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.
An essay competition jointly organized by a local writing society and a publisher affiliated with the Chinese Communist Party (CCP) might have contravened the Act Governing Relations Between the People of the Taiwan Area and the Mainland Area (臺灣地區與大陸地區人民關係條例), the Mainland Affairs Council (MAC) said on Thursday. “In this case, the partner organization is clearly an agency under the CCP’s Fujian Provincial Committee,” MAC Deputy Minister and spokesperson Liang Wen-chieh (梁文傑) said at a news briefing in Taipei. “It also involves bringing Taiwanese students to China with all-expenses-paid arrangements to attend award ceremonies and camps,” Liang said. Those two “characteristics” are typically sufficient
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