Macleods Pharmaceuticals Limited on Monday recalled a portion of the blood pressure medication losartan after detecting traces of a likely carcinogen. Reminished 100 mg / 25 mg losartan and potassium / hydrochlorothiazide tablets contain small amounts of N-nitrosodiethylamine or NDEA, according to a company announcement shared on the Food and Drug Administration website.
Doctors advise affected users to continue taking their medications while the pharmacist exchanges medicines or offers no other treatment. Cessation of a recalled medicine can cause more immediate harm than staying on the medicine.
The ongoing reminders have prompted the US Energy and Commerce Commission to ask the staff of the Food and Drug Administration this month for the safety of drugs produced abroad. There were more than 15 calls to versions of blood pressure medications and the heart of losartan, valsartan and irbesartan that contained traces of NDEA or other probable carcinogen, N-nitrosodimethylamine or NDMA. Reminded medicines are part of a large class of medicines called angiotensin II receptor blockers or antiretroviral agents that act by relaxing blood vessels. More: Do you have high blood pressure? More: FDA: Carcinogens of the blood pressure medicine have not been detected for four years, the risk of cancer is small FDA: The carcinogens of the blood pressure medicine have not been discovered for four years, the risk of cancer is small
Last month, the FDA lowered the risk of cancer for any person who received valsartan with small amounts of NDMA. The FDA concluded that there would be another cancer case over the average for every 8000 of the highest dose of valsartan for four years.
In September, the FDA issued an import warning to block products manufactured in Zhejiang Huahai Pharmaceutical in China to enter the United States.
FDA Commissioner Scott Gottlieb last week said in a tweet that the FDA had a "steady increase" in inspections of generic drug companies abroad over the past four years.
He added that the FDA had a fivefold increase in warning letters to drug makers.
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