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| |  GlaxoSmithKline Changes Lamictal (Lamotrigine) Label Appearance to Reduce Likelihood of Dispensing Errors RESEARCH TRIANGLE PARK, NC -- July 26, 2001 -- GlaxoSmithKline Inc. announced today that it has substantially changed the appearance of container labeling in an effort to reduce the potential for dispensing errors involving its antiepileptic drug Lamictal® (lamotrigine) Tablets. Dispensing errors are often a result of miscommunication, which can include poor handwriting of the prescription and confusion between drugs with similar names. Lamictal is one of several prescription drugs that has encountered the problem of dispensing errors. As a result, GlaxoSmithKline has worked closely with the Food and Drug Administration (FDA) in an effort to educate pharmacists and physicians about the potential for Lamictal dispensing errors. The container label change is part of this effort. The most common dispensing errors have been between Lamisil®, an antifungal tablet manufactured by Novartis Pharmaceutical Corp., and Lamictal. In these instances, either Lamisil was substituted for Lamictal or Lamictal was substituted for Lamisil. GlaxoSmithKline has received reports of prescription dispensing errors involving Lamictal and other medications including lamivudine, Ludiomil®, labetalol, and Lomotil®. In order to more clearly differentiate Lamictal from other prescription products on pharmacists' shelves, the following packaging changes have been implemented: * The Lamictal proprietary name has been visually modified to minimize potentially confusing syllables. * Use of different color labels to distinguish the different tablet strengths of Lamictal from each other as well as other drugs. * Addition of the following message to the label "CAUTION: Verify Product Dispensed." * Use of a yellow bottle cap rather than a white bottle cap.
"We've taken a number of steps to make Lamictal 'stand out' from any other product on the pharmacists' shelves," said Shirley Murphy, M.D., vice president of NeuroHealth Specialty Division at GlaxoSmithKline. "Epilepsy is a serious, chronic disease and an interruption in treatment could lead to serious consequences. We want to help make sure that patients are getting the right medicine, which is why we are continuing this communications program to help avoid further dispensing errors." It is important for patients with epilepsy not to have an interruption in treatment because it could lead to consequences such as status epilepticus. Conversely, those patients that do not have epilepsy could be placed at unnecessary risk of adverse events, including serious rash, if they are mistakenly given Lamictal. The company has been working closely with the FDA to develop and implement a multifaceted education program directed to healthcare professionals, including these packaging changes. These efforts reinforce the importance of clear communication between physicians, pharmacists and patients.
SOURCE: GlaxoSmithKline Related Link: GlaxoSmithKline.
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