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Topamax Suicide and Birth Defect Lawsuits, Topamax Birth Defect Lawsuits, and Antiepileptic Drug (APD)
Lawsuits
(Topamax Suicide and Birth Defect
Lawyer)
Topiramate
(brand name Topamax) is a anticonvulsant drug. It has been
approved for the treatment of epilepsy and migraines, but has been
aggressively marketed for many off-label uses including
bipolar disorder, cluster headaches, eating disorders,
obesity, fibromyalgia, depression, posttraumatic stress
disorder (PTSD), alcoholism, sleep disorders, sleep-eating disorders,
infantile spasms, autism, periventricular leukomalacia in
preterm infants after an hypoxic-ischemic injury, essential
tremor, bulimia nervosa, obsessive-compulsive disorder,
smoking cessation, idiopathic intracranial hypertension,
neuropathic pain, and cocaine dependence. In May of
2009, the FDA
issued a warning of an increased risk of suicidal
thoughts and behaviors in patients taking topiramate.
If you or a loved one have been taking
Topamax and has attempted suicide or were taking
Topamax
during pregnancy and had a child with a birth defect, it is important to seek
medical assistance. If you have questions regarding a
potential Topamax lawsuit for the death of a loved one or
birth defect,
please feel free to e-mail Texas Topamax Suicide Lawyer
Jason Coomer with your name & contact information.
or to
submit an
inquiry through this submission form.
Antiepileptic Drug (AEDs),
Anticonvulsant Drugs, and Topamax FDA Warnings and Safety
Alerts (Topiramate Suicide
Lawsuits)
On May 5, 2009, the FDA mandated a new
warning for Topamax and all anticonvulsant drugs. The
antiepileptic drug (AED) class label changes mandated that
Topamax and all anticonvulsant drugs update product labeling
to include a warning about an increased risk of suicidal
thoughts or actions. Further, these manufacturers were
directed to develop a Medication Guide to help patients
understand the risk of suicidal thoughts or actions caused
by the antiepileptic drugs. These changes affected all
approved AEDs including Topamax except those indicated only
for short-term use.
The FDA approved advice to be given to
healthcare professionals is that "epilepsy and other
illnesses for which antiepileptic drugs are prescribed are
associated with an increased risk of suicidal thoughts and
behavior. If suicidal thoughts or behavior emerge during
treatment with AEDs, the prescriber should consider whether
these symptoms may be related to the illness being treated.
All patients who currently are taking or starting on any
antiepileptic drug for any indication should be monitored
for notable changes in behavior that could indicate the
emergence or worsening of suicidal thoughts or behavior or
depression."
Since the FDA issued safety alerts for
the antiepileptic drugs on December 16, 2008 and January 31,
2008, FDA has been working with the manufacturers of drugs
in this class to better understand the suicidality risk.
As described in the January 31, 2008, Information for Health
Care Professionals Sheet on AEDS, eleven antiepileptic drugs
were included in FDA’s original pooled analysis of
placebo-controlled clinical studies in which these drugs
were used to treat epilepsy as well as psychiatric disorders
and other conditions. The increased risk of suicidal
thoughts or behavior was generally consistent among the
eleven drugs, with varying mechanisms of action and across a
range of indications. This observation suggests that the
risk applies to all antiepileptic drugs used for any
indication.
Topamax Birth Defect Malformation
Lawsuits and Cleft Lips or Palate Lawsuits (Topiramate
Birth Defect
Lawsuits)
The epilepsy and migraine drug Topamax
has also been associated with an increased risk of birth
defects for children of mothers that were taking the drug
during pregnancy. Research studies have found that there are
higher than expected rates of babies born with cleft lips,
cleft palates, genital defects and other birth malformations
when Topamax is used by women during pregnancy. Thus
there is growing amounts of research that indicate that the
use of the epilepsy and migraine drug, Topamax, either on
its own or in combination with other epilepsy drugs, may
increase the risk of birth defects when it is used during
pregnancy.
Topamax and Topiramate FDA Approved Uses
Topamax (generic name: Topiramate) is an
anticonvulsant drug also referred to as an antiepileptic
drug (AED) that is
produced by Ortho-McNeil Neurologics and Noramco, Inc., both
divisions of Johnson & Johnson. Topamax was first approved by the Food
and Drug Administration in 1996 to treat epilepsy. In
2010, Topamax is approved for use by itself or
in combination with other meds to treat a variety of forms
of epilepsy as well as to treat migraines.
Off-Label Uses of Topamax and Topiramate
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.
Topamax is also being marketed for
several off-label uses. Some of the off-label uses of
Topamax include for treatment of bipolar disorder, cluster headaches,
eating disorders, obesity, fibromyalgia, depression,
posttraumatic stress disorder (PTSD), alcoholism, sleep disorders, sleep-eating disorders,
infantile spasms, autism, periventricular leukomalacia in
preterm infants after an hypoxic-ischemic injury, essential
tremor, bulimia nervosa, obsessive-compulsive disorder,
smoking cessation, idiopathic intracranial hypertension,
neuropathic pain, and cocaine dependence.
FDA Requires Warnings about Risk of Suicidal
Thoughts and Behavior for Antiepileptic Drugs AEDs
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)
Topamax Suicide Lawyers and
Topiramate Suicide Attorneys
Texas Dangerous Drug Attorney Jason
Coomer commonly works with other lawyers throughout Texas
and the United States including Texas Topamax Lawyers,
Houston Topiramate Lawyers, Boston Suicide Lawyers, San Antonio
Pharmaceutical Lawyers, Dallas Off-label Topamax 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 Topamax 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 Topamax or another Antiepileptic Drug
(AED) and have had suicidal
thoughts, or attempted suicide consult your doctor. If you
or a loved one has questions about a potential
antiepileptic drug (AED) or Topamax
Suicide or Attempted Suicide
Lawsuit, feel free to e-mail any questions you might have to
TopamaxLawyer@texaslawyers.com. |
