Reminder about antidepressants

August 20, 2004

I belong to a few groups for parents of kids with bipolar disorder. We have

noticed a LOT of parents of bipolar kids have RA, fibromyalgia, MS etc.

This report I am going to post is a serious thing to keep in mind. I suppose

prolly everyone here is aware of potential serious negative side effects from

meds.

FDA Public Health Advisory

March 22, 2004

Subject: 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.

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

August 20, 2004

One of the best articles I've read about this problem:

The Underlying Cause of Suicides and Homicides with SSRI Antidepressants:

Is It the Drugs, the Doctors, or the Drug Companies?

http://www.medicationsense.com/articles/april_june_04/underlying_cause.html

Educating ourselves is our best defense.

a

> I belong to a few groups for parents of kids with bipolar disorder. We have

> noticed a LOT of parents of bipolar kids have RA, fibromyalgia, MS etc.

> This report I am going to post is a serious thing to keep in mind. I suppose

> prolly everyone here is aware of potential serious negative side effects from

> meds.

> FDA Public Health Advisory

> March 22, 2004

> Subject: 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.

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

>

August 20, 2004