07/19/2010 — Neurontin, a drug developed to treat epilepsy, was approved in 1994 by the Federal Food and Drug Administration (FDA) as an anticonvulsant, to control epileptic seizures. Epilepsy is a brain disorder in which clusters of nerve cells sometimes fire abnormally. This disturbance in normal brain activity manifests in different types of seizures. Anticonvulsant drugs act on the brain to reduce the frequency and severity of seizures brought on by epilepsy, head injuries, brain tumors or infections, or metabolic disturbances such as low blood sugar.
The drug’s efficacy against epileptic seizure has been shown. But Neurontin taken for other disorders has been linked to a frightening side effect: the desire to commit suicide.
Shortly after its introduction, some small studies in the later 1990s — mostly sponsored by Pfizer and its affiliates — looked at Neurontin’s effectiveness in treating disorders other than epilepsy. Some results suggested that Neurontin (generically known as gabapentin) looked promising for the treatment of bipolar disorder, migraines, ADD, Lou Gehrig’s Disease, drug and alcohol withdrawal symptoms, and other conditions.
Other more recent studies found it to be no more effective (and in one study, slightly less effective) than placebo. Regardless, the drug was prescribed for so-called “off-label” uses – uses other than those for which it was approved by the FDA.
Since its inception Neurontin has been prescribed for over 10 million patients. By 2004, over 100 of those taking Neurontin had committed suicide. More than 2000 people attempted suicide over the same time frame.
By 2005, the number of suicides had escalated to 258.
All of the suicides and suicide attempts were by people taking Neurontin for off-label uses.
In 2004, Pfizer agreed to pay $430 million to settle criminal charges and product liability cases associated with the company’s alleged marketing of Neurontin for off-label uses.
In 2008, the FDA required Neurontin to carry a label warning alerting users to the risk of suicidal thoughts.
In March 2010 a federal jury in Boston concluded that Pfizer was guilty of violating federal racketeering laws for promoting Neurontin’s off-label uses. The jury said that Pfizer engaged in a racketeering conspiracy over a 10-year period. The litigation resulted in a verdict of over $47 million.
That amount was automatically tripled. Under the federal Racketeer Influenced and Corrupt Organizations Act, or RICO, the amount of actual damages found by the jury – $47.36 million – was tripled to nearly $142 million. Pfizer, which has extensive facilities in Connecticut, said it would appeal the decision.
Most recently, Pfizer settled a lawsuit mid-trial with the family of a Massachusetts man who had committed suicide. The suit alleged that Pfizer knew Neurontin posed a suicide risk but failed to disclose it to patients and physicians. Pfizer will pay $400,000 to the family.
Pfizer now faces more than 1,200 pending lawsuits brought by plaintiffs who say that Neurontin helped cause some users’ suicides.
Since it was introduced in 1994, Neurontin sales have topped $2.7 billion worldwide.