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
-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
-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.