A study of compliance with FDA recommendations for pemoline (Cylert).
OBJECTIVE
To assess compliance with product labeling recommendations to use pemoline as second-line therapy for attention-deficit/hyperactivity disorder (ADHD) and to obtain baseline and biweekly liver enzyme tests.


METHODS
Retrospective cohort study using administrative claims data to identify first-line therapies and liver enzyme tests among pemoline users between January 1, 1998, and March 31, 2000. Prescriptions for first-line therapy were searched for 90 days prior to the first pemoline claim. Liver enzyme testing (baseline and follow-up) was compared between two groups (the prerecommendation cohort October 1,1998, to March 31, 1999, and the postrecommendation cohort October 1,1999, to March 31,2000).


RESULTS
1,308 patients received at least one pemoline prescription during the study period; 76% of patients < or = 20 years were male. ADHD was the claims-identified indication for 688 patients (52%). Despite the labeling recommendation for use as second-line therapy, only 237 ADHD patients (34%) received a first-line therapy prior to pemoline. Only 12% and 11% of the pre- and post-cohort patients, respectively, received baseline liver enzyme tests; 9% in the pre- and 12% in the post-cohort received at least one liver enzyme follow-up test.


CONCLUSIONS
Compliance with product labeling was low for both recommendations. Understanding the reasons for this finding could help improve risk management strategies.
Office of Drug Safety, Food and Drug Administration, Rockville, MD 20857, USA.
Mary E
ME
Willy
Bharati
B
Manda
Deborah
D
Shatin
Carol R
CR
Drinkard
David J
DJ
Graham
D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D002648:Child; D017408:Guidelines as Topic; D006801:Humans; D008099:Liver / Q000201:enzymology; D008111:Liver Function Tests; D010389:Pemoline / Q000627:therapeutic use*; D012189:Retrospective Studies; D014481:United States; D014486:United States Food and Drug Administration
D000697:Central Nervous System Stimulants; D010389:Pemoline