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Neurontin

What is Neurontin?

Neurontin (gabapentin) is a prescription drug used in the treatment of post-herpetic neuralgia (PHN) and partial seizures in adults and children. The drug, manufactured by Pfizer, first received FDA approval in 1993 as an "adjunctive therapy" for patients suffering from epilepsy. Since that time, the FDA has also approved Neurontin for use in patients who afflicted with PHN.

Unfortunately , Pfizer illegally and fraudulently marketed the drug for use outside of these conditions (generally referred to as off-label usage) - a move that unnecessarily put many Neurontin users at risk for serious adverse side effects.

Pfizer Defies FDA Regulations

The FDA regulatory system is designed to protect the public from potentially harmful drugs. When the FDA approves a drug, it clearly defines the purposes for which the drug can be used based on extensive studies and testing. Pfizer intentionally encouraged off-label usage of Neurontin through direct and indirect marketing and promotional campaigns even though it knew that the drug was not effective and in many cases harmful for unapproved usage. The off-label uses Pfizer misleadingly endorsed include :

  • Bipolar disorder
  • Various pain disorders
  • Amyotrophic lateral sclerosis (ALS)
  • Attention Deficit Disorder (ADD)
  • Restless Leg Syndrome (RLS)
  • Migraine
  • Drug and alcohol withdrawal seizures

The FDA never approved Neurontin for use in any of these conditions. Studies have not established the efficacy or safety of Neurontin for any of these off-label uses . In fact, a 1998 study sponsored by Parke-Davis (now owned by Pfizer) at the Harvard Bipolar Research Program found that patients taking Neurontin did worse than those taking sugar pills. They waited two years to publish the findings and still continued to promote Neurontin for off-label usage.

Neurontin Litigation: Past & Present

In 2002, a whistleblower complaint initiated a suit against Pfizer (then Warner-Lambert), exposing the company's deceptive promotional scheme. Two years later, the manufacturer agreed to pay $430 million to settle criminal charges and civil liabilities associated with the illegal Neurontin campaign .

Pfizer is currently engaged in multi-district litigation (MDL) and Neurontin lawsuits in state court . The MDL primarily involves cases of consumers who purchased Neurontin for off-label uses that Pfizer knew showed no efficacy. The majority of personal injury cases stemming from off-label Neurontin use have been filed in state courts. The first Neurontin personal injury trial is expected to take place in late 2006 or early 2007.

If you or someone you love has suffered injury as a result of off-label Neurontin use, you may wish to seek the counsel of a qualified attorney who can help you understand your legal rights. Contact us for a FREE consultation with an experienced personal injury attorney.

More Neurontin Resources

Neurontin Side Effects - Legal rights and information for patients suffering from the side effects of neurontin.

Neurontin - Prescribing and product information on Neurontin, including side effects, uses and other commonly asked questions.

Neurology.org - Articles and information on partial seizures.