Ross
Well-known member
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA and GlaxoSmithKline notified healthcare professionals of revisions to
the WARNINGS and PRECAUTIONS sections of Paxil (paroxetine hydrochloride)
labeling to alert healthcare professionals that 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.
The warning recommends patients being treated with antidepressants 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.
Read the MedWatch 2004 safey summary, including links to the "Dear
Healthcare Professional" letter and revised label, at:
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#paxil
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FDA and GlaxoSmithKline notified healthcare professionals of revisions to
the WARNINGS and PRECAUTIONS sections of Paxil (paroxetine hydrochloride)
labeling to alert healthcare professionals that 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.
The warning recommends patients being treated with antidepressants 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.
Read the MedWatch 2004 safey summary, including links to the "Dear
Healthcare Professional" letter and revised label, at:
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#paxil
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