Important Drug Warning! Dispensing Errors Continue With Lamotrigine (LAMICTAL)

In the August 2000 issue of Worst Pills, Best Pills News we wrote about reports of dispensing errors involving the drugs lamotrigine (LAMICTAL) and terbinafine (LAMISIL). Lamotrigine is approved by the Food and Drug Administration (FDA) for certain types of seizure disorders and terbinafine for the treatment of toenail and fingernail fungal infections.

On December 7, 2001 Lamictal’s manufacturer, GlaxoSmithKline, issued another warning about dispensing errors involving substitution of their drug with four other drugs. In addition to Lamisil, errors have been reported with the AIDS drug lamivudine (EPIVIR), maprotiline (LUDIOMIL), an antidepressant, labetalol (NORMODYNE, TRANDATE) used for high blood pressure, and diphenoxylate and atropine (LOMOTIL), an old and dangerous anti-diarrhea drug.

Patients with seizure disorders who do not receive their antiepileptic drug lamotrigine due to a dispensing error would be inadequately treated and could experience serious consequences including continuous seizures (status epilepticus). Conversely, patients mistakenly given Lamictal instead of one of the drugs listed above would be unnecessarily subjected to a risk of potential adverse effects. This is especially true if patients receive a high initial dose of Lamictal.

The professional product labeling or “package insert” for lamotrigine carries, in part, the following bold-faced, boxed warning regarding skin reactions including a potentially life-threatening reaction called “toxic epidermal necrolysis,” in which the skin sloughs off:

SERIOUS RASHES REQUIRING HOSPITALIZATION AND DISCONTINUATION OF TREATMENT HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF LAMICTAL. THE INCIDENCE OF THESE RASHES WHICH HAVE INCLUDED STEVENS-JOHNSON SYNDROME IS APPROXIMATELY 1% (1/100) IN PEDIATRIC PATIENTS (AGE <16 YEARS) AND 0.3% (3/1000) IN ADULTS. IN WORLDWIDE POSTMARKETING EXPERIENCE, RARE CASES OF TOXIC EPIDERMAL NECROLYSIS AND/OR RASH-RELATED DEATH HAVE BEEN REPORTED, BUT THEIR NUMBERS ARE TOO FEW TO PERMIT A PRECISE ESTIMATE OF THE RATE.

Lamictal is marketed as 25, 100, 150, and 200 milligram six-sided, shield-shaped tablets bearing “Lamictal” and the numeric representation of the strength (e.g., “Lamictal 150”). Lamictal Chewable Dispersible Tablets are 5 milligram, and 25 milligram white tablets engraved with “GX CL2” and “GX CL5,” respectively.

What You Can Do

If you are taking lamotrigine, always check the tablets before you leave the pharmacy and verify by reading on the tablets the words LAMICTAL.

If you are taking one of the other drugs mentioned above, always check before you leave the pharmacy and verify that the tablets do not have LAMICTAL imprinted on them.

If you become aware of a prescription-dispensing error involving these or any other products it should be reported to the FDA MEDWATCH program by phone 1-800-FDA-1088, by FAX 1-800-FDA-0178, by internet www.fda.gov/medwatch, or by mail: MedWatch HF-2, FDA, 5600 Fishers Lane Rockville, MD 20857.