Fioricet Pregnancy and Breastfeeding Warnings

Acetaminophen / butalbital / caffeine is also known as: Alagesic LQ, Anolor 300, Anoquan, Arcet, Dolmar, Esgic, Esgic-Plus, Ezol, Femcet, Fioricet, Fiorpap, Geone, Isocet, Margesic, Orbivan, Pharmagesic, Phrenilin Forte, Repan, Tenake, Tencet, Triad, Two-Dyne, Vanatol LQ, Vtol LQ, Zebutal

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)

The pregnancy, breastfeeding and fertility warning while taking gabapentin

Gabapentin capsules, tablets, and oral solution are used along with other medications to help control certain types of seizures in people who have epilepsy. Gabapentin capsules, tablets, and oral solution are also used to relieve the pain of postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles). Gabapentin extended-release tablets (Horizant) are used to treat restless legs syndrome (RLS; a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down).

Gabapentin is in a class of medications called anticonvulsants. Gabapentin treats seizures by decreasing abnormal excitement in the brain. Gabapentin relieves the pain of PHN by changing the way the body senses pain. It is not known exactly how gabapentin works to treat restless legs syndrome.

Gabapentin and pregnancy

Gabapentin is not generally recommended in pregnancy as there is not enough information about whether it’s safe for your baby.

However, from the small amount of information that is available, there’s no clear evidence that it’s harmful. It should only be taken if the benefits of the medicine outweigh the risks.

If you take gabapentin for epilepsy, it’s important that this is well treated during pregnancy, as seizures can harm you and your baby. Keep taking gabapentin, but talk to your doctor urgently. They may recommend you change to a different medicine.

If you’re trying to get pregnant or have become pregnant while taking gabapentin, it is recommended to take a high dose of folic acid (5mg a day). You can get this from your doctor or midwife.

Ideally you’ll take high dose folic acid for 3 months before you start trying to get pregnant and for the first 12 weeks of pregnancy. Do not worry if you have not taken it before you get pregnant, but start taking it as soon as possible once you know that you are pregnant. It helps your baby to grow normally.

If you take gabapentin around the time of giving birth, your baby may need extra monitoring for a few days after they’re born. This is because they may have withdrawal symptoms from gabapentin.

We do not know what the long term effects of taking gabapentin in pregnancy may be on childhood learning and development. For safety, you’ll usually be advised to take it only if the benefits of the medicine outweigh the risks. Talk to your doctor about the benefits and risks.

Gabapentin and breastfeeding

If your doctor or health visitor says your baby is healthy, you can take gabapentin while breastfeeding. It’s important to keep taking gabapentin to keep you well.

Gabapentin passes into breast milk in small amounts. It has not been known to cause any side effects in breastfed babies.

If your baby is not feeding as well as usual, seems unusually sleepy, has a stomach upset, or if you have any other concerns about your baby, talk to your doctor, pharmacist, health visitor or midwife.

Gabapentin and fertility

There’s no evidence to suggest that taking gabapentin reduces fertility in either men or women. However, discuss your pregnancy plans with a doctor. They may wish to review your medicine and prescribe a higher dose of folic acid for you to take (5mg a day) before you become pregnant.

Speak to a pharmacist or your doctor before taking gabapentin if you’re trying to get pregnant.