A growing number of lawsuits have been filed by women who used anti-seizure drugs like Neurontin and had a baby with a birth defect. Pfizer has also paid nearly $1 billion in settlements for aggressively marketing Neurontin for “off-label” purposes.
What is Neurontin?
Neurontin (gapapentin) is an anti-seizure drug made by Pfizer, Inc. It is primarily used in patients with epilepsy, but also sometimes for the treatment of painful complications of shingles. Neurontin was approved by the FDA in 1993.
Anti-Seizure Drugs and Pregnancy
All anti-epileptic medications carry some risk of causing birth defects when they are taken during pregnancy. Unfortunately, having an epileptic seizure can also harm a developing fetus. Therefore, pregnant women must walk a fine line between controlling epilepsy and protecting their baby.
Is Neurontin Safe to Use During Pregnancy?
Neurontin is Pregnancy Category C. This means it is not approved or recommended for use during pregnancy. Studies in pregnant animals (mice and rabbits) have found that it is “developmentally toxic”.
In mice, Neurontin caused skeletal defects at doses equivalent or lower than what a pregnant woman would use.
Our lawyers are investigating Neurontin lawsuits involving the following birth defects:
- Cleft lip
- Cleft palate
- Heart defects
- Spina bifida
- Limb reduction defects
- Gastrointestinal defects
- Reproductive system defects (hypospadia)
- And more
Epilepsy Drugs and Birth Defects
Certain epilepsy drugs have a higher risk of causing birth defects than others. Neurontin is a newer epilepsy drug, and several studies have found no increased risk of birth defects, or at least lower than Topamax.
Topamax (topiramate) is a “Pregnancy Category D” anti-seizure drug that has been linked to a 20-fold increased risk of cleft palate and cleft lip.
Another “Category D” drug, Depakote (valproate), has been linked to heart defects, spina bifida, craniofacial defects, and more.
$430 Million Settlement for Illegal Marketing
In May 2004, the manufacturer of Neurontin agreed to plead guilty and pay $430 million to the Justice Department. The settlement resolved civil and criminal allegations that Neurontin was aggressively, illegally promoted for “off-label” uses, including:
- Bipolar mental disorder
- Various pain disorders
- Amyotrophic Lateral Sclerosis (ALS, a degenerative nerve disease commonly referred to as Lou Gehrig’s Disease)
- Attention deficit disorder
- Drug and alcohol withdrawal seizures
- Restless leg syndrome
- As a first-line monotherapy treatment for epilepsy (using Neurontin alone, rather than in addition to another drug).
Neurontin Class Action Lawsuit
The Schmidt Firm, PLLC is nationally recognized as a class action law firm, but we are not filing a Neurontin class action. Instead, we file individual lawsuits so our lawyers can focus on seeking justice for clients with the most serious injuries.