Pregabalin (Lyrica) Lawsuit | Dementia and Memory Loss

Gabapentin and pregabalin dementia claims allege that manufacturers failed to adequately warn prescribing physicians about possible long-term cognitive injuries.

The allegations remain unproven, and the available scientific evidence does not establish that Lyrica causes dementia.

A person pursuing a claim would need evidence of a diagnosed injury, a legally sufficient basis for holding the appropriate manufacturer responsible, and a reliable connection between the medication and the injury.

People diagnosed with dementia, mild cognitive impairment, or another documented cognitive disorder after taking Lyrica may want their treatment history assessed.

No particular number of pregabalin prescriptions, age at diagnosis, or length of treatment automatically makes someone eligible to sue.

Factors relevant to an individual review include:

• Medication and manufacturer: Whether the patient received brand-name Lyrica, generic pregabalin, or both, and which company manufactured the dispensed product.
• Pregabalin drug exposure: The prescribed dose, refill history, and total pregabalin exposure period, including any treatment interruptions or dose increases.
• Cognitive diagnosis: Medical records documenting memory complaints, clinical symptoms, cognitive testing, and a diagnosis of dementia or mild cognitive impairment.
• Major risk factors: Previous cognitive symptoms, family history, diabetes, vascular disease, decreased renal function, other medications, and relevant substance abuse history.
• Effect on daily life: Lost income, increased medical needs, changes in independence, or assistance provided by relatives and caregivers.

Repeated treatment and a diagnosis at a younger age may warrant particular attention, but the scientific studies do not establish universal legal screening criteria.

Can You Sue Over Generic Pregabalin?

Generic pregabalin contains the same active ingredient as Lyrica, but the identity of the manufacturer can affect which legal claims are available.

The FDA approved the first generic pregabalin products in July 2019.

In PLIVA, Inc. v. Mensing, the U.S. Supreme Court held that federal labeling requirements preempt certain state-law failure-to-warn claims against generic drug manufacturers.

That ruling does not determine every possible case, but pharmacy records identifying the actual product and manufacturer are particularly important for someone who received generic pregabalin.

Lyrica received its first FDA approval in 2004 and is prescribed to treat patients suffering from several forms of nerve pain and certain seizure disorders.

Pregabalin is a gabapentinoid that binds to alpha-2-delta subunits of voltage-gated calcium channels in the central nervous system.

Pregabalin affects calcium-channel activity and the release of neurotransmitters involved in pain signaling.

Although its mechanism is not fully understood, these effects are believed to contribute to its ability to relieve neuropathic pain and control seizures.

According to the FDA-approved Lyrica prescribing information, its approved uses include:

• Diabetic peripheral neuropathy: Treatment of diabetic nerve pain.
• Postherpetic neuralgia: Persistent pain after shingles.
• Fibromyalgia: Doctors prescribe Lyrica to treat fibromyalgia, which involves widespread chronic pain and other symptoms.
• Spinal cord injury: Treatment of chronic neuropathic pain associated with damage to the spinal cord.
• Partial-onset seizures: Treatment alongside another seizure medication, sometimes called epilepsy adjuvant therapy.

Physicians may prescribe pregabalin for other conditions, including certain anxiety disorders and pain syndromes, even when those uses have not been approved by the FDA.

Off-label prescribing by a physician is not automatically unlawful, although pharmaceutical manufacturers face restrictions on promoting medications for unapproved uses.

Lyrica is related to gabapentin, but the two drugs have different dosing and approved indications, and research on one drug should not automatically be applied to the other.

Lyrica can cause cognitive adverse effects during treatment, including amnesia, confusion, slowed thinking, and concentration problems.

Whether pregabalin causes lasting cognitive function impairment or contributes to the development of dementia is unresolved.

A medication-related problem with attention or memory is not the same as a progressive neurodegenerative disorder.

FDA-Recognized Cognitive Side Effects

The FDA-approved Lyrica label identifies abnormal thinking, amnesia, and confusion among adverse drug reactions observed in clinical trials.

Difficulty concentrating and slowed thinking are among the frequently reported neuropsychiatric symptoms associated with pregabalin in the label’s clinical trial data.

In randomized controlled trials involving adults receiving pregabalin as an additional treatment for partial-onset seizures, abnormal thinking was reported in 8% of pregabalin-treated participants compared with 2% receiving placebo.

Amnesia was reported in 5% of the pregabalin group compared with 2% of the placebo group.

These figures come from specific seizure trials and should not be presented as the incidence of cognitive problems in every person prescribed Lyrica.

Some patients discontinued treatment because of adverse reactions, including dizziness, coordination problems, drowsiness, and abnormal thinking.

These trials documented neuropsychiatric adverse effects during pregabalin treatment but did not follow patients long enough to determine whether the medication increased their risk of developing dementia.

What Did the 2010 Pregabalin Cognitive Study Find?

A 2010 randomized trial tested pregabalin against placebo in 32 healthy volunteers, increasing the pregabalin dose over eight weeks to 600 mg daily.

Thirty participants completed the 12-week study.

Participants taking pregabalin showed greater cognitive impairment on several tests of attention, processing speed, and verbal fluency than those receiving placebo.

The adverse cognitive effect was measured during treatment, not years afterward, so the trial did not establish a risk of permanent impairment or dementia.

How Are Memory Loss, Mild Cognitive Impairment, and Dementia Different?

Memory loss is a symptom that can arise from medication effects, sleep disorders, depression, neurological illness, or other causes.

Mild cognitive impairment involves measurable changes in memory or thinking that generally do not prevent independent daily functioning.

Very mild dementia may initially resemble mild cognitive impairment, but dementia ultimately interferes with a person’s ability to manage everyday activities.

Alzheimer’s disease is the most common cause of dementia and progressively damages the brain regions responsible for memory, reasoning, and other cognitive functions.

Dementia patients may develop behavioral and psychological symptoms, including changes in mood, judgment, or behavior, although such symptoms do not reveal whether a medication contributed to the illness.

Someone experiencing new or worsening memory difficulties should seek medical assessment rather than abruptly discontinue Lyrica, particularly when the medication is being used for seizures.

Other Serious Lyrica Warnings

The FDA warns that antiepileptic medications, including pregabalin, increase the risk of suicidal thoughts or behavior.

The Lyrica label also warns about angioedema, a potentially life-threatening allergic reaction that can cause swelling of the face, throat, or airway.

Another warning concerns respiratory depression, particularly when pregabalin is taken with opioids or other central nervous system depressants or by patients with underlying respiratory impairment.

Because pregabalin is eliminated primarily through the kidneys, patients with decreased renal function may need adjusted doses.

Pregabalin has also been investigated for possible birth defects following exposure during pregnancy.

A 2016 study reported major birth defects in 6% of first-trimester pregnancies exposed to pregabalin, compared with approximately 2% of unexposed pregnancies.

However, larger studies have found smaller associations, and the FDA’s prescribing information acknowledges important limitations in the available evidence.

The findings do not establish that Lyrica causes birth defects or triples the risk in all pregnancies.

Pregnancy-related injuries are separate from the dementia claims being investigated.

Studies involving human participants have examined both cognitive changes during pregabalin therapy and subsequent dementia diagnoses among people prescribed gabapentinoids.

The distinction is essential: a clinical trial measuring performance during medication use cannot show whether patients later develop dementia, and research combining two drugs cannot establish a risk specific to Lyrica.

2023 Taiwan Study on Gabapentin, Pregabalin, and Dementia

A 2023 Taiwanese cohort study, titled The association between Gabapentin or Pregabalin use and the risk of dementia: an analysis of the National Health Insurance Research Database in Taiwan, examined 206,802 adults.

Researchers compared 34,467 adult patients taking gabapentin or pregabalin with 172,335 matched nonusers.

The study reported several findings:

• Dementia diagnoses: The combined exposed group had 980.60 diagnoses per 100,000 person-years, compared with 605.48 among nonusers.
• Adjusted association: Gabapentin or pregabalin use was associated with a 45% higher adjusted hazard of dementia (HR 1.45; 95% CI 1.36–1.55).
• Cumulative exposure: The cumulative incidence curve revealed a significantly higher cumulative incidence of dementia among exposed patients, with stronger associations at higher cumulative doses.
• Younger participants: Adults younger than 50 had an adjusted hazard ratio of 3.16 relative to matched nonusers in the same age range.

The study’s drug exposure assessment was based on insurance records documenting prescriptions, not direct observation of medication use.

The researchers grouped gabapentin and pregabalin users together rather than analyzing the drugs separately.

As a result, the study cannot establish whether pregabalin exposure carries the same dementia risk as the combined group. The reported 45% increase should not be presented as a Lyrica-specific finding.

The combined gabapentin or pregabalin exposure group had higher rates of diabetes, hypertension, stroke, and depression, all of which may affect dementia risk.

2026 Meta-Analysis of Gabapentinoid Use and Dementia

A 2026 systematic review and meta-analysis combined five observational studies involving 325,245 participants.

Across the included studies, gabapentinoid exposure was associated with 28% higher estimated odds of Alzheimer’s disease and related dementias (OR 1.28; 95% CI 1.10–1.50).

The studies produced substantially different results, and the authors rated the certainty of evidence as low.

When the analysis was restricted to studies considered at low risk of bias, the association was no longer statistically significant (OR 1.23; 95% CI 0.83–1.84).

The pooled estimate cannot establish that Lyrica independently causes dementia, particularly where the underlying research combines gabapentin with pregabalin.

What Do Pregabalin-Specific and Gabapentin-Only Studies Show?

A 2023 meta-analysis of anti-seizure medications found no statistically significant pregabalin-specific association with dementia across the two studies available for that medication (OR 0.84; 95% CI 0.64–1.11).

The limited evidence does not prove that pregabalin prevents dementia, nor does it rule out a possible risk.

A separate 2025 study of chronic low back pain patients reported higher rates of dementia and mild cognitive impairment after repeated gabapentin treatment, particularly among patients receiving six or more prescriptions.

Because the study evaluated gabapentin treatment rather than pregabalin, its prescription thresholds and dementia risk estimates cannot be applied directly to Lyrica users.

Why Are the Findings Difficult to Interpret?

Many participants in these studies were being treated for chronic pain, epilepsy, or other medical conditions that can independently affect cognition.

Among medically ill patients, depression, poor sleep, other medications, and vascular disease can influence memory and concentration.

Researchers investigating risk factors for dementia must also consider modifiable risk factors, including smoking, diabetes, hypertension, and cardiovascular disease, alongside family history and other neurological conditions.

The Taiwanese study identified dementia diagnoses using insurance records rather than independently examining participants. Researchers therefore relied on recorded diagnoses without performing their own cognitive assessments.

A diagnosis after pregabalin treatment cannot establish whether the medication caused the disease, aggravated an existing problem, or was unrelated to the patient’s cognitive decline.

Potential Lyrica dementia claims allege that manufacturers failed to give prescribing doctors adequate warnings about long-term cognitive injuries associated with pregabalin.

Such a claim must distinguish the cognitive adverse effects already identified in Lyrica’s labeling from a separate alleged risk of dementia.

A viable pharmaceutical product liability claim may require evidence about what the manufacturer knew, whether additional warnings were legally required, and whether the prescribing decision would have changed with a different warning.

Proving that a person developed dementia after taking Lyrica is not enough to establish causation or liability.

Pfizer’s Earlier Lyrica Marketing Settlements

Pfizer agreed to a $2.3 billion federal criminal and civil settlement in 2009 involving marketing and other allegations related to multiple medications.

The $1.3 billion criminal portion concerned Bextra, while approximately $50 million of the separate civil resolution related to allegations about Lyrica promotion.

As part of that settlement, Pfizer entered a five-year Corporate Integrity Agreement requiring compliance measures and independent oversight of certain business practices.

In 2012, Pfizer reached a further $42.9 million multistate settlement over marketing allegations concerning Lyrica and Zyvox.

State attorneys general alleged that Lyrica had been promoted for unapproved uses, including migraine, perioperative pain, and certain other chronic pain conditions, and the settlement imposed additional marketing restrictions.

Neither settlement established that Lyrica causes dementia, and the payments cannot be used to estimate compensation for a cognitive-injury claim.

A legal review begins with proof of medication use and an established cognitive diagnosis, but medical causation and manufacturer liability require separate examination.

Records that may be useful include:

• Pharmacy records: Pregabalin prescriptions, dispensing dates, dosage, brand or generic status, and manufacturer information.
• Medical evaluations: Neurologist records, cognitive testing results, clinical symptoms, and any documented dementia diagnosis.
• Treatment timeline: The date pregabalin was started, the duration and dose of treatment, and when memory symptoms first appeared.
• Prior health history: Earlier cognitive complaints, vascular or psychiatric diagnoses, kidney function, and other drugs that could affect cognition.
• Financial and caregiving losses: Medical expenses, lost wages, long-term care needs, and increased dependence on family members.

Dementia patients may need help from an authorized representative to obtain records or discuss possible legal claims.

If a claimant proves a legally attributable injury and manufacturer responsibility, recoverable damages depend on the law and the circumstances of the case.

Potential compensation may address:

• Medical evaluations, treatment, and other related healthcare expenses.
• Long-term assistance, in-home care, or residential memory care.
• Lost income and diminished future earning capacity.
• Physical and emotional suffering and loss of enjoyment of life, where allowed by law.
• Wrongful death losses for eligible survivors or estates if a legally attributable injury caused death.

There is no established settlement value for an individual Lyrica dementia claim, and Pfizer’s earlier marketing settlements do not provide a reliable comparison.

Obtain pharmacy records identifying the pregabalin product, its manufacturer, the number of refills, and the dates of treatment.

Preserve records of memory complaints, neurological testing, diagnoses, and any changes in work or independent living.

An attorney can review the prescription and medical history, assess the available scientific evidence, identify potential defendants, and determine which filing deadlines may apply.

The statute of limitations depends on state law and the facts of the case, and a recent diagnosis does not necessarily restart the filing period.

Zoll & Kranz is reviewing possible claims involving documented cognitive injuries after Lyrica or generic pregabalin treatment.

If you or a loved one developed dementia or mild cognitive impairment after using pregabalin, contact Zoll & Kranz for a free consultation or use the website chat feature to discuss the treatment history and available legal options.