Gabapentin, an anti-seizure drug marketed by Pfizer Laboratories in the United States under the trademark name Neurontin, has been the subject of numerous claims of malfeasance, with the Pfizer company intentionally and knowingly marketing the medication for uses not approved by the FDA (Food and Drug Administration).
The allegations against Pfizer are based on claims that the pharmaceutical company marketed the medication for uses not authorized by the FDA and that the pre-approval tests on which the FDA found its approval were intentionally incomplete and faulty, especially for the non-approved uses for which the medication was being sold.
While physicians may prescribe pharmaceuticals for off-label applications when it is right for their patients, it is specifically against the law for a pharmaceutical manufacturer to sell a medication for purposes for which it has not been authorized.
What Are the Approved Neurontin Applications?
Neurontin has just two FDA-authorized uses:
- Treatment of partial seizures in children and adults (only when combined with other therapies)
- Relief from nerve pain caused by shingles or herpes
Per stories in the NYT and the consumer organization Public Citizen, Neurontin sales surpassed one billion dollars, largely due to Pfizer’s planned, purposeful push to sell Neurontin for non-authorized applications.
Indeed, it is claimed that these unapproved Neurontin usages account for nearly all of the projected $1.3 billion in sales.
What Are the Non-Approved Neurontin Applications?
Many of the Neurontin cases allege that the medicine was administered to patients for, among other things, the following off-label purposes:
- Restless leg syndrome
- Migraines
- Amyotrophic lateral sclerosis (ALS)
- Pain
- Seizures from alcohol and drug withdrawal
- Bipolar disorder
- Attention deficit disorder
Neurontin has not been authorized for any of the disorders stated above; therefore, if you or a loved one was given Neurontin for any of the aforementioned issues, you might have the standing to sue Pfizer to collect any damages, including the price of the wrongly prescribed prescription.
How Is Neurontin Administered?
Neurontin is available in tablet form and solution form. It can be taken with food or without food.
The medication is taken by mouth. The dosage provided will be based on the medication condition and the patient’s response to treatment.
If the patent is a child, the dosage will also be based on their weight.
What Is the Right Dose?
In adults who have postherpetic neuralgia, Neurontin may be started as one 300 mg dosage on the first day, 600 mg/day (300 mg twice a day) on day two, and 900 mg/day on the third day.
The dosage may then be titrated up to 1800 mg daily for pain relief (600 mg thrice daily).
In clinical tests, effectiveness was established, spanning a dosage range of 1800 mg/day to 3600 mg/day, with similar effects across the dose range; however, the added advantage of employing doses larger than 1800 mg/day was not proven in these clinical investigations.
Dosage for Partial Onset Seizures in Epilepsy
Patients Twelve Years Old and Up
The recommended beginning dosage is 300 mg 3x per day. Neurontin’s maintenance dosage is 300 mg to 600 mg thrice daily.
Long-term clinical investigations have shown that doses of up to 2400 mg/day are well tolerated.
Doses of 3600 mg/day have also been given to a limited number of individuals for a short time and have been well tolerated.
Children Aged 3 to 11 Years Old
The initial dosage range is 10 mg/kg/day to 15 mg/kg/day, given in three separate doses, with the recommended maintenance level obtained after roughly three days of upward titration.
In patients aged 3 to 4 years, the suggested maintenance dosage of Neurontin is 40 mg/kg/day, split into three doses.
In children aged 5 to 11, the recommended maintenance dosage of Neurontin is 25 mg/kg/day to 35 mg/kg/day, given in three separate doses.
Neurontin may be taken as an oral solution, pill, tablet, or combination of these forms. In a long-term clinical investigation, doses of up to 50 mg/kg/day were well tolerated. The maximum duration between dosages should not be more than 12 hours.
Dosage Modification in Renal Impairment Patients
Dosage reduction is advised in individuals 12 years of age and older who have renal impairment or are on hemodialysis.
What Are the Strengths and Forms of Dosage?
- Capsules:
- 400 milligrams: orange hard jello-like capsules printed with the letters “PD” on the side of the pill and “Neurontin/400 mg” on the top
- 300 milligrams: yellow hard jello-like capsules printed with “PD” on the side and “Neurontin/300 mg” on the top
- 100 mg: white hard gelatin capsules printed with “PD” on the side and “Neurontin/100 mg” on the top
- Tablets:
- 800 mg: elliptical film-coated white scored tablets embossed with “NT” and “26” on the body
- 600 mg: elliptical film-coated white scored tablets printed with “16” and “NT” on the side
- Doses Taken Orally:
- 250 mg (roughly five mL or 50 mg/mL), slightly yellow to a colorless solution
What Are Neurontin’s Dangerous Unintended Effects?
While being misprescribed, Neurontin has been related in analyses to several dangerous disorders, some of which are not adequately mentioned in the drug research or patient instructions.
The following are some of the significant problems connected with Neurontin use:
- Infections caused by viruses;
- Diarrhea and vomiting;
- Convulsions;
- Memory lapses;
- Suicidal thoughts and inclinations;
- Increased aggression;
- Mood swings; and
- Hyperactivity.
Unfortunately, some dangerous adverse effects, such as suicidal thoughts and impulses, are more prevalent among kids.
Because many of the applications Neurontin was given for were not authorized, establishing a clear relationship between some of these adverse effects and the medicine may be challenging.
The absence of authorization for specific indications indicates that the medicine needs to be thoroughly studied for use in those situations.
What Was the Urgent Warning in December 2019?
In December 2019, the FDA issued an urgent Drug Safety Communication warning claiming severe breathing problems might develop in patients taking gabapentin (Horizant, Gralise, or Neurontin) or pregabalin (Lyrica CR, Lyrica, Lyrica) who have respiratory risk factors. Among them include the usage of narcotic pain relievers.
The FDA expressly warned clinicians that combining an opioid with medications such as Lyrica and Neurontin raises the risk of respiratory depression.
The Food and Drug Administration said it had received nearly 50 complaints of people experiencing respiratory problems while using gabapentinoids. Twelve of these people were sadly killed.
The FDA’s warnings align with the findings of multiple scientific analyses, including those published in late 2019 and early 2020.
These recent investigations discovered that combining opioids with medications like Neurontin and Lyrica during and post-surgery was related to considerably increased chances of post-op respiratory issues.
Is There a Way I Can Find Out Whether I Was Given Neurontin or Lyrica?
The first step in determining if you were taking Neurontin, Lyrica, or another type of gabapentinoid is to review your prescription records.
You should check your hospital records if you believe you were given Neurontin or Lyrica during surgery.
How Are Seizure Medication Injuries Proven in a Lawsuit?
In order to prove seizure medications in a lawsuit, there are certain elements that a plaintiff must prove, such as:
- Causation: It must be shown that the seizure medicine was responsible for their injuries or damages
- This may include showing that:
- the prescription was faulty
- the healthcare professional provided an incorrect medication or dose, or
- the patient was not appropriately cautioned regarding the hazards associated with the medication
- Damages: The plaintiff must prove that the medicine caused the injuries, which may include:
- medical costs
- lost earnings
- pain and suffering, and
- other damages, such as long-term effects on their quality of life
- Breach of duty: In certain cases, the plaintiff may be required to show that the healthcare professional violated their duty of care to the patient, such as by failing to offer necessary warnings or failing to correctly diagnose or treat the patient’s seizure disease
- Proximate cause: The plaintiff must show that the medication was the proximate cause of their injuries or damage, meaning that the injury was a direct and predictable outcome of the use of the prescription medication
- Negligence: A plaintiff may be required to show that a healthcare professional behaved negligently, meaning that they failed to exercise due care and caution in their conduct.
It may be difficult to establish these elements. Typically, it will require help from a skilled lawyer, medical expert, or other specialist.
If an individual suspects they have been injured by a seizure medication, it is important to consult with a lawyer as soon as possible to learn about the individual’s rights and legal options.
What Are Some Other Legal Issues Involved in Seizure Medication Lawsuits?
In addition to the issues listed above, there may also be other legal issues that arise in seizure medication lawsuits, such as:
- Wrongful death: If an individual dies because of seizure drug harm, their family members may be eligible to sue the healthcare practitioner or prescription manufacturer for wrongful death
- Fraud: A healthcare professional may be charged with fraud if they misrepresent the safety or effectiveness of a seizure medication
- Violations of consumer protection laws: If a drug manufacturer engages in unfair or misleading commercial practices, they may face legal consequences under state consumer protection laws
- Breach of warranty: If it is determined that a seizure medication is faulty, an individual may be able to to file a breach of warranty claim against the drug’s manufacturer or distributor
- Punitive damages: Punitive damages may be imposed in order to punish the offending party for egregious conduct or violations
Are There Any Legal Remedies for Seizure Medication Injuries?
The legal remedies that may be available in seizure medication injury cases will depend on the individual’s specific situation and the legal claim they are pursuing. Common examples of remedies include:
- Compensatory damages: Compensatory damages are intended to compensate the plaintiff for the injury they have incurred, such as:
- medical expenditures
- lost earnings
- pain and suffering
- Injunctions: A court may order an injunction in certain situations that restricts a drug manufacturer from selling or marketing a harmful medication
- Punitive damages: Punitive damages may be awarded by a court to penalize the defendant for egregious acts
- Settlements: A lawsuit involving seizure medication injuries may be resolved by a settlement agreement between the plaintiff and defendant, which may include compensation for the plaintiff as well as additional stipulations
If an individual believes a seizure medication has injured themselves or a loved one, they should consult with a legal expert to determine their legal options and the remedies they can obtain.
Should I Contact a Lawyer to Pursue Compensation?
Pfizer has already been compelled to pay nearly $500 million in civil penalties for illegally promoting the medicine for off-label purposes, and further cases are being filed to compensate patients and their loved ones who Pfizer’s illicit acts have damaged.
If you or a family member has had any of the aforementioned Neurontin adverse effects, especially if it was administered for an unapproved purpose, you should contact an experienced class action attorney to talk about your case and learn more about your options.
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