U.S. health officials cautioned against the use of Abbott Laboratories’ HIV drug Kaletra in premature babies because they could be at greater risk for serious and possibly fatal side effects.
In a warning issued on Tuesday, the Food and Drug Administration said oral solutions of the drug given to premature babies could raise the risk of serious heart, kidney, or breathing trouble.
The problem is that the drug contains alcohol and propylene glycol, and the premature infants cannot eliminate the propylene glycol, FDA said. The agency also noted that there is no safe, established dose for Kaletra in any baby younger than 2 weeks old.
“The use of Kaletra oral solution should be avoided in premature babies until 14 days after their due date, or in full-term babies younger than 14 days of age unless a healthcare professional believes that the benefit of using Kaletra oral solution to treat HIV infection immediately after birth outweighs the potential risks,” FDA said.
If a doctor does decide to use the drug in such babies, FDA said it strongly recommends monitoring infants for toxicity.
Kaletra is approved for use in adults and children at least 2 weeks old in combination with other antiretroviral drugs to treat HIV-1 infection.
