FDA Warns of Pulmonary Hypertension in Infants and Newborns Linked to Proglycem (diazoxide)

Washington, DC: The Food and Drug Administration (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 Proglycem (diazoxide) for low blood sugar.

In all cases, the pulmonary hypertension resolved or improved after Proglycem was stopped. The FDA is continuing to investigate this safety issue and will determine whether changes are needed in the Proglycem prescribing information.

The FDA has identified 11 cases of pulmonary hypertension in infants and newborns treated with diazoxide, the active ingredient in Proglycem, since the drug was approved in 1973.

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Last updated on Jul-22-15