A drug used primarily to treat depression was recalled on April 18, after it was found to contain nitrosamine impurities above acceptable levels, the Food and Drug Administration (FDA) said yesterday.
Authorities in Canada on April 17 announced that local manufacturers conducted stability tests on a batch of “pms-Duloxetine Capsules 30mg” and found nitrosamine levels above the daily acceptable intake, which could increase the risk of cancer, FDA Deputy Director-General Wang Te-yuan (王德原) said.
The drug is used to treat major depressive disorder, generalized anxiety disorder, diabetic neuropathy and fibromyalgia, the FDA said.
Photo courtesy of the Food and Drug Administration
Taiwan has imported about 60,000 capsules of the problematic batch, Wang said.
As soon as it was notified, the FDA ordered the Taiwanese distributor to withdraw the batch by May 17, as well as to submit a report on the withdrawal and preventive measures, he said.
About 100,000 of the capsules are consumed domestically each year, National Health Insurance Administration data showed, although they only account for 0.3 percent of the market, as there are many alternatives.
Therefore, the withdrawal is unlikely to cause a shortage of the drug.
Taking a drug containing nitrosamine daily for more than 70 years is not expected to increase the risk of cancer, as long as the level is at or below the acceptable daily limit, the US FDA says.
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