I received this email today:
Dear Friends,
You are receiving this notice because you signed the Eli Lilly and
Prozac Petition:
Prozac Petition
Please accept our deepest sympathy if you or someone you know has
suffered an adverse reaction to Prozac (fluoxetine).
As most of you are probably aware, the CSM (Committee on Safety of
Medicines) in the United Kingdom has launched an investigation to
re-examine the safety of antidepressants in the SSRI class. Thus far, two drugs
which have similar chemical profiles – Paxil (Paroxetine/Seroxat), and
Effexor (Venlafaxine) have both been banned for use in children under the age
of eighteen.
The FDA (Food & Drug Administration) of the United States followed
suit, and has issued letters of warning against prescribing these two drugs to
children.
Please refer to these links for further information:
UK Position Paper Regarding Seroxat for the Pediatric Population:
http://www.number-10.gov.uk/output/Page3851.asp
FDA Statement Regarding Paxil for the Pediatric Population:
http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01230.html
Manufacturer of Effexor (Wyeth) Statement Regarding Use of Effexor in
Pediatric Population:
http://www.rphlink.com/wyethpharmaceuticals.html
CSM Warns Doctors to No Longer Prescribe Effexor to Children
http://news.independent.co.uk/uk/health/story.jsp?story=445176
THE INVESTIGATION CONTINUES…
Many of you may be aware that in January 2003 the FDA approved lowering
the age for which Prozac can be prescribed, moving the age limit from
eighteen years of age to eight years of age. This leads the public to believe
that Prozac is “safe” for children, whereas other SSRIS are not.
This is absolutely NOT true, and those of you who have experienced the
disastrous effects that Prozac can induce know only too well that the
motivating factor was profit.
It is now up to us to square off with Eli Lilly.
I have been in contact with an official of the CDER unit of the FDA.
His recommendation is to encourage all who have experienced an adverse
effect from Prozac and/or those effected by the adverse effects from Prozac in
another – to file a report through the FDA’s adverse event reporting
system.
I am copying for you the correspondence I received from this official:
============================================================================
From: *****@cder.fda.gov
To: "'Dawn Rider'"
Subject: reporting SSRI adverse events to the FDA's MedWatch system
Date: Fri, 18 Jul 2003 15:04:54 -0400
Hi Dawn,
… contact the petition signers and ask if they submitted their adverse
event experiences (AEs) to the FDA's adverse event reporting system. If they
didn't (and I would guess almost all would not have), I suggest that
they report online at: https://www.accessdata.fda.gov/scripts/medwatch
or download a form from the website at:
http://www.fda.gov/medwatch/getforms.htm
and then mail or fax it back. I know that FDA only sees a small portion of drug AEs so we always want this information. … the withdrawal adverse experiences especially should be recorded.
Thanks,
(FDA Official)
=================================================================================
Time is of the essence. Please file your report as soon as possible.
I believe this step is absolutely essential if we wish to see Prozac
added to the warning list. I respectfully request that you send an email to me
at this address: aspireagent@hotmail.com to confirm that you have
completed your report and have mailed or faxed it to the FDA. This email
address is being reserved exclusively for replies and/or questions from the Eli
Lilly and Prozac petition signers.
I intend to hold the FDA accountable for every confirmation I receive.
If you need help in filling out the form, please let me know and I will
assign an ASPIRE advisor to assist you in this process.
With sincere appreciation,
Dawn Rider
President,
A.S.P.I.R.E. – http://www.aspire.us
Owner/Moderator – SSRI Crusaders
http://groups.yahoo.com/group/SSRI-Crusaders