Japan to discuss pediatric drug use

The study committee on pediatric drug therapy of Japan's Ministry of Health, Labor and Welfare has determined to discuss the line extension for pediatric use of eight drugs, which have been requested by the related academic societies at its recent meeting.

The committee will evaluate the pediatric indications of eight drugs including: Novartis' Ritalin (methylphenidate HCl) for the treatment of attention-deficit hyperactivity disorder in children; Bayer Yakuhin's Ciproxacin (ciprofloxacin) for the treatment of serious infectious diseases in children; Eisai's Tambocor (flecainide acetate) as a tachyarrhythmia therapy in children, Wyeth's Rheumatrex (methotrexate) for the treatment of juvenile idiopathic arthritis; GlaxoSmithKline's Botox (botulinum toxin type A) for the treatment of blepharism in children; GlaxoSmithKline's Zovirax (acyclovir) for the treatment of neonatal herpes simplex virus infectious diseases; and Shionogi's Endoxan (cyclophosphamide) for the treatment of pediatric rheumatic diseases. It will also review the use of acetaminophen for pediatric dosage as an antipyretic.

At the same meeting, the MHLW reported that it will collect literature on the off-label use of drugs for children - domestically and abroad - and discuss these in an attempt to establish formal pediatric indications for such drugs. If it collects sufficient evidence for the pediatric indications of these products, the MHLW plans to request drug manufacturers to change package inserts and to apply for a partial change of approvals of them based on the data.