The popular anti-seizure drug Neurontin has found a frequent off-label use as treatment for anxiety.

However, it’s still not certain whether using Neurontin while pregnant is safe for the unborn child.

Neurontin is Pfizer Inc.’s brand name for its drug known generically as gabapentin. It works by chemically mimicking the neurotransmitter gamma-aminobutyric acid, or GABA, which occurs naturally in the human body. The FDA first approved Neurontin in December 1993 to be used in combination with other drugs as a treatment for partial seizures. It was later approved as an effective treatment for pain, especially for nerve pain relief.

Since then, Neurontin has found additional application as a treatment for psychiatric symptoms, particularly for anxiety associated with bipolar disorder. It’s not lawful for the drug’s manufacturer to promote the drug for such an “off-label” use, and Pfizer has already been taken to task for promoting off-label use of Neurontin.

In 2014, Pfizer agreed to a $325 million settlement in a lawsuit that alleged the company promoted off-label use of Neurontin by offering payments to doctors in exchange for prescribing Neurontin for off-label uses, specifically for treatment of anxiety.

However, physicians themselves are free to exercise their own judgment in prescribing drugs for uses other than those approved by the FDA – so a prescription for Neurontin for bipolar disorder-related anxiety should not raise suspicions. But off-label use of Neurontin carries the same risks of side effects as with approved uses.

Women with bipolar disorder anxiety who take Neurontin while pregnant should be aware of these potential side effects, some of which could affect their unborn child.

Neurontin During Pregnancy

While studies have yet to find a conclusive evidence of Neurontin birth defects in humans, they also have not been able to rule out such a link. Studies of Neurontin use in animals have found a possible link to delayed fetal bone development and malformations of parts of the genitourinary system.

Some observations in humans suggest Neurontin is capable of reaching the fetus by way of the placenta. A study published in the May 2011 Journal of the American Medical Association was unable to rule out an association of minor to moderate risks of major birth defects.

The FDA’s most recent Neurontin medication guide states it is unknown if Neurontin can harm an unborn baby. The FDA currently places Neurontin in pregnancy category C, meaning it’s possible the potential benefits of taking the drug while pregnant may outweigh the risks of Neurontin birth defects.

If Neurontin use does lead to birth defects, the results can be devastating. Birth defects linked to other anti-convulsant drugs include cleft palate, deformities of the skull, heart defects, malformations of the kidneys or ureter, supernumerary fingers and toes, and spina bifida.

Birth defects lawsuits may not be able to undo the damage done, but they may provide funding for future medical care. Neurontin birth defects may also be a basis for compensation for past medical bills and emotional harm.

Attorneys are available to counsel mothers whose babies suffered birth defects following treatment with Neurontin for anxiety.