UCB Pharma and FDA issue advisory letter
UCB Pharma and FDA issue advisory letter
UCB Pharma Inc. and the Food and Drug Administration recently issued a "Dear health care professional" letter advising health care professionals of the risk of dispensing errors between lopinavir/ritonavir (Kaletra), an antiretroviral, and levetiracetam (Keppra), an antiepileptic drug.
According to the letter, "Medication dispensing errors are a serious threat to quality health care 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 levetiracetam tablets and oral solution and 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.
"Levetiracetam, an antiepileptic, is available as tablets and oral solution. Levetiracetam 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.
"Levetiracetam oral solution is a clear, colorless, grape-flavored liquid supplied in 16 fl oz white HDPE bottles containing 500 mg levetiracetam per 5 mL.
"Lopinavir/ritonavir, an antiretroviral, is available as capsules or oral solution. Lopinavir/ritonavir 133.3 mg lopinavir/33.3 mg ritonavir capsules are orange soft-gelatin capsules imprinted with the Abbott corporate logo and "PK." Lopinavir/ritonavir is available in bottles of 180 capsules.
"Lopinavir/ritonavir 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 levetiracetam by making sure that levetiracetam 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 Levetiracetam, please contact UCB Pharma Inc. immediately. Phone: (800) 477-7877, option 9. Or call USP Medication Errors Reporting Program. Phone: (800) 233-7767. Call the FDA MEDWATCH program. Phone: (800) FDA-1088. Fax: (800) FDA-0178. Web: http:// www.fda.gov/medwatch.
"Before prescribing levetiracetam [Keppra], please consult the enclosed full-prescribing information. Lopinavir/ritonavir (Kaletra) is a registered trademark of Abbott Laboratories. K1312-0403."
UCB Pharma Inc. and the Food and Drug Administration recently issued a Dear health care professional letter advising health care professionals of the risk of dispensing errors between lopinavir/ritonavir (Kaletra), an antiretroviral, and levetiracetam (Keppra), an antiepileptic drug.Subscribe Now for Access
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