Taipei, Taiwan’s Food and Drug Administration (FDA) said Thursday that the sale of 36 drugs for the treatment of stomach ulcers will be prohibited in the country, with effect from Aug. 1, as they have been found to pose a cancer risk.
The ban will apply 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 have also found that the NDMA levels in drug products increase over time and with exposure to heat, sometimes in excess of the acceptable daily intake of 96 nanograms, the FDA said.
On the Taiwan market, there are 36 drug products that contain ranitidine, 29 of which are prescription drugs and seven over-the-counter medications, all for the treatment of stomach ulcers, the FDA said in a press release.
The move by Taiwan to ban the products followed similar decisions by regulators in the United States and Europe, where ranitidine products were withdrawn and suspended, respectively, in April.
When the ban in Taiwan takes effect on Aug. 1, retailers found selling the drugs will be subject to fines of between NT$60,000 (US$2,046) and NT$1.5 million, under the Consumer Protection Act, while those who do not comply with the recall guidelines will risk a fine of NT$200,000-NT$5 million, the FDA said.
According to statistics from Taiwan’s National Health Insurance Administration, more than 80 million doses of stomach ulcer drugs containing ranitidine are sold in the country each year.
Meanwhile, Taiwanese pharmaceutical companies said Thursday that NDMA contamination is usually found in the raw materials used to make the drugs, but does not occur in the production process.
They also said that ranitidine belongs to a family of drugs known as H2 blockers, which includes famotidine and cimetidine, two viable substitutes.
Two of the holders of drug permit licenses for ranitidine — China Chemical and Pharmaceutical Co. and Standard Chemical and Pharmaceutical Co. — told CNA they had phased out production of ranitidine since last year, after the release of research on its risks.
Meanwhile, Yung Shin Pharmaceutical Industrial Co. said it had a substitute for ranitidine and was unlikely to be significantly affected by the ban.
In 2018, the high blood pressure drug valsartan was recalled globally due to NDMA contamination. The United States’ FDA raised concerns about similar impurities in ranitidine products in September 2019, prompting regulators in several countries to place the drug under review.
Source: Focus Taiwan News Channel