Nashville Gabapentin Dementia Lawsuit | (855) 846–6529

• Gabapentin is an anticonvulsant medication. The brand version, Neurontin, was originally developed by Parke-Davis Pharmaceutical Company, later tied to Warner-Lambert Company and Pfizer, inc. The drug is now widely available in generic form.
• The FDA-approved uses for Neurontin are narrower than many patients realize. The current label identifies two main uses: (1) management of postherpetic neuralgia in adults, which is nerve pain after shingles, and (2) adjunctive therapy for partial-onset seizures in adults and pediatric patients with epilepsy.  However, gabapentin is prescribed off label for many conditions outside those approved uses.
• Off-label prescribing is an integral part of medicine and can be beneficial for many individuals under circumstances where not specified on the label approved by the FDA. Doctors prescribe FDA-approved drugs for conditions not listed on the label when they believe it is justified and the medication may be beneficial.
• Notwithstanding, drug companies generally cannot market a drug for unpproved use, and they must provide adequate warnings about known or reasonably knowable risks. Indeed, off label prescribing can be harmful to patients particularly where no solid and established evidentiary basis exists for the off-label use.
• Gabapentin became widely used in part because it was seen as a safer alternative to opioids. Initially, it was not viewed as highly addictive, it became very inexpensive once generic versions hit the market.
• Doctors under pressure to reduce opioid prescribing increasingly prescribed gabapentin for chronic pain patients. Consequently, this made gabapentin a routine medication in pain clinics, primary care offices, and even postoperative care.
• However, in recent years, the recreational abuse of gabapentin or intentional misuse of the medication, has skyrocketed at alarming rates.  Furthermore, the adverse effects of gabapentin become more prevalent when taken in combination with other central nervous system depressants, such as opioids

In short, the medication became so popular so fast and was given off label in cases where no established evidentiary basis existed. But eventually time catches up with popularity and proof of serious adverse effects surfaces.

In a perfect world, all uses of drugs and devices would be supported by solid research. The existing regulatory system fails to impose this high standard, however, and the private sector often lacks incentives to conduct rigorous evaluations of off-label uses. In the current situation, the medical community has primary responsibility for determining when off-label prescribing is appropriate for patients. But appropriate off-label prescribing can be challenging for physicians today, because of time pressures, information overload, and the involvement of industry in research and education about off-label uses.

Dresser R, Frader J. Off-label prescribing: a call for heightened professional and government oversight. J Law Med Ethics. 2009 Fall;37(3):476-86, 396. doi: 10.1111/j.1748-720X.2009.00408.x. PMID: 19723258; PMCID: PMC2836889 (emphasis supplied).

That is the overriding concern now driving gabapentin dementia lawsuits.

• Gabapentin is an anticonvulsant medication. The brand version, Neurontin, was originally developed by Parke-Davis Pharmaceutical Company, later tied to Warner-Lambert Company and Pfizer, inc. The drug is now widely available in generic form.
• The FDA-approved uses for Neurontin are narrower than many patients realize. The current label identifies two main uses: (1) management of postherpetic neuralgia in adults, which is nerve pain after shingles, and (2) adjunctive therapy for partial-onset seizures in adults and pediatric patients with epilepsy.  However, gabapentin is prescribed off label for many conditions outside those approved uses.
• Off-label prescribing is an integral part of medicine and can be beneficial for many individuals under circumstances where not specified on the label approved by the FDA. Doctors prescribe FDA-approved drugs for conditions not listed on the label when they believe it is justified and the medication may be beneficial.
• Notwithstanding, drug companies generally cannot market a drug for unpproved use, and they must provide adequate warnings about known or reasonably knowable risks. Indeed, off label prescribing can be harmful to patients particularly where no solid and established evidentiary basis exists for the off-label use.
• Gabapentin became widely used in part because it was seen as a safer alternative to opioids. Initially, it was not viewed as highly addictive, it became very inexpensive once generic versions hit the market.
• Doctors under pressure to reduce opioid prescribing increasingly prescribed gabapentin for chronic pain patients. Consequently, this made gabapentin a routine medication in pain clinics, primary care offices, and even postoperative care.
• However, in recent years, the recreational abuse of gabapentin or intentional misuse of the medication, has skyrocketed at alarming rates.  Furthermore, the adverse effects of gabapentin become more prevalent when taken in combination with other central nervous system depressants, such as opioids

In short, the medication became so popular so fast and was given off label in cases where no established evidentiary basis existed. But eventually time catches up with popularity and proof of serious adverse effects surfaces.

In a perfect world, all uses of drugs and devices would be supported by solid research. The existing regulatory system fails to impose this high standard, however, and the private sector often lacks incentives to conduct rigorous evaluations of off-label uses. In the current situation, the medical community has primary responsibility for determining when off-label prescribing is appropriate for patients. But appropriate off-label prescribing can be challenging for physicians today, because of time pressures, information overload, and the involvement of industry in research and education about off-label uses.

Dresser R, Frader J. Off-label prescribing: a call for heightened professional and government oversight. J Law Med Ethics. 2009 Fall;37(3):476-86, 396. doi: 10.1111/j.1748-720X.2009.00408.x. PMID: 19723258; PMCID: PMC2836889 (emphasis supplied).

That is the overriding concern now driving gabapentin dementia lawsuits.