Kaletra Side Effects Pose Serious Risk for Premature Babies: FDA

Federal health regulators are warning that Kaletra, an HIV drug that is sometimes used to treat infected children, should not be given to premature babies before their due date, due to a potential risk of serious and potentially life-threatening side effects. 

The FDA issued a Kaletra drug safety communication on Tuesday, warning that premature babies could suffer serious heart, kidney or breathing problems if given the oral solution to treat an HIV infection before their due date.

A review of adverse events reported to the FDA revealed at least 10 cases of serious injuries that resulted from premature newborns being given Kaletra; one of which resulted in a child’s death due to cardiogenic shock.

According to the FDA, premature babies have not yet fully developed the ability to metabolize propylene glycol, which accumulates in their system. When used on premature neonates, Kaletra side effects can include lactic acidosis, acute renal failure, central nervous system (CNS) depression, and respiratory problems. All newborns, including those born prematurely, are at increased risk of lopinavir, ethanol and propylene glycol toxicity.

In the 10 cases examined by the FDA, the newborns were given Kaletra the day they were born or the day after. Toxicity occurred within 1 to 6 days in eight of the 10 cases. Once use of the Kaletra oral solution was discontinued, six of the infants recovered within 5 days.

The FDA notes that there is no safe and effective dose of Kaletra for babies less than 14 days of age. The FDA is recommending that doctors avoid using it on newborns before a postnatal age of 14 days unless absolutely necessary. The agency also warned that signs of Kaletra toxicity could be mistaken for neonatal sepsis and that they should immediately discontinue use if any signs of Kaletra problems appear.

Kaletra (lopinavir/ritonavir) is an antiviral medication approved for the treatment of HIV infections in patients 14 days of age and older. It Is manufactured by Abbott Laboratories and was approved by the FDA in September 2000.