Zoloft: Warning for risk of Selfharm

[Guest guest]

> JustSayNo

> Mon, 12 Jul 2004 23:44:20 -0400

> [sSRI-Research] Zoloft: Warning for risk

> of Selfharm

>

>

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/zoloft_hpc_e.pdf

>

> Health Canada Endorsed Important Safety Information

> on

> ZOLOFT (sertraline hydrochloride)

>

> May 26, 2004

>

> Stronger WARNING for SSRIs and other newer

> antidepressants

> regarding

> the potential for behavioural and emotional changes,

> including risk of

> selfharm

>

> Dear Healthcare Professional,

>

> Pfizer Canada Inc., following discussions with

> Health Canada, would like to

> inform you of

> important safety information regarding the

> possibility that SSRIs (selective

> serotonin reuptake

> inhibitors) and other newer antidepressants may be

> associated with

> behavioural and emotional

> changes, including risk of self-harm.

>

> The new Class warning incorporated in the Product

> Monograph of ZOLOFT*

> (sertraline

> hydrochloride) capsules is provided below.

>

> POTENTIAL ASSOCIATION WITH THE OCCURRENCE OF

> BEHAVIOURAL AND

> EMOTIONAL CHANGES, INCLUDING SELF-HARM.

>

> Pediatrics: Placebo-Controlled Clinical Trial Data

>

> . Recent analyses of placebo-controlled clinical

> trial safety databases from

> SSRIs and other newer antidepressants suggest that

> use of these drugs in

> patients under the age of 18 may be associated with

> behavioural and

> emotional

> changes, including an increased risk of suicidal

> ideation and behaviour over

> that of placebo.

>

> . The small denominators in the clinical trial

> database, as well as the

> variability in

> placebo rates, preclude reliable conclusions on the

> relative safety profiles

> among these drugs.

>

> Adult and Pediatrics: Additional data

>

> . There are clinical trial and post-marketing

> reports with SSRIs and other

> newer

> antidepressants, in both pediatrics and adults, of

> severe agitation-type

> adverse

> events coupled with self-harm or harm to others. The

> agitation-type events

> include: akathisia, agitation, disinhibition,

> emotional lability, hostility,

> aggression, depersonalization. In some cases, the

> events occurred within

> several weeks of starting treatment.

>

> Rigorous clinical monitoring for suicidal ideation

> or other indicators of

> potential for

> suicidal behavior is advised in patients of all

> ages. This includes

> monitoring for

> agitation-type emotional and behavioural changes.

>

> Discontinuation Symptoms [aka: WITHDRAWAL FROM

> ADDICTION]

>

> Patients currently taking sertraline hydrochloride

> should NOT be

> discontinued

> abruptly, due to risk of discontinuation symptoms.

> At the time that a

> medical decision

> is made to discontinue an SSRI or other newer

> antidepressant drug, a gradual

> reduction in the dose rather than an abrupt

> cessation is recommended.

>

> It should be noted that a causal role for SSRIs and

> other newer

> antidepressants in inducing

> self-harm or harm to others has not been

> established. The possibility of a

> suicide attempt is

> inherent in depression and other psychiatric

> disorders, and may persist

> until remission occurs.

> Therefore, high-risk patients should be closely

> supervised throughout

> therapy with appropriate

> consideration to the possible need for

> hospitalization. The updated warning

> informs

> practitioners that all patients being treated with

> SSRIs and other newer

> antidepressants should

> be rigorously monitored for clinical worsening, or

> onset/ worsening of

> agitation-type adverse

> events, or other indicators of potential for

> suicidal behaviour.

>

> Sertraline hydrochloride is not indicated for use in

> the pediatric

> population

>

> New Information Added to the Consumer Information

> Section

>

> The Consumer Information Section of the Product

> Monograph has been updated

> to reflect this new

> Class warning, and to advise patients that treatment

> with SSRIs and other

> newer antidepressants

> is most safe and effective when there is good

> communication with the

> treating physician about how

> the patient is feeling.

>

> Background

>

> In February 2004, a scientific advisory panel set up

> by Health Canada was

> asked to provide the

> clinical practice perspective on the pediatric

> clinical trial safety data,

> and the spontaneous postmarketing

> reports for SSRIs and other newer antidepressants.

> The panel agreed that a

> contraindication was not warranted for these

> medications, and supported

> Health Canada's

> recommendation for stronger warnings, while

> providing suggestions and

> comments. The record

> of proceedings, and other information about the

> panel, can be found on

> Health Canada's website

> at

>

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/sap_ssri_2004-02-20_rop_e.html.

> Pfizer Canada Inc. continues to work closely with

> Health Canada to monitor

> adverse event

> reporting and to ensure that up-to-date information

> regarding the use of

> ZOLOFT (sertraline

> hydrochloride) is available.

>

> The identification, characterization and management

> of drug-related adverse

> events are dependent

> on the active participation of healthcare

> professionals in adverse drug

> reaction reporting programs.

> Healthcare professionals are asked to report any

> suspected adverse reactions

> in patients receiving

> ZOLOFT (sertraline hydrochloride) directly to Pfizer

> Canada Inc. or Health

> Canada at the following

> addresses:

>

> Pfizer Canada Inc.

> Medical Information

> P.O. Box 800

> Pointe-Claire, Quebec

> H9R 4V2

> 1 800 463-6001

>

> Any suspected adverse reaction can also be reported

> to:

>

> Canadian Adverse Drug Reaction Monitoring Program

> (CADRMP)

> Marketed Health Products Directorate

> HEALTH CANADA

> Address Locator: 0701C

> OTTAWA, Ontario, K1A 0K9

>

> Tel: (613) 957-0337 or Fax: (613) 957-0335

> To report an Adverse Reaction, consum ers and health

> professionals may call

> toll free:

> Tel: 866 234-2345

> Fax: 866 678-6789

> cadrmp

>

> For other inquiries: please refer to contact

> information.

>

> The AR Reporting Form and the AR Guidelines can be

> found on the Health

> Canada web site or in The Canadian

> Compendium of Pharmaceuticals and Specialties.

>

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adverse_e.html

> http://www

> .hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adr_guideline_e.htm

> l

>

> Your professional commitment in this regard has an

> important role in

> protecting the well-being of

> your patients by contributing to early signal

> detection and informed drug

> use.

>

> Any questions from healthcare professionals may be

> directed to the Pfizer

> Medical Information

> Group at Tel: 1 800 463-6001.

>

> Sincerely,

>

> original signed by

> Bernard Prigent, M.D.

> Vice President & Medical Director

> Pfizer Canada Inc.

> *Trademark Pfizer Inc.

> Pfizer Canada Inc. Licensee

>