Valsartan belongs to a class of drugs called Angiotensin II Receptor Antagonist and is used to treat high blood pressure (Hypertension), and Congestive heart failure.
Diovan (Valsartan) was manufactured by Novartis International AG and was approved by the FDA on August 14, 2002. Diovan lost its patent in September 2014. The launch of the generic drug had been on hold since patent expiry due to regulatory problems with the FDA. In 2014, a US-based Ohm Laboratories (Ohm), a subsidiary of Ranbaxy Laboratories, was the first to get the approval from FDA for generic Valsartan. Thereafter, many generic versions of Valsartan came into the market via many other pharma companies.
The usage of Diovan had no evidence of any adversity in its entire span, but the FDA did find that the generic versions of Valsartan were causing issues. The most serious issue reported was that it had the presence of an impurity called N-Nitrosodimethylamine (NDMA), which was believed to be formed as a byproduct through a chemical reaction. Not only was this an impurity, but a concern was also raised when it was detected that NDMA is carcinogenic and can lead to cancer in people consuming this drug for the long term.
Immediately, the FDA called for its largest recall of Class I drug, Valsartan on 13 July 2018. The following manufacturers recalled their Valsartan containing drugs.
Medicine Company Valsartan – Major Pharmaceuticals
Valsartan – Solco Healthcare
Valsartan – Teva Pharmaceuticals Industries Ltd
Valsartan/Hydrochlorothiazide (HCTZ) – Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ) – Teva Pharmaceuticals Industries Ltd
The exact nature of injuries and its effects on the human body is still being studied to derive any strong conclusions. Meanwhile, patients consuming these generic drugs and facing injuries are advised to come ahead.
Along with Valsartan, there are other generic drugs belonging to the same class which can come under the FDA radar due to similar issues, which are: