FDA Warns of Serious Lung Condition in Infants Treated with Proglycem

Warning - Lung Condition in Infants Treated with Proglycem

Warning – Lung Condition in Infants Treated with Proglycem


In a recent drug safety alert, the Food and Drug Administration (FDA) warned that a serious lung condition, pulmonary hypertension, has been reported in infants and newborns treated with Proglycem (diazoxide) for low blood sugar. Pulmonary hypertension is high pressure in the blood vessels leading to the lungs.

The FDA identified 11 cases of pulmonary hypertension in infants and newborns treated with diazoxide, the active ingredient in Proglycem, since the drug was approved in 1973. In all cases, according to the safety announcement, pulmonary hypertension resolved or improved after Proglycem was stopped.

Proglycem is used to treat low blood sugar levels due to certain medical conditions that cause the release of too much insulin from the pancreas. According to the FDA, Proglycem works mainly by blocking the pancreas from releasing insulin; this action helps to increase blood sugar. Proglycem is usually given in the hospital, and health care professionals should closely monitor babies receiving it, especially those with risk factors for pulmonary hypertension such as meconium aspiration syndrome, respiratory distress syndrome, transient tachypnea of the newborn, pneumonia, sepsis, congenital diaphragmatic hernia, and congenital heart disease. Pulmonary hypertension makes it harder for the heart to pump blood to the lungs, and it can cause heart failure and lower oxygen in the blood. Proglycem should be stopped if pulmonary hypertension is identified.

Anyone caring for a child receiving Proglycem should watch for signs of difficulty breathing including flaring nostrils, grunting, unusual movement of the child’s chest, rapid breathing, difficulty feeding, or bluish color of the lips or skin. A health care professional should be alerted if any of these signs is seen.

The FDA identified 11 cases of pulmonary hypertension in infants and newborns treated with diazoxide through the FDA Adverse Event Reporting System (FAERS) database and the medical literature. Because FAERS includes only reports that have been submitted to the FDA, there are likely additional cases of which the agency is not aware. In addition to having other serious medical conditions, most of these babies were also at high risk for developing pulmonary hypertension, a condition in which the pressure in the blood vessels leading to the lungs is too high. The babies affected developed pulmonary hypertension within a day to a few months after starting Proglycem, and they were hospitalized or had their neonatal intensive care unit (NICU) hospitalization extended because of the condition. All of them either recovered or improved after Proglycem was discontinued.

The FDA urges health care professionals, parents, and caregivers to report side effects involving Proglycem to the FDA MedWatch program: www.fda.gov/MedWatch/report.

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