Paxil CR™ product monograph Canada - BEHAVIOURAL AND EMOTIONAL CHANGES / Suicidality

POTENTIAL ASSOCIATION WITH BEHAVIOURAL AND EMOTIONAL

CHANGES, INCLUDING SELF-HARM.

http://www.gsk.ca/english/docs-pdf/Paxil_CR_2010.pdf



Pediatrics: Placebo-Controlled Clinical Trial Data

• Recent analyses of placebo-controlled clinical trial safety databases from
SSRIs and other newer anti-depressants suggests 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 anti-depressants, in both pediatrics and adults, of severe agitationtype
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 behaviour is advised in patients of all ages. This includes monitoring for
agitation-type emotional and behavioural changes.