Pemoline (withdrawn from US market 2005)
- Life threatening hepatotoxicity limits use as first line agent in ADHD. May have long latency period
- Written informed consent from patient prior to initiation
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Unresponsive patients should be removed from therapy at 3 wks.
- Initiate therapy only in patients with normal baseline LFTs and without liver disease.
- Serum ALT (SGPT) at baseline & every 2 weeks thereafter. If therapy interrupted, repeat baseline ALT and continue every 2 weeks, thereafter.
- Informed Consent recommended
- Discontinue if serum ALT increases are clinically significant or any increase > 2 times upper limit of normal
FDA and Industry Communications
- FDA Safety Alert published 6/1999
- Pemoline market withdrawal: October 2005
Patient Counseling Information
Updated January 2018