The U.S. Food and Drug Administration (FDA) is warning that a serious lung condition called pulmonary hypertension, which is high pressure in the blood vessels leading to the lungs, has been reported in infants and newborns treated with Proglycem (diazoxide) for low blood sugar. In all cases, the pulmonary hypertension resolved or improved after Proglycem was stopped. We are continuing to investigate this safety issue and will determine whether changes are needed in the Proglycem prescribing information.
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. Stop Proglycem treatment if pulmonary hypertension is identified.
Parents and caregivers of any child receiving Proglycem should watch for signs 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. Immediately alert your child’s health care professionals if you see any of these signs, and talk to them if you have any questions or concerns about Proglycem.
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. Proglycem works mainly by blocking the pancreas from releasing insulin; this action helps to increase blood sugar.
We searched the FDA Adverse Event Reporting System (FAERS) database1 and the medical literature2-4 and 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. FAERS includes only reports submitted to FDA, so there are likely additional cases about which we are unaware. In addition to having other serious medical conditions, most of these babies also were at high risk for developing pulmonary hypertension, a condition in which the pressure in the blood vessels leading to the lungs is too high. This makes it harder for the heart to pump blood to the lungs, and it can cause heart failure and lower oxygen in the blood. 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.
We urge health care professionals, parents, and caregivers to report side effects involving Proglycem to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.