Acetaminophen / benzhydrocodone Pregnancy and Breastfeeding Warnings

Brand names: Apadaz

Medically reviewed by Drugs.com. Last updated on Jan 23, 2024.

Acetaminophen / benzhydrocodone Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There are no available human data on this drug or hydrocodone use during pregnancy to inform drug associated risks; prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal and other adverse reactions during pregnancy and labor. Acetaminophen has not been associated with major congenital malformations, although animal studies have identified adverse effects at clinically relevant doses.

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.
-Monitor neonates exposed to opioid analgesics for signs of excess sedation and respiratory depression.

No reproductive or developmental toxicity studies have been conducted with benzhydrocodone or the combination benzhydrocodone/acetaminophen; data is based on hydrocodone and acetaminophen alone. Opioid analgesics cross the placenta. During labor, hydrocodone may cause respiratory depression in the newborn infant. Prolonged use of opioids during pregnancy can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Epidemiologic data does not report an association with oral acetaminophen and major birth defects, miscarriage, or adverse maternal or fetal outcomes during pregnancy, but due to methodological limitations cannot definitively establish the absence of any risk. In pregnant rats receiving oral drug at doses up to 0.88 times maximum human daily dose (MHDD) during the period of organogenesis, fetotoxicity (reduced fetal weight and length) and dose-related increases in bone variations (reduced ossification and rudimentary rib changes) were observed. Areas of necrosis in both the liver and kidney of pregnant rats and fetuses were observed when pregnant rats were given oral drug throughout gestation at doses 1.2 times the maximum human daily dose. There are no controlled data in human pregnancy.

Chronic use of opioids may cause reduced fertility; it is unknown whether these effects are reversible. According to published animal studies, acetaminophen may cause reduced fertility in both males and females described as decreased testicular weights, reduced spermatogenesis, reduced fertility, and reduced implantation sites, respectively.

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.

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Acetaminophen / benzhydrocodone Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Yes (acetaminophen); Yes (hydrocodone)

Comments:
-Breastfed infants should be monitored for excess sedation and respiratory depression; immediate medical attention is necessary if infant develops breathing difficulties or limpness.
-Withdrawal symptoms can occur in breastfed infants when maternal drug use or breastfeeding are stopped.

Breastfed infants of mothers who receive opioids, especially newborns, can experience drowsiness, CNS depression, and even death. Benzhydrocodone is a prodrug of the opioid agonist hydrocodone. The conversion to hydrocodone occurs via enzymes in the intestinal tract. Hydrocodone and hydromorphone (its active metabolite) have been shown to be present in human milk in variable concentrations; acetaminophen is present in small quantities. There is a well-documented case report of rash in a breastfed infant exposed to acetaminophen. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for therapy and any potential adverse effects on the breastfed infant from the underlying maternal condition.

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Further information

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