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OSTRZEZENIE FDA - GWOZDZ DO TRUMNY!

IP: *.west.biz.rr.com 16.10.04, 21:44
Zamiast wycofac z rynku bardzo grozne leki, aby firmy farmaceutyczne i
ichn inwestorzy robili pieniadze, FDA wydalo "BLACK BOX" ostrzezenie
odnosnie lekow powodujacych samobojstwa:

To ostrzezenie oznacza ze NIE WOLNO DAWAC OGLOSZEN na te leki i
LEKARZE MAJA NATYCHMIAT wycofac ze swoich biur wszystkie pamflety
reklamujace te "GWOZDIE DO TRUMNY"!

Jest to jedyne tego typu ostrzezenie wydane przez FDA od bardzo dawnego
czasu!
DOTYCZY ono WSZYSTKICH SSRI trucizn przepisywanych przez bandytow
udajacych psychiatrow i rownierz sprzedawanych w aptekach.

www.fda.gov/bbs/topics/news/2004/NEW01124.html

www.fda.gov/cder/drug/antidepressants/SSRIlabelChange.htm

www.fda.gov/cder/drug/antidepressants/default.htm

Anafranil (clomipramine HCl)

Aventyl (nortriptyline HCl)

Celexa (citalopram HBr)

Cymbalta (duloxetine HCl)

Desyrel (trazodone HCl)

Effexor (venlafaxine HCl)

Elavil (amitriptyline HCl)

Lexapro (escitalopram oxalate)

Limbitrol (chlordiazepoxide/amitriptyline)

Ludiomil (Maprotiline HCl)

Luvox (fluvoxamine maleate)

Marplan (isocarboxazid)

Nardil (phenelzine sulfate)

Norpramin (desipramine HCl)

Pamelor (nortriptyline HCl)

Parnate (tranylcypromine sulfate)

Paxil (paroxetine HCl)

Pexeva (paroxetine mesylate)

Prozac (fluoxetine HCl)

Remeron (mirtazapine)

Sarafem (fluoxetine HCl)

Serzone (nefazodone HCl)

Sinequan (doxepin HCl)

Surmontil (trimipramine)

Symbyax (olanzapine/fluoxetine)

Tofranil (imipramine HCl)

Tofranil-PM (impiramine pamoate)

Triavil (Perphenaine/Amitriptyline)

Vivactil (protriptyline HCl)

Wellbutrin (bupropion HCl)

Zoloft (sertraline HCl)

Zyban (bupropion HCl)


FDA News
FOR IMMEDIATE RELEASE
P04-97
October 15, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA



FDA Launches a Multi-Pronged Strategy to Strengthen Safeguards for Children
Treated With Antidepressant Medications
The Food and Drug Administration (FDA) today issued a Public Health Advisory
announcing a multi-pronged strategy to warn the public about the increased
risk of suicidal thoughts and behavior ("suicidality") in children and
adolescents being treated with antidepressant medications.

The agency is directing manufacturers to add a "black box" warning to the
health professional labeling of all antidepressant medications to describe
this risk and emphasize the need for close monitoring of patients started on
these medications. FDA has also determined that a Patient Medication Guide
(MedGuide), which will be given to patients receiving the drugs to advise
them of the risk and precautions that can be taken, is appropriate, and is in
the process of developing one.

"Today's actions represent FDA's conclusions about the increased risk of
suicidal thoughts and the necessary actions for physicians prescribing these
antidepressant drugs and for the children and adolescents taking them. Our
conclusions are based on the latest and best science. They reflect what we
heard from our advisory committee last month, as well as what many members of
the public have told us," said Dr. Lester M. Crawford, Acting FDA
Commissioner.

In letters issued today, FDA directed the manufacturers of all antidepressant
medications to add a "black box" warning that describes the increased risk of
suicidality in children and adolescents given antidepressant medications and
notes what uses the drugs have been approved or not approved for in these
patients. FDA's letters to the manufacturers also discuss other labeling
changes designed to include additional information about pediatric studies of
these drugs. These labeling changes are applicable to the entire category of
antidepressant medications because the currently available data are not
adequate to exclude any single medication from the increased risk of
suicidality.

Prozac is currently the only medication approved to treat depression in
children and adolescents. The analyses of the placebo controlled trials in
children and adolescents summarized in the revised labeling are based on
studies of five selective serotonin reuptake inhibitors (SSRIs) (Celexa,
Prozac, Luvox, Paxil and Zoloft) and four "atypical" antidepressants
(Wellbutrin, Remeron, Serzone and Effexor XR). In these studies, there was no
reported case of a suicide.

A "black box" warning is the most serious warning placed in the labeling of a
prescription medication. Advertisements that serve to remind health care
professionals of a product's availability (so-called "reminder ads") are not
allowed for products with "black box" warnings. Until now, only ten drug
products approved for children contained a black box warning about their use
in children. The new warning language does not prohibit the use of
antidepressants in children and adolescents. Rather, it warns of the risk of
suicidality and encourages prescribers to balance this risk with clinical
need.

FDA recognizes that depression and other psychiatric disorders in pediatric
patients can have significant consequences if not appropriately treated. The
new warning language recognizes this need but advises close monitoring of
patients as a way of managing the risk of suicidality.

The second element of the agency's strategy is a Patient Medication Guide
(MedGuide), FDA-approved user-friendly information for patients. MedGuides
are intended to be distributed by the pharmacist with each prescription or
refill of a medication. FDA will work with the manufacturers of
antidepressant medications to make the MedGuides available as soon as
possible.

In addition, FDA intends to work with manufacturers to implement "Unit of
Use" packaging for all antidepressants as a means of ensuring that patients
receive a MedGuide with every prescription or refill. "Unit of use" packaging
is a method of preparing a medication in an original container, sealed and
pre-labeled by the manufacturer, and containing sufficient medication for one
normal course of therapy.

Today's actions are consistent with the recommendations made at the September
2004 joint meeting of the FDA's Psychopharmacologic Drugs Advisory Committee
and Pediatric Drugs Advisory Committee.
Obserwuj wątek
    • Gość: ex-pacjent Domorosły psychiatro!!! IP: *.neoplus.adsl.tpnet.pl 17.10.04, 01:23
      A czym chcecie leczyć depresję? Zimnymi okładami?
      To ostrzeżenie dotyczy TYLKO dzieci .
      G... wiesz o depresji!!! Pewnie nigdy jej nie doświadczyłeś. Ja cierpiałem na
      depresję przez kilka lat (z przerwami). Zażywałem przez te lata polskie
      odpowiedniki zarówno Prozacu, jak i Effectoru i podczas kuracji ani przez
      moment nie miałem myśli samobójczych, ani też żadnych innych skutków ubocznych.
      To dzięki tym lekom w końcu wydobyłem się z nawracających epizodów depresyjnych
      i od 2 lat jestem w końcu zdrowy. Jestem wdzięczny lekarzom, którzy nie
      zlekceważyli mojej choroby i, mimo moich wątpliwości, przepisywali mi leki
      antydepresyjne.

    • Gość: synergy Re: OSTRZEZENIE FDA - GWOZDZ DO TRUMNY! IP: *.west.biz.rr.com 18.10.04, 04:00
      All antidepressants should carry a "black box" warning on the label saying that
      the pills can cause suicidal behavior in children, FDA scientific advisers told
      the Food and Drug Administration.


      "In a sharp departure from a decade-old position, FDA officials said the
      increase in suicidal tendencies was not a result of the children's underlying
      depression but was caused by the medications themselves."

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