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May 29, 2017

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FDA abolishes oral chloramphenicol certificates after adverse effects found

TAIPEI, Taiwan -- The Food and Drug Administration (FDA) yesterday announced that it will abolish 36 certificates for oral chloramphenicol medication — a type of antibiotic — as its potential adverse effects are associated with bone marrow toxicity.

The FDA said recent research suggests that patients taking chloramphenicol have a higher risk of developing severe side effects, including bone marrow suppression and aplastic anemia.

The administration noted that because there are substitutes for chloramphenicol in Taiwan, after meetings with local experts the FDA decided to withdraw the medication's current 36 certificates in Taiwan.

FDA official Tai Hsueh-yung (戴雪詠) said the U.S. FDA conducted evaluations on the safety and efficiency of the oral chloramphenicol treatment in 2012 and deemed that the risk of taking the medication is higher than its potential benefits. Tai said the U.S. therefore banned the oral chloramphenicol in the country. Not just the U.S. but also Canada and the United Kingdom do not use oral antibiotics that contain chloramphenicol, the FDA added.

The administration said there are currently 66 medications that contain chloramphenicol in Taiwan, 36 of which are oral chloramphenicol, noting that after the FDA's official announcement on the latest policy, all medical institutes in the nation will not be allowed to adopt the oral chloramphenicol treatment for patients.

According to the FDA, the most serious side effect of chloramphenicol treatment is aplastic anemia, which is generally fatal. The highest risk is with oral chloramphenicol, and the lowest risk is from eye drops.

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