Suicide Risk Added To The Professional Product Labeling For Eight Antidepressants

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> SSRI-Research

> Thu, 19 Aug 2004 19:15:57 -0400

 

> [sSRI-Research] SUICIDE RISK ADDED TO THE

> PROFESSIONAL PRODUCT LABELING FOR EIGHT

> ANTIDEPRESSANTS

>

>

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

> {From Worst Pills, Best Pills, August 2004, Public

> Citizen Health

> Research Group, Sidney M. Wolfe M. D., Editor.

>

> SUICIDE RISK ADDED TO THE PROFESSIONAL PRODUCT

> LABELING FOR EIGHT

> ANTIDEPRESSANTS

>

> At the request of the Food and Drug Administration

> (FDA), eight of

> ten manufacturers of newer antidepressants have

> agreed to add a

> warning about the possibility of an increased risk

> of suicide

> associated with the use of these drugs. The warning

> will appear in

> the professional product labeling, or package

> insert, for these

> drugs.

>

> *************************************

> The package insert is written for pharmacists and

> physicians and is

> not routinely distributed to patients or their

> families unless

> requested, which we strongly urge you to do.

> *************************************

>

> The manufacturers who complied with the FDA's

> request and the

> antidepressants they produce are:

>

> Bristol-Meyers Squibb -- nefazodone (SERZONE)

>

> Forest -- citalopram (CELEXA); escitalopram

> (LEXAPRO)

>

> GlaxoSmithKline -- paroxetine (PAXIL); bupropion

> (WELLBUTRIN)

>

> Lilly -- fluoxetine (PROZAC)

>

> Organon -- mirtazipine (REMERON)

>

> Wyeth - venlaxefine (EFFEXOR)

>

> Pfizer, Inc. of New York, at the time this was

> written, was in

> negotiations with the FDA regarding the exact

> language that will be

> used for their antidepressant sertraline (ZOLOFT).

> Fluvoxamine

> (LUVOX), produced by Solvay, was withdrawn from the

> market in 2002

> and has not yet been re-approved by the FDA.

>

> Below is the text of the new warning now required in

> the professional

> product labeling for paroxetine (PAXIL). The

> wording in the new

> warning is similar for all of the antidepressants

> listed above.

>

> >> WARNINGS - Clinical Worsening and Suicide Risk

>

> >> Patients with major depressive disorder, both

> adult and pediatric, may

> >> experience worsening of their depression and/or

> the emergence of suicidal

> >> ideation and behavior (suicidality), whether or

> not they are taking

> >> antidepressant medications, and this risk may

> persist until significant

> >> remission occurs. Although there has been a

> long-standing concern that

> >> antidepressants may have a role in inducing

> worsening of depression and the

> >> emergence of suicidality in certain patients, a

> causal role for

> >> antidepressants in inducing such behaviors has

> not been established.

> >> Nevertheless, patients being treated with

> antidepressants should be observed

> >> closely for clinical worsening and suicidality,

> especially at the beginning

> >> of a course of drug therapy, or at the time of

> dose changes, either increases

> >> or decreases. Consideration should be given to

> changing the therapeutic

> >> regimen, including possibly discontinuing the

> medication, in patients whose

> >> depression is persistently worse or whose

> emergent suicidality is severe,

> >> abrupt in onset, or was not part of the patient's

> presenting symptoms.

> >>

> >> Because of the possibility of comorbidity between

> major depressive disorder

> >> and other psychiatric and nonpsychiatric

> disorders, the same precautions

> >> observed when treating patients with major

> depressive disorder should be

> >> observed when treating patients with other

> psychiatric and nonpsychiatric

> >> disorders.

> >>

> >> The following symptoms, anxiety, agitation, panic

> attacks, insomnia,

> >> irritability, hostility (aggressiveness),

> impulsivity, akathisia (psychomotor

> >> restlessness), hypomania, and mania, have been

> reported in adult and

> >> pediatric patients being treated with

> antidepressants for major depressive

> >> disorders well as for other indications, both

> psychiatric and

> >> nonpsychiatric. Although a causal link between

> the emergence of such

> >> symptoms and either the worsening of depression

> and/or the emergence of

> >> of suicidal impulses has not been established,

> consideration should be given

> >> to changing he therapeutic regimen, including

> possibly discontinuing the

> >> medication, in patients for whom such symptoms

> are severe, abrupt in onset,

> >> or were not part of the patient's presenting

> symptoms.

> >>

> >> Families and caregivers of patients being treated

> with antidepressants for

> >> major depressive disorder or other indications,

> both psychiatric and

> >> nonpsychiatric, should be alerted about the need

> to monitor patients for the

> >> emergence of agitation, irritability, and the

> other symptoms described above,

> >> as well as the emergence of suicidality, and to

> report such symptoms

> >> immediately to health care providers.

> Prescriptions for PAXIL should be

> >> written for the smallest quantity of capsules

> consistent with good patient

> >> management, in order to reduce the risk of

> overdose.

>

> In the group of antidepressants known as selective

> serotonin reuptake

> inhibitors (SSRIs) there is a recommendation in

> their package inserts

> on how to taper the dose to avoid a withdrawal

> reaction if the

> decision is made to stop one of these drugs. The

> SSRIs, in addition

> to paroxetine, include citalopram, escitalopram, and

> fluoxetine. The

> withdrawal symptoms from these drugs generally start

> within one to

> three days after stopping the drug, and generally

> resolve within one

> to two weeks after the drug has been discontinued.

> Withdrawal

> symptoms may occur even when the dosage of the drug

> is gradually

> decreased. The main symptoms of this reaction are:

> dizziness,

> vertigo, uncoordination, nausea and vomiting, and

> flu-like symptoms

> that include fatigue, lethargy, muscle pain, and

> chills.

>