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Breaking News: Kaletra (lopinavir/ritonavir) oral solution may cause serious health problems in premature babies. An increased risk of heart, kidney, and breathing problems is due to one of the main ingredients in the drug (propylene glycol). FDA recommends that the use of Kaletra be avoided unless absolutely necessary.

What’s the problem?

March 8, 2011 - Today, the U.S. Food & Drug Administration (FDA) announced that the label of Kaletra (lopinavir/ritonavir) oral solution is being revised to include a new warning about the serious health problems that have been reported in premature babies after receiving the drug.

Kaletra contains alcohol and propylene glycol, both of which present a risk to premature babies because they have a decreased ability to eliminate propylene glycol. This could lead to adverse events such as serious heart, kidney, or breathing problems.

The FDA is recommending that the use of Kaletra be avoided in premature babies unless a healthcare professional believes that the benefit of using the drug 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.