Japan to promote pediatric acetaminophen

The study committee on pediatric drug therapy of Japan's Ministry of Health, Labor and Welfare has decided to request that drugmakers should apply for a partial approval change from acetaminophen, an anti-inflammatory and analgesic drug, because there is sufficient evidence to support pediatric use domestically and abroad. In the meantime, concerning flecainide acetate as the treatment of arrhythmia, the panel determined to conduct a fact-finding survey on the off-label use of the drug and to discuss it further at a later date.

The panel's mission is to discuss the line extension for pediatric use of approved drugs, where these are requested by the respective academic societies, and to collect data on the off-label use of products for children - in Japan and elsewhere. It also urges relevant manufacturers to amend package inserts and to apply for a partial change of drug approval for pediatric use.