Women who took the epilepsy medication Neurontin during pregnancy have given birth to children with severe defects including cleft lip, cleft palate, heart problems, nervous system defects and other congenital malformations.

What is Neurontin?

Manufactured by Pfizer Inc., Neurontin (generic: gabapentin) was originally designed and approved as an epilepsy medication, but has since received clearance to treat post-herpetic neuralgia, a form of neuropathic pain that some people develop after having shingles. Neurontin is one of the most widely-prescribed drugs on the U.S. market, bringing in more than $2 billion in annual revenue for Pfizer.

What’s the Problem?

In epileptic women who become pregnant, an unexpected seizure could injure both the mother and her unborn child. However, epilepsy medications like Neurontin may also harm the baby in the form of severe congenital birth defects. The U.S. Food & Drug Administration (FDA) classifies Neurontin as a Pregnancy Category C drug, which means that it should only be taken by pregnant women when the potential benefits outweigh the risks.

Neurontin Birth Defects

Birth defects linked to the use of Neurontin during pregnancy include:

  • Cleft lip
  • Cleft palate
  • Heart defects
  • Nervous system defects
  • Gastrointestinal defects
  • Reproductive system defects

Neurontin Birth Defect Studies

In 2011, a Danish study published in the Journal of the American Medical Association (JAMA) looked at 837,795 live births that occurred in Denmark between Jan. 1996 and Sept. 2008. Researchers identified a 3.2% birth defect rate among women who had taken a newer generation seizure medication like Neurontin, compared to 2.4% of babies whose mothers did not take any medications during pregnancy.

When the study’s authors took into account that many of the birth defects had been among women who had previously taken an older generation anticonvulsant in pregnancy, they concluded there was no increased risk of defects with the new drugs. However, researchers cautioned that the results did not include enough women who had taken either Neurontin or Keppra (generic: levetiracetam) to reach any conclusions about the pregnancy risk associated with them.

“[O]ur study cannot exclude minor to moderate risks of major birth defects,” associated with the pregnancy use of gabapentin or levetiracetam, the researchers concluded.

In animal studies, Neurontin has been linked to delayed ossification of bones, hydroureter and hydronephrosis.

Side Effects of Neurontin

In addition to being linked to birth defects in babies born to mothers who take the drug during pregnancy, Neurontin may cause the following side effects in users:

  • Dizziness
  • Drowsiness
  • Unsteadiness
  • Memory loss
  • Lack of coordination
  • Difficulty speaking
  • Viral infections
  • Tremors
  • Double vision
  • Fever
  • Unusual eye movements
  • Jerky movements
  • Mood or behavior changes
  • Depression
  • Anxiety

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