Hypertensive patients may take contaminated tablets during valsartan shortage, says FDA

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Since July, separate lots of angiotensin II receptor blockers, or ARBs, have been removed from the shelves of pharmacies due to the manufacture of impurities.

Some of these drugs, containing valsartan, losartan or irbesartan as the active pharmaceutical ingredient, had been contaminated with nitrosamines, the FDA reported. Nitrosamines, which can be introduced unintentionally when certain chemical reactions are used in the production process, present a risk of cancer.

The FDA has worked with manufacturers to identify and recall the contaminated pills that have been sent to the market while keeping pharmacies and patients informed. The resultant drug shortages led the agency to adopt more flexible quality and safety standards.

Last month, for example, the FDA did not oppose that some manufacturers temporarily distribute contaminated losartan pills to ensure continued access to the drug until the elimination of the drug. 39; impurity.
Thursday's statement reaffirms this position but focuses on patients. Scott Gottlieb, Commissioner of the FDA, and Janet Woodcock, Director of the FDA's Center for Evaluation and Drug Research, said that they had carefully evaluated the safety data, weighed the risks and estimated " that it is essential that patients have access to these drugs while impurities – free losartan is manufactured. "

"Our scientists believe that the cancer risk will not be significantly increased for the time needed to market losartan without impurities," wrote Gottlieb and Woodcock. "We want to reassure patients by making them believe that risks, such as stroke, from abrupt discontinuation of these important medications far outweigh the low risk associated with continuing treatment containing these. impurities. "

The drug recall for the heart has further increased

Since the discovery of the first impurity of nitrosamine last summer, the FDA has identified 40 drugs that do not contain nitrosamine, the statement said. And it is expected that this number will only increase, but in the meantime, the agency recommends that patients continue to take the available tablets, if they are contaminated.

Losartan was the 9th most-dispensed drug in the country, according to 2016 data. Valsartan had number 92 and irbesartan, number 171, according to Maisha Kelly Freeman, professor and director of the Center for Research on HIV. 39 Health Care Innovation and Outcomes for Patients of Samford University.

In a single year, 49 million patients were dispensed losartan, 8 million valsartan and 3 million irbesartan, said Freeman, noting that the 60 million US patients do not include hospitals or the AV system , but only patients purchased in community pharmacies. These are physical operations supervised by pharmacists and include chain stores but not hospital or online pharmacies.

FDA approves new generic valsartan to make up for drug shortage

In short, the risk of cancer in these many patients seems low. "If 8,000 patients take a contaminated product over a four-year period, only one will develop cancer," said Freeman. "It's the worst case scenario if someone took the product concerned each time he filled it."

Patients involved in the recall may not have taken a contaminated product continuously, as pharmacies often buy the same drug from different manufacturers, she explained.

The FDA maintains that "even if they learn that their ARAB medication is being recalled," patients should continue to take their medications until their doctor or pharmacist offers them a different treatment option or treatment safe replacement.

"We will continue to give priority to our investigation of this ongoing problem," concluded Gottlieb and Woodcock. "This will remain an area of ​​intense concentration in the coming months."

The agency expects manufacturers to rebuild their stocks of uncontaminated antihypertensive drugs by about six months ago, they said.

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