Zoloft: Dangerous in the UK & Canada, but not in the US

[Guest guest]

> JustSayNo

> Thu, 5 Aug 2004 23:27:07 -0400

> [sSRI-Research] Zoloft: Dangerous in the UK

> & Canada, but not in the US

>

>

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

>

> 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