Serious Lung Problem Seen in Babies Receiving Proglycem

The FDA has identified 11 cases of pulmonary hypertension in infants and newborns treated with diazoxide (Proglycem).

In all reported cases, the serious lung condition resolved or improved after the low blood sugar treatment was stopped.

The FDA is investigating this issue to determine whether changes to Proglycem’s prescribing information are warranted.

In the meantime, health care professionals should closely monitor babies receiving Proglycem, especially those with risk factors for pulmonary hypertension, which include meconium aspiration syndrome, respiratory distress syndrome, transient tachypnea of the newborn, pneumonia, sepsis, congenital diaphragmatic hernia, and congenital heart disease.

Caregivers are advised to closely monitor children on Proglycem for symptoms such as flaring nostrils, grunting, rapid breathing, and bluish coloring of the lips and skin. Any health concerns should be immediately reported to health care professionals.

Side effects related to Proglycem use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Proglycem is usually administered in the hospital to manage hypoglycemia caused by certain cancers, surgery, or other conditions.