March 9, 2011
On Tuesday, the Food and Drug Administration advised against using Kaletra (lopinavir/ritonavir) oral solution in premature babies, which can cause severe or possibly fatal health problems, and in all babies younger than 14 days. There is no safe, established dose for babies younger than two weeks, whether premature or full-term, FDA said.
The Kaletra oral solution contains alcohol and propylene glycol, and the inability of premature babies to eliminate propylene glycol can lead to adverse events, including "serious heart, kidney or breathing problems," said the notice to health professionals. FDA has received reports of serious problems in premature babies receiving Kaletra.
"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 the new warning," stated the notice. "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 health care professional believes that the benefit of using Kaletra oral solution to treat HIV infection immediately after birth outweighs the risks. In such cases, FDA strongly recommends monitoring for increases in serum osmolality, serum creatinine, and other signs of toxicity."
For additional information, visit www.fda.gov/Drugs/DrugSafety/ucm246002.htm.