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FDA changes labeling for lopinavir/ritonavir oral solution; linked to serious health issues in preemies

The FDA is changing the label on lopinavir/ritonavir oral solution to include a warning about its use in premature infants, according to a new report from the FDA’s MedWatch.

The FDA notified health care professionals of serious health problems that have been reported in premature babies receiving lopinavir/ritonavir (Kaletra, Abbott Laboratories) oral solution immediately after birth. Lopinavir/ritonavir oral solution contains alcohol and propylene glycol, and premature infants may be at increased risk for health problems because they have a decreased ability to eliminate propylene glycol. This could result in adverse events such as serious heart, kidney or breathing problems.

Lopinavir/ritonavir oral solution is used in combination with other antiretroviral drugs for the treatment of HIV-1 infection in pediatric patients aged 14 days (whether premature or full term) or older and in adults.

The FDA now recommends use of lopinavir/ritonavir oral solution be avoided in premature babies until 14 days after their due date, or in full-term babies aged younger than 14 days, unless a health care professional believes that the benefit of using this drug to treat HIV infection immediately after birth outweighs the potential risks. In such cases, FDA strongly recommends monitoring for increases in serum osmolality, serum creatinine, and other signs of toxicity, according to the MedWatch report.

Physicians are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm.

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