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Drug errors involving Keppra and Kaletra
Click here to view original press release.
Accession Number
A00694
Author
US Department of Health and Human Services (HHS), Food and Drug Administration (FDA)
Source
FDA Consumer Magazine
Release Date
January 12, 2004
Major Descriptors
Drug administration
FDA
Safety
Topic
Drugs and Treatment
Text
The Food & Drug Administration would like to alert healthcare providers that dispensing errors
between Keppra (levetiracetam) and Kaletra (lopinavir/ritonavir) have occurred. The FDA has received
four reports of confusion between Keppra and Kaletra, one of which resulted in administration
of the wrong drug product. Fortunately, this patient did not experience any adverse events as a
result of the errors. Two cases were caught prior to patient administration, and the remaining case describes
the potential for confusion between the two products due to their sound-alike properties. See
table above for a description of the four cases.
Medication errors have occurred despite characteristics that differ between Keppra and Kaletra.
Specifically, Keppra and Kaletra are used to treat different conditions, and Kaletra contains two active
ingredients while Keppra contains a single active ingredient. Although there is no overlap of the dosage
strengths, both products are available in oral solid dosage forms, oral solutions, and are administered twice daily.
Keppra contains the active ingredient levetiracetam and is indicated as adjunctive treatment of partial-onset
seizures in adults with epilepsy. Keppra is available as 250-, 500-, and 750-mg tablets and as an oral
solution containing 100 mg/ml, and is manufactured by UCB Pharma. The initial dose of Keppra is 500 mg taken
twice daily. The dose may be increased at two-week intervals in increments of 1 gm per day, up to a maximum of
3 gm per day. Keppra tablets were approved by the FDA in November 1999, and Keppra oral solution was approved in
July 2003.
Kaletra contains a combination of lopinavir and ritonavir and is indicated for treatment of human
immunodeficiency virus (HIV) infection. Kaletra is available as an oral capsule in a strength of 133.3mg/33.3 mg
and as an oral solution containing 80 mg/20 mg per milliliter. Kaletra can be taken by adults and by children six months
of age and older. The usual adult dose of Kaletra is three capsules (400 mg/100 mg) or 5 ml twice daily taken with food.
Kaletra oral capsules and oral solution were approved by the FDA in September 2000. The sponsor is Abbott Laboratories.
Based upon the reports received, errors occurred between Keppra and Kaletra due to their sound-alike
proprietary names. Keppra and Kaletra are both available in solid oral dosage forms (capsules or tablets)
and as an oral solution. Additionally, both products share an overlapping dosing quantity (5 ml) and are
administered twice daily. From our perspective, the similarities between the names in addition to the similarities
in route of administration, dosage form, and dosing quantity may further increase the risk of confusion
between Keppra and Kaletra, particularly if healthcare providers are not educated concerning this
potential for confusion.
Clearly, patients with epilepsy or HIV who mistakenly receive an incorrect medication are at risk for
experiencing severe health consequences. In addition to not receiving the appropriate lifesaving
medication, patients would be at risk for experiencing side effects associated with the unintended drug
product.
In order to avert future medication errors between Keppra and Kaletra we recommend:
- Educating healthcare staff (physicians, pharmacists,
nurses, nurse practitioners, and technicians) about
the potential medication errors between Keppra and
Kaletra
- Verifying all orders for Keppra and Kaletra between
pharmacists and prescribers by spelling both the proprietary
name as well as the established name (e.g.,
Keppra, levetiracetam)
- Counseling all patients receiving either Keppra or
Kaletra regarding the drug indication, strength, and
dosing regimen
- Including the indications with the prescription when
ordering either medication
- Implementing computerized alerts when prescriptions
are processed for Keppra and Kaletra, as well as
pharmacy shelf reminders to double-check product
selection
Note: Always store Kaletra capsules and oral solution in the refrigerator. This will ensure the two products
are not colocated on pharmacy shelves.
If you become aware of prescription dispensing errors involving Keppra and Kaletra, please contact the
FDA MedWatch program by telephone at 1-(800) FDA- 1088, by fax at 1-(800) FDA-0178, or by Internet at
www.fda.gov/medwatch.
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