Gabapentin Dementia Lawsuit

The Gabapentin lawsuit centers on allegations that manufacturers failed to adequately warn patients and healthcare providers about a potential connection between long-term gabapentin use and cognitive decline.

Gabapentin is commonly prescribed to treat seizures, nerve pain, and a variety of off-label conditions, leading millions of patients to take the drug over extended periods.

Recent research has raised concerns that some adult patients prescribed gabapentin may face significantly increased risks of developing mild cognitive impairment or dementia after repeated exposure.

Plaintiffs argue that many patients continued taking the medication without being informed of these potential neurocognitive risks.

In many cases, individuals were initially prescribed the drug following an initial pain diagnosis and later experienced memory problems, cognitive difficulties, or dementia diagnoses.

Lawsuits seek to hold manufacturers accountable while allowing affected individuals and families to attempt to secure compensation for medical expenses, lost income, and other damages.

Current lawsuits generally allege that manufacturers:

• Failed to warn patients and healthcare providers about a potential increased risk of dementia and cognitive decline.
• Failed to adequately investigate reports of neurocognitive injuries associated with long-term gabapentin use.
• Continued marketing gabapentin without adding warnings regarding dementia or mild cognitive impairment.
• Misrepresented the safety profile of gabapentin while omitting information about potential long-term cognitive effects.
• Failed to provide guidance regarding monitoring patients for signs of memory loss or cognitive decline.
• Promoted gabapentin for widespread use despite emerging research examining possible neurocognitive risks.
• Failed to update prescribing information to reflect newly available safety data and scientific literature.

Understanding the litigation begins with understanding the medication itself. Gabapentin has been prescribed for decades to treat seizures, nerve pain, and a variety of off-label conditions, making it one of the most widely prescribed neurological medications in the United States.

New Research Reported Higher Rates of Dementia and Mild Cognitive Impairment Among Certain Gabapentin Users

Recent research examining the long-term neurological effects of gabapentin has become a central focus of the emerging litigation.

The most widely cited study, published in Regional Anesthesia & Pain Medicine and summarized by the BMJ Group, analyzed medical records from more than 52,000 patients with chronic low back pain and compared individuals who received gabapentin prescriptions to those who did not.

Researchers found that patients who received six or more prescriptions faced a heightened risk of cognitive decline, including a 29% greater likelihood of being diagnosed with dementia and an 85% greater likelihood of developing mild cognitive impairment (MCI) within ten years of their initial pain diagnosis.

The evaluation based on prescription frequency revealed an even stronger association among patients who received the drug more often.

Individuals with 12 or more prescriptions were approximately 40% more likely to develop dementia and 65% more likely to develop MCI than patients who received fewer prescriptions.

Researchers also reported that adults between the ages of 35 and 64 experienced some of the strongest associations observed in the study, with risks increasing substantially compared to similar patients who were not prescribed gabapentin.

According to the study, cognitively normal adults may show cognitive decline within 2 years of gabapentin use, and overall, gabapentin use increases dementia risk by 45%, according to studies.

The authors emphasized that the study was observational and did not establish a direct cause-and-effect relationship between gabapentin use and dementia.

Nevertheless, the results support additional investigation into whether gabapentin contributes to neurodegenerative changes and whether certain patients may be particularly vulnerable to cognitive decline.

The researchers further stated that their findings support the need for close monitoring of patients prescribed gabapentin to identify potential signs of memory loss, cognitive impairment, or dementia as early as possible.

Plaintiffs Claim Manufacturers Failed to Warn About Potential Long-Term Cognitive Risks

Plaintiffs allege that manufacturers knew or should have known for years that gabapentin could contribute to cognitive decline, memory problems, and a higher dementia risk among certain patients.

According to the lawsuits, scientific literature, adverse event reports, and post-market safety data provided opportunities to further investigate these potential neurological effects long before the current litigation emerged.

Despite those alleged warning signs, plaintiffs claim the manufacturers continued marketing gabapentin without adding any dementia-related information to the drug’s warning label.

The lawsuits further allege that healthcare providers and patients were never informed that long-term use could potentially be associated with an increased risk of mild cognitive impairment or dementia.

As a result, gabapentin continued to be prescribed to tens of thousands of patients each year for both approved and off-label uses without any guidance regarding cognitive monitoring.

Plaintiffs contend that stronger warnings and additional safety information could have influenced prescribing decisions and helped patients recognize possible symptoms of cognitive decline sooner.

Gabapentin is a prescription medication that affects signaling pathways within the central nervous system and is classified as an anticonvulsant.

The U.S. Food and Drug Administration originally approved the drug to treat epileptic seizures as an adjunctive therapy and later approved it for the treatment of shingles-related nerve pain, also known as postherpetic neuralgia.

It is sold under the brand name Neurontin and is also available in generic forms that are widely prescribed throughout the United States.

Because gabapentin can influence the activity of certain neurotransmitters and calcium channels in the brain, physicians have prescribed it for a variety of neurological and pain-related conditions beyond its approved uses.

Researchers have also studied gabapentin in connection with conditions affecting older adults, including neurological disorders such as Alzheimer’s disease, although it is not approved to treat or prevent dementia.

FDA-Approved Uses for Gabapentin

Gabapentin is an anti-seizure medication that received FDA approval in 1993 as an adjunctive treatment for partial seizures in adults with epilepsy.

Over time, the FDA expanded its approved indications to include the treatment of postherpetic neuralgia, a form of nerve damage that can occur after a shingles infection.

Today, the drug is widely known for its role in treating nerve pain, seizures, and more, although many of its most common uses fall outside its FDA-approved indications.

FDA-approved uses for gabapentin include:

• Adjunctive treatment of partial seizures in adults and pediatric patients with epilepsy
• Management of postherpetic neuralgia (shingles-related nerve pain)
• Adjunctive treatment of partial seizures with and without secondary generalization
• Use as part of a broader seizure management regimen when prescribed alongside other anti-epileptic medications

Common Off-Label Uses Identified in Current Lawsuits

Although gabapentin is approved for seizures and postherpetic neuralgia, physicians have prescribed it off-label for many other conditions for decades.

Off-label prescribing is legal and common in the United States when a healthcare provider believes a medication may benefit a patient despite the condition not appearing on the FDA-approved label.

Because gabapentin can affect nerve signaling and pain pathways, it became widely used to treat neuropathic pain and other conditions involving chronic discomfort or neurological symptoms.

Some of the current lawsuits involve patients who were prescribed gabapentin for off-label purposes rather than its approved indications.

As a result, chronic back pain and several other forms of pain management have become recurring topics in the litigation.

Common off-label uses for gabapentin include:

• Chronic back pain
• Neuropathic pain unrelated to postherpetic neuralgia
• Fibromyalgia
• Anxiety disorders
• Migraine prevention
• Restless leg syndrome
• Hot flashes associated with menopause
• Diabetic neuropathy
• Insomnia and certain sleep disorders
• Chronic musculoskeletal pain

Gabapentin affects the central nervous system by binding to specific calcium channel subunits that help regulate communication between nerve cells.

Specifically, gabapentin mimics GABA to inhibit nerve cell activity and may affect cognition.

Although the drug was originally developed to help control seizures, researchers now understand that it can alter the release of neurotransmitters involved in pain signaling, nerve activity, and other brain functions.

These effects help explain why gabapentin is used to treat certain neurological conditions and forms of nerve-related pain.

Researchers have also identified biological pathways through which gabapentin may influence synaptic activity and neural communication within the brain.

As a result, scientists have become increasingly interested in whether long-term exposure could contribute to potential cognitive decline in some patients.

Gabapentin is known to:

• Alter communication between neurons in the central nervous system
• Bind to alpha-2-delta subunits of voltage-gated calcium channels
• Reduce the release of certain excitatory neurotransmitters
• Affect pain-processing pathways within the brain and spinal cord
• Influence neural activity involved in seizure control
• Produce side effects such as dizziness, sedation, and difficulties with concentration in some patients
• Cross the blood-brain barrier and act directly within the central nervous system

Questions about the drug’s long-term neurological effects gained additional attention following research published in the journal Regional Anesthesia & Pain Medicine that reported higher rates of dementia and mild cognitive impairment among certain gabapentin users.

The study did not establish that gabapentin directly causes dementia, and researchers emphasized that additional investigation is needed to better understand the relationship.

Current litigation relies in part on these findings while alleging that manufacturers failed to adequately evaluate and disclose potential cognitive risks associated with long-term use.

Dementia, mild cognitive impairment (MCI), and memory loss are related but distinct conditions that affect cognitive function in different ways.

Memory loss can occur for many reasons and does not necessarily indicate a progressive neurological disorder.

MCI is characterized by measurable changes in memory, thinking, or reasoning abilities that exceed normal age-related decline but do not substantially interfere with daily independence.

Dementia is a broader clinical syndrome involving progressive impairment of memory, language, judgment, problem-solving, and other cognitive functions that can significantly affect daily life.

Understanding the differences between these conditions is important because they may represent different stages of cognitive decline and often require different approaches to diagnosis, treatment, and long-term care.

What Is Mild Cognitive Impairment?

Mild cognitive impairment, often called MCI, describes measurable problems with memory, language, judgment, attention, or reasoning that are greater than expected with normal aging.

People with MCI can usually manage daily activities independently, but they or their family members may notice recurring cognitive changes that affect work, appointments, conversations, or routine tasks.

Medical sources describe MCI as a condition between typical age-related cognitive changes and dementia, although not every person with MCI develops dementia.

Common symptoms of mild cognitive impairment may include:

• Forgetting appointments, conversations, or recent events more often than usual
• Misplacing items frequently
• Having trouble finding the right words during conversation
• Losing focus more easily
• Difficulty planning, organizing, or completing familiar tasks
• Problems with judgment or decision-making
• Repeating questions or stories
• Needing more reminders to manage daily responsibilities

MCI can have many causes, including neurological disease, medication effects, depression, sleep disorders, stroke, metabolic problems, or other medical conditions.

Some people with MCI remain stable or improve, while others progress to dementia over time.

A medical evaluation may include cognitive testing, neurological examination, medication review, bloodwork, brain imaging, and assessment for conditions that can mimic or worsen cognitive decline.

How Dementia Affects Memory, Reasoning, and Daily Functioning

Dementia is not a single disease but a broad term used to describe a group of conditions that cause progressive impairment of memory, thinking, reasoning, and other cognitive abilities.

Alzheimer’s disease is the most common cause of dementia, although vascular dementia, Lewy body dementia, and several other neurological disorders can produce similar symptoms.

Unlike normal age-related forgetfulness, dementia involves cognitive changes severe enough to interfere with a person’s ability to function independently.

Symptoms typically worsen over time as the underlying disease affects additional areas of the brain.

The severity and progression of dementia vary from person to person, but the condition often affects nearly every aspect of daily life.

Dementia may affect:

• Short-term and long-term memory
• Problem-solving and decision-making abilities
• Language skills, including speaking and understanding conversations
• Attention, concentration, and focus
• Judgment and risk assessment
• Ability to manage finances and medications
• Driving and transportation safety
• Recognition of familiar people, places, or objects
• Personal care activities such as bathing, dressing, and eating
• Mood, behavior, and emotional regulation

Although some medications may help manage symptoms or slow progression in certain forms of dementia, there is currently no cure for most underlying causes of the condition.

As cognitive impairment advances, many individuals require increasing levels of supervision, assistance, or full-time care.

Family members often take on significant caregiving responsibilities, including managing medical appointments, finances, transportation, and daily living needs.

The emotional, physical, and financial burden associated with dementia can affect entire families for years after the initial diagnosis.

Individuals who developed early-onset dementia or mild cognitive impairment after prolonged gabapentin use may qualify to pursue a claim, depending on their medical history and prescribing records.

Because the litigation remains in its early stages, cases are evaluated based on specific criteria designed to identify individuals whose diagnoses may be consistent with the allegations raised in current lawsuits involving dangerous medications.

Eligibility requirements may change as additional research emerges and the litigation develops.

Factors that may support eligibility for a gabapentin lawsuit include:

• Receiving six or more gabapentin prescriptions between 2000 and 2024
• Being prescribed gabapentin for a purpose other than seizures or nerve pain
• Receiving a diagnosis of early-onset dementia before age 65
• No prior history of traumatic brain injury (TBI)
• No diagnosis of schizophrenia
• No known genetic markers or mutations associated with dementia or Alzheimer’s disease
• Not currently represented by another attorney regarding the claim

Meeting one or more of these factors does not automatically establish eligibility for a lawsuit.

Attorneys typically review prescription records, medical diagnoses, treatment history, and other relevant information before determining whether a claim may qualify for further investigation.

Individuals who believe they may have a potential claim should seek a legal review to better understand their options and whether they meet current screening criteria.

Research examining the potential relationship between gabapentin and cognitive decline continues to evolve, and lawsuits filed across the country allege that patients were not adequately warned about possible long-term neurological risks.

Individuals diagnosed with early-onset dementia, mild cognitive impairment, or significant memory loss after prolonged gabapentin use may have legal options worth exploring.

As courts, researchers, and attorneys continue to evaluate the evidence, affected patients and their families are seeking answers and pursuing opportunities to seek justice for the harm they allegedly suffered.

Zoll & Kranz is actively investigating claims involving gabapentin-related cognitive injuries.

If you or a loved one developed dementia, mild cognitive impairment, or serious memory problems after taking gabapentin, contact our team for a free case review.

We handle qualifying cases on a contingency fee basis, which means there are no upfront costs and no attorney fees unless we recover compensation on your behalf.