Proglycem Side Effects May Increase Risk of Pulmonary Hypertension In Newborns: FDA Warns

Federal drug regulators are warning that side effects of Proglycem, a drug used to treat low blood sugar, may increase the risk of a dangerous respiratory problems when given to infants and newborns. 

The FDA issued a drug safety communication on July 16, indicating that Proglycem (diazoxide) may cause pulmonary hypertension in infants and newborns, who sometimes receive the drug when hospitalized.

The agency indicates that it is investigating the issue and trying to determine whether any regulatory actions are needed, or whether the label warnings for the drug need to be changed.

According to the FDA there have been only 11 cases of pulmonary hypertension in newborns or infants given Proglycem since its approval in 1973. However, the agency found that in every case the infant’s condition improved or resolved completely after Proglycem treatments were stopped.

The agency is warning health care professionals to closely monitor babies given the drug, especially those children with respiratory problems that could increase their risks of pulmonary hypertension. These problems could inculde meconium aspiration syndrome, respiratory distress syndrome, transient tachypnea, pneumonia, sepsis, congenital diaphramic hernia or congenital heart disease. The FDA warns doctors to stop Proglycem treatment immediately if the baby is diagnosed with pulmonary hypertension.

Parents and caregivers are being warned to watch children given the medication for signs of difficulty breathing, including:

• Flaring nostrils
• Grunting
• Unusual chest movements
• Rapid breathing
• Difficulty eating
• Bluish skin or lips

They should notify a healthcare professional immediately if any of these signs are observed.

Proglycem, a liquid taken by mouth, is used to treat low blood sugar by blocking the pancreas from creating insulin. The Merck drug has been on the market since 1973.

The FDA discovered the cases of pulmonary hypertension by searching medical literature and its own adverse event reporting database.