Neurontin / Gabapentin

Neurontin/Gabapentin is indicated for the treatment of partial seizures (when symptoms are limited) in patients with epilepsy and for the relief of nerve pain after shingles. Neurontin, available by prescription only, comes in capsule form to be taken three times a day. Approved by the U.S. Food and Drug Administration (FDA) in 1993, Neurontin is made by Pfizer, Inc.

Side effects of Neurontin use included, but may not be limited to, drowsiness, headache, dizziness, unwanted eye movements, anxiety and nausea.

The practice of promoting off-label uses of drugs is standard for medical doctors who are then able to use the latest medical findings to benefit patients without first waiting for regulatory approval for a new use of a drug. Drug companies, on the other hand, are not allowed to promote these off-label uses until FDA approval for it has been granted. The practice is becoming more heavily scrutinized as government agencies have been investigating big drug companies because of these unauthorized drug promotions.

In 2000, Pfizer acquired Warner-Lambert and paid doctors consultant fees to attend conferences in Hawaii and Florida, as well as the 1996 Atlanta Olympics. According to the Justice Department, who was involved in investigating Pfizer's Warner-Lambert unit, the company discussed unapproved uses of its epilepsy drug Neurontin at these events. As a result, the company defrauded the government's Medicare and Medicaid programs by urging doctors to prescribe Neurontin for off-label purposes.

Pfizer had previously said it had set aside $427 million to settle a whistle-blower lawsuit and federal and state investigations related to the Neurontin off-label sales.

In July 2003, NBC=s Dateline ran a story accusing pharmaceutical company Warner-Lambert, which was acquired by Pfizer in 2000, of deliberately falsifying medical information about Neurontin so doctors would prescribe the drug for "off-label" uses (conditions not approved by the FDA). Although it is legal for physicians to prescribe medications for "off-label" uses, it is not legal for a drug company to promote unapproved uses or distort information about a medication's "off-label" benefits. In its year-long investigation, Dateline interviewed a former Warner-Lambert scientist who alleges company officials encouraged him to persuade physicians to prescribe Neurontin for a number of disorders, including attention deficit disorder and bipolar disease, even though there was minimal preliminary data indicating that Neurontin could help patients with those diseases.

On May 13, 2004, Pfizer pled guilty to U.S. criminal charges of misbranding Neurontin and will pay more than $430 million to settle the charges. The $240 million criminal fine Pfizer is paying for health care fraud is a record amount according to the Justice Department, in addition to the $190 million in civil settlements with state and federal health care programs.

The following is a list of Illegally Unapproved Uses of Neurontin/Gabapentin:

• Bipolar Disorder (Suicide Effects)
• Pain Syndromes, Peripheral Neuropathy, and Diabetic Neuropathy
• Treatment of Epilepsy alone (as Monotherapy)
• Reflex Sympathetic Dystrophy (RSD)
• Attention Deficit Disorder (ADD)
• Restless Leg Syndrome (RLS)
• Trigeminal Neuralgia
• Post-Hepatic Neuralgia (PHN)
• Essential Tremor Period Limb Movement
• Migraine
• Drug and Alcohol Withdrawal Seizures

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