Opana Pregnancy Warnings
Benefit should outweigh risk
US FDA pregnancy category: Not assigned
Risk Summary: Based on animal data, may cause fetal harm; prolonged maternal use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome.
Comments:
-Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.
-Long-acting opioids should not be used during and immediately prior to labor, when short acting analgesics or other analgesic techniques are more appropriate.
Animal studies have shown exposure during pregnancy is associated with reduced postnatal survival. Administration to female rats during gestation and through lactation at doses 2.4 and 12 times the human daily dose (HDD) of 20 mg/day showed reduced postnatal survival of pups and an increased incidence of stillborn pups, respectively. Reduced fetal weights were observed in rats and rabbits born to dams taking this drug during organogenesis at exposures up to 4.9 (rats) and 48.8 (rabbits) times the HDD, respectively Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. There are no adequate and well-controlled studies in pregnant women.
Chronic use of opioids may cause reduced fertility in females and males of reproductive potential; it is unknown if these effects are reversible.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
See references
Opana Breastfeeding Warnings
Benefit should outweigh risk
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-Monitor breastfed infants for excess sedation and respiratory depression; withdrawal symptoms can occur when maternal administration of this drug is stopped.
-Because of the potential for serious adverse reactions, including excess sedation and respiratory depression, breastfeeding is not recommended with use of the extended-release tablets.
See references
