March 24, 2019

Blood stress drug recall expands over third attainable carcinogen

05 March 2019, 10:44 | Silvia Roy

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Doctor measuring patient's blood pressure

N-Nitroso-N-methyl-4-aminobutyric acid or NMBA was identified by the FDA in a news release announcing a voluntary recall by Camber Pharmaceuticals Inc. after it had detected trace amounts of the impurity in the drugs, though the company was not aware of any adverse effects from the recalled batch.

The impurity in the AurobindoPharma USA products is N-nitrosodiethylamine (NDEA), which is classified as a "probable human carcinogen".

United States health regulators said on Friday a third cancer-causing toxin was found in some blood pressure pills recalled by India's Hetero Labs Ltd a day earlier, adding to a global recall of commonly used drugs to treat hypertension.

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Gottlieb said the agency is "deeply concerned about the presence of a third nitrosamine impurity" in hypertension drugs and is working on "novel and sophisticated testing methods" to detect these impurities. The recalled medication is half of a giant class of medicine referred to as angiotensin II receptor blockers, or ARBs, which work by enjoyable the blood vessels. That said, any presence of such impurities in drug products is not acceptable.

He added: "Our ongoing effort has determined that the impurities may be generated by specific chemical reactions in the manufacturing process of the drug's active pharmaceutical ingredients".

"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.

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There are FDA safeguards in place to prevent drug contamination, Maisha Kelly Freeman, a professor and director of Samford University's Center for Healthcare Innovation and Patient Outcomes Research, said this week. However, there's a catch. Other people are getting their prescriptions changed. The company also makes losartan for other Indian drugmakers, including Torrent Pharmaceuticals Ltd. and Macleods Pharmaceuticals Ltd., that has been recalled for containing NDEA.

But patients should speak with their doctor to discuss the recall before they stop taking the drug.

Since then, generic drugmakers such as Mylan NV, Teva Pharmaceutical and Novartis' Sandoz have recalled products containing the tainted ingredients.

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