Tag: Pregnancy

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.

Is it Safe to Take Gabapentin When you are Pregnant or Breast-feeding

The FDA placed Gabapentin in pregnancy category C. According to studies done on animals, there was harm done to fetuses.

It is very important that your doctor check your progress at regular visits, especially in the first few months if you have epilepsy. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Check with your doctor right away if you have a fever, rash, swollen, painful, or tender lymph glands in the neck, armpit, or groin, unusual bleeding or bruising, or yellow eyes or skin. These may be symptoms of a serious and life-threatening allergic reaction called drug reaction with eosinophilia and systemic symptoms (DRESS) or multiorgan hypersensitivity.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Gabapentin may cause vision changes, clumsiness, unsteadiness, dizziness, drowsiness, sleepiness, or trouble with thinking. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well. If these side effects are especially bothersome, check with your doctor.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors, such as feeling sad or hopeless, getting upset easily, or feeling nervous, restless, or hostile. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicine or narcotics, other medicines for seizures (eg, barbiturates), muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you or your child are using gabapentin.

This medicine may cause respiratory depression, a serious breathing problem that can be life-threatening, when used together with narcotic pain medicines. Check with your doctor right away if you have pale or blue lips, fingernails, or skin, difficult or troubled breathing, or irregular, fast or slow, or shallow breathing.

Do not stop using gabapentin without checking with your doctor. Stopping the medicine suddenly may cause seizures. Your doctor may want you or your child to gradually reduce the amount you are taking before stopping it completely.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

However, there have been no studies done on humans. Despite all this, experts believe that the benefits gained from taking Gabapentin may outweigh its risks.

Animal studies have revealed evidence of fetotoxicity involving delayed ossification in several bones of the skull, vertebrae, forelimbs, and hindlimbs. Hydroureter and hydronephrosis have also been reported in animal studies. There are no controlled data in human pregnancy.

To provide information regarding the effects of in utero exposure to this drug, physicians are advised to recommend that pregnant patients enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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.

 Can Children and Adolescents Safely Take Gabapentin?

In other countries besides the United States, children have been prescribed Gabapentin. However, Gabapentin has only been approved for use in adolescents above the age of 12.

This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: B1
US FDA pregnancy category: C

Comments:
-Women on antiepileptic drugs (AEDs) should receive prepregnancy counseling with regard to the risk of fetal abnormalities.
-AEDs should be continued during pregnancy and monotherapy should be used if possible at the lowest effective dose as the risk of abnormality is greater in women taking combined medication.
-Folic acid supplementation (5 mg) should be started 4 weeks prior to and continued for 12 weeks after conception.
-Specialized prenatal diagnosis including detailed mid-trimester ultrasound should be offered.
-The risk of having a child with a congenital defect as a result of antiepileptic medication is far outweighed by the dangers to the mother and fetus of uncontrolled epilepsy.

Gabapentin Breastfeeding Warnings

Benefit should outweigh risk.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Limited information indicates that maternal doses up to 2.1 g daily produce relatively low levels in infant serum.
-Breastfed infants should be monitored for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of anticonvulsant or psychotropic drugs.

Gabapentin Pregnancy Warnings

Animal studies have revealed evidence of fetotoxicity involving delayed ossification in several bones of the skull, vertebrae, forelimbs, and hindlimbs.

Gabapentin 800mg
Gabapentin 800mg

Hydroureter and hydronephrosis have also been reported in animal studies. There are no controlled data in human pregnancy.

To provide information regarding the effects of in utero exposure to this drug, physicians are advised to recommend that pregnant patients enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: B1
US FDA pregnancy category: C

Comments:
-Women on antiepileptic drugs (AEDs) should receive prepregnancy counseling with regard to the risk of fetal abnormalities.
-AEDs should be continued during pregnancy and monotherapy should be used if possible at the lowest effective dose as the risk of abnormality is greater in women taking combined medication.
-Folic acid supplementation (5 mg) should be started 4 weeks prior to and continued for 12 weeks after conception.
-Specialized prenatal diagnosis including detailed mid-trimester ultrasound should be offered.
-The risk of having a child with a congenital defect as a result of antiepileptic medication is far outweighed by the dangers to the mother and fetus of uncontrolled epilepsy.

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.