Pemoline

General information

Pemoline has similar pharmacological actions to dexamfetamine and methylphenidate, and was used in the management of hyperactivity disorders in children. However, the evidence linking pemoline to life-threatening liver failure prompted the Food and Drugs Administration to require the manufacturer to add a black box warning to the package insert, and in the UK the Committee on Safety of Medicines withdrew marketing approval for pemoline, citing safety and a lack of adequate evidence of efficacy as the reason [ ]. It was also subsequently withdrawn elsewhere [ ]. Nevertheless, it continues to be used in the USA and elsewhere, and reports of suspected adverse reactions continue to appear. Risk management plans have been developed [ ].

Organs and systems