When taken during pregnancy, the epilepsy medication Neurontin (generic: gabapentin) has been linked to birth defects including cleft lip / cleft palate, heart problems, gastrointestinal malformations and nervous system defects.
Neurontin belongs to a newer generation of epilepsy medications that affect chemicals in the body that cause seizures and certain types of pain. The drug is prescribed to treat seizures caused by epilepsy in adults and children who are at least 12 years old, and to treat partial seizures in children between the ages of 3 and 12. Neurontin is made by Pfizer Inc., and was approved by the U.S. Food & Drug Administration (FDA) in 1993.
What’s the Problem?
Any time a pregnant woman has a condition that requires treatment with prescription medications, the benefit of the drug must be carefully weighed against the potential risks to the mother and her unborn child. One such condition is epilepsy, a neurological disorder which causes seizures that could harm both mother and child.
A 2011 article published in the Los Angeles Times highlighted the difficult situation women with epilepsy face during pregnancy by stating “managing a pregnancy in an epileptic woman has generally involved walking a fine line between controlling seizures and reducing developmental problems.”
Unfortunately, medications used to treat epilepsy have also been associated with serious side effects. One such drug is Neurontin, which has been linked to birth defects and developmental delays when taken during pregnancy.
Neurontin Birth Defects
The following defects have been reported in babies born to mothers who take epilepsy medications like Neurontin during pregnancy:
- Heart defects
- Cleft lip
- Cleft palate
- Bone malformations
- Hypoplasia of the mid-face and fingers
- Spina bifida
- Growth retardation
- Gastrointestinal defects
- Nervous system defects
- Reproductive system defects
- Other birth defects
Neurontin Birth Defect Studies
A 2002 study published in the Journal of the American Academy of Family Physicians (AAFP) stated that newer generation seizure medications like Neurontin are not known to cause birth defects in animal studies, but “… there has been insufficient reporting in human pregnancy experience to accurately portray risk.”
The researchers went on to cite an earlier study published in the New England Journal of Medicine (NEJM) which concluded that epilepsy medications were more likely to cause birth defects than the mother having seizures during pregnancy. That study’s authors also noted that “women using these drugs to treat conditions other than epilepsy are also at a higher risk for giving birth to a baby with a birth defect.”
FDA classifies Neurontin as a pregnancy category C drug, which means that it is not known whether it will harm an unborn baby. The American Academy of Neurology (AAN) recommends that women who use Neurontin or other seizure medications during pregnancy undergo prenatal diagnostic testing and take Vitamin K during the last trimester to reduce their risk of neonatal hemorrhage.
In May 2014, Pfizer agreed to pay $325 million to resolve claims that it marketed Neurontin for unapproved uses. Plaintiffs in the decade-old lawsuit included third-party payers that said they bought or reimbursed patients for the purchase of Neurontin from Pfizer, or bought gabapentin from Pfizer’s Greenstone LLC generic drug unit. The case is: In re Neurontin Marketing, Sales Practices, and Products Liability Litigation, U.S. District Court, District of Massachusetts, Nos. MDL 1629, 04-10981.