FDA Warns of Lung Problems in Infants Treated With Diazoxide

Disclosures

July 16, 2015

Clinicians need to watch for signs of pulmonary hypertension in infants treated with the antihypoglycemia drug diazoxide (Proglycem, Merck) and discontinue it if they appear, the US Food and Drug Administration (FDA) announced today.

The agency said it has identified 11 cases of pulmonary hypertension in infants receiving diazoxide in the medical literature and in its FDA Adverse Event Reporting System since 1973, when the drug was approved. Once diazoxide was stopped, the pulmonary hypertension resolved or improved in each case.

Usually administered in the hospital, diazoxide blocks the release of insulin from the pancreas, which helps increase blood glucose.

Clinicians as well as parents and caregivers should monitor infants treated with diazoxide for signs of respiratory distress, which include flaring nostrils, grunting, unusual chest movements, rapid breathing, difficulty feeding, or a bluish tint to the lips or skin. The need for such monitoring is especially important for infants with risk factors for pulmonary hypertension such as meconium aspiration syndrome, respiratory distress syndrome, transient tachypnea of the newborn, pneumonia, sepsis, congenital diaphragmatic hernia, and congenital heart disease

More information about today's announcement is available on the FDA's website.

To report problems with diazoxide, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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