FDA Strengthens Kaletra Warning for Use in Premature Infants

The FDA has notified healthcare professionals of serious health problems that have been reported in premature babies receiving Kaletra (lopinavir/ritonavir oral solution; Abbott). Kaletra oral solution contains alcohol and propylene glycol. Premature babies have a decreased ability to eliminate propylene glycol, thus they may be at increased risk for adverse effects (eg, serious heart, kidney, or breathing problems). Because the consequences of using Kaletra oral solution in babies immediately after birth can be severe or possibly fatal, the labeling is being revised to include a new warning.

The new warning specifies that the use of Kaletra oral solution should be avoided in premature babies until 14 days after their due date and in full-term babies <14 days of age unless a healthcare professional believes the benefit of using Kaletra oral solution to treat HIV infection immediately after birth outweighs the potential risks. In such cases, the FDA strongly recommends monitoring for increases in serum osmolality, serum creatinine, and other signs of toxicity.

Kaletra oral solution is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults and patients ≥14 days of age (whether premature or full term).

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm246167.htm.