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Lamictal (lamotrigine) and Lamisil (terbinafine hydrochloride) Dear Healthcare Professional Letter - text version - Aug 2000

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.

This is the retyped text of a letter from GlaxoWellcome, Inc. Contact the company for a copy of any referenced enclosures.


August 2000

Dear Health Professional:

Medication dispensing errors are a serious threat to quality health care and necessitate the combined efforts of prescribers, dispensers, manufacturers and patients to minimize their occurrence. Glaxo Wellcome Inc. has received reports of dispensing errors involving LAMICTAL (lamotrigine) Tablets and other prescription drugs; most of these errors have been with the prescription medication LAMISIL (terbinafine hydrochloride) Tablets, some of which have resulted in serious adverse events. Your assistance is requested in clearly communicating oral and written prescriptions for these two products to help avoid future dispensing errors. For example, you might consider, when appropriate, including the intended use on prescriptions for these products. Please alert patients for whom you are prescribing these medications that they should carefully check the medication they receive and promptly bring any questions or concerns to the attention of the pharmacist. Additional efforts to address this situation within pharmacies are under way.

The error reports involve dispensing LAMISIL Tablets when LAMICTAL Tablets were prescribed and the reverse scenario. Patients erroneously receiving either medication would be unnecessarily subjected to the risk of adverse events. In addition, patients with epilepsy who do not receive their antiepileptic drug due to a dispensing error would be inadequately treated and could experience serious consequences including status epilepticus. Patients erroneously receiving LAMICTAL instead of their antifungal drug LAMISIL would not have the dose of LAMICTAL properly titrated and would be unnecessarily subjected to a risk of potential side effects, including serious rash (see enclosed Prescribing Information for LAMICTAL Tablets, Warning section and Dosage and Administration section).

LAMICTAL is an antiepileptic drug marketed as 25-mg (white), 100-mg (peach), 150-mg (cream) and 200-mg (blue), shield-shaped tablets bearing "Lamictal" and the numeric representation of the strength (e.g., "Lamictal 150"). Lamictal Chewable Dispersible Tablets are 5mg and 25mg white tablets engraved with "GX CL2" and "GX CL5," respectively. LAMISIL is an antifungal drug marketed as 250-mg circular tablets bearing "Lamisil" on one side and "250" on the other side.

Clear communication when prescribing any drug product is an important measure in the effort to reduce the occurrence of dispensing errors. If you become aware of a prescription dispensing error involving LAMICTAL, please contact Glaxo Wellcome, Inc. at 1-800-334-4153; the USP Medication Errors Reporting Program (1-800-233-7767) or the FDA MEDWATCH program by phone 1-800-FDA-1088, by FAX 1-800-FDA-0178, by Internet http://www.fda.gov/medwatch or www.fda.gov/medwatch, or by mail:

5600 Fishers Lane
Rockville, MD 20852-9787

Thank you.

Richard S. Kent, M.D.
Vice President US Medical Operations



Glaxo Wellcome Inc.
Five Moore Drive Telephone
PO Box 13398
Research Triangle Park, NC 27709-3398