FDA approves anti-high blood pressure drug with recalls

WEDNESDAY, March 13, 2019 (HealthDay News) – The US Food and Drug Administration on Tuesday approved a new generic version of valsartan, a medicine for high blood pressure and heart failure, pointing out that this decision could help alleviate the current shortage of drugs.

The agency said that it gave priority to the review of drug Alkem Laboratories Ltd. after several reminders of supplies of generic drugs exhausted in valsartan.

These recalls have occurred as it has been discovered that certain lots of angiotensin II receptor antagonist drugs (ARBs) containing valsartan contain trace amounts of carcinogens called nitrosamines.

"We know that ongoing recalls aimed at preventing certain lots of valsartan containing unacceptable limits of impurities from reaching patients have resulted in a shortage of these important drugs," said Dr. Scott Gottlieb, Commissioner of Veterinary Medicine. the FDA, in a press release.

"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.

ARA medications relax the blood vessels, allowing the heart to pump more easily.

In the case of this new generic drug, the FDA stated that it evaluated the company's manufacturing process to ensure that there was no risk of impurity formation in the company. nitrosamine. The agency also confirmed that she had used proper testing methods to prove that the newly approved generic valsartan was not contaminated.

The FDA said it was continuing its research on drugs containing ARB containing nitrosamine impurities and not meeting the agency's quality standards.

In addition, the agency "will continue to work with manufacturers so that more drugs like valsartan (…) can be approved without nitrosamine impurities in order to continue addressing this persistent shortage," said Gottlieb.

Based on ongoing testing, the FDA continues to update lists on its website of recalled products of Valsartan, Losartan and Irbesartan. Patients who take an ARB medication should check the listings periodically because the information may change, the agency noted.

And do not panic because not all ARA medications have been recalled. In addition, experts suggest that patients can talk to their doctor about alternative medicines.

More information

The US Food and Drug Administration has more information on impurities in some generic BRA products.