RESOUR> [NetGold] MEDICAL: NEWS : PRODUCTS: ALERTS: United States. Food and Drug Administration. (FDA) MedWatch
- From: Gleason Sackmann <gleason@xxxxxxxxxxxxxxx>
- To: NetHappenings <nethappenings@xxxxxxxxxxxxx>
- Date: Thu, 30 Oct 2003 08:59:10 -0600
**************************************************************
Net Happenings - From Educational CyberPlayGround
**************************************************************
Date: Tue, 28 Oct 2003 11:53:20 -0500 (EST)
From: David P. Dillard <jwne@xxxxxxxxxx>
To: NetGold <NetGold@xxxxxxxxxxxxxxx>
Subject: [NetGold] MEDICAL: NEWS : PRODUCTS: ALERTS: United States. Food
and Drug Administration. (FDA) MedWatch
Keeping up with the dangers in the use of medical devices and both
prescription and over the counter drugs. These messages can save lives.
MEDICAL: NEWS : PRODUCTS: ALERTS: United States. Food and Drug
Administration. (FDA) MedWatch
MedWatch
<http://www.fda.gov/medwatch/>
The FDA safety information and adverse event reporting service.
MedWatch is the Internet gateway for timely safety information on the
drugs and other medical products regulated by the U.S. Food and Drug
Administration.
Medical Product Safety Information
<http://www.fda.gov/medwatch/safety.htm>
MedWatch Safety Information
Safety Alerts for Drugs, Biologics, Devices, and Dietary Supplements (last
revised 10/27/2003)
Medical product safety alerts, Class I recalls, market withdrawals, public
health advisories
2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996
Safety-Related Drug Labeling Changes
2003: Jan | Feb | Mar | Apr | May | Jun | Jul
2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996
Other FDA Safety-Related Information
Recalls - FDA Enforcement Report
All FDA-classified recalls
Medication Errors
Drug Shortages
Biological Products
Safety Information
Recalls and Withdrawals
Dietary Supplements: Warnings and Safety Information
Medical Devices: Safety Alerts, Public Health Advisories, and Notices
FDA Patient Safety News
Video News Show for Health Professionals
Searchable FDA Safety Databases
Vaccine Adverse Event Reporting System (VAERS)
VAERS is a cooperative program for vaccine safety of the Centers for
Disease Control and Prevention (CDC) and the Food and Drug Administration
(FDA). VAERS collects information about adverse events that occur after
the administration of U.S. licensed vaccines.
The Special Nutritionals Adverse Event Monitoring System
Adverse event (illness or injury) reports associated with use of dietary
supplements, infant formulas, and medical foods. (1993-1998 data)
Manufacturer and User Facility Device Experience Database (MAUDE)
Search database information of all voluntary reports since June, 1993,
user facility reports since 1991, distributor reports since 1993, and
manufacturer reports since August, 1996. (MDR Data files, 1992-1996)
-----------------------
Reporting Adverse Reactions and Medical Product Problems to the FDA
<http://www.fda.gov/medwatch/how.htm>
Message About HIPAA Compliance for Reporters to FDA MedWatch
Voluntary Reporting
Reporting by Consumers
Reporting by Health Professionals
Reporting by Veterinarians and Animal Owners
Mandatory Reporting
Drug/Biologic Manufacturers and Packers
Medical Device Manufacturers, Distributors, and User-facilities
Download Mandatory Reporting Form 3500A (PDF format)
Information about medical device reporting
This CDRH page provides contact information and answers to questions about
mandatory device reporting
-----------------------
This is both an important alert and will also serve as an example of the
kind of alerts that are provided by this government agency:
Public Health Advisory - Suicidality in Pediatric Patients Treated with
Antidepressants for Major Depressive Disorder (MDD)
<http://www.fda.gov/medwatch/SAFETY/2003/safety03.htm#suicide>
Audience: Mental health professionals, pediatricians, and other healthcare
professionals
The FDA notified healthcare professionals of reports of the occurrence of
suicidality (both suicidal ideation and suicide attempts) in clinical
trials for various antidepressant drugs in pediatric patients with major
depressive disorder (MDD). FDA has completed a preliminary review of such
reports for 8 antidepressant drugs (citalopram, fluoxetine, fluvoxamine,
mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine) studied
under the pediatric exclusivity provision, and has determined that
additional data and analysis, and also a public discussion of available
data, are needed. FDA plans to hold an advisory committee meeting before
the Psychopharmacologic Drugs Advisory Committee and the Pediatric
Subcommittee of the Anti-Infective Drugs Advisory Committee on February 2,
2004.
[October 27, 2003 Public Health Advisory - FDA]
<http://www.fda.gov/cder/drug/advisory/mdd.htm>
[October 27, 2003 Talk Paper - FDA]
<http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01256.html>
Full Text of the Advisory
FDA PUBLIC HEALTH ADVISORY
October 27, 2003
Subject: REPORTS OF SUICIDALITY IN PEDIATRIC PATIENTS BEING TREATED WITH
ANTIDEPRESSANT MEDICATIONS FOR MAJOR DEPRESSIVE DISORDER (MDD)
Dear Health Care Professional:
The Food and Drug Administration (FDA) would like to call your attention
to reports of the occurrence of suicidality (both suicidal ideation and
suicide attempts) in clinical trials for various antidepressant drugs in
pediatric patients with major depressive disorder (MDD). While
occurrences of suicidality are not unexpected in patients with MDD,
preliminary data suggest an excess of such reports for patients assigned
to several of these antidepressant drugs compared to those assigned to
placebo. FDA has completed a preliminary review of such reports for 8
antidepressant drugs (citalopram, fluoxetine, fluvoxamine*, mirtazapine,
nefazodone, paroxetine, sertraline, and venlafaxine) studied under the
pediatric exclusivity provision, and has determined that additional data
and analysis, and also a public discussion of available data, are needed.
FDA plans to hold an advisory committee meeting before the
Psychopharmacologic Drugs Advisory Committee and the Pediatric
Subcommittee of the Anti-Infective Drugs Advisory Committee on February
2, 2004.
You may also be aware of press and medical journal reports of suicide
attempts and completed suicides in pediatric patients receiving
antidepressants. Such reports are very difficult to interpret, in the
absence of a control group, as these events also occur in untreated
patients with depression. Data available to FDA on these spontaneous
reports will also be presented at the February 2, 2004, advisory committee
meeting mentioned above.
Pending the broad public discussion of these issues, FDA wishes to
emphasize several critical points.
In the 20 placebo-controlled trials being considered for these 8 drugs,
involving over 4100 pediatric patients, there have been no reports of
completed suicides. However, FDA has not at this point been able to rule
out an increased risk of suicidality for any of these drugs, including
Paxil (paroxetine), which was the subject of a FDA Talk Paper on June 19,
2003.
FDA emphasizes that, for the 7 drugs evaluated in pediatric major
depressive disorder (MDD), data reviewed by FDA were adequate to establish
effectiveness in MDD for only one of these drugs, Prozac (fluoxetine).
Failure to show effectiveness in any particular study in pediatric MDD,
however, is not definitive evidence that the drug is not effective since
trials may fail for many reasons. FDA recognizes that pediatric MDD is a
serious condition for which there are few established treatment options,
and that clinicians often must make choices among treatments available for
adult MDD.
FDA emphasizes that these drugs must be used with caution. Prescribers
are reminded of the following statement present in all antidepressant
labeling:
Suicide: The possibility of a suicide attempt is inherent in major
depressive disorder and may persist until significant remission occurs.
Close supervision of high-risk patients should accompany initial drug
therapy. Prescriptions for Drug X should be written for the smallest
quantity of tablets consistent with good patient management, in order to
reduce the risk of overdose.
As recommended in the June 19, 2003 Talk Paper for Paxil, FDA advises that
caretakers of pediatric patients receiving treatment with Paxil, or with
any of the antidepressants, talk to their doctor regarding the use of the
drug. Patients should not discontinue use of any of these drugs without
first consulting with their physicians, and, for certain of these drugs,
it is important that they not be abruptly discontinued (see labeling for
individual drugs).
*Although fluvoxamine data was reviewed with the other antidepressant
drugs data, it should be noted that it is not approved as an
antidepressant in the United States.
Additional Information (FDA Talk Paper)
[URL for this document was provided above.]
Sincerely,
David Dillard
Temple University
(215) 204 - 4584
jwne@xxxxxxxxxxxxxxxx
<http://groups.yahoo.com/group/NetGold/>
<http://www.edu-cyberpg.com/ringleaders/davidd.html>
<>~~~~~<>~~~~~<>~~~~~<>~~~~~<>~~~~~<>~~~~~<>~~~~~<>~~~~~<>~~~~~<>
EDUCATIONAL CYBERPLAYGROUND
http://www.edu-cyberpg.com
VENDORS REACH THE EDUCATION MARKET
FREE EDUCATION VENDOR DIRECTORY LISTING
Find PREMIUM & FEATURED MERCHANT LISTING ALSO
http://www.edu-cyberpg.com/Directory/default.asp
HOT LIST OF SCHOOLS ONLINE
http://www.edu-cyberpg.com/Schools/default.asp
SERVICES
http://www.edu-cyberpg.com/PS/Home_Products.html
Net Happenings,K12 Newsletters, Network Newsletters
http://www.edu-cyberpg.com/Community/index.html
<>~~~~~<>~~~~~<>~~~~~<>~~~~~<>~~~~~<>~~~~~<>~~~~~<>~~~~~<>~~~~~<>
Other related posts:
- » RESOUR> [NetGold] MEDICAL: NEWS : PRODUCTS: ALERTS: United States. Food and Drug Administration. (FDA) MedWatch
