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How can a clinically approved, FDA-endorsed medication endanger human life? One way is to use the drug for illnesses for which it was neither approved nor endorsed.

That’s what thousands of patients are believed to have done with the prescription medication Neurontin, an epilepsy drug illegally marketed for a dozen other medical uses that had not been approved by the Food and Drug Administration (FDA). Because Neurontin was being prescribed for “off-label” illnesses such as restless leg syndrome and bipolar disorder, a previously unforeseen side effect has surfaced: suicide, and suicide attempt.

Neurontin (generic name: gabapentin) was approved for two uses. First, it may be prescribed with other medications to treat partial seizures, as in epilepsy. Second, it can be prescribed to relieve the burning nerve pain that often follows an attack of shingles (herpes zoster). When taken for these reasons, as prescribed by a doctor, clinical studies have shown that side effects of Neurontin, in both children and adults, were mild to moderate.

However, recent lawsuits against Neurontin manufacturer Pfizer Inc. – and its subsidiary, Warner-Lamber – reveal the extent to which the company circumvented FDA regulations by paying doctors tens of thousands of dollars to promote and prescribe Neurontin for scientifically unproven “off-label” uses, based on faulty drug trial results. Pfizer has stated that off-label uses account for 80 percent of Neurontin prescriptions.

Though it is not illegal for a doctor to prescribe a drug for unapproved conditions, it is illegal for drug companies like Pfizer Inc. to market a medication for unapproved uses. When used for non-FDA approved indications, the manufacturers may be especially culpable for negative effects.

A list of unapproved, illegally promoted conditions Neurontin was marketed to treat:

  • Bipolar disorder

  • Pain syndromes, peripheral neuropathy, diabetic neuropathy

  • Treatment of epilepsy alone

  • Reflex sympathetic dystrophy

  • Reflex sympathetic dystrophy (RSD)

  • Attention deficit disorder (ADD)

  • Restless leg syndrome (RLS)

  • Trigeminal neuralgia

  • Post-hepatic neuralgia (PHN)

  • Essential tremor periodic limb movement

  • Migraines

  • Drug and alcohol withdrawal seizures

Potential Neurontin side effects due to off-label use include viral infections, convulsions, memory loss, and vomiting/diarrhea. The most severe of the potential Neurontin side effects is a suicidal tendency. Children are more susceptible to Neurontin side effects than adults.

If you or a loved one has taken Neurontin for a disorder other than epilepsy, you may have a legal right to compensation for damages. The pharmaceutical manufacturers have admitted guilt for illegal marketing of Neurontin - speak to an experienced pharmaceutical attorney now. Learn more about your legal rights.
 

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