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Saturday, October 16, 2004

Neurontin (gabapentin)

Drug Maker to Pay $430 Million in Fines, Civil Damages
FDA - Pharmaceutical manufacturer Warner-Lambert has agreed to plead guilty and paymore than $430 million to resolve criminal charges and civil liabilities in connection with its Parke-Davis division's illegal and fraudulent promotion of unapproved uses for the drug Neurontin (gabapentin).

The drug was approved by the Food and Drug Administration in December 1993 solely for use with other drugs to control seizures in people with epilepsy.

The company promoted Neurontin for the treatment of:

* bipolar mental disorder
* various pain disorders
* amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's disease
* attention-deficit disorder
* migraine
* drug and alcohol withdrawal seizures
* restless leg syndrome.

with Neurontin even when scientific studies had shown it was not effective. For example, the pharmaceutical company falsely promoted Neurontin as effective for treating bipolar disorder, even when a scientific study demonstrated that a placebo worked as well or better than the drug.


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