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Back To Vidyya FDA Alert

Prescription Dispensing Errors Involving Lamictal Tablets And Lamisil Tablets

Glaxo Wellcome Inc. has received reports of prescription dispensing errors involving LAMICTAL (lamotrigine) Tablets and LAMISIL (terbinafine hydrochloride) Tablets resulting in serious adverse events. The error reports involve dispensing Lamictal Tablets when Lamisil Tablets were prescribed and the reverse scenario.

Patients with epilepsy who do not receive their antiepileptic drug LAMICTAL due to a dispensing error would be inadequately treated and could experience serious consequences including status epilepticus. Conversely, patients erroneously receiving Lamictal instead of their antifungal drug LAMISIL would be unnecessarily subjected to a risk of potential side effects (including serious rash). This is especially true if patients receive an initial high dose of Lamictal

LAMICTAL is an antiepileptic drug marketed as 25-, 100-, 150-, and 200-mg six-sided, shield- shaped tablets bearing "Lamictal" and the numeric representation of the strength (e.g., "Lamictal 150"). Lamictal Chewable Dispersible Tablets are 5-mg and 25-mg white tablets engraved with "GX CL2" and "GX CL5," respectively. To initiate therapy with Lamictal, the dose is titrated over a period of several weeks.

LAMISIL is an antifungal drug marketed as 250-mg circular, biconvex, bevelled tablets bearing "Lamisil" on one side and "250" on the other side. The recommended dosage for Lamisil is one 250-mg tablet daily for six or twelve weeks depending on the affected nail. Topical formulations of Lamisil are also available by prescription and over-the-counter.

Pharmacists are asked to be alert for both written and oral prescriptions for LAMICTAL and LAMISIL, and to promptly share information with their staffs. Measures to avoid dispensing errors should be assessed and implemented as appropriate.

Pharmacists aware of a prescription dispensing error involving these products are asked to contact the appropriate manufacturer:


Glaxo Wellcome Inc.: 1-800-334-4135
Novartis Pharmaceuticals Corp.: 1-888-669-6682

The USP Medication Errors Reporting Program 1-800-233-7767


The FDA MEDWATCH program
by phone 1-800-FDA-1088
by FAX 1-800-FDA-0178
by internet www.fda.gov/medwatch
by mail:
MedWatch HF-2
FDA
5600 Fishers Lane
Rockville, MD 20857

For further information on Lamictal, please call 1-888-TALK-2-GW (1-888-825-5249).


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Editor: Susan K. Boyer, RN
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