FDA MedWatch - Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in Infants and Newborns

Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in Infants and Newborns

AUDIENCE: Pulmonology, Pediatrics, Nursing, Critical Care Medicine

ISSUE:  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. FDA is continuing to investigate this safety issue and will determine whether changes are needed in the Proglycem prescribing information.

BACKGROUND: FDA 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.

RECOMMENDATION: Proglycem is usually given in the hospital, and health care professionals should closely monitor babies receiving it, especially those 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. Stop Proglycem treatment if pulmonary hypertension is identified.

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. Immediately alert your child’s health care professionals if you see any of these signs, and talk to them if you have any questions or concerns about Proglycem.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm455125.htm