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)
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
- Bleeding or crusting sores on lips
- chest pain
- fever with or without chills
- hive-like swellings (large) on eyelids, face, lips, and/or tongue
- muscle cramps or pain
- red, thickened, or scaly skin
- shortness of breath, troubled breathing, tightness in chest, or wheezing
- skin rash, itching, or hives
- sores, ulcers, or white spots in mouth (painful)
Symptoms of overdose
- Anxiety, confusion, excitement, irritability, nervousness, restlessness, or trouble in sleeping (severe, especially with products containing caffeine)
- convulsions (seizures) (for products containing caffeine)
- diarrhea, especially if occurring together with increased sweating, loss of appetite, and stomach cramps or pain
- dizziness, lightheadedness, drowsiness, or weakness, (severe)
- frequent urination (for products containing caffeine)
- hallucinations (seeing, hearing, or feeling things that are not there)
- increased sensitivity to touch or pain (for products containing caffeine)
- muscle trembling or twitching (for products containing caffeine)
- nausea or vomiting, sometimes with blood
- ringing or other sounds in ears (for products containing caffeine)
- seeing flashes of “zig-zag” lights (for products containing caffeine)
- shortness of breath or unusually slow or troubled breathing
- slow, fast, or irregular heartbeat
- slurred speech
- swelling, pain, or tenderness in the upper abdomen or stomach area
- unusual movements of the eyes
Check with your doctor as soon as possible if any of the following side effects occur:
- Confusion (mild)
- mental depression
- unusual excitement (mild)
- Bloody or black, tarry stools
- bloody urine
- pinpoint red spots on skin
- swollen or painful glands
- unusual bleeding or bruising
- unusual tiredness or weakness (mild
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Bloated or “gassy” feeling
- dizziness or lightheadedness (mild)
- drowsiness (mild)
- nausea, vomiting, or stomach pain (occurring without other symptoms of overdose)
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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