RESOUR> Acne: The Use of Accutane and Possible Side Effects Including Depression
- From: Gleason Sackmann <gleason@xxxxxxxxxxxxxxx>
- To: NetHappenings <nethappenings@xxxxxxxxxxxxx>
- Date: Mon, 28 Apr 2003 10:00:00 -0500
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Net Happenings - From Educational CyberPlayGround
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Date: Sun, 27 Apr 2003 11:29:24 -0400 (EDT)
From: "David P. Dillard" <jwne@xxxxxxxxxxxxxxxxxxxxx>
Adolescents with acne, as well as adults with acne, are likely to want to
have clear skin. They may turn to over the counter solutions for this
problem, but they may also go to physicians for help. One prescription
drug used for acne is the prescription drug Accutane. Some concern,
however, has been expressed regarding Accutane being a possible cause of
severe depression.
From
AMedNews.com
HEALTH & SCIENCE
Mental risks from Accutane draw attention
Evidence linking the drug to depression and suicidal tendencies remains
anecdotal but enough to cause concern.
By Victoria Stagg Elliott, AMNews staff. May 6, 2002.
<http://www.ama-assn.org/sci-pubs/amnews/pick_02/hlsd0506.htm>
Evidence linking Accutane (isotretinoin) to depression and even suicide
remains anecdotal. Dr. Chapman says that he has only seen two or three
patients out of the thousands to whom he has prescribed it get depressed.
None have committed suicide. Moreover, patients get happier as skin clears
up.
"I've seen patients who were depressed with their acne," said Stephen
Webster, MD, a dermatologist with Gundersen Lutheran Medical Center in La
Crosse, Wis. "When the acne cleared up, they became a different
individual."
But several high-profile incidents possibly linking the drug with severe
depression have moved the question into the spotlight. These events
include the suicide of the son of Rep. Bart Stupak (D, Mich.) in May 2000,
and the tragedy of the adolescent who flew a small plane into a Tampa,
Fla., office building earlier this year.
Stupak has lobbied for changes to the drug's label. Last month, the mother
of the boy in Tampa filed suit against the drug's manufacturer, Hoffman-La
Roche Inc.
Full Story at the URL above.
The Center for Drug Evaluation and Research has a web page devoted to
Accutane
Accutane (Isotretinoin)
<http://www.fda.gov/cder/drug/infopage/accutane/>
Accutane Label. (Revised) (6/20/2002)
Full, revised 6/20/2002 label, changes highlighted
Letter from Roche regarding 6/20/2002 labeling changes
Medication Guide.
Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide
for Prescribers of Accutane (insotretinoin). (Posted 4/9/2002)
The System to Manage Accutane Related Teratogenicity (S.M.A.R.T.) Guide to
Best Practices. (Posted 4/25/2002)
FDA Labeling Supplement Approval Letter. (2/21/2002)
Accutane (isotretinoin): A Letter to Consumers and Health Care Providers.
Optional Format: PDF
Revised Informed Consent. Optional Format: PDF. (1/23/2001)
FDA Talk Paper: FDA Announces Changes to the Risk Management Program to
Prevent Birth Defects Caused by Accutane. (10/31/2001)
Advisory Committee Meeting Transcripts.
--------------------------
The manufacturer has a product guide
<http://www.rocheusa.com/products/accutane/>
This article appeared in the FDA Consumer:
U.S. Food and Drug Administration
FDA Consumer magazine
March-April 2001
The Power of Accutane:
The Benefits and Risks of a Breakthrough Acne Drug
By Michelle Meadows
<http://www.fda.gov/fdac/features/2001/201_acne.html>
Considered the biggest breakthrough in acne drug treatment over the last
20 years, Accutane is the only drug that has the potential to clear severe
acne permanently after one course of treatment. (See "Why Acne Forms, and
How Accutane Knocks It Out.") One course, which is typically five months,
results in prolonged remission of acne in up to 85 percent of patients. A
member of a class of drugs known as retinoids, Accutane is highly
effective. But it doesn't work for everyone, and some patients need more
than one course of treatment. Dr. Harper took a second course of Accutane
one year after the first and has been free of severe acne ever since, now
only occasionally using a topical medication.
No other acne medicine works as well for severe acne. Patients generally
have to keep using other medications because they only suppress acne
temporarily. But as powerful as Accutane can be in improving patients'
lives, its adverse effects can be just as powerful. The drug is known to
cause miscarriage and severe birth defects. Patients taking Accutane may
develop potentially serious problems affecting a number of organs,
including the liver, intestines, eyes, ears, and skeletal system. And some
patients taking Accutane have developed serious psychiatric problems,
including depression. More rarely, patients have developed suicidal
behavior and killed themselves.
[Full Story at the URL above.]
-----------------
Congressman Bart Stupak's website has a hearing in Congress regarding
Accutane linked to his web page.
<http://www.house.gov/stupak/accutane.htm>
Congressman Bart Stupak's Statement
Background Information
FDA Memorandum dated 2/23/98
FDA "MedWatch" dated 2/26/98
FDA's Warning Letter to Roche dated 3/5/98 (PDF - 4 pages)
FDA's May 1, 2000 letter to Roche (PDF - 16 pages)
Summary of Accutane Serious Adverse Events (PDF - 21 pages 35KB)
Accutane Adverse Events Report
Roche Delivers Different Labeling In Same Box
Recommendations
Detailed Chronology
File an Adverse Event Report with FDA or call FDA @ 800-FDA-1088
Correspondence
Revised Informed Consent/Patient Agreement (PDF - 3 pages 144KB)
Accutane Medication Guide (PDF - 6 pages 792KB)
Other Accutane Links
========================
There is also a website created by an action group for this drug:
Accutane/Roaccutane Action Group Homepage
<http://www.accutaneaction.com/>
One person has kept a diary regarding her involvement with the drug
JENN'S ACCUTANE JOURNAL
<http://jmhpr.tripod.com/accutanediary/>
A medical resource list for information regarding this drug's use has been
created by the March of Dimes:
Accutane and Other Retinoids
<http://www.marchofdimes.com/professionals/681_1168.asp>
Drug Education.net also has an Accutane page
<http://www.drugeducation.net/accutane.htm>
The Medline Plus page regarding Accutane may be found here:
Isotretinoin
<http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a681043.html>
and Hardin MD provides this page of links:
Accutane / Isotretinoin
<http://www.lib.uiowa.edu/hardin/md/accutane.html>
and there is an Accutane Survivors group that has created this page with
extensive source listings for further information:
Accutane - Is this Acne Drug Treatment Linked to Depression and Suicide?
<http://www.roaccutanesurvivors.com/Congress/ODonnel_051201.htm>
Since adolescents and young adults may be a very concerned population if
they are effected by acne, knowing more about this drug may be useful for
those who work with adolescents and may encounter teens who are
considering the use of this drug or who are already using it.
Sincerely,
David Dillard Research Librarian
david@xxxxxxxxxxxxxxx
ECP RingLeader
http://www.edu-cyberpg.com/ringleaders/davidd.html
Temple University
(215) 204 - 4584
jwne@xxxxxxxxxxxxxxxx
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