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Lower phenytoin serum levels in persons switched from brand to generic phenytoin

From MINCEP Epilepsy Care (Drs. Leppik and Gapany, K. Blesi, and S. Scott), Minneapolis, MN; and the College of Pharmacy, (Drs. Leppik, Cloyd, and Burkhardt), University of Minnesota, Minneapolis, MN.

Address correspondence and reprint request to Dr. Ilo E. Leppik, Director of Research, MINCEP Epilepsy Care, Suite 200, 5775 Wayzata Boulevard, Minneapolis, MN 55416; e-mail: mincepmail{at}mincep.com

After generic phenytoin (PHT) was marketed, the authors identified eight adult patients (ages 34 to 49) whose seizures increased enough to require intervention after switching to generic PHT. The mean total PHT concentration on brand (before generic) was 17.7 ± 5.3 mg/L, decreased to 12.5 ± 2.7 mg/L with generic, and increased to 17.8 ± 3.9 mg/L after brand was re-introduced. Brand and generic PHT do not yield equivalent concentrations in some patients and substitution should not be permitted without physician notification.

Received January 21, 2004. Accepted in final form June 17, 2004.

Dr. Leppik has received honoraria from Abbott Laboratories, Pfizer, and UCB Pharma. Dr. Cloyd has received honoraria from Elan Pharmaceuticals and GlaxoSmithKline, honoraria in excess of $10,000 from Abbott Laboratories and Ovation Pharmaceuticals, and a grant in excess of $10,000 from Novartis.

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