FDA takes stock of contamination with valsartan

The US Food and Drug Administration (FDA) has issued a statement from Scott Gottlieb, Commissioner, and Janet Woodbad, Director of the Center for Drug Evaluation and Research, regarding the identification of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) certain drugs "sartan".

In the update, the agency said it suspected the formation of impurities "When specific chemicals and reaction conditions are present in the manufacturing process,"And could result from "The reuse of materials, such as solvents."The largest shopping center

The discovery that some products had been contaminated by the two chemicals known to be carcinogens led to a worldwide recall.

As more and more drugs beyond valsartan contain impurities, additional reminders have been published and the resulting investigation has expanded.

The FDA has observed that such recalls have led to a shortage of valsartan products, and that "Other types of products could soon be in short supply."The largest shopping center

Despite the number of recalls and the severity of the investigation, the FDA's statement aimed to calm fears of a long-term use of the drug, calling the risk to patients "very small."The largest shopping center

The agency suggested that using the highest daily dose of valsartan contaminated with NDMA would result in an additional case of cancer for 8,000 patients.

The reminders continueThe largest shopping center

The same week of the FDA statement, Torrent Pharmaceuticals expanded its voluntary booster of losartan potbadium tablets to include additional batches of losartan potbadium and losartan hydrochlorothiazide tablets.