Key Points
- Six medication errors involving Lamictal starter kits were reported to FDA.
- The differences between the 3 kits are not always understood.
- The 3 different titration schedules depend on patient's use of other medications.
The Food and Drug Administration (FDA) has received six unique reports of medication errors involving Lamictal starter kits.
Three of the six reports indicate that the wrong kit was dispensed to the patient; the other three reports say the patient
incorrectly administered the product. The adverse events reported ranged from sensations of fuzziness and buzzing in the head
to Stevens-Johnson Syndrome. Factors contributing to these errors are users' lack of awareness these kits are available, and
their incomplete understanding of the differences between the three available kits.
Lamictal starter kits were designed by the manufacturer, GlaxoSmithKline, to provide the recommended initial dose and dose
escalation regimen for the first five weeks of treatment with lamotrigine for patients older than 12. It is important to note
that the sponsor currently markets three different starter kits with titration schedules that vary depending on what other
medications a patient is taking (see below).
Lamictal starter kits:
• The orange Lamictal starter kit is for patients who are not taking the following medications: Carbamazepine, phenytoin, phenobarbital, primidone, rifampin,
or valproate (valproate includes valproic acid and divalproex sodium).
• The blue Lamictal starter kit is for patients taking valproate.
• The green Lamictal starter kit is for patients taking carbamazepine, phenytoin, phenobarbital, primidone, or rifampin and not taking valproate.
To help ensure that the appropriate Lamictal starter kit is prescribed and given to patients, pharmacists should:
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It is important that patients receive the correct starter kit to avoid adverse events resulting from over- or underdosing.
Overdosing a patient could result in ataxia, nystagmus, increased seizures, decreased level of consciousness, coma, and intraventricular
conduction delay. Patients receiving less than the recommended dose could experience sub-therapeutic blood levels of Lamictal
and may only get limited relief from epilepsy or bipolar disorder.
If you become aware of medication errors involving Lamictal starter packs or other products, report them to the FDA MedWatch
program online at http://www.fda.gov/medwatch/
Carol Holquist, RPh, is Director, Division of Medication Error Prevention and Analysis, Office of Surveillance and Epidemiology, FDA;
Todd Bridges, RPh, is a Safety Evaluator Team Leader, Division of Medication Error Prevention and Analysis,Office of Surveillance and
Epidemiology, FDA;
Zachary Oleszczuk, RPh, PharmD, is a Safety Evaluator, Division of Medication Error Prevention and Analysis, Office of Surveillance and Epidemiology,
FDA.
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