FDA revises label to include new warning outlining serious event risk in premature babies
TUESDAY, March 8 (HealthDay News) -- The U.S. Food and Drug Administration has notified health care providers of a revision to the label of lopinavir/ritonavir (Kaletra) oral solution to include a new warning, as administration of the oral solution may result in serious health problems among premature babies.
Lopinavir/ritonavir oral solution is an antiviral medication indicated for the treatment of HIV-1 infection in pediatric patients 14 days of age or older and in adults. It is used in combination with other antiretroviral drugs. The oral solution contains alcohol and propylene glycol.
The FDA issued the label change because premature babies may not effectively eliminate propylene glycol, which could lead to serious or fatal adverse events such as cardiac, kidney, or breathing problems. An FDA review of the Adverse Events Reporting System database between September 2000 and September 2010 revealed 10 post-marketing cases with life-threatening events reported in neonates who were predominantly born preterm and who received lopinavir/ritonavir oral solution.
According to the FDA, "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 potential risks. In such cases, FDA strongly recommends monitoring for increases in serum osmolality, serum creatinine, and other signs of toxicity."