This Drug is Not for Preemies

Kaletra anti-HIV drug can cause serious health problems in premature babies

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) The FDA has warned health care professionals that an antiretroviral drug used to treat HIV infection may lead to serious heart, kidney, and breathing problems in premature babies.

Kaletra® (lopinavir/ritonavir) oral solution - an antiviral drug used in combination with other antiretrovirals in the treatment of HIV-1 infection - could lead to serious health problems in premature babies.

dailyRx Insight: Kaletra® should not be used on preemies until 14 days after they are born, it can cause many organ defects. Also, Kaletra® should not be used on full-term babies in the first 2 weeks of life unless your doctor decides the benefits outweigh the risks.

Premature babies are more likely to experience health problems because of their decreased ability to break down propylene glycol, an ingredient of Kaletra®. Propylene glycol is an organic compound that generally has a low oral toxicity. However, it can become toxic if an infant's body cannot break it down.

According to an FDA warning, premature babies' decreased ability to eliminate propylene glycol could lead to severe or potentially fatal heart, kidney, and breathing problems. As such, the label of Kaletra® is being revised to include a new warning.

The FDA recommends that Kaletra® oral solution not be used on premature babies until 14 days after their expected due date. Unless a health care professional believes that the benefits outweigh the risks, use of Kaletra® should also be avoided in full-term babies younger than 14 days of age. If a doctor does decide to use Kaletra® in babies younger than 14 days, the baby should be closely monitored for various signs of toxicity.

Kaletra® is an antiretroviral medication used to treat HIV-1 infection. Kaletra® is used in combination with other anti-HIV-1 medications to increase the chance that a patient responds to treatment.

According to the U.S. Centers for Disease Control and Prevention, an estimated 599,819 people were living with HIV infection in the United States in 2007. However, other estimates put that number closer to 1.1 million people. This discrepancy is due to a few factors, including: lack of confidentiality protections in some states; home diagnosis tests are excluded from many reports; and one in five people living with HIV either go undiagnosed or without reporting their infection.

Of the nearly 4,000 children (younger than 13 years at time of diagnosis) living with an AIDS diagnosis, the majority acquired their HIV infection from their mother. Having said that, mother-to-child transmission has decreased significantly in the last decade with the large increase in HIV testing among pregnant women as well as the increase in antiretroviral drugs such as Kaletra®.

Reviewed by: 
Review Date: 
March 8, 2011
Last Updated:
March 9, 2011