French researchers indicate that use of the drug Kaletra to prevent transmission of HIV from mothers to newborns could cause some infants to suffer life-threatening adrenal problems.
In a study published this week in the Journal of the American Medical Association, researchers indicate that Kaletra should no longer be used as a routine HIV neonatal prophylactic, because it is too dangerous to the newborn and there are other drugs on the market that could be used.
The study comes just a couple months after the FDA issued a warning about Kaletra toxicity in premature newborns.
The researchers took blood samples from 50 newborns who were given Kaletra and compared them with 108 infants who were given other drugs to prevent HIV transmission. They found that seven of the children given Kaletra developed adrenal problems. There were no adrenal problems detected among newborns given other drugs.
Adrenal problems can cause development abnormalities in both boys and girls. Girls can develop a deep voice, excessive body hair, abnormal menstrual periods and genital defects. Boys with adrenal problems can develop exaggerated male traits like overdeveloped musculature, deep voice, enlarged penis but small testicles. Both sexes often grow up to be short as adults.
Kaletra (lopinavir/ritonavir) is an antiviral medication approved for the treatment of HIV infections in patients 14 days of age and older. It Is manufactured by Abbott Laboratories and was approved by the FDA in September 2000.
In March, the FDA issued a Kaletra drug safety communication, warning that premature babies could suffer serious heart, kidney or breathing problems if given the drug before their due date. A review of adverse events reported to the FDA revealed at least 10 cases of serious injuries that resulted from premature newborns being given Kaletra; one of which resulted in a child’s death due to cardiogenic shock.