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The Food and Drug Administration has published information on its website listing the antihypertensive drugs recalled for their combination with carcinogens. Here's what to watch for.
UNITED STATES TODAY & # 39; HUI

The Food and Drug Administration on Tuesday approved a new generic version of valsartan to address recent shortages of blood pressure medications after a series of safety reminders.

More than 15 recalls of generic versions of valsartan, losartan and irbesartan, commonly prescribed for the treatment of blood pressure and heart, which contained trace amounts of potentially carcinogenic substances.

FDA commissioner Scott Gottlieb said the reminders of valsartan containing impurities of nitrosamine "have resulted in a shortage of these important drugs."

Mr Gottlieb said the agency was giving priority to reviewing applications for new generic versions to address the drug shortage. The brand version of the drug, Diovan, has not been recalled.

The FDA has stated that it has evaluated the manufacturing and testing of Alkem Laboratories Ltd. to verify that his valsartan contained no impurities found in the drugs for the treatment of high blood pressure recalled by his competitors.

Alkem, based in Mumbai, India, did not immediately answer questions about the company's plans to sell the drug in the United States.

"We hope that today's approval of this new generic drug will help reduce the shortage of valsartan, and we remain committed to taking steps to prevent the formation of these impurities in the future." process of making drugs for existing and future products, "said Gottlieb.

Mr Gottlieb said the FDA would work with drug manufacturers to ensure that other similar drugs for hypertension, being part of a class of drugs called receptor antagonists of the Angiotensin II, or ARA, is available to consumers.

More: A committee of the House wants to know why foreign-made hypertension drugs contain carcinogens

More: FDA: Carcinogenic substances for high blood pressure have not been detected for four years, cancer risk is low

More: Medicines Recall Against Hypertension: FDA Investigates Foreign Plants Producing Drugs Containing Carcinogenic Impurities

The pharmaceutical companies recalled hundreds of lots of valsartan, losartan and irbesartan – alone or in combination with other drugs – after tests revealed that these drugs contained traces of N-Nitrosodimethylamine, or NDMA. Follow-up tests conducted last fall showed that some lots of valsartan also contained another probable carcinogen, N-Nitrosodiethylamine or NDEA.

More recent recalls have revealed the presence of a third probable carcinogen – N-nitroso-N-methyl-4-aminobutyric acid, or NMBA -, which is found in some anti-cancer drugs. # 39; hypertension.

On February 28, Camber Pharmaceuticals Inc. recalled 87 batches of losartan containing small amounts of NMBA, the company said in a recall. A day later, Torrent Pharmaceuticals recalled 114 batches of losartan tablets containing traces of NMBA.

Consumers can check the FDA website for a complete list of medications for the treatment of high blood pressure.

Physicians advise the concerned consumers to continue taking their medications until a pharmacist replaces them or offers them another treatment. Stopping the treatment of a recalled drug could cause more immediate damage than maintaining the drug.

Following the recalls of its competitors, Alembic Pharmaceuticals more than tripled last July the price of 17 of its own formulations of valsartan.

These price increases ranged from 329% to 469%, according to data from the Elsevier Health Analysis Company.

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