BlackBoxRX
 
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Pemoline (withdrawn from US market 2005)

Hepatotoxicity

  • 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

Patient Counseling Information

Package Inserts

Pemoline

Additional Information

Updated January 2018