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FDA Warns About Serious Lung Condition in Infants and Newborns Treated With Diazoxide (Proglycem)
The FDA is warning health care professionals that serious pulmonary hypertension has been reported in infants and newborns treated with diazoxide (Proglycem, Merck) for hypoglycemia. In all cases, the disorder resolved or improved after diazoxide was stopped. The FDA is continuing to investigate this safety issue and will determine whether changes are needed in the drug’s prescribing information.
Diazoxide 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. Diazoxide should be stopped if pulmonary hypertension is identified.
Caregivers and parents of a child receiving diazoxide should watch for signs of difficulty breathing, such as flaring nostrils, grunting, unusual movement of the child’s chest, rapid breathing, difficulty feeding, or a bluish color of the lips or skin. If a child’s parents observe any of these signs, they should immediately contact a health care professional.
Diazoxide is used to treat hypoglycemia due to certain medical conditions that cause the release of too much insulin from the pancreas. Diazoxide works mainly by blocking the pancreas from releasing insulin; this action helps to increase blood sugar.
The FDA searched its adverse event reporting system database (FAERS) along with the medical literature, and identified 11 cases of pulmonary hypertension in infants and newborns treated with diazoxide since the drug was approved in 1973. FAERS includes only reports submitted to the FDA, so there are likely additional cases about which the agency is unaware. In addition to having other serious medical conditions, most of these infants were at high risk for developing pulmonary hypertension. The affected babies developed pulmonary hypertension within a day to a few months after starting diazoxide, and they were hospitalized or had their neonatal intensive care unit (NICU) hospitalization extended because of the condition. All of the infants either recovered or improved after diazoxide was discontinued.
Source: FDA; July 16, 2015.