Serious Health Problems Reported in Premature Babies Given Kaletra

Washington, DC: FDA notified healthcare professionals of serious health problems that have been reported in premature babies receiving Kaletra (lopinavir/ritonavir) oral solution.

Kaletra oral solution contains the ingredients alcohol and propylene glycol. Premature babies may be at increased risk for health problems because they have a decreased ability to eliminate propylene glycol; this could lead to adverse events such as 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 label is being revised to include a new warning.

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

MAR-08-11: Kaletra (lopinavir/ritonavir): Label Change - Serious Health Problems in Premature Babies [FDA: MEDWATCH]

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Published on Mar-8-11