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

March 14, 2011

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.

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 adults and in pediatric patients aged 14 days (whether premature or full term) or older.

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.

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.

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 by calling 1-800-332-1088 to request a reporting form.

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