Acetaminophen / butalbital / caffeine / codeine Pregnancy and Breastfeeding Warnings

Brand names: Fioricet with Codeine, Phrenilin with Caffeine and Codeine

Medically reviewed by Drugs.com. Last updated on Jan 18, 2024.

Acetaminophen / butalbital / caffeine / codeine Pregnancy Warnings

Use is not recommended unless clearly needed

US FDA pregnancy category: Not assigned

Risk Summary: Available data on use of this drug in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage.

Comments:
-Monitor for barbiturate withdrawal in neonates
-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.

Animal reproduction studies have not been conducted on this combination product. Epidemiologic data for acetaminophen, including a population based case-control study from the National Birth Defects Prevention Study (n= 11,610) and data from 26,424 live singleton births have shown no increased risk of major birth defects in children with first trimester prenatal exposure. In 2015, the US Food and Drug Administration released results of their evaluation on published research studies looking at mothers who took acetaminophen (either over the counter or as a prescription product) at any time during their pregnancy and the risk of attention deficit hyperactivity (ADHD) in their babies. They found all studies reviewed had potential limitations in their designs that prevented drawing reliable conclusions. Barbiturates have been reported to readily cross the placental barrier. A 2-day old infant whose mother had taken a butalbital-containing product during the last two months of pregnancy experienced withdrawal seizures; butalbital was found in the infant's serum. Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes may result in physical dependence in the newborn and neonatal opioid withdrawal syndrome shortly after birth. Use of codeine during labor may produce respiratory depression in the neonate. There are no controlled data in human pregnancy.

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 / butalbital / caffeine / codeine Breastfeeding Warnings

Codeine is present in breast milk. For women with normal codeine metabolism (normal CYP450 2D6 activity) the amount of codeine secreted is low and dose-dependent; however, in women who are ultra-rapid metabolizers (those with multiple copies of the gene for CYP450 2D6) higher-than-expected serum levels of morphine (active metabolite) may be present in their breast milk leading to dangerously high serum morphine levels in their breastfed infants. In most cases, a person's specific CYP450 2D6 genotype is unknown. Several small series and 1 small retrospective study suggest that codeine may be causative in episodes of apnea, bradycardia, and cyanosis in the first week 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. The significance of small amounts of acetaminophen, butalbital, and caffeine excreted into human milk has not been reported, but due to the potential for serious adverse reactions in nursing infants, other agents may be preferred.

Not recommended

Excreted into human milk: Yes (acetaminophen); Yes (barbiturates); Yes (caffeine); Yes (codeine)

Comment:
-Breastfeeding is not recommended due to the potential for serious adverse reactions in the breastfed infant including excess sedation, respiratory depression, and death.

See references

Further information

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