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Pulmonary Hypertension in infants and newborns treated with Diazoxide

Diazoxide is used to treat low blood sugar levels due to certain medical conditions that cause the release of too much insulin from the pancreas. It works mainly by blocking the pancreas from releasing insulin; this action helps to increase blood sugar. 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 diazoxide for low blood sugar. In all cases, the pulmonary hypertension resolved or improved after the drug was stopped.

Diazoxide 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 treatment if pulmonary hypertension is identified.

Parents and caregivers of any child receiving diazoxide 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,

FDA identified 11 cases of pulmonary hypertension in infants and newborns treated with diazoxide, 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 drug, and they were hospitalized or had their neonatal intensive care unit (NICU) hospitalization extended because of the condition. Extensive medical interventions were required to treat the severity of the pulmonary hypertension or manage the clinical condition of the patient. Interventions included initiation of oxygen supplementation, mechanical ventilation, and the use of vasodilator medications such as sildenafil and nitric oxide. There were no fatalities.All of them either recovered or improved after drug was discontinued.

Additional information for parents and care givers :

·If your child is receiving diazoxide, watch for signs of difficulty breathing such as flaring nostrils, grunting, unusual movement of your child’s chest, rapid breathing, difficulty feeding, or a bluish color of the lips or skin.

·Talk to your child’s health care professional if you have any questions or concerns about diazoxide.

·Report side effects from diazoxide.

Additional information for health care professionals:

There have been reports of pulmonary hypertension occurring in infants and neonates treated with diazoxide. The pulmonary hypertension either resolved or improved when drug was discontinued.

·Monitor patients, especially those with risk factors for pulmonary hypertension, for signs of respiratory distress, including tachypnea, flaring nostrils, grunting, and chest wall retractions. Other signs can include feeding intolerance and cyanosis.

·Common risk factors for pulmonary hypertension include meconium aspiration syndrome, respiratory distress syndrome, transient tachypnea of the newborn, pneumonia, sepsis, congenital diaphgragmatic hernia, and congenital heart disease.

·Discontinue diazoxide if pulmonary hypertension is identified.

·Report adverse events involving diazoxide.

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