GSK Lamictal Packaging Altered In Lieu Of FDA-Suggested Name Change

GlaxoSmithKline is altering packaging for the anti-epileptic Lamictal to help reduce medical errors as a compromise in lieu of FDA's suggestion to change the brand name.

FDA agreed to the compromise after GSK put forth a persuasive argument that patients could be confused by a Lamictal name change, and that compliance is especially important for epilepsy patients, FDA said.

The most common dispensing errors involved name confusion between Lamictal (lamotrigine) and Novartis' antifungal Lamisil. GSK has also received reports of confusion with Novartis' antidepressant Ludiomil (maprotiline), Pharmacia's antidiarrheal Lomotil (diphenoxylate/atropine), the HIV drug lamivudine and the anti-adrenergic labetalol.

FDA said it will step up its monitoring efforts for Lamictal and has not ruled out a name change if the altered packaging fails to prevent mistakes.

In the new packaging, the Lamictal brand name has been modified "to minimize potentially confusing syllables," GSK said. Dosage strengths will be identified with different color labels and the existing white bottle cap will be replaced with a yellow top.

The warning statement: "CAUTION: Verify Product Dispensed" has been added to the label. The new packaging will be fully phased in by the end of 2001.

The packaging change is part of a multi-pronged awareness campaign to notify physicians of the risk for prescribing errors. Discussions about possible responses to the mix-ups began last year.

FDA has received 40 reports regarding mix-ups between Lamisil and Lamictal. In June 2000, FDA had recieved 29 reports.

The announcement follows several "Dear Doctor" and "Dear Pharmacist" letters issued by Glaxo regarding the potential for confusion between Lamictal and Lamisil. The most recent letters were issued in June 2000 (¹ (Also see "Lamictal/Lamisil Dispensing Errors Targeted In Glaxo Education Campaign" - Pink Sheet, 3 Jul, 2000.)).

FDA is also in discussions with Novartis over the errors. Novartis recently added a line to Lamisil's patient information on the topic.