Re: Reminder about antidepressants I agree

August 20, 2004

I agree and I did post that article at the other groups I go to.....THANKS.

Knowledge is power.

- In , a54 <a54@s...> wrote:

> 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