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38 stomach medications ordered off shelves amid cancer concern

2019/09/20 22:40:14

Heartburn medication Zantac / Photo from GSK website

Taipei, Sept. 20 (CNA) Taiwan's health authorities on Friday ordered the recall of 38 stomach medications as a precaution amid concerns they contained a chemical that could cause cancer.

The Food and Drug Administration (FDA) announced the recall at 7 p.m., after it was alerted by the regulators of the United States and Europe a week ago that a small trace of a carcinogen NDMA was found in Zantac, a popular heartburn medication produced by British pharmaceutical company GlaxoSmithKline.

Because the level of NDMA, short for N-Nitrosodimethylamine, was very low, no recalls of the medication was requested in the international markets, according to the administration.

However, the FDA said that as soon as it received the report of the finding, it launched a comprehensive inspection on all the medications permitted to be sold in Taiwan that contained ranitidine, the key ingredient of Zantac, the FDA said in a statement.

The FDA found there were 21 drug companies across Taiwan that held a total of 38 licenses to produce ranitidine-based gastric-medications, including widely-known Culcer DAILY F.C. Tablet 300mg.

The administration then ordered a precautionary recall of the 38 medications, the statement said.

A deputy FDA division chief, Wu Ming-mei (吳明美), told the press on Friday that the drug makers have to complete their recalls by Monday. They will not be allowed to market the medications before the drugs passed a test to see if the amount of the carcinogen NDMA was within a safe level, she said.

Those failing to take the medications off shelves based on the regulations will be slapped with a fine of NT$60,000 (US$1,938) to NT$300,000 according to the Consumer Protection Act, Wu added.

According to the FDA, over 80 million tablets of gastric-medications containing ranitidine were prescribed for National Health Insurance patients each year.

(By Chang Ming-hsuan and Elizabeth Hsu)
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