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FDA warns about problems with Proglycem in infants

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FDA is warning that diazoxide (Proglycem) for low blood sugar has caused pulmonary hypertension (high pressure in the blood vessels leading to the lungs) in infants and newborns.

FDA is warning that diazoxide (Proglycem) for low blood sugar has caused pulmonary hypertension (high pressure in the blood vessels leading to the lungs) in infants and newborns. 

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FDA found 11 cases of pulmonary hypertension in infants and newborns treated with diazoxide, the active ingredient in Proglycem, since the drug was approved in 1973 in its FDA Adverse Event Reporting System (FAERS) database and the medical literature. There are likely additional cases about which FDA is unaware, according to the agency.

“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,” FDA wrote in its July 16 Drug Safety Communication.

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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. 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,” the FDA wrote.

The FDA said that 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. The agency is also urging healthcare professionals, parents, and caregivers to report side effects involving Proglycem to the FDA MedWatch program.

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