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FDA Should Ax Sale of Medication Linked to Severe Intestinal Disorder

Nov. 15, 2017

FDA Should Ax Sale of Medication Linked to Severe Intestinal Disorder

Keeping Olmesartan on the Market Would Risk Patients’ Lives for Corporate Profits

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should ban the sale of a certain hypertension medication because it can cause life-threatening health risks, Public Citizen said today.

Keeping the medication on the market would continue to put hypertension patients’ lives at risk for the sake of corporate profits, the organization warned.

Public Citizen is petitioning the FDA to stop the sale of olmesartan medoxomil – an angiotensin II receptor blocker (ARB) found in the widely prescribed hypertension medications marketed under the brand names Azor, Benicar, Benicar HCT and Tribenzor, as well as in other generic versions – because it can cause a severe gastrointestinal disorder that leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss.

The condition is called sprue-like enteropathy because of its similarity to sprue or celiac disease – a gastrointestinal illness triggered by gluten ingestion. However, unlike with celiac disease, sprue-like enteropathy does not improve with a gluten-free diet.

The petition noted that with millions of prescriptions for olmesartan-containing medications filled each year, immediately banning the drug is essential to prevent avoidable serious harm to thousands of patients.

In 2012, researchers at the Mayo Clinic published the first study documenting the link between olmesartan use and sprue-like enteropathy. By 2013, the FDA had concluded that olmesartan “can cause” sprue-like enteropathy and issued a safety warning about the medication. However, rather than pulling olmesartan from the market, the agency required only the addition of a weak warning about this risk to the product’s labeling.

Since 2012, numerous studies together have documented more than 150 cases of this disorder in patients worldwide who took this medication. The studies found that most of the patients experienced serious complications – including profound malnutrition and kidney injury – and required hospitalization.

In addition, many other medications exist that are equally effective for treating hypertension and do not pose these risks to patients. In short, the petitioners say, olmesartan “has unique serious risks but no unique benefit.”

“There is overwhelming evidence that olmesartan causes severe sprue-like enteropathy and that the risk of this life-threatening complication is far greater with olmesartan than with the other seven FDA-approved ARBs,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “There is no justification, other than corporate profits, to subject any patient to this danger when there are so many effective but much safer alternatives for treating hypertension.”