Safety Alerts & Recalls

What does this mean?

In most babies, the benefits of Kaletra oral solution will continue to outweigh the risks. Call your healthcare professional right away if your baby appears too sleepy or their breathing has changed while taking Kaletra oral solution. Kaletra oral solution contains alcohol and propylene glycol, and babies less than 14 days old (whether premature or full-term) may develop high blood levels of these ingredients resulting in sleepiness and changed breathing. These and other symptoms can also occur if your baby takes more than the usual dose of Kaletra all at once. Contact your local poison control center or emergency room right away if an overdose occurs.

Please discuss any questions or concerns about Kaletra oral solution with your healthcare professional. Do not stop giving Kaletra oral solution without talking to your healthcare professional.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of Kaletra products to the FDA's MedWatch Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA Warns About Serious Health Problems Seen in Premature Babies Given Kaletra Oral Solution

The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals of serious health problems that have been reported in premature babies receiving Kaletra (lopinavir/ritonavir) oral solution. Kaletra oral solution contains the ingredients alcohol and propylene glycol. A safe and effective dose for babies less than 14 days of age (whether born premature or full term) has not been established. 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.

The label (prescribing information) for Kaletra oral solution is being revised to include the new warning: 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 healthcare professional believes that the benefit of using Kaletra oral solution to treat HIV infection immediately after birth outweighs the potential risks.

Kaletra oral solution is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection in pediatric patients 14 days of age (whether premature or full term) or older and in adults.

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Source: FDA
Publication Date: 2011-03-08
Last Updated: 2011-03-08

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