Antiviral drug poses threat to premature infants

March 17, 2011

Premature babies who receive lopinavir/retonavir (Kaletra) oral solution immediately after birth to treat HIV-1 infection are at risk of serious heart, kidney, or breathing problems, the United States Food and Drug Administration (FDA) warns.

Premature babies who receive lopinavir/retonavir (Kaletra) oral solution immediately after birth to treat HIV-1 infection are at risk of serious heart, kidney, or breathing problems, the United States Food and Drug Administration (FDA) warns.

The oral solution contains propylene glycol, which premature infants have difficulty eliminating, and alcohol. Buildup of propylene glycol can lead to serious or even fatal adverse effects on the heart, kidney, and lungs.

FDA is revising the labeling of lopinavir/retonavir to warn against giving it to premature infants until 14 days after their due date or to full-term infants younger than 14 days of age because a safe and effective dose for these infants has not been established. In those cases when a healthcare professional believes that the benefit to the infant outweighs the potential risks, FDA strongly recommends monitoring the infant for increases in serum osmolality, serum creatinine, and other signs of toxicity.