FDA Warning for Proglycem and Pulmonary Hypertension

July 16, 2015 — The FDA is warning that a serious lung condition called pulmonary hypertension has been reported in infants who were treated with Proglycem for low blood-sugar.

Proglycem (diazoxide) has been on the market since 1973 and the FDA has received 11 reports of pulmonary hypertension, a condition that causes high blood pressure in the blood vessels leading to the lungs.

Most of the babies had risk-factors for pulmonary hypertension and developed the condition within a few days or months after starting Proglycem. In all cases, the babies were hospitalized and the condition went away or improved when Proglycem was discontinued.

The FDA is particularly concerned about administering Proglycem to infants with risk-factors for pulmonary hypertension, such as meconium aspiration syndrome, pneumonia, sepsis, congenital heart disease, and more.

The agency asks parents to immediately tell the child’s doctor if any of the following symptoms of pulmonary hypertension appear:

“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.”

Pulmonary hypertension makes it harder for the heart to pump blood to the lungs, which can cause heart failure and death. When pressure gets too high, arteries in the lungs narrow and blood does not flow as well as it should. As a result, there is less oxygen in the bloodstream.

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