Posted by: "atracyphd2@aol.com" atracyphd2@aol.com
Fri Feb 1, 2008 10:05 pm (PST)
The FDA has wasted no time in issuing the first warning they mentioned justlast week would be coming soon. What should be shocking to all who have taken
SSRIs is what the FDA is now warning of - which is that the drugs they gave
everyone after reacting negatively to an SSRI, the anti-epileptic drugs, are
just as deadly when it comes to suicide as an antidepressant. According to
the FDA data they too produce DOUBLE THE RATE OF SUICIDE for those who take
them. Interestingly they noted that those taking the drugs for seizures had a
higher rate of suicide than those taking them for psychiatric disorders, thus
negating the theory that the suicide is a result of the mental illness rather
than the medication.
"The agency also said patients currently on the drugs or starting treatment
with the drugs "should be closely monitored for notable changes in behavior
that could indicate the emergence or worsening of suicidal thoughts or
behavior or depression."
Apparently warnings will also be placed on the product labels since the FDA
said it would be working with manufacturers of the anti-epileptic drugs to
include the new information in product labeling. Hopefully that does not mean
that those warnings will be buried deep in that long paper strip - about a
long as a toilet paper roll with print so small that you need a magnifying glass
to read it. You know, that package insert that is suppose to come with the
medication - the one you have to beg to get because they apparently hate
giving them to you. That is why they give you that short version with nothing on
it which is only one page in larger print. Why that is not considered "failure
to warn," I don't know what is!
The FDA also said it planned to discuss the data at an upcoming advisory
committee meeting. Hopefully that will be open for a public hearing and we will
keep you informed as to when and where that will be for those of you who want
to testify.
Now, if you have been given a diagnosis of Bipolar Disorder after starting
on an antidepressant, you need to learn the truth about what really happened
to you. For that we suggest you get our new DVD, "Bipolar Schmypolar: Are You
Really Bipolar or Misdiagnosed Due to the Use and/or Abrupt Withdrawal of an
Antidepressant?"
Since the introduction of the SSRI antidepressants Bipolar rates have
skyrocketed with over a recent ten year period an increase of 4000% was reported.
But learn in this DVD that mania or bipolar has to do with continuous mild
seizure activity - which is why they give anti-epileptic drugs for it. But you
need to know that this seizure activity is chemically induced and will subside
minus the offending chemical. In other words it is caused by your stimulant
medication - your ANTI-depressant.
So, in light of this new warning I am going to offer a special on that DVD.
The DVD itself normally sells for $17.95, but starting tomorrow February 3 at
noon Pacific Time continuing through the next 7 days we will offer a special
price of only $12.95 when you buy this DVD.
Learn the real truth about Bipolar Disorder and learn how many who thought
they had it are now drug free, symptom free and healthy again. For an
introduction to this concept go to the following link:
_http://www.drugawareness.org/Ribbon/Alternatives.html_
(http://www.drugawareness.org/Ribbon/Alternatives.html)
Next scroll down and read two personal accounts, one by Leslie Judd, who is
now normal and healthy again after spending 10 years on these drugs and
accumulating a lot list of disease labels. Then read Merrill Osmond's story. Yes,
that is one of Donnie and Marie Osmond's older brothers. When I first met
Merrill he had been on Lithium for a total of 20 years with antidepressants
added later on. Today Merrill is drug free and his story about how he got there
on our website for you to read.
WARNING: WHATEVER YOU DO, DO NOT ABRUPTLY DISCONTINUE YOUR MEDICATION!!! The
warning about abrupt change in dose should also be issued, and likely will
be, to these anti-epileptic medications and anti-psychotic medications as well
as the SSRI and SNRI antidepressant medications.
I want everyone reading this to clearly understand that the withdrawal
information and information on rebuilding one's health contained in my CD or tape
"Help! I Can't Get Off My Antidepressant!" applies to all these
anti-epileptic drugs and all the atypical anti-psychotic drugs as well. For a long time I
have said that I need to change the name to reflect that fact. I have seen
this process used successfully for all of these drugs for many years now. You
can even download it right from our site at _www.drugawareness.org_
(http://www.drugawareness.org) and not have to wait for it to come in the mail. The
cost is nominal when you consider the high cost that can result in withdrawing
incorrectly from these meds - possible hospitalization, incarceration, or
death to name a few. One of my neighbors became a Scotish Crown Prince for six
months when he tried an abrupt withdrawal - what a trip that was! These drugs
are NOT forgiving if you go about withdrawing too rapidly! As the FDA has
now warned EXTREME CAUTION must be exercised in making any changes in dose.
Physicians still remain almost completely ignorant of this and must be
warned. If yours has not, you warn him. Take him a CD or tape on withdrawal so he
knows how this is done safely. Make sure he is familiar with the withdrawal
of these medications. I am sick and tired of having to help people in serious
trouble because their doctors have taken them off any of these meds too
quickly! Even worse they refuse to have any more to do with their patient
(including prescribing the drug as they continue the gradual withdrawal process)
because they are offended that the patient wants off the drug and they do not
want to be forced to deal with the withdrawal from the addictive drug they gave
the patient to begin with! That is a practice that is far too common and
completely inexcusable!
Ann Blake Tracy, Ph.D., Executive Director,
International Coalition For Drug Awareness
Website: _www.drugawareness.org_ (http://www.drugawareness.org/) &
_www.ssristories.com_ (http://www.ssristories.com)
Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare
& CD or audio tape on safe withdrawal: "Help! I Can't Get
Off My Antidepressant!"
Order Number: 800-280-0730
_______________________
Paragraph 7 reads: "The FDA said four patients who were taking one of the
antiepileptic drugs committed suicide compared to none of the patients in the
placebo group."
_http://money.cnn.com/news/newsfeeds/articles/djf500/200801311523DOWJONESDJONL
INE001003_FORTUNE5.htm
_
(http://money.cnn.com/news/newsfeeds/articles/djf500/200801311523DOWJONESDJONLINE001003_FORTUNE5.htm) Epilepsy Drugs
(http://www.dj.com/) (http://www.dj.com/) (http://www.dj.com/)
January 31, 2008: 03:23 PM EST
(Updates throughout with details on specific drugs.)
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration warned
patients and health-care professionals Thursday about an increased risk of suicidal
thoughts and behaviors associated with 11 drugs used to treat epilepsy and
certain pyschiatric disorders.
The FDA said, in an alert posted to its Website, that it looked at nearly
200 clinical studies involving the 11 drugs and found a doubling of the risk of
suicidal thinking or behavior. The drugs include Topamax by Johnson &
Johnson ( JNJ), Lamictal by GlaxoSmithKline PLC (GSK), Pfizer Inc.'s (PFE) Lyrica,
and Novartis AG's (NVS) Tegretol and Trileptal. Topamax is also approved to
treat migraine while Lyrica is approved to treat certain pain conditions from
diabetes, shingles and fibromyalgia. The four companies either could not
immediately comment on the FDA's alert or didn't immediately return requests for
comment.
The FDA said patients receiving any of the 11 drugs had approximately twice
the risk of suicidal behavior or ideation, or 0.43%, compared to 0.22% of
patients receiving placebo in studies involving about 44,000 patients. The
agency said increased risk was observed as early as one week after starting an
anti-epileptic drug and continued through 24 weeks.
The agency also said patients currently on the drugs or starting treatment
with the drugs "should be closely monitored for notable changes in behavior
that could indicate the emergence or worsening of suicidal thoughts or behavior
or depression."
The FDA said it would be working with manufacturers of the antiepileptic
drugs to include the new information in product labeling. The FDA also said it
planned to discuss the data at an upcoming advisory committee meeting.
The review looked at reports of suicidal behavior, which includes completed
suicides, suicide attempts and preparatory acts and suicidal ideation or
thinking about suicide that were seen in clinical studies of the drugs. The
analysis included a total of 43,892 patients ages five and older with 27,863 in
drug treatment groups and 16,029 in placebo groups or groups receiving fake
drugs.
The FDA said four patients who were taking one of the antiepileptic drugs
committed suicide compared to none of the patients in the placebo group.
The FDA said because most trials included in the analysis did not extend
beyond 24 weeks, the risk of suicidal thoughts or behavior that point could not
be reliably assessed.
The review of suicidality data was similar to an earlier analysis of
antidepressants, which resulted in the FDA's toughest black-box warning being placed
on those drugs in 2004 to warn about the risks of suidical behaviors and
thoughts.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
_jennifer.corbett@dowjones.com_ (mailto:jennifer.corbett@dowjones.com)
(END) Dow Jones Newswires
01-31-08 1523ET
Copyright (c) 2008 Dow Jones & Company, Inc.
________________________________________________
_http://www.fda.gov/CDER/drug/infopage/antiepileptics/default.htm
_ (http://www.fda.gov/CDER/drug/infopage/antiepileptics/default.htm)
(http://www.fda.gov/cder) (http://www.fda.gov/cder)
(http://www.fda.gov/cder) (http://www.fda.gov/cder/about/default.htm)
(http://www.fda.gov/cder/about/default.htm) (http://www.fda.gov/cder/drug/default.htm)
(http://www.fda.gov/cder/drug/default.htm)
(http://www.fda.gov/cder/regulatory/default.htm) (http://www.fda.gov/cder/regulatory/default.htm)
(http://www.fda.gov/cder/calendar/default.htm) (http://www.fda.gov/cder/calendar/default.htm)
(http://www.fda.gov/cder/audiences/default.htm)
(http://www.fda.gov/cder/audiences/default.htm) (http://www.fda.gov/cder/archives/default.htm)
(http://www.fda.gov/cder/archives/default.htm)
(http://www.fda.gov/cder/archives/default.htm) Suicidality and Antiepileptic
Drugs
FDA ALERT [1/31/2008] - The FDA has analyzed reports of suicidality
(suicidal behavior or ideation) from placebo-controlled clinical studies of eleven
drugs used to treat epilepsy as well as psychiatric disorders, and other
conditions. These drugs are commonly referred to as antiepileptic drugs (see the
list below). In the FDA’s analysis, patients receiving antiepileptic drugs had
approximately twice the risk of suicidal behavior or ideation (0.43%) compared
to patients receiving placebo (0.22%). The increased risk of suicidal behavior
and suicidal ideation was observed as early as one week after starting the
antiepileptic drug and continued through 24 weeks. The results were generally
consistent among the eleven drugs. Patients who were treated for epilepsy,
psychiatric disorders, and other conditions were all at increased risk for
suicidality when compared to placebo, and there did not appear to be a specific
demographic subgroup of patients to which the increased risk could be attributed.
The relative risk for suicidality was higher in the patients with epilepsy
compared to patients who were given one of the drugs in the class for psychiatric
or other conditions.
All patients who are currently taking or starting on any antiepileptic drug
should be closely monitored for notable changes in behavior that could indicate
the emergence or worsening of suicidal thoughts or behavior or depression.
This information reflects FDA’s current analysis of available data concerning
these drugs. Posting this information does not mean that FDA has concluded
there is a causal relationship between the drug products and the emerging safety
issue. Nor does it mean that FDA is advising health care professionals to
discontinue prescribing these products. FDA intends to update this document when
additional information or analyses become available.
* Healthcare Professional Information
* _Information for Healthcare Professionals_
(http://www.fda.gov/CDER/drug/InfoSheets/HCP/antiepilepticsHCP.htm)
The following is a list of antiepileptic drugs* included in the analyses:
Labeling and approval history from Drugs@FDA.
* _Carbamazepine_
(http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=carbamazepine&SearchType=
BasicSearch) (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
* Felbamate (marketed as Felbatol)
* _Gabapentin_
(http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=020235&SearchType=BasicSearc
h) (marketed as Neurontin)
* _Lamotrigine_
(http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=020241&SearchType=BasicSear
ch) (marketed as Lamictal)
* _Levetiracetam_
(http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=021035&SearchType=BasicSe
arch) (marketed as Keppra)
* _Patient Information Sheet_
(http://www.fda.gov/CDER/drug/InfoSheets/patient/levetiracetamPIS.htm)
* _Oxcarbazepine_
(http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=021014&SearchType=BasicSe
arch) (marketed as Trileptal)
* _Pregabalin_
(http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=021446&SearchType=BasicSearc
h) (marketed as Lyrica)
* _Tiagabine_
(http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=gabitril&SearchType=BasicSear
ch) (marketed as Gabitril)
* _Topiramate_
(http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=020505&SearchType=BasicSearc
h) (marketed as Topamax)
* _Valproate_
(http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=valproate&SearchType=BasicSea
rch) (marketed as Depakote, Depakote ER, Depakene, Depacon)
* _Zonisamide_
(http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=zonegran&SearchType=BasicSea
rch) (marketed as Zonegran)
* Some of these drugs are also available in generic form.
_Back to Top_ (mip://060e1998/default.html#top) _Back to Drug
Information_ (http://www.fda.gov/CDER/drug/DrugSafety/DrugIndex.htm)
PDF requires the free _Adobe Acrobat Reader_
(http://www.fda.gov/cder/pdf.htm)
Date created: January 31, 2008
