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For Consumers

Medication Dispensing Errors ~ Kaletra (lopinavir/ritonavir) and Keppra (levetiracetam)

10/16/2003

UCB Pharma, Inc. and FDA recently issued a "Dear Healthcare Professional" letter advising health care professionals of the risk of dispensing errors between KALETRA (lopinavir/ritonavir), an antiretroviral, and KEPPRA (levetiracetam), an antiepileptic drug.

Medication dispensing errors are a serious threat to quality healthcare and necessitate the combined efforts of all involved to minimize their occurrence. UCB Pharma, Inc. would like to advise you that dispensing errors may occur between KEPPRA (levetiracetam) tablets and oral solution and KALETRA (lopinavir/ritonavir) capsules and oral solution. Your assistance is requested in clearly communicating oral and written prescriptions for these two products to help avoid dispensing errors.

Patients erroneously receiving either medication would be unnecessarily subjected to the risk of adverse effects. 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.
KEPPRA, an antiepileptic, is available as tablets and oral solution. KEPPRA tablets, 250 mg are blue, 500 mg are yellow, and 750 mg are orange, oblong-shaped, scored, film-coated tablets debossed with "ucb" and "strength" on one side. They are supplied in containers of 120 tablets. KEPPRA oral solution is a clear, colorless, grape-flavored liquid supplied in 16 fl oz white HDPE bottles containing 500 mg levetiracetam per 5 mL.

KALETRA, an antiretroviral, is available as capsules or oral solution. KALETRA 133.3 mg lopinavir/33.3 mg ritonavir capsules are orange soft gelatin capsules imprinted with the Abbott corporate logo and "PK". KALETRA is available in bottles of 180 capsules. KALETRA oral solution is a light yellow to orange colored liquid supplied in amber-colored 160 mL glass bottles containing 400 mg lopinavir/100 mg ritonavir per 5 mL.

Please take great care when writing a prescription for KEPPRA by making sure that KEPPRA can be easily read and understood by the person filling the prescription. Clearly communicating both written and verbal prescriptions is a vital step in the prevention of future dispensing errors. You might consider, when appropriate, including the intended use on prescriptions for these products. Please inform your patients that they should carefully check all medications they receive, and immediately bring any problems, questions, or concerns to the pharmacist's attention.
If you become aware of a prescription dispensing error involving KEPPRA, please contact UCB Pharma, Inc. immediately at 1-800-477-7877, option 9; the USP Medication Errors Reporting Program at 1-800-233-7767 or the FDA MEDWATCH program by telephone at 1-800-FDA-1088, by FAX at 1-800-FDA-0178, or by Internet http://www.fda.gov/medwatch.

Thank for your continued support in this very important matter.

Sincerely,
Leslie Magnus, MD
Vice President, Medical Affairs
UCB Pharma, Inc.

Before prescribing KEPPRA, please consult the enclosed full prescribing information.
KALETRA is a registered trademark of Abbott Laboratories. K1312-0403

A pdf version of the original letter is posted at: http://www.fda.gov/medwatch/SAFETY/2003/keppra_deardoc.pdf

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Page Last Updated: 08/01/2014
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