The Food and Drug Administration posted information on its website listing the blood pressure medications recalled for containing carcinogens. Here’s what to watch out for.
Macleods Pharmaceuticals Limited on Monday recalled one lot of the blood pressure medication losartan after discovering trace amounts of a probable carcinogen.
The recalled 100 mg/25 mg losartan and potassium/hydrochlorothiazide tablets contained small amounts of N-nitrosodiethylamine, or NDEA, according to a company recall notice shared on the Food and Drug Administration’s website.
Doctors advise affected consumers to continue taking their medication until a pharmacist replaces the drugs or provides another treatment. Discontinuing a recalled drug could cause more immediate harm than staying on the medication.
The active drug ingredient was made at Hetero Labs Limited in India, one of two overseas drug factories linked to repeated blood medication recalls since last July.
The ongoing recalls prompted the U.S. House Committee on Energy and Commerce to ask Food and Drug Administration officials this month about the safety of drugs made overseas.
There have been more than 15 recalls of versions of the blood pressure and heart medications losartan, valsartan and irbesartan that contained trace amounts of NDEA or another probable carcinogen, N-nitrosodimethylamine, or NDMA. The recalled drugs are part of a large class of drugs called angiotensin II receptor blockers, or ARBs, which work by relaxing the blood vessels.
Last month, the FDA downplayed the cancer risk for any person who took valsartan that had small amounts of NDMA. The FDA concluded there would be one more cancer case above average rates for every 8,000 people on the highest dose of valsartan for four years.
In September, the FDA issued an import alert to block products made at Zhejiang Huahai Pharmaceutical in China from entering the United States.
FDA officials said Monday that the agency is reviewing the committee letter and will respond directly to Congressional staff.
FDA Commissioner Scott Gottlieb last week said in a tweet that the FDA has had a “steady increase” in inspections of overseas generic drug plants over the last four years.
He added that the FDA has had a five-fold increase in warning letters to human drug manufacturers.
While the numbers of inspections have varied by country over the past few years, total enforcement actions have increased. This is clear evidence that #FDA‘s risk-based surveillance model is working and our limited inspectional resources are targeted at the higher risk facilities pic.twitter.com/13DhAB2APa
— Scott Gottlieb, M.D. (@SGottliebFDA) February 23, 2019
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