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Butorphanol Pregnancy and Breastfeeding Warnings

Butorphanol is also known as: Stadol

Butorphanol Pregnancy Warnings

There have been rare reports of infant respiratory distress/apnea associated with the administration of a dose of butorphanol within 2 hours of delivery, use of multiple drugs, use with additional analgesic or sedative drugs, or use in preterm pregnancies. The manufacturer has reported that a study (n=119) of the administration of 1 mg of IV butorphanol injection during labor was associated with transient (10 to 90 minute) sinusoidal fetal heart rate patterns, but was not associated with adverse neonatal outcomes. In the presence of abnormal fetal heart rates, butorphanol injection should be used with caution. Because butorphanol nasal spray has not been studied for use in labor, use of the nasal spray for labor is not recommended.

Butorphanol has been assigned to pregnancy category C by the FDA. Animal studies have reported a higher frequency of stillbirths and a higher incidence of post implantation loss than controls. There are no controlled data in human pregnancy before 37 weeks gestation. Butorphanol should be used during pregnancy only if the potential benefit justifies the potential risk to the infant.

See references

Butorphanol Breastfeeding Warnings

Butorphanol has been detected in human milk. Adverse effects in the nursing infant are unlikely. The amount of butorphanol an infant may receive has been estimated to be 4 ug/L of milk in a mother receiving 2 mg IM 4 times a day. Butorphanol is considered to be compatible with breast-feeding by the American Academy of Pediatrics.

See references

References for pregnancy information

  1. Hatjis CG, Meis PJ "Sinusoidal fetal heart rate pattern associated with butorphanol administration." Obstet Gynecol 67 (1986): 377-80
  2. "Product Information. Stadol (butorphanol nasal)." Bristol-Myers Squibb, Princeton, NJ.

References for breastfeeding information

  1. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  2. "Product Information. Stadol (butorphanol nasal)." Bristol-Myers Squibb, Princeton, NJ.

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