Warning for lopinavir/ritonavir oral solution

April 1, 2011

The US Food and Drug Administration has notified health care practitioners that severe, possibly fatal, health problems have been reported in babies who have received lopinavir/ritonavir oral solution.

The US Food and Drug Administration (FDA) has notified health care practitioners that severe, possibly fatal, health problems have been reported in babies who have received lopinavir/ritonavir oral solution.

Lopinavir/Ritonavir oral solution is an antiviral medication containing alcohol and propylene glycol that is used in combination with other antiretroviral drugs to treat human immunodeficiency virus (HIV-1) infection .

Preterm neonates have a decreased ability to eliminate propylene glycol, which could lead to adverse events including serious heart, kidney, and respiratory problems.