The Food and Drug Administration (FDA) on Thursday announced a ban on 36 drugs for the treatment of stomach ulcers, as they have been found to pose a cancer risk.
The ban, which takes effect today, applies to drugs with the active ingredient ranitidine, which contains traces of the contaminant and probable carcinogen N-nitrosodimethylamine (NDMA), the agency said, citing international studies.
The studies also found that the NDMA levels in drugs increase over time and with exposure to heat, sometimes in excess of the maximum acceptable daily intake of 96 nanograms, the FDA said.
Prior to the ban, there were 36 drugs containing ranitidine marketed in Taiwan — 29 prescription drugs and seven over-the-counter medications, the FDA said in a press release.
The ban follows similar decisions by regulators in the US and Europe, where ranitidine products were withdrawn and suspended in April.
Retailers found selling the drugs would be fined between NT$60,000 and NT$1.5 million (US$2,034 and US$50,844) under the Consumer Protection Act (消費者保護法), while those who fail to comply with the recall guidelines risk being fined between NT$200,000 and NT$5 million, the FDA said.
More than 80 million doses of stomach ulcer drugs containing ranitidine are sold in the country each year, National Health Insurance Administration statistics showed.
Taiwanese drug companies on Thursday said that NDMA contamination is usually found in the raw materials used to make the drugs, but does not occur in the production process.
Ranitidine belongs to a family of drugs known as H2 blockers, which include famotidine and cimetidine, two viable substitutes, the companies added.
Two of the holders of drug permit licenses for ranitidine — China Chemical and Pharmaceutical Co and Standard Chemical and Pharmaceutical Co — said they had phased out production of ranitidine last year, after the release of research on its risks.
Yung Shin Pharmaceutical Industrial Co said it has a substitute for ranitidine and is unlikely to be significantly affected by the prohibition.
In 2018, the high blood pressure drug valsartan was recalled globally due to NDMA contamination.
The US’ FDA raised concerns about similar impurities in ranitidine products in September last year, prompting regulators in several countries to place the drug under review.
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