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.
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.