Gabapentin, an anti-seizure medication sold by Pfizer Laboratories in the US under the brand name Neurontin, has been the subject of multiple claims of malfeasance on the part of Pfizer, who knowingly and intentionally marketed the drug for uses that had not been approved by the Food and Drug Administration (FDA).
Complaints against Pfizer center in part on alleged claims that the drug company marketed the drug for uses not approved by the FDA, and that pre-approval trials on which the FDA based its approval were intentionally faulty and incomplete, particularly for the non-approved uses the drug was being marketed for.
While it is legal for doctors to prescribe drugs for off-label uses, in the best interests of their patients, it is explicitly illegal for a drug manufacturer to market a drug for uses for which it is not approved.
Approved Uses
The only two FDA approved uses for Neurontin are:
- Treatment of partial seizures in adults or children, but only in conjunction with other treatment
- Treatment for nerve pain resulting from herpes or shingles
According to articles in the New York Times and from the consumer group Public Citizen, however, sales of Neurontin exceeded the one billion dollar mark, in large part due to a targeted, intentional campaign by Pfizer to market Neurontin for non-approved uses. In fact, over 90% of the estimated $1.3 billion dollars in sales is alleged to be from these unapproved uses of Neurontin.
Non-Approved Uses
Many of the Neurontin lawsuits filed against Pfizer claim that the drug was prescribed to patients for the following off-label uses, among others:
- Attention deficit disorder
- Bipolar disorder
- Seizures from drug and alcohol withdrawal
- Pain
- Amyotrophic lateral schlerosis
- Migraines
- Restless leg syndrome
Neurontin hasn’t been approved for any of the above listed conditions, however, so if you or someone you love was prescribed Neurontin for any of these problems, you may have sufficient grounds to sue Pfizer to recover any losses, including the cost of the incorrectly prescribed drug.
Dangerous Neurontin Side Effects
In addition to being incorrectly prescribed, Neurontin has been shown in studies to be linked to some very serious conditions, many of which are not sufficiently described in the drug literature or in patient instructions.
Some of the serious conditions associated with use of Neurontin include:
- Viral infections
- Vomiting and diarrhea
- Convulsions
- Memory loss
- Suicidal ideation and tendencies
- Mood swings
- Hyperactivity
- Increased aggression
Sadly, some of the most serious side effects listed—including suicidal ideation and tendencies—are most pronounced among children who are prescribed the drug.
Due to the fact that so many of the uses for which Neurontin were prescribed were not FDA approved, it can be difficult to establish a clear link between some of these side effects and the drug. The lack of approval for those uses means that the drug has not been sufficiently tested for use for those conditions.
Compensation For Patients
Pfizer has already been ordered to pay at least $400 million in civil damages for its illegal marketing of off-label uses for the drug, and additional lawsuits are currently underway to provide compensation to the patients and their families who have been harmed by Pfizer’s illegal activities.
If you or a loved one has suffered from any of the above side effects of Neurontin, particularly if it was prescribed for a nonapproved use, it is important that you contact an experienced pharmaceutical injury lawyerto discuss your case and learn more about your rights. You can find one from your areas using the map below.
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