US FDA reveals valsartan impurity caused by reusing solvents
The US Food and Drug Administration (FDA) provided a statement from Scott Gottlieb, commissioner, and Janet Woodcock, direct of the Center for Drug Evaluation and Research, regarding the identification of N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in certain ‘sartan’ medicines.
In the update, the agency noted that it suspects the impurities may be formed “when specific chemicals and reaction conditions are present in the manufacturing process,” and could result from “the reuse of materials, such as solvents.”
The discovery that certain products had been contaminated with the two chemicals known to be probable carcinogens led to a global recall.
As more medicines beyond valsartan have been found to contain the impurities, additional recalls have been issued and the resulting investigation has broadened.
The FDA observed that such recalls have led valsartan products to be in shortage, and that “other types of products may fall into shortage soon.”
Despite the number of recalls and the serious nature of the investigation, the FDA statement aimed to calm any fears over long-term use of the medicine, calling the risk to patients “very small.”
The agency suggested that use of the highest daily dose of valsartan contaminated with NDMA would result in one additional case of cancer per 8,000 patients.
Recalls continue
The same week of the FDA’s statement, Torrent Pharmaceuticals expanded its voluntary recall of losartan potassium tablets to include additional lots of losartan potassium and losartan hydrochlorothiazide tablets.
The recall expansion was made after NDEA was detected in an active pharmaceutical ingredient (API) produced by Hetero Labs and used by Torrent.
Losartan is used to treat hypertension, hypertension patients with left ventricular hypertrophy, and nephropathy in type 2 diabetic patients.
Torrent advised that it had not received any reports of adverse events related to the recall.
