Print this page    •   Back to Web version of article

Medical News
U.S. Warns Against Abbott HIV Drug in Premature Babies

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

Back to other news for March 2011

Excerpted from:
03.08.2011; Susan Heavey

This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. You can find this article online by typing this address into your Web browser:

General Disclaimer: is designed for educational purposes only and is not engaged in rendering medical advice or professional services. The information provided through should not be used for diagnosing or treating a health problem or a disease. It is not a substitute for professional care. If you have or suspect you may have a health problem, consult your health care provider.