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Topamax Birth Defect Lawyer, Topiramate Birth Defect Lawyer,
Topamax Heart Defect Lawyer, Topamax Cleft Palate Lawyer,
Topamax Cleft Lip Lawyer, and Antiepileptic Drug (APD) Birth
Defect
Lawyer
(Topamax and Topiramate Birth Defect
Lawsuits)
The
FDA has recently announced that Topiramate
(brand name Topamax) causes an increased risk
of development of cleft lip and/or cleft palate (oral
clefts) in infants born to women treated with Topamax (topiramate)
during pregnancy. If you or a loved one have been 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 Birth Defect Lawyer
Jason Coomer with your name & contact information.
or to
submit an
inquiry through this submission form.
Topamax Birth Defect Lawyer, Topiramate Birth Defect Lawyer,
Topamax Heart Defect Lawyer, Topamax Cleft Palate Lawyer,
Topamax Cleft Lip Lawyer, and Antiepileptic Drug (APD) Birth
Defect
Lawyer
(Topamax and Topiramate Birth Defect
Lawsuits)
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. If you or a loved one have been taking
Topamax during pregnancy and had a child with a birth
defect, it is important to seek medical assistance.
The FDA recommends that "before starting
topiramate, pregnant women and women of childbearing
potential should discuss other treatment options with their
health care professional. Women taking topiramate should
tell their health care professional immediately if they are
planning to or become pregnant. Patients taking topiramate
should not stop taking it unless told to do so by their
health care professional. Women who become pregnant while
taking topiramate should talk to their health care
professional about registering with the North American
Antiepileptic Drug Pregnancy Registry, a group that collects
information about outcomes in infants born to women treated
with antiepileptic drugs during pregnancy."
Topamax Birth Defect Malformation
Lawsuits and Cleft Lips or Palate Lawsuits (Topiramate
Birth Defect
Lawsuits)
The epilepsy and migraine drug Topamax
has 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 a growing amount of research that indicates 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.
In February 2011, U.S. Health Officials
announced that Topamax increases the risk for birth defects
in babies born to pregnant mothers taking the medication.
The Food and Drug Administration said new data shows the
drug, sold generically and as Johnson & Johnson's Topamax,
can cause cleft lips and cleft palate deformities.
Drug Birth Defect Lawyer, Infant Malformation Lawyer, Cleft
Palate Lawyer, Infant Heart Defect Lawyer, Texas Birth
Defect Lawyer, Texas Cleft Lip Birth Defect Lawyer, Heart
Defect Lawyer, Drug Pregnancy Lawyer, Infant Disability
Lawyer, and Paxil Birth Defect
Lawyer
Avoidable birth defects are one of the
most devastating problems that can occur to a family and a
new baby. Parents who should be celebrating the birth
of a new child, are often caught off guard when their child
is born with severe disabilities and often do not
realize that someone may be responsible for the birth defect including drug manufacturers that hid information
about medications that can cause birth defects. The
family is typically busy taking care of the child with the
serious health problems and often does not know that the
birth defect was preventable. When they discover the
probable cause of the preventable birth defect they are
often filled with anger and rage. To find out that
their child will have permanent health problems or that they
lost their baby because a drug company hid research and did
not provide an adequate warning of a product's safety can be
extremely difficult.
Several
medications, products, and drugs have been linked to birth
defects. Some of these medications were intentionally
marketed by drug
manufacturers that have hidden the real dangers of their product
in order to sell more of their product and that value profits
over healthy babies. For these manufacturers, they may
have short term profits, but over the long term they should
suffer for the long term birth defects that they have
caused.
Federal and Texas Birth Defect Lawyers, Drug Birth Defect Lawyer,
Infant Heart Birth Defect Lawyer, Spina Bifida Lawyer, and
Infant Malformation & Deformity Lawyer
Federal and Texas Birth Defect Lawsuits are
some of the most complicated types of cases in the practice
of law. As a Texas birth defect and birth injury lawyer that handles
birth defect, infant death and stillborn baby claims, Jason
S. Coomer works with
other Birth Defect Lawyers throughout the United States including Boston
Birth Defect Lawyers, Illinois Birth Defect Lawyers,
Atlanta Birth Defect Lawyers, Virginia Birth Defect Lawyers,
Dallas Birth Defect Lawyers, Houston Birth Defect
Lawyers, and other Birth Defect Lawyers. In working with other birth defect lawyers,
we seek compensation from negligent drug companies, medical
providers, and other
companies that
have severely injured or killed infants or mothers through
selling and using dangerous products, medications, and drugs that they
should have know were dangerous, but hid significant
research in order to sell more product to make a profit. If you have suffered the loss of your
baby or your baby has been born with a significant birth
defect, feel free to
contact Texas
Birth Defect Attorney, Jason S. Coomer.
Paroxetine, Seroxat, and Paxil
Selective Serotonin Reuptake Inhibitor Antidepressants (SSRIs)
PPHN
Birth Defect Lawsuits
Paroxetine (trade names Seroxat, Paxil)
is a selective serotonin reuptake inhibitor (SSRI)
antidepressant that has been linked to
birth defects including Persistent Pulmonary
Hypertension (PPHN), heart, lung, abdominal and cranial
defects. Women that
have taken Selective Serotonin Reuptake Inhibitor
Antidepressants (SSRIs)
after the 20th week of pregnancy have a 6-fold
increased risk of having their child develop persistent pulmonary
hypertension, a life-threatening lung disorder.
Infants with persistent pulmonary hypertension have
abnormal blood flow through the heart and lungs and do not
get enough oxygen to their bodies and may become very sick
or die.
The SSRIs antidepressants that have been
linked to persistent pulmonary hypertension (PPHN) include
Paxil by GlaxoSmithKline, Zoloft marketed by Pfizer; Prozac
sold by Eli Lilly; Celexa and Lexapro by Forest
Laboratories, Effexor marketed by Wyeth, Luvox by Solvay,
and the generic makers of these drugs include Barr
Pharmaceuticals, Ranbaxy Labs and Genpharm.
Infants born with PPHN often require
mechanical assistance to breath and even worse about 10% to
20% of the infants do not survive even when they receive
treatment. The PPHN babies that do survive often experience
developmental delays, brain abnormalities and hearing loss,
experts say.
Other birth defects that have been
associated with SSRIs include Anencephaly, a neural tube
defect where much of the brain does not develop;
Craniosynostosis, an abnormality in which connections of the
skull bones close prematurely; and Heart birth defects
including septal defects and ventricular defects.
SSRIs have not only been associated to
birth defects, but have been associated with increased risk
of suicide. For more information on suicide claims
from antidepressants, please see our
antidepressant
suicide claim information page.
Depakote Birth Defect Lawsuit Information, Valproate Birth
Defect Lawsuit Information, Spina Bifida Lawsuit Information &
Defective Drug Birth Defect Lawsuit Information by
Depakote Birth Defect Lawyer, Texas Birth Defect Lawyer, & Depakote Spina Bifida Lawyer
Jason Coomer
Depakote also known as Valproate
semisodium (INN), Depakote ER, Depakene, Depacon, Epival,
Dépakine Chrono,Valance, and divalproex sodium (USAN) is a
drug prescribed to treat seizures, migraine headaches, and
some psychiatric disorders. In the UK, Canada, and
U.S., the drugs are used for the treatment of the manic
episodes of bipolar disorder, major depressive disorder,
prevention of both manic and depressive phases of bipolar
disorder, epilepsy, chronic pain associated with neuropathy,
and migraine headaches. Off-label use of the drug include
treatment of mild depression, the depressive stage of
bi-polar disorder, and chronic pain such as migraine
headaches.
Depakote has been linked to major birth
defects in children of women that were taking this drug.
According to a recent medical scientific study, women taking
Depakote had four times the risk of delivering a child with
major birth defects, compared to women taking other, similar
drugs. The range of birth defects associated with
Depakote is broad, however the report specifically cited
neural tube defects such as spina bifida. Neural tube
defects are birth defects that affect the brain and spinal
cord; spinal bifida is a defect affecting the spinal cord
that causes paralysis of the legs.There is no known cure.
In addition to spina bifida, other birth
defects caused by Depakote include cleft palate, cleft lip,
heart defects, limb and digital deformities, facial
dysmorphism, mental developmental delays, and (difficult)
genitourinary maloformations.
If you believe that your child has
suffered a birth defect or birth injury as a result of a
defective drug, medication, or product,
contact
Depakote Birth Defect Lawyer Jason Coomer
for a free review of your Depakote Birth
Injury Lawsuit or Depakotel Birth Defect Lawsuit or
use our online submission form.
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)
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 Lawyer, Topamax
Cleft Palate Lawyer, Topamax Cleft Lip Lawyer, Topamax Hear
Defect Lawyer, Topiramate Cleft Palate Lawyer, and Topiramate
Birth Defect Lawyer
Texas Birth Defect Attorney Jason
Coomer commonly works with other lawyers throughout Texas
and the United States including Texas Topamax Birth Defect Lawyers,
Houston Topiramate Birth Defect Lawyers, Boston Topamax
Birth Defect Lawyers, San Antonio
Birth Defect Lawyers, Dallas Off-label Topamax Infant Heart
Problem Lawyers,
and other Austin Dangerous Drug Infant Birth Defect 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 Birth Defect Lawyer Jason Coomer
works on catastrophic injury and death cases including
defective drug mediation
lawsuits. If you or a loved one were
given Topamax or another Antiepileptic Drug
(AED) during pregnancy and have had a child
with a birth defect, please feel free to e-mail any questions you might have to
TopamaxBirthDefectLawyer@texaslawyers.com. |
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