FDA declares list of 40 nitrosamine-free valsartan and ARB class drugs

By PharmaCompass

2019-04-11

Impressions: 513

For the first time since the first nitrosamine impurity was discovered in the summer of last year, the United States’ Food and Drug Administration (FDA) published a list of currently marketed blood pressure medicines belonging to the drug class of angiotensin receptor blockers (ARB), which are now considered safe for patient use.

These 40 ARB drugs present in FDA’s new list include valsartan and losartan which have undergone analysis of overall nitrosamine content and have been determined as being free of nitrosamines, or genotoxic impurities that can potentially cause cancer.

The agency said the assessment is based on the particular batches/lots of drugs tested by the FDA along with the information provided by applicants and active pharmaceutical ingredient (API) suppliers.

On the whole, the FDA tested ARB drugs by focusing on the analysis of the API and the highest dosage strength available from firms making drug products for the US market.

Until now, FDA had placed some of the ARB drugs under recall for containing nitrosamine impurities such as N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and the recently found N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).

The measure to qualify sartan drugs as ‘safe’ is being seen as an effort to curb drug shortages of losartan and valsartan. Patients with high blood pressure face the life-threatening risks of suffering a heart disease and stroke in the event of not taking their medications on time.

Outgoing FDA Commissioner, Scott Gottlieb, and the Director of the Center for Drug Evaluation and Research, Janet Woodcock, said in a statement: “We want to reassure patients that we strongly believe the risks, such as stroke, of abruptly discontinuing these important medicines far outweighs the low risk associated with continuing the medications with these impurities.”

The PharmaCompass Newsletter – Sign Up, Stay Ahead

Feedback, help us to improve. Click here

Image Credit : #Phisper Infographic by SCORR MARKETING & PharmaCompass is licensed under CC BY 2.0

“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

NEWS

DRUGS & DEVELOPMENTS

MARKET INTEL by PharmaCompass