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Neurontin Off-label Use
Suicide and Attempted Suicide Lawsuits
(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.
If you or a loved one have been taking
Neurotin and has attempted suicide, it is important to seek to
medical assistance. If you have questions regarding a potential
Neurontin lawsuit for the death of a loved one,
please feel free to e-mail Texas Neurontin Suicide Lawyer
Jason Coomer with your name & contact information.
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
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)
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. If you have questions about a loved one
that has committed suicide and was taking Neurotin and a
potential Neurontin lawsuit for the death of a loved one,
please feel free to e-mail Texas Neurontin Suicide Lawyer
Jason Coomer with your name & contact information.
Neurontin Suicide Lawyers and Gabapentin
Suicide Attorneys
Texas Dangerous Drug Attorney Jason Coomer
commonly works with other lawyers throughout Texas and the
United States including Texas Neurontin Lawyers, Houston
Gabapentin Lawyers, Boston Suicide Lawyers, San Antonio
Pharmaceutical Lawyers, Dallas Off-label Neurontin Lawyers, and
other Austin Dangerous Drug Claim Lawyers. By sharing
information and working together, his law firm and other firms
throughout Texas and the United States are able to provide
better representation for there clients.
Texas Chantix Lawyer Jason Coomer also works
on
Reglan Tardive Dyskinesia Lawsuits and other
defective drug mediation lawsuits. If you or
a loved one have or are taking Neurontin and have had suicidal
thoughts, or attempted suicide consult your doctor. If you or a
loved one has questions about a potential Neurontin Suicide or
Attempted Suicide Lawsuit, feel free to e-mail any questions you
might have to
NeurontinSuicideLawyer@texaslawyers.com. |
