Aspirin / caffeine / dihydrocodeine Pregnancy and Breastfeeding Warnings

Brand names: Synalgos-DC

Aspirin / caffeine / dihydrocodeine Pregnancy Warnings

Animal reproduction studies have not been conducted. Prolonged maternal use of dihydrocodeine ay lead to neonatal abstinence syndrome. Maternal aspirin use during later stages of pregnancy may cause low birth weight, increased incidence of intracranial hemorrhage in premature infants, stillbirths, and neonatal death. There are no controlled data on this combination product in human pregnancy.

Chronic use of opioids may cause reduced fertility in males and females; it is unknown whether these effects on fertility 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.

Use is not recommended

US FDA pregnancy category: Not assigned

Risk Summary: Available data are insufficient to inform a drug-associated risk for major birth defects and miscarriage.

Comment:
-Aspirin should be avoided after 30 weeks gestation as it may lead to premature closure of the fetal ductus arteriosus.
-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.

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Aspirin / caffeine / dihydrocodeine Breastfeeding Warnings

Not Recommended

Excreted into human milk: Yes (aspirin); Yes (caffeine); Yes (dihydrocodeine)

Comments:
-Breastfeeding is not recommended due to the potential for serious adverse reactions including excess sedation and respiratory depression, rashes, platelet abnormalities, bleeding, and the possibility of Reye Syndrome in the breast fed infant.

Dihydrocodeine is a semi-synthetic narcotic analgesic related to codeine; it is secreted into human milk in low, dose-dependent quantities in women with normal metabolism (normal CYP450 2D6 activity). However, in women who are ultra-rapid metabolizers (those with multiple copies of the gene for CYP450 2D6), higher-than-expected levels of dihydromorphine may be excreted in breast milk; dihydromorphine has a potency similar to morphine. In most cases, a person's specific CYP450 2D6 genotype is unknown. Several small series and 1 small retrospective study suggest that codeine may have been causative in episodes of apnea, bradycardia, and cyanosis in the first weeks of life. A death of a breastfeed infant due to respiratory depression has been reported; the mother was found to be a CYP450 2D6 ultrarapid metabolizer. Due to the potential for serious adverse reactions in nursing infants, other agents are preferred. If infants are breastfed, monitor for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infant if maternal administration of opioid is stopped or when breastfeeding is stopped.

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Further information

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