Pulmonary HTN Reported With Proglycem in Newborns, Infants
The Food and Drug Administration (FDA) has issued a warning that pulmonary hypertension has been reported in infants and newborns treated with Proglycem (diazoxide; Teva) for low blood glucose. The pulmonary hypertension either improved or resolved upon discontinuation of Proglycem.
Since the approval of Proglycem in 1973, the FDA has identified 11 cases of pulmonary hypertension in infants and newborns. Healthcare professionals are recommended to closely monitor babies that are administered Proglycem, especially those with risk factors for pulmonary hypertension, which include meconium aspiration syndrome, respiratory distress syndrome, transient tachypnea of the newborn, pneumonia, sepsis, congenital diaphragmatic hernia, and congenital heart disease. Proglycem should be discontinued if pulmonary hypertension is identified.
Proglycem is indicated to treat low blood sugar levels due to certain conditions that cause the release of too much insulin from the pancreas. It works mainly by blocking the pancreas from releasing insulin thereby increasing blood sugar.
The FDA is investigating the safety issue and will decide if changes are needed in the drug's prescribing information.
For more information call (800) 332-1088 or visit FDA.gov.