The Food and Drug Administration (FDA) is alerting doctors and health care professionals that serious health problems have been reported in premature babies who receive the oral solution Kaletra (lopinavir/ritonavir). Kaletra is used in combination with other antiretroviral dugs to treat HIV-1 infection in patients 14 days of age (whether premature or full term) and older, including adults. Kaletra does not cure the disease, but helps people with the condition stay healthier for a longer period of time.

The medication contains alcohol and propylene glycol. Premature babies may be more vulnerable to side effects caused by this drug because they have a decreased ability to eliminate propylene glycol. As a result, premature babies who are given the solution may experience serious problems with their heart or kidneys or have difficulty breathing. If the solution is given to babies immediately after birth, the results can be fatal.

Thus, the FDA has ordered that the safety label for Kaletra include a 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. In these cases, the FDA strongly recommends doctors monitor the baby for increases in serum osmolality, serum creatinine, and other signs of toxicity.

Parents or caregivers of babies who are taking Kaletra oral solution should contact their doctors if their babies appear too sleepy or their breathing has changed. If accidental overdose occurs, caregivers should call their local poison control center or go to the emergency room right away.

Any side effects with this or any other medication should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.

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