[H] Antidepressants cause dep & suicide (kinda off topic)
Posted: Thu Apr 01, 2004 3:45 am
The information in this article is worth noting for those practitioners who
see clients on these drugs. It makes it very difficult to assess symptoms at
the best of time when on these meds, but in some they create what they are
prescribed to cover up - I have a client at the moment who is on an
assortment of drugs, including Lithium and has just had 3 weeks of Electro
convulsive therapy - makes the picture very difficult for even the client to
tell you how they were before.
Robyn
Medscape Alert
Antidepressants May Cause Depression and Suicidality
Yael Waknine
March 22, 2004 — The U.S. Food and Drug Administration (FDA) has asked
manufacturers of the several antidepressant drugs to include in their
labeling a warning statement that recommends close observation of adult and
pediatric patients treated with their agents for worsening depression or the
emergence of suicidality
The antidepressant drugs are fluoxetine (Prozac), sertraline (Zoloft),
paroxetine (Paxil), fluvoxamine (Luvox), citalopram (Celexa), escitalopram
(Lexapro), buproprion (Wellbutrin), venlafaxine (Effexor), nefazodone
(Serzone), and mirtazapine (Remeron).
Several of these drugs are approved for the treatment of
obsessive-compulsive disorder in pediatric patients (sertraline, fluoxetine,
fluvoxamine). Only fluoxetine is approved for use in children with major
depressive disorder. None of these drugs are approved as monotherapy in
treating bipolar depression, either in adults or children, and fluvoxamine
is not approved as an antidepressant in the U.S.
The FDA has been closely reviewing the results of antidepressant studies in
children since June 2003, after an initial report appeared to suggest
increased risk of suicidal thoughts and actions in the pediatric population,
according to today's advisory.
Although it is unclear whether antidepressants contribute to the emergence
of suicidal thinking and behavior, these interim actions are intended to
draw more attention to the need for careful monitoring of patients being
treated with these drugs, especially at the beginning of therapy and during
dose changes.
Discontinuation of medication may be appropriate in patients whose
depression is persistently worse or whose emergent suicidality is severe,
abrupt in onset, or was not part of the patient's presenting symptoms.
Therapy changes should be made under the guidance of a physician, as certain
medications should be tapered rather than stopped abruptly.
The warning also alerts physicians, patients, and caregivers to symptoms
such as anxiety, agitation, panic attacks, insomnia, irritability,
hostility, impulsivity, akathisia, hypomania, and mania in patients being
treated with antidepressants for major depressive disorder as well as other
indications. According to the FDA, there is concern that patients who
experience one or more of these symptoms may be at increased risk for
worsening depression or suicidality.
Because antidepressants are believed to have the potential for inducing
manic episodes in patients with bipolar disorder, the FDA recommends that
physicians be particularly vigilant in screening and monitoring patients who
may be at risk.
The FDA is continuing to review available clinical trial data for pediatric
patients with depression and other psychiatric disorders to determine
whether there is evidence that some or all antidepressants increase the risk
of suicidality in children.
Later this summer, the FDA plans to update the Psychopharmacological Drugs
Advisory Committee (PDAC) and the Pediatric Subcommittee of the
Anti-Infective Drugs Advisory Committee (Peds AC) about the results of this
review.
In the interim, the FDA plans to work closely with each of the nine
manufacturers of the antidepressants involved to optimize safe drug use and
implement proposed labeling changes and other safety communications in a
timely manner.
Reviewed by Gary D. Vogin, MD
Yael Waknine is a freelance writer for Medscape.
"If the matter is one that can be settled by observation, make the
observation yourself." (Bertrand Russell)
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see clients on these drugs. It makes it very difficult to assess symptoms at
the best of time when on these meds, but in some they create what they are
prescribed to cover up - I have a client at the moment who is on an
assortment of drugs, including Lithium and has just had 3 weeks of Electro
convulsive therapy - makes the picture very difficult for even the client to
tell you how they were before.
Robyn
Medscape Alert
Antidepressants May Cause Depression and Suicidality
Yael Waknine
March 22, 2004 — The U.S. Food and Drug Administration (FDA) has asked
manufacturers of the several antidepressant drugs to include in their
labeling a warning statement that recommends close observation of adult and
pediatric patients treated with their agents for worsening depression or the
emergence of suicidality
The antidepressant drugs are fluoxetine (Prozac), sertraline (Zoloft),
paroxetine (Paxil), fluvoxamine (Luvox), citalopram (Celexa), escitalopram
(Lexapro), buproprion (Wellbutrin), venlafaxine (Effexor), nefazodone
(Serzone), and mirtazapine (Remeron).
Several of these drugs are approved for the treatment of
obsessive-compulsive disorder in pediatric patients (sertraline, fluoxetine,
fluvoxamine). Only fluoxetine is approved for use in children with major
depressive disorder. None of these drugs are approved as monotherapy in
treating bipolar depression, either in adults or children, and fluvoxamine
is not approved as an antidepressant in the U.S.
The FDA has been closely reviewing the results of antidepressant studies in
children since June 2003, after an initial report appeared to suggest
increased risk of suicidal thoughts and actions in the pediatric population,
according to today's advisory.
Although it is unclear whether antidepressants contribute to the emergence
of suicidal thinking and behavior, these interim actions are intended to
draw more attention to the need for careful monitoring of patients being
treated with these drugs, especially at the beginning of therapy and during
dose changes.
Discontinuation of medication may be appropriate in patients whose
depression is persistently worse or whose emergent suicidality is severe,
abrupt in onset, or was not part of the patient's presenting symptoms.
Therapy changes should be made under the guidance of a physician, as certain
medications should be tapered rather than stopped abruptly.
The warning also alerts physicians, patients, and caregivers to symptoms
such as anxiety, agitation, panic attacks, insomnia, irritability,
hostility, impulsivity, akathisia, hypomania, and mania in patients being
treated with antidepressants for major depressive disorder as well as other
indications. According to the FDA, there is concern that patients who
experience one or more of these symptoms may be at increased risk for
worsening depression or suicidality.
Because antidepressants are believed to have the potential for inducing
manic episodes in patients with bipolar disorder, the FDA recommends that
physicians be particularly vigilant in screening and monitoring patients who
may be at risk.
The FDA is continuing to review available clinical trial data for pediatric
patients with depression and other psychiatric disorders to determine
whether there is evidence that some or all antidepressants increase the risk
of suicidality in children.
Later this summer, the FDA plans to update the Psychopharmacological Drugs
Advisory Committee (PDAC) and the Pediatric Subcommittee of the
Anti-Infective Drugs Advisory Committee (Peds AC) about the results of this
review.
In the interim, the FDA plans to work closely with each of the nine
manufacturers of the antidepressants involved to optimize safe drug use and
implement proposed labeling changes and other safety communications in a
timely manner.
Reviewed by Gary D. Vogin, MD
Yael Waknine is a freelance writer for Medscape.
"If the matter is one that can be settled by observation, make the
observation yourself." (Bertrand Russell)
---
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Checked by AVG anti-virus system (http://www.grisoft.com).
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