The Food and Drug Administration posted information on its website listing the blood pressure medications recalled for containing carcinogens. Here’s what to watch out for.
The Food and Drug Administration on Tuesday approved a new generic version of valsartan to alleviate recent shortages of the blood pressure medication following a series of safety recalls.
There have been more than 15 recalls of generic versions of the commonly-prescribed blood pressure and heart medications valsartan, losartan and irbesartan that contained trace amounts of probable carcinogens.
FDA Commissioner Scott Gottlieb said the recalls of valsartan that contained nitrosamine impurities “resulted in a shortage of these important medicines.”
Gottlieb said the agency prioritized review of applications for new generic versions to address the drug’s shortage. The drug’s brand version, Diovan, has not been recalled.
The FDA said it evaluated Alkem Laboratories Ltd.’s manufacturing and testing to verify its valsartan does not contain impurities found in competitors’ recalled blood pressure drugs.
Mumbai, India-based Alkem did not immediately respond to questions about the company’s plans to sell the drug in the United States.
“We hope that today’s approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products,” Gottlieb said.
Gottlieb said the FDA will work with drug manufacturers to ensure other similar blood pressure medications, part of a class of drugs called angiotensin II receptor blockers, or ARBs, are available to consumers.
Drug companies recalled hundreds of lots of valsartan, losartan and irbesartan – alone or in combination with other drugs – after testing revealed the drugs had trace amounts of N-Nitrosodimethylamine, or NDMA. Follow-up testing last fall showed some batches of valsartan also contained another probable carcinogen, N-Nitrosodiethylamine, or NDEA.
More recent recalls revealed a third probable carcinogen – N-Nitroso-N-methyl-4-aminobutyric acid, or NMBA – found in some blood pressure drugs.
On Feb. 28, Camber Pharmaceuticals Inc. recalled 87 lots of losartan that contained small amounts of NMBA, the company said in a recall notice. A day later, Torrent Pharmaceuticals recalled 114 lots of losartan combination tablets that had trace amounts of NMBA.
Consumers can check the FDA’s website for a complete list of the recalled blood pressure drugs.
Doctors advise affected consumers to continue taking their medication until a pharmacist replaces the drugs or provides another treatment. Discontinuing a recalled drug could cause more immediate harm than staying on the medication.
In the wake of its competitors’ recalls, Alembic Pharmaceuticals last July more than tripled the price of 17 of its own formulations of valsartan.
Those price hikes ranged from 329 percent to 469 percent, according to data from the health care analytics firm Elsevier.
Read or Share this story: https://www.usatoday.com/story/news/nation/2019/03/12/fda-approves-generic-valsartan-following-series-safety-recalls/3144040002/