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FDA warns hypoglycemia drug may cause pulmonary hypertension in infants
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The FDA has announced that there are potential risks for pulmonary hypertension in infants and newborns treated with Proglycem, according to an agency press release.
Proglycem (diazoxide, Teva Pharmaceuticals), a hypoglycemia drug, is typically given to patients in a hospital setting.
The FDA has identified 11 cases of pulmonary hypertension in infants and newborns treated with the drug since its approval in 1973, according to the release.
In each case, the pulmonary hypertension improved after administration of the drug had stopped.
The FDA is advising clinicians to closely monitor babies receiving the drug, especially infants and newborns with risk factors such as meconium aspiration syndrome, pneumonia, sepsis and congenital heart disease. Clinicians are advised to stop treatment if they identify pulmonary hypertension, according to the release.
The FDA is investigating the safety of the drug in infants and newborns and will determine what, if any, changes are needed in the prescription information of the drug.
Parents and guardians of children receiving Proglycem should watch for signs of difficulty breathing such as flaring nostrils and rapid breathing, difficulty feeding or a bluish color of lips or skin, according to the release.