Neurontin Off-label Use Suicide and Attempted Suicide Lawsuits
(Gabapentin Off-label Use Suicide Lawyer)
(Gabapentin Off-label Use Suicide Lawyer)
Gabapentin (brand name Neurontin) is a GABA analogue. It was originally developed for the treatment of epilepsy, but has been aggressively marketed for many off-label uses including to relieve pain, migraine headaches, neuropathic pain, nystagmus, Complex Regional Pain Syndrome, mood-stabilizing treatment for bipolar disorder, menopausal hot flashes, and idiopathic subjective tinnitus. The FDA has issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking gabapentin.
Neurontin FDA Actions and Warnings (Gabapentin Suicide Lawsuits)
The U.S. Food and Drug Administration (FDA) has issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking gabapentin. An independent analysis by the FDA showed that anticonvulsant drugs, including gabapentin, can increase suicidal thoughts in patients. The approved label for Neurontin now includes a warning about an increased risk of suicidal thoughts or actions and a guide to help patients understand this risk.
FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications Including Neurontin
In December 2008, the U.S. Food and Drug Administration announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.
The FDA is also requiring the manufacturers to submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications.
"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. " Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional."
The FDA today also disseminated information to the public about the risks associated with antiepileptic medications by issuing a public health advisory and an information alert to health care professionals. Health care professionals should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed.
The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo.
Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.
The FDA alerted health care professionals in January 2008 that clinical trials of drugs to treat epilepsy showed increased risk of suicidal thoughts and actions. In July 2008, the FDA held a public meeting to discuss the data with a committee of independent advisors. At that meeting the committee agreed with the FDA's findings that there is an increased risk of suicidality with the analyzed antiepileptic drugs, and that appropriate warnings should extend to the whole class of medications. The panel also considered whether the drugs should be labeled with a boxed warning, the FDA's strongest warning. The advisers recommended against a boxed warning and instead recommended that a warning of a different type be added to the labeling and that a Medication Guide be developed.
Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.
The following antiepileptic drugs are required to add warnings about the risk of suicidality:
- Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR
- Clonazepam (marketed as Klonopin)
- Clorazepate (marketed as Tranxene)
- Divalproex sodium (marketed as Depakote, Depakote ER)
- Ethosuximide (marketed as Zarontin)
- Ethotoin (marketed as Peganone)
- Felbamate (marketed as Felbatol)
- Gabapentin (marketed as Neurontin)
- Lamotrigine (marketed as Lamictal)
- Lacosamide (marketed as Vimpat)
- Levetiracetam (marketed as Keppra)
- Mephenytoin (marketed as Mesantoin)
- Methosuximide (marketed as Celontin)
- Oxcarbazepine (marketed as Trileptal)
- Phenytoin (marketed as Dilantin)
- Pregabalin (marketed as Lyrica)
- Primidone (marketed as Mysoline)
- Rufinamide (marketed as Banzel)
- Tiagabine (marketed as Gabitril)
- Topiramate (marketed as Topamax)
- Trimethadione (marketed as Tridione)
- Valproic Acid (marketed as Depakene, Stavzor Extended Release Tablets)
- Zonisamide (marketed as Zonegran)
Off-Label Marketing Claims and Off-Label Marketing Lawsuits
The Federal Food Drug and Cosmetic Act (”FDCA”), provides a systematic scheme for the approval of new drugs and new drug formulations intended to be marketed for use in interstate commerce. Under the FDCA, a new drug product cannot be marketed unless the FDA approves the product and determines that it is safe and effective for its intended use. When the FDA approves a drug, it approves the drug only for the particular use for which it was tested, but after the drug is approved for a particular use, the FDCA does not regulate how the drug may be prescribed. Thus, a drug that has been tested and approved for one use only can also be prescribed by a physician for another use, known as “off-label.”
Though physicians may prescribe drugs for off-label usage, the FDA prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved. A manufacturer illegally “misbrands” a drug if the drug’s labeling includes information about its unapproved uses. A drug is deemed misbranded unless its labeling bears adequate directions for use. The courts have agreed with the FDA that the FDCA requires information not only on how a product is to be used (e.g. dosage and administration), but also on all the intended uses of the product. Oral statements and materials presented at industry-support scientific and educational activities may provide evidence of a product’s intended use. If these statements or materials promote a use that is inconsistent with the product’s approved labeling, the product is misbranded under the FDCA for failure to bear labeling with adequate directions for all intended uses.
Gabapentin (brand name Neurontin) has been aggressively marketed for many off-label uses including to relieve pain, migraine headaches, neuropathic pain, nystagmus, Complex Regional Pain Syndrome, mood-stabilizing treatment for bipolar disorder, menopausal hot flashes, and idiopathic subjective tinnitus. This off-label marketing for Neurontin is a serious problem in that the FDA has issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking Neurotin.
It is estimated that over 90 percent of Pfizer's revenue from Neurontin which is in the billions of dollars is from off-label use. Pfizer has paid a total of $2.75 billion in off-label penalties since 2004 which is a little more than 1 percent of the company’s revenue of $245 billion from 2004 to 2008. (Pfizer Broke the Law by Promoting Drugs for Unapproved Uses)
For more information on Off-Label Pharmacy Practices, please feel free to go to the following Website on Medicare Fraud and False Claims Act Qui Tam Claims.
Neurontin Suicide Lawsuits (Gabapentin Suicide Lawyers)
In July 2009, the first case against Pfizer, the maker of Neurontin, went to trial, and there are an estimated 1200 pending cases regarding the safety of Neurontin. Although a Pfizer spokesperson noted that "the reliable scientific evidence does not demonstrate a causal association between Neurontin treatment and suicidal behavior," the FDA analysis found an 80 percent rise in suicidal thoughts and behavior in data from 199 studies of gabapentin and other anticonvulsants.
If you or a loved one have been taking Neurontin have attempted suicide, it is important to seek to medical assistance. For more information on a potential Neurontin lawsuit for the death of a loved one, please go to the following webpage on Neurontin Suicide Lawsuits or please feel free to e-mail Texas Neurontin Suicide Lawyer Jason Coomer with your name & contact information.