Acetaminophen / butalbital / caffeine Pregnancy Warnings
Use is not recommended unless clearly needed
US FDA pregnancy category: C
Comment: Monitor for barbiturate withdrawal in neonates
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. 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.
Acetaminophen / butalbital / caffeine Breastfeeding Warnings
Acetaminophen, butalbital, and caffeine are excreted into human milk in small concentrations. The significance of the effects on nursing infants 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)
Can I take Fioricet (Acetaminophen, Butalbital, And Caffeine) if I’m pregnant or breastfeeding?
It is not known whether this medicine will harm an unborn baby. If you use butalbital while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.
This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.