Neurontin

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The side effects of Neurontin have caused serious medical complications in some patients and have most recently been linked to suicide and attempted suicides.

Neurontin (also know by it’s generic name, Gabapentin) was approved by the Food and Drug Administration (FDA) in the mid-1990s as an anticonvulsant used to treat seizures associated with epilepsy. Since that time, Neurontin has been prescribed for several disorders that the FDA did not approve. In fact, it is believed that the majority of Neurontin prescriptions were filled for unapproved medical conditions such as bipolar disorder, chronic pain, and migraines. The Warner-Lambert Corp., who was acquired by Pfizer in 2000, used an illegal marketing strategy to promote Neurontin for “off-label” or untested uses with no indication Neurontin had any effect at all on those medical conditions. Neurontin’s sales have climbed from $97.5 million in 1995, when the false advertising began, to nearly $2.7 billion by 2003, becoming Pfizer’s top selling product. More than 10 million prescriptions for Neurontin have been written in the United States since 1996.

Legal History
In 2003, the U.S. Attorney’s office in Boston initiated a lawsuit against Pfizer for the illegal marketing scheme the company had used to induce Neurontin sales. The suit was based on the testimony of David Franklin, a former scientist at the Parke-Davis division of Warner-Lambert, who revealed the company’s deliberate plans to market Neurontin for unapproved uses. Franklin reported that he was encouraged to persuade physicians to prescribe Neurontin for a number of disorders even though there was little indication that the drug could help patients with those disorders. Franklin testified that the company used a variety of schemes, such as paying huge fees to doctors and giving free vacations to doctors if they prescribed Neurontin for unapproved uses, to support the false advertising of the drug. Franklin even accused Warner-Lambert of hiring an outside firm to write several articles for medical journals that endorsed unauthorized uses of Neurontin and then paying doctors for use of their name as authors of the reports. The reasoning behind such an attempt to “circumvent” the FDA’s approval is that it is not illegal for a physician to prescribe medications for “off-label” uses. However, it is illegal for drug companies to market medications for unapproved uses. Under FDA law, a company is not allowed to promote a prescription drug for a medical condition without first proving to the FDA that the drug effectively works for that condition and is safe.

In May of 2004, Pfizer and the U.S. Justice Department reached a settlement agreement in which Pfizer agreed to plead guilty to the charges it illegally promoted non-FDA approved uses for Neurontin and to pay a $430 million fine, including a $240 million criminal fine.

Also in May of 2004, a New York law firm filed a petition asking the FDA to act on claims that Neurontin may be tied to suicidal behavior. The firm has accumulated a list of 160 suicides and 2,000 attempted suicides by people who were taking Neurontin for a variety of ailments. The petition shows the number of suicides reported by Pfizer (which the law requires them to do) to the FDA jumped to 17 in the first six months of 2003 compared with a total of 8 from 1998 through 2002.

Illegally promoted, unapproved uses:
Here is a list of illegally promoted, unapproved uses for Neurontin:

• Bipolar Disorder
• 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 Periodic Limb Movement
• Migraine
• Drug and Alcohol Withdrawal Seizures
• Lou Gherig’s Disease
• Several conditions associated with chronic pain
  

Side Effects

As the Food and Drug Administration has stated, some people who take Neurontin can develop serious medical and/or physical problems. Some of the side effects are listed below:

• Blurred vision or double vision
• Decreased Coordination (clumsiness, unsteadiness, dizziness)
• Continuous, uncontrolled, back and forth and/or rolling eye movements
• Unusual tiredness or weakness (fatigue, drowsiness)
• Persistent sore throat or fever
• Swelling of hands, ankles, or feet
• Mental or mood changes (anger, depression, irritability)
• Memory loss
• Trembling or shaking
• Severe Anxiety
• Joint pain
• Difficulty breathing
• Potential links to suicidal behavior

Neurontin has been prescribed to children for a variety of reasons as well. Here are some common side effects in patients 3 to 12 years of age:

• Aggressive behavior or other behavior problems
• Anxiety
• Concentration problems
• Changes in school performance
• Crying
• False sense of well-being
• Hyperactivity
• Increase in body movements
• Mental depression
• Reacting too quickly, too emotionally, or overreacting
• Rapidly changing mood
• Restlessness
• Suspiciousness or distrust
• Amnesia
• Thought disorders (Attention problems, concentration problems)

While these are resourceful lists of potential side effects of taking Neurontin, they are by no means exhaustive. There are several other potential side effects that may develop in particular patients. If you are taking Neurontin, you should check with your doctor as soon as possible if you are experiencing any of the symptoms listed above or you believe you have had other adverse reactions from taking this medication.

Although only a limited amount of information regarding the connection between Neurontin and suicide is available at this time, more data is being gathered all the time. If you believe that you or a loved one has suffered as a result of a link between Neurontin and suicide, you may want to speak with an attorney. A lawyer familiar with new developments in the investigation of Neurontin and suicide may be able to help you make important personal and legal decisions. Please CLICK HERE for a free consultation.