The Ministry of Food and Drug Safety has banned the use of dihydrocodeine-containing antitussives for children under the age of 12, despite criticism from the Korean Pediatric Association (KPA).

The ministry said Thursday it ordered drugmakers to delete the phrase, “use for children aged under 12,” in the usage and dosage of dihydrocodeine-including combination drugs. The ministry instead had them state an additional phrase, “Do not administer to children under 12 years old.”

In usage precautions, drugmakers should state, “Do not administer to children under 12 because severe respiratory depression can occur.”

The statements should also include, “Children under the age of 12 have a high respiratory susceptibility, and there was an overseas report citing a high risk of severe respiratory depression for children under 12.”

Earlier last month, the KPA criticized the ministry’s plan for banning dihydrocodeine-containing antitussives for children under 12.

The KPA argued the government reversed its previous stance, copied Japan’s regulation without reviewing it through actual examination in Korea, and suddenly ordered the drug ban without an alternative.

Earlier, the ministry had concluded that dihydrocodeine did not need changes in monitoring and approval conditions. “Although dihydrocodeine is similar to codeine, it’s different in the metabolite’s structure and function. Many studies showed it did not cause a respiratory problem in children under 12,” the ministry had said.

In Japan, the health authorities decided in July to prohibit the use of dihydrocodeine-containing antitussives for children under 12 by 2019 in a phased way.

“Unlike Korea, only a few cold tablets for children are banned Japan. The Japanese government put a grace period of one year and six months, minimizing the impact of the drug ban and allowing a switch to alternative drugs,” the KPA said.

Aware of the KPA’s criticism, the ministry said it thoroughly reviewed dihydrocodeine-containing drugs’ adverse effect reports in Korea, regulations of the Japanese Ministry of Health, Labor and Welfare, and the U.S. Food and Drug Administration, as well as the opinions of local experts.

The government made a final decision after consultations with the central pharmaceutical affairs advisory committee, the ministry said.

Meanwhile, 28 approved combo drugs use dihydrocodeine as an ingredient in Korea. Their combined annual output reached 69.2 billion won ($65 million) in 2016.

lhs@docdocdoc.co.kr

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