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Neurontin® promoted for uses by drug company for which the drug had no effect
In April, 2005 the Food and Drug Administration (FDA) asked the makers of all epilepsy drugs to reexamine their study data following claims that the epilepsy drug Neurontin increases the risk of suicide. According to a report by the Alliance for Human Research Protection, Neurontin has caused over 2,000 patients to attempt suicide with 160 resulting in death.
In 2004, the manufacturer of Neurontin, Warner-Lambert, agreed to pay a settlement of $430 million to resolve criminal charges, which claimed the company had used illegal and fraudulent promotion of unapproved uses for the drug Neurontin. The company promoted off-label uses for which the drug had no effect, and for which there is no scientific basis to prescribe the drug. By FDA definition, it is illegal for companies to market drugs that it has not approved.
Neurontin has been approved for two uses. First, it can be used with other medications in the treatment of partial seizures associated with epilepsy. Second, it can be used to relieve the pain that follows an attack of shingles.
Neurontin affects the chemicals and nerves in the body that cause seizures or the pain associated with shingles.
Neurontin Adverse Side Effects
Adverse side effects cannot be anticipated. If any develop, you may wish to contact your doctor immediately.
Common adverse side effects in adults include:
- Blurred, dimmed or double vision
- Decreased coordination (clumsiness, dizziness)
- Continuous, uncontrolled, back and forth or rolling eye movement
- Unusual tiredness or weakness (fatigue, drowsiness)
- Persistent sore throat or fever
- Swelling of hands, ankles or feet
- Mood changes (anger, depression, irritability)
- Memory loss
- Trembling or shaking
- Severe Anxiety
- Joint Pain
- Difficulty breathing
- Potential links to suicidal behavior
Adverse side effects common in children (3 to 12 years old):
- Aggressive behavior or other behavioral problems
- Concentration problems
- Changes in school performance
- False sense of well-being
- Increase in body movements
- Mental depression
- Reacting too quickly, too emotionally, or overreacting
- Rapidly changing moods
- Suspiciousness or distrust
- Thought disorders
If you or your loved one has suffered a Neurontin injury, contact us today. Submit the form to the right and we’ll let you know if you have a case and if we can represent you.