Antidepressant containing cancer-inducing level of impurities recalled

Taipei, April 29 (CNA) A drug used primarily to treat depression was recalled April 18, after being found to contain nitrosamine impurities above acceptable levels, Taiwan's Food and Drug Administration (TFDA) announced Monday.

The authorities in Canada announced on April 17 that local manufacturers conducted stability tests on a batch of "pms-Duloxetine Capsules 30mg" and found nitrosamine levels above the daily acceptable intake limit, which may increase cancer risks, said TFDA Deputy Director-General Wang Te-yuan (王德原).

The drug treats major depressive disorder, generalized anxiety disorder, diabetic neuropathy and fibromyalgia, according to the TFDA.

Wang said in an interview that Taiwan has imported around 60,000 capsules of the problematic batch.

As soon as it was notified, the TFDA ordered the Taiwanese distributor to withdraw the batch by May 17, as well as submit a report on withdrawal results and preventive measures for the future, Wang added.

The TFDA has also instructed hospitals, clinics and pharmacies to cooperate with withdrawal operations and cease prescribing or supplying the drug.

According to statistics from the National Health Insurance Administration, around 100,000 of the capsules are consumed domestically each year, but only account for 0.3 percent of the market as there are many alternatives. Therefore, the withdrawal is unlikely to cause a drug shortage.

According to the U.S. Food and Drug Administration, taking a drug containing nitrosamine daily for over 70 years is not expected to increase cancer risk, as long as the level is at-or-below the acceptable limit.