US biotechnology firm Pfizer is recalling four lots of Champix anti-smoking tablets in Taiwan after elevated levels of nitrosamine impurities were found in the prescription drug, the Food and Drug Administration (FDA) said yesterday.
Hung Kuo-teng (洪國登), head of the FDA’s Medicinal Products Division, said that about 600,000 Champix pills with the four lot numbers 00019669, 00019012, 00019601 and 00019602 are to be recalled by July 22.
The announcement came after Pfizer said that it found elevated levels of nitrosamines in Chantix, the name under which Champix is sold in the US.
Photo courtesy of the Food and Drug Administration via CNA
Hung said that Pfizer is investigating the situation.
The US Food and Drug Administration in a report in February identified seven nitrosamine impurities that could theoretically be present in medicines, adding that five of them have been detected.
Bloomberg reported that they include N-nitrosodimethylamine (NDMA), which is suspected to increase the risk of cancer, and that US health authorities have asked drugmakers to test their products for the impurities.
Pfizer’s Taiwanese subsidiary yesterday said in a statement that impurities that had been found in Champix’s active component, varenicline, include nitrosamines, but not NDMA or any other impurities mentioned in the US report.
International media reported that Pfizer has yet to determine the health risk posed by nitrosamines, but it has halted the global distribution of the anti-smoking drugs and is recalling the affected lots.
In Taipei, the FDA said that medical institutions and pharmacies should stop prescribing and dispensing Champix, adding that they should return the product.
People concerned about their use of the medication should immediately consult their doctors, the agency said.
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