The Food and Drug Administration (FDA) has ordered that two generic blood pressure drugs be removed from shelves, after its US counterpart found new potentially carcinogenic impurities in them.
The first, Losacar 50 Tablets (50mg), is made by Hetero Labs Ltd in India and is distributed by Chi Fu Trading Company (吉富貿易有限公司), the FDA said in a news release on Saturday night, adding that about 2.18 million of the tablets had been imported.
The second, Hysartan FC Tablets 50mg/12.5mg, is made by Anxo Pharmaceutical Co (瑩碩生技醫藥) in Taiwan, which had used Losacar from Hetero Labs in about 66 of its batches, or 29.7 million tablets, it said.
Photo: Wu Liang-yi, Taipei Times
Hetero Labs announced a recall of its tablets after tests showed that they contained n-nitroso-n-methyl-4-aminobutyric acid, a known animal and potential human carcinogen.
The recall was the latest in an ongoing investigation into angiotensin receptor blockers (ARBs, also known as sartans), which are used to treat conditions such as high blood pressure and heart failure.
SUSPECT DRUGS
In July last year, many ARB medications from companies around the world were recalled, as they were found to contain impurities that are suspected carcinogens: n-nitrosodimethylamine and n-nitrosodiethylamine.
The FDA said it has asked Hetero Labs to confirm whether the batches imported into Taiwan were from the lots that might have been contaminated, adding that it would also test samples of the drugs that are being removed from shelves.
It urged people who are taking the affected drugs not to suddenly stop taking them, but consult their doctor to discuss alternative drugs.
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