Interventions Research

Medscape

On Aug. 23, the FDA approved safety labeling revisions for nalbuphine injection (Nubain, made by Endo Pharmaceuticals, Inc) to warn of the risk for serious fetal and neonatal adverse events associated with its use during labor and delivery.

The placental transfer of nalbuphine is high, rapid, and variable, with a maternal to fetal ratio ranging from 1:0.37 to 1:6. Fetal and neonatal adverse events have included reports of fetal bradycardia, respiratory depression at birth, apnea, cyanosis, and hypotonia. Some of these events have been life-threatening. Although maternal administration of naloxone during labor has normalized these effects in some cases, severe prolonged fetal bradycardia has occurred, and in some cases, resulted in permanent neurologic damage. Nalbuphine has also been linked to reports of sinusoidal fetal heart pattern.

The FDA advises that nalbuphine be used during labor and delivery only if clearly indicated and the potential benefit outweighs the risk to the infant. Newborns exposed to maternal nalbuphine should be monitored for respiratory depression, apnea, bradycardia, and arrhythmias. Nalbuphine injection is indicated for the relief of moderate to severe pain.

Nalbuphine Injection (Nubain) Linked to Risk for Fetal Adverse Events

Research to Remember: Perchlorate

Text Box: A Texas Tech University Institute of Environmental and Human Health study of breastmilk from 36 women in 18 states has concluded that perchlorate, a toxic component of rocket fuel, most likely contaminates breastmilk in "virtually all" women. An average concentration of 10.5 micrograms per liter was found in the samples. Health experts say infants and fetuses are the most vulnerable to the chemical's effects. Perchlorate blocks iodide and inhibits thyroid hormones, which are necessary for normal brain development and cellular growth of a fetus or infant. Impaired thyroid development may preclude neurological defects and attendant learning disabilities. Members of the research team recommend that pregnant and nursing women block the effects of the substance by taking iodine supplements. ~ Environmental Science and Technology, February 2005

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