Lower phenytoin serum levels in persons switched from brand to generic phenytoin
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To the Editor:
The disclosure included in this article states:
“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.”
But on another website (http://www.princetoncme.com/public/2004-79-4/) I found the following disclosure:
“Ilo E. Leppik, MD: Honoraria/Consultant/Speaker/Grant–Abbott Laboratories, AstraZeneca, Athena, Bristol-Myers Squibb, Carter-Wallace, Cephalon, Ciba-Geigy, Cognetix, Cyberonics, Dainippon, Elan Pharmaceuticals, Eli Lilly and Company, GlaxoSmithKline, Hoechst Marion Roussel, MedPointe, Medtronic, Merck Sharp & Dohme, Novartis, Ortho-McNeil, Parke-Davis, Pfizer, Shire, Synthe Labo, UCB Pharma, Inc., Upshire-Smith, Wyeth Ayerst, Xcel Pharmaceuticals.”
Since my understanding is that Parke-Davis manufacture brand name phenytoin, I would suggest that these differences deserve explanation. And perhaps a follow-up study of the bioequivalence of generic and brand name phenytoin by a different, independent group is in order.
To the Editor:
Burkhardt et al.1 identified a case series of “… adult patients whose seizures increased enough to require intervention.” The authors determined that of the 11 cases, 10 had been switched from brand to generic phenytoin and concluded that use of the generic product resulted in lower phenytoin blood levels than the brand product in eight of these patients. We can not assess the strength of the finding from the information provided in the publication. Additional information provided by the authors has been insufficient. The case definition and methods used for case identification are unclear.
We expected that the authors would have used a well-defined denominator of patients and a control group of patients who were candidates to switch from brand to generic phenytoin and matched by disease severity. Both groups would be followed to determine the rate of lowered phenytoin blood levels and worsening of underlying seizure control. …
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