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Acetaminophen / butalbital / caffeine / codeine Pregnancy and Breastfeeding Warnings

Acetaminophen / butalbital / caffeine / codeine is also known as: Fioricet with Codeine, Phrenilin with Caffeine and Codeine

Acetaminophen / butalbital / caffeine / codeine Pregnancy Warnings

Use is not recommended unless clearly needed US FDA pregnancy category: C Comment: -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. Codeine may lead to respiratory depression in the neonate. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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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 CYP2D6 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.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes (acetaminophen); Yes (barbiturates); Yes (caffeine); Yes (codeine) Comments: -The American Academy of Pediatrics recommends against use of codeine during breastfeeding as other agents are preferred. -Monitor breastfed infants for signs of morphine toxicity including increase sleepiness, difficulty breastfeeding, breathing difficulties, or limpness; seek medical attention promptly if these signs occur.

See references

References for pregnancy information

  1. "Product Information. APAP/Butalbital/Caffeine/Codeine (acetaminophen/butalbital/caffeine/codeine)." West-Ward Pharmaceutical Corporation, Eatontown, NJ.
  2. U.S. Food and Drug Administration U.S. Food and Drug Administration U.S. Food and Drug Administration U.S. Food and Drug Administration "FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy Available from: URL: http://www.fda.gov/Drugs/DrugSafety/ucm429117.htm." (01/09/2015):

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. APAP/Butalbital/Caffeine/Codeine (acetaminophen/butalbital/caffeine/codeine)." West-Ward Pharmaceutical Corporation, Eatontown, NJ.

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