July 16, 2015 — The FDA has issued a warning that pulmonary hypertension has been reported in babies who were treated with Proglycem (diazoxide) for low blood-sugar levels.
Proglycem was approved in 1973 and is usually given to babies with hypoglycemia due to certain medical conditions that cause the release of too much insulin from the pancreas.
Unfortunately, the FDA has identified 11 cases of pulmonary hypertension in infants and newborns. It is likely that more cases were never reported. The condition occurred within a few days or months of taking Proglycem. All of the babies were hospitalized and recovered after discontinuing Proglycem.
The FDA was specifically concerned about babies with risk-factors for pulmonary hypertension, such as respiratory distress syndrome, sepsis, meconium aspiration, congenital heart disease, pneumonia, and more. Most cases occurred in babies with risk-factors.
Parents whose baby must take Proglycem for hypoglycemia should contact their child’s doctor immediately if any of the following symptoms appear:
“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.”
Pulmonary hypertension occurs when there is abnormally high blood-pressure in arteries to the lungs. Over time, blood vessels become hard and narrow. The heart must work harder to force blood into the lungs, which can lead to deadly heart failure. It can also cause low oxygen levels in the bloodstream.
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