Blood pressure drug recall: Teva pulls losartan tablets tainted with possible carcinogen
Teva Pharmaceuticals this week expanded its recall of losartan potassium tablets after detecting a possible human carcinogen in the blood pressure medication.
The Israel-based drugmaker recalled six more lots of losartan potassium that contained unacceptable levels of a nitrosamine impurity. In April, Teva pulled 35 lots of the drug after detecting the same impurity, N-Nitroso-N-methyl-4-aminobutyric acid, or NMBA.
Teva sold bulk lots of the drug to California-based Golden State Medical Supply, which packaged and shipped the medication to pharmacies in bottles that contain 30, 90 and 1000 tablets, according to a recall notice shared by the U.S. Food and Drug Administration.
Consumers affected by the recall should continue taking their medication and ask their doctor or pharmacist about alternatives or replacement drugs. Discontinuing a medication without a replacement could cause a patient more harm than continuing the drug.
Since July, two dozen drug companies have recalled hundreds of lots of commonly-prescribed blood pressure and heart medications losartan, valsartan and irbesartan after testing revealed some versions had small amounts of suspected carcinogens. The recalls of the class of drugs called angiotensin II receptor blockers (ARBs) have highlighted the complex international drug supply chain with 80 percent of drug ingredients consumed by U.S. residents made at factories overseas.
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Teva said in its recall notice the NMBA impurity was traced to ingredients made at Hetero Labs Limited in India, a factory linked to multiple recalls. The FDA and European drug regulators first traced the carcinogen-tainted ingredients last July to Zhejiang Huahai Pharmaceutical in Linhai, China,
Despite the widespread recalls affecting this class of drugs, the FDA says that versions of losartan are available.
The FDA will allow losartan with tiny amounts of a nitrosamine impurities because the agency says it will not increase a person’s cancer risk. The measure is designed to avert a shortage of the critical medication – the nation’s ninth-most commonly prescribed drug.
This content was originally published here.