FDA lopinavir/ritonavir label change warns of serious health risks in premature babies

FDA notified healthcare professionals of serious health risks that have been reported in premature babies receiving lopinavir/ritonavir (Kaletra, Abbott) oral solution. Lopinavir/ritonavir oral solution contains the ingredients alcohol and propylene glycol.

Lopinavir/ritonavir oral solution is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection in pediatric patients aged 14 days (whether premature or full term) or older and in adults. Premature babies may be at increased risk for health problems because they have a decreased ability to eliminate propylene glycol; this could lead to adverse events such as serious heart, kidney, or breathing problems. Because the consequences of using lopinavir/ritonavir oral solution in babies immediately after birth can be severe or possibly fatal, the label is being revised to include a new warning.

“In its review of the adverse event reporting system, FDA identified adverse events in premature infants potentially related to ethanol and propylene glycol, 2 ingredients in Kaletra oral solution that are also commonly found in many oral solutions,” Abbott spokesman Derin Denham told Formulary. “Abbott will make the agency's requested changes to the prescribing information.”

FDA warns that the use of lopinavir/ritonavir 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 lopinavir/ritonavir 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. “The use of Kaletra in high risk babies was already an issue for clinicians and it is well known that glycol-containing products in particular are an issue for premature babies due to their premature organs versus adults,” Randy Vogenberg, PhD, principal at the Institute for Integrated Healthcare in Sharon, Mass., and executive director of the Biologic Access & Finance program at The Jefferson School of Population Health in Philadelphia.

In the United States, Kaletra oral solution is indicated for use in children aged 14 days and older. Kaletra is the only protease inhibitor approved to be used in children under age 2 years and has been studied extensively in children.

Healthcare professionals and patients are encouraged to report problems to FDA’s MedWatch Safety Information and Adverse Event Reporting Program online at http://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-332-1088 to request a reporting form.