Study: In Utero Antiretroviral Exposure Possibly Linked to Neurologic Outcomes – APhA submits compounding comments to FDA.

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Study: In Utero Antiretroviral Exposure Possibly Linked to Neurologic Outcomes – APhA submits compounding comments to FDA. – (866) 348-2889.

Efavirenz exposure (EVF) in utero is being linked to higher risk of neurologic abnormalities in infants and children. The association was made through a study by the Pediatric HIV/AIDS Cohort Study (PHACS) network that analyzed antiretroviral (ARV) medication exposure and possible adverse neurologic outcomes.1

ARV therapy for pregnant women with HIV has dramatically decreased preinatal transmission of HIV, according to researchers, but concerns regarding adverse neurologic outcomes from possible mitochondrial dysfunction or other mechanisms in children exposed to in utero ARV medications remain. The Surveillance Monitoring for ART Toxicities (SMARTT) study’s primary outcome of interest was a “neurologic case,” as determined by clinical review blinded to ARV exposure.1 Results of the study were presented Thursday at the ID Week conference in San Francisco.

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