Blood pressure drug recall expands over third possible carcinogen

FDA recalls another blood pressure medication over concerns of cancer-causing ingredients

FDA recalls another blood pressure medication over concerns of cancer-causing ingredients

USA health regulators said on Friday a third cancer-causing toxin was found in some blood pressure pills recalled by India's Hetero Labs a day earlier, adding to a global recall of commonly used drugs to treat hypertension. The recall is due to an "impurity" that is classified as a potential human carcinogen.

Camber Pharmaceuticals voluntarily recalled an additional 87 lots of Losartan potassium drugs used to treat high blood pressure and congestive heart failure Thursday.

None of the companies have received reports of "adverse events" related to the recalls.

The U.S. Food and Drug Administration weighed in on the recalls of multiple generic angiotensin II receptor blocker, or ARB, drugs, on Friday, saying the impurities may be the result of chemical reactions that occur in the drugmaking process or from the reuse of materials, such as solvents.

A Bloomberg investigation found that an FDA inspector had raised concerns at the factory that made the valsartan in May 2017. The impurity in the Torrent Pharmaceuticals products is N-Methylnitrosobutyric acid (NMBA), a "potential human carcinogen", which was found in an active pharmaceutical ingredient used in the medication.

"FDA scientists have developed novel and sophisticated testing methods specifically created to detect and measure N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) impurities in [angiotensin II receptor blocker (ARB)] medicines", Gottlieb wrote.

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The FDA said the increased risk of cancer in patients exposed to the new impurity, NMBA, appeared to be the same as those exposed to NDMA, but less than the risk from NDEA.

Maisha Kelly Freeman, a professor and director of Samford University's Center for Healthcare Innovation and Patient Outcomes Research, told CNN that the impurities in the medications were only found after production because the agency wasn't aware of the potential for active ingredients to form a compound that would produce the carcinogen.

The previous recalls of Losarta, Valsartan or Irbesartan involved too much N-Nitrosodiethylamine (NDEA) or N-nitrosodimethylamine (NDMA).

"We are making important strides at understanding how these impurities form and we are continuing to examine if nitrosamine impurities may also arise during the manufacture of other ARB drug products", Gottlieb wrote. However, there's a catch. Other people are getting their prescriptions changed.

AurobindoPharma USA announced its voluntary recall on Friday of 38 lots of medication that included tablets of valsartan and another in which valsartan is combined with amlodipine.

The FDA warns that consumers should contact their doctor before stopping any medication. The recalled products vary in dosage from 40 mg to 320 mg, and have expiration dates that range from October 2019 to July 2020.

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