Infants and newborns who have been treated with Proglycem (diazoxide) for low blood pressure are at risk for pulmonary hypertension, according to a press release from the Food and Drug Administration.

As Proglycem is usually given in a hospital setting, all babies receiving it should be closely monitored by a health care professional, especially if a risk factor for pulmonary hypertension is present, such as meconium aspiration syndrome, respiratory distress syndrome, transient tachypnea of the newborn, pneumonia, sepsis, congenital diaphragmatic hernia, and congenital heart disease, the FDA said.

The FDA identified 11 cases of pulmonary hypertension since Proglycem was approved in 1973. In all cases, pulmonary hypertension was stopped or was improved by stopping Proglycem treatment.

If a parent or caregiver notices any sign of difficulty breathing such as flaring nostrils, grunting, unusual movement of their child’s chest, rapid breathing, difficulty feeding, or a bluish color of the lips or skin, he or she should contact a doctor immediately, the FDA recommended.

“FDA is continuing to investigate this safety issue and will determine whether changes are needed in the Proglycem prescribing information,” the FDA said in the press release.


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