Azor and Tribenzor, frequent users have suffered from enteropathy concerning years without realizing that the problems may be caused by the medication. The deep-seated diarrhea and other symptoms of sprue-like enteropathy bring forth left many of these users by permanent gastrointestinal damage known as villous marasmus, which is likely to cause them to actual presentation complications for the rest of their lives.

The Benicar, Azor and Tribenzor lawyers at Saiontz & Kirk, P.A. are providing enfranchise consultations and claim evaluations for individuals from first to last the United States who suspect that they or a loved the same may have a case.

All enteropathy lawsuits are vital principle pursued by our Benicar attorneys in the state a contingency fee agreement, which the wherewithal that there are no fees unless a recovery is obtained either end a Benicar settlement or trial. To retrospect a potential claim for yourself, a dear companion or family member, request a ready case review.

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