Sociology > Depression > FDA MedWatch: Wellbutrin & Paxil warnings added concerning emergence of suicidal ideation & behavior
| Topic: |
Sociology > Depression |
| User: |
"" |
| Date: |
23 Jun 2004 06:53:26 AM |
| Object: |
FDA MedWatch: Wellbutrin & Paxil warnings added concerning emergence of suicidal ideation & behavior |
Hi,
I just received the following email from FDA MedWatch and thought I
would pass it along:
MedWatch- The FDA Safety Information and Adverse Event Reporting Program
FDA and GlazoSmithKline notified healthcare professionals of revisions
to the WARNINGS and PRECAUTIONS sections of Wellbutrin (bupropion
hydrochloride) & 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 anitdepressants be observed
closely for clinical worsening and suicidaltiy, 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 safety summary, including links to the "Dear
healthcare Professional" letter and the revised label, at:
For Wellbutrin:
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#wellbutrin
For Paxil: http//www.fda.gov/medwatch/SAFETY/2004/safety04.htm#paxil
caroline
.
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| User: "Lisa" |
|
| Title: Re: FDA MedWatch: Wellbutrin & Paxil warnings added concerning emergence of suicidal ideation & behavior |
23 Jun 2004 10:31:18 AM |
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Ah, big deal.
<my-support@earthlink.net> wrote in message
news:40D98C09.E66E98F4@earthlink.net...
Hi,
I just received the following email from FDA MedWatch and thought I
would pass it along:
MedWatch- The FDA Safety Information and Adverse Event Reporting Program
FDA and GlazoSmithKline notified healthcare professionals of revisions
to the WARNINGS and PRECAUTIONS sections of Wellbutrin (bupropion
hydrochloride) & 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 anitdepressants be observed
closely for clinical worsening and suicidaltiy, 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 safety summary, including links to the "Dear
healthcare Professional" letter and the revised label, at:
For Wellbutrin:
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#wellbutrin
For Paxil: http//www.fda.gov/medwatch/SAFETY/2004/safety04.htm#paxil
caroline
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