It has been more than twenty years since the U.S. Food and Drug Administration (FDA) approved Neurontin for the treatment of epilepsy in the United States. Since then, the FDA has expanded the approval of Neurontin (Gabapentin) to treat shingles pain.
But the Drug Has Been Prescribed for Much More Than That
Neurontin is allegedly routinely prescribed to treat conditions for which the drug has never received FDA approval. Some of those conditions include:
- Bipolar disorder
- Other conditions
When a drug is prescribed for a condition for which it does not have FDA approval it is known as an “off-label” prescription. While it is legal for a doctor to write an off-label prescription, it is illegal for a drug manufacturer to market its drug for an off-label use.
Pfizer, the drug manufacturer of Neurontin, has been accused of marketing the drug for off-label prescriptions. In 2004, Pfizer pleaded guilty to advertising the drug for non-FDA approved uses and reached a settlement worth approximately $430 million with the U.S. Justice Department. In 2014, Pfizer reached another settlement of about $325 million for the off-label marketing of Neurontin.
Why This Is Dangerous for Patients
Neurontin has been linked to serious side effects, including depression and suicidal thoughts. While the FDA has reviewed studies that weigh the benefits of Neurontin against the potential side effects for the treatment of epilepsy and shingles pain, it has not reviewed similar studies for the treatment of other conditions. Thus, the risks of depression and suicide may outweigh the potential benefits from the medication, and patients’ lives may be ruined—or ended—because of these side effects.
If you have questions about the safety of this drug, then we encourage you to talk to your doctor about your options.