WASHINGTON, D.C. — The Food and Drug Administration said that the recall of Losartan drugs must be expanded after detection of the carcinogen NMBA. The FDA, in its announcement, said the Torrent Pharmaceuticals manufacturers the recall high blood pressure medication. Fox News said that there are only small amounts of the carcinogen found. The UPI said that this recall is the fifth expansion of the original recall in 2019. Torrent Pharmaceuticals voluntarily recalled three lots of Losartan Potassium Tablets USP and two lots of Losartan Potassium/hydrochlorothiazide tablets USP. Each of the drugs treats patients with high blood pressure who also may have other heart ailments but who also have Type-2 diabetes.
Torrent said that it is recalling all of its Losartan products that contain traces of NMBA, or N-Methylnitrosobutyric acid, that exceed allowable daily limits of the suspected carcinogen according to FDA guidelines. Torrent found the trace amounts by testing some of their product. A company called Hetero Labs Limited manufactured the active ingredient of Losartan. It was in this ingredient in which NMBA was detected.
The FDA counseled patient not to stop taking their medications without first speaking with their doctor or pharmacist about a suitable substitution for their dose of Losartan. The FDA conceded that stopping the course of prescribed medication without first having an alternative plan in place is more dangerous to the patient than taking the Losartan drug itself. Patients are free to return their medication to their doctor or pharmacist after a suitable substitution plan is in place.
Torrent Pharmaceuticals Limited is contacting distributors, doctors, and pharmacists to warn them about the expanded Losartan recall. Patients who experience adverse effects after taking these products should consult their physicians immediately. The UPI reported that a study of 5,000 patients taking medications with trace levels of NMBA in them experienced no greater risk of developing cancer in the short term.
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