Fwd: [drugawareness] FDA WARNING ISSUED: WORSENING DEPRESSION, SUICIDE, MANIA, ETC.

[Guest guest]

drugawareness

atracyphd2

Tue, 23 Mar 2004 02:00:57 EST

[drugawareness] FDA WARNING ISSUED: WORSENING DEPRESSION, SUICIDE,

MANIA, ETC.

 

 

 

This speaks for itself, which is good, because most all of us are tired of

doing interviews today! Hope you were able to hear and see all of the press

coverage.

 

It is still shocking that the warnings are going out to all patients, not

just children - something that should have happened LONG AGO.

 

PLEASE read the following warnings carefully and share them with others along

with info on how to withdraw safely.

 

 

Ann Blake Tracy, PhD

 

Executive Director, International Coalition For Drug Awareness

Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare

& audio tape or CD on safe withdrawal: " Help! I Can't Get

Off My Antidepressant! "

 

Order Number: 800-280-0730

Website: www.drugawareness.org

 

 

FDA: WARNING LABELS FOR 10 ANTIDEPRESSANTS: PROZAC, ZOLOFT, PAXIL, LUVOX,

CELEXA, LEXAPRO, WELLBUTRIN, EFFEXOR, SERZONE AND REMERON Â

 

Anxiety, agitation, panic attacks, insomnia, irritability, hostility,

impulsivity, akathisia (severe restlessness), hypomania, and mania have been

reported

in adult and pediatric patients being treated with antidepressants for major

depressive disorder as well as for other indications, both psychiatric and

nonpsychiatric. Although FDA has not concluded that these symptoms are a

precursor to either worsening of depression or the emergence of suicidal

impulses,

there is concern that patients who experience one or more of these symptoms may

be at increased risk for worsening depression or suicidality. Therefore,

therapy should be evaluated, and medications may need to be discontinued, when

symptoms are severe, abrupt in onset, or were not part of the patient’s

presenting

symptoms.

 

 

http://www.fda.gov/cder/drug/antidepressants/AntidepressanstPHA.htm

 

 

FDA Public Health Advisory

 

March 22, 2004

 

WORSENING DEPRESSION AND SUICIDALITY IN PATIENTS BEING TREATED WITH

ANTIDEPRESSANT MEDICATIONS

 

Today the Food and Drug Administration (FDA) asked manufacturers of the

following antidepressant drugs to include in their labeling a Warning statement

that recommends close observation of adult and pediatric patients treated with

these agents for worsening depression or the emergence of suicidality. The drugs

that are the focus of this new Warning are: Prozac (fluoxetine); Zoloft

(sertraline); Paxil (paroxetine); Luvox (fluvoxamine); Celexa (citalopram);

Lexapro

(escitalopram); Wellbutrin (bupropion); Effexor (venlafaxine); Serzone

(nefazodone); and Remeron (mirtazapine).

 

Warning Information

 

 

Health care providers should carefully monitor patients receiving

antidepressants for possible worsening of depression or suicidality, especially

at the

beginning of therapy or when the dose either increases or decreases. Although

FDA has not concluded that these drugs cause worsening depression or

suicidality, health care providers should be aware that worsening of symptoms

could be

due to the underlying disease or might be a result of drug therapy.

 

 

Heath care providers should carefully evaluate patients in whom depression

persistently worsens, or emergent suicidality is severe, abrupt in onset, or was

not part of the presenting symptoms, to determine what intervention,

including discontinuing or modifying the current drug therapy, is indicated.

 

 

Anxiety, agitation, panic attacks, insomnia, irritability, hostility,

impulsivity, akathisia (severe restlessness), hypomania, and mania have been

reported

in adult and pediatric patients being treated with antidepressants for major

depressive disorder as well as for other indications, both psychiatric and

nonpsychiatric. Although FDA has not concluded that these symptoms are a

precursor to either worsening of depression or the emergence of suicidal

impulses,

there is concern that patients who experience one or more of these symptoms may

be at increased risk for worsening depression or suicidality. Therefore,

therapy should be evaluated, and medications may need to be discontinued, when

symptoms are severe, abrupt in onset, or were not part of the patient’s

presenting

symptoms.

 

 

If a decision is made to discontinue treatment, certain of these medications

should be tapered rather than stopped abruptly (see labeling for individual

drug products for details).

 

 

Because antidepressants are believed to have the potential for inducing manic

episodes in patients with bipolar disorder, there is a concern about using

antidepressants alone in this population. Therefore, patients should be

adequately screened to determine if they are at risk for bipolar disorder before

initiating antidepressant treatment so that they can be appropriately monitored

during treatment. Such screening should include a detailed psychiatric history,

including a family history of suicide, bipolar disorder, and depression.

 

 

Health care providers should instruct patients, their families and their

caregivers to be alert for the emergence of agitation, irritability, and the

other

symptoms described above, as well as the emergence of suicidality and

worsening depression, and to report such symptoms immediately to their health

care

provider.

 

Background

 

Among antidepressants, only Prozac (fluoxetine) is approved for the treatment

of pediatric major depressive disorder. Prozac (fluoxetine), Zoloft

(sertraline), and Luvox (fluvoxamine) are approved for pediatric obsessive

compulsive

disorder. None of these drugs is approved as monotherapy for use in treating

bipolar depression, either in adults or children.

 

The requested labeling changes are consistent with recommendations made to

the Agency at a meeting of the Psychopharmacological Drugs Advisory Committee

(PDAC) and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory

Committee (Peds AC), held on February 2, 2004. The possibility of suicidality

associated with the use of antidepressant drug products in the pediatric

population

was also the subject of two previous FDA communications (FDA Talk Paper on

June 19, 2003, and FDA Public Health Advisory on October 27, 2003).

 

FDA is continuing to review available clinical trial data for pediatric

patients with depression and other psychiatric disorders to try to determine

whether there is evidence that some or all antidepressants increase the risk of

suicidality. Later this summer, the FDA plans to update the PDAC and Peds AC

about

the results of this review.

 

FDA plans to work closely with each of the nine manufacturers of the

antidepressants that are the subject of today’s request to continue

investigating how

to optimize the safe use of these drugs and implement the proposed labeling

changes and other safety communications in a timely manner.

 

Back to Top    Back to Antidepressant Info

 

Date created: March 22, 2004