Anti-depressants
Commentary on Anti-depressant Warnings -- Is the cure worse than the
disease?
Johns Hopkins psychiatrist Dr. Karen L. Swartz discusses the risks and benefits of SSRIs.
Call it the pill paradox: Some 20 years ago, selective serotonin re-uptake inhibitors (SSRIs) burst
onto the scene, lauded for their ability to treat depression. Today, however, some studies have
linked SSRIs to an increased incidence of suicidal thoughts and behavior, and the U.S. Food and
Drug Administration (FDA) is in the midst of an extensive review of drug safety data. This has led to
what’s being called a “crisis of confidence” in antidepressants, with many people wondering
whether antidepressants, especially SSRIs, are safe to take.
The controversy began with concern over the use of SSRIs in children and adolescents, with
studies indicating an increased risk of suicide. For adults, the issue heated up recently, when
researchers reported an increased risk of suicidal behavior during the first month of treatment with
SSRIs. The study presented data on nearly 160,000 people treated in Britain with one of four
antidepressants, two of which were the SSRIs fluoxetine (Prozac) and paroxetine (Paxil). The
others were the tricyclic antidepressants amitriptyline (Elavil) and dothiepin (Dothep).
While the risk of suicidal behavior did not differ from drug to drug, the researchers found, it was
elevated during the first month of antidepressant treatment and highest during the first nine days of
treatment. It is important to note, however, that other studies have not found such a link. For
instance, in another study in 2006, researchers analyzed drug safety data from that country’s
regulatory agency. They found no evidence that SSRIs increase the risk of suicide. And a Swedish
study found no link between SSRIs and an increased risk of suicide in either children or adults
over a nine-year period. Moreover in the United States the suicide rate has actually declined since
a peak in the late 1980s -- a drop that coincides with the introduction of SSRIs.
FDA Warnings on SSRIs
Because of the importance of this issue, the FDA is moving ahead with a safety review of
antidepressant medications in adults, with the results expected later this year. In the interim, the
FDA issued a public health advisory in July 2006 directed at adults. According to the advisory,
adults who are being treated with antidepressants should be watched closely for worsening of
depression and for increased suicidal thoughts or behavior. The FDA added that this increased
surveillance might be especially necessary when a person goes on antidepressant medications
for the first time or when doses are changed.
Where does all this leave us? It is essential to remember that serious depression poses a
significant risk to a person’s life. The vast majority of people who commit suicide have major
depressive disorder or bipolar disorder that is not being treated at all. Overall, SSRIs have a good
safety profile, with fewer side effects than other antidepressants, which is why they are widely
used. And beyond that, it is essential to remember that the real threat lies with the disease itself. If
you are struggling with depression, get treatment. Untreated bipolar disorder and major
depression kill people every year; their threat to your health is significant and should never be
ignored or glossed over.
disease?
Johns Hopkins psychiatrist Dr. Karen L. Swartz discusses the risks and benefits of SSRIs.
Call it the pill paradox: Some 20 years ago, selective serotonin re-uptake inhibitors (SSRIs) burst
onto the scene, lauded for their ability to treat depression. Today, however, some studies have
linked SSRIs to an increased incidence of suicidal thoughts and behavior, and the U.S. Food and
Drug Administration (FDA) is in the midst of an extensive review of drug safety data. This has led to
what’s being called a “crisis of confidence” in antidepressants, with many people wondering
whether antidepressants, especially SSRIs, are safe to take.
The controversy began with concern over the use of SSRIs in children and adolescents, with
studies indicating an increased risk of suicide. For adults, the issue heated up recently, when
researchers reported an increased risk of suicidal behavior during the first month of treatment with
SSRIs. The study presented data on nearly 160,000 people treated in Britain with one of four
antidepressants, two of which were the SSRIs fluoxetine (Prozac) and paroxetine (Paxil). The
others were the tricyclic antidepressants amitriptyline (Elavil) and dothiepin (Dothep).
While the risk of suicidal behavior did not differ from drug to drug, the researchers found, it was
elevated during the first month of antidepressant treatment and highest during the first nine days of
treatment. It is important to note, however, that other studies have not found such a link. For
instance, in another study in 2006, researchers analyzed drug safety data from that country’s
regulatory agency. They found no evidence that SSRIs increase the risk of suicide. And a Swedish
study found no link between SSRIs and an increased risk of suicide in either children or adults
over a nine-year period. Moreover in the United States the suicide rate has actually declined since
a peak in the late 1980s -- a drop that coincides with the introduction of SSRIs.
FDA Warnings on SSRIs
Because of the importance of this issue, the FDA is moving ahead with a safety review of
antidepressant medications in adults, with the results expected later this year. In the interim, the
FDA issued a public health advisory in July 2006 directed at adults. According to the advisory,
adults who are being treated with antidepressants should be watched closely for worsening of
depression and for increased suicidal thoughts or behavior. The FDA added that this increased
surveillance might be especially necessary when a person goes on antidepressant medications
for the first time or when doses are changed.
Where does all this leave us? It is essential to remember that serious depression poses a
significant risk to a person’s life. The vast majority of people who commit suicide have major
depressive disorder or bipolar disorder that is not being treated at all. Overall, SSRIs have a good
safety profile, with fewer side effects than other antidepressants, which is why they are widely
used. And beyond that, it is essential to remember that the real threat lies with the disease itself. If
you are struggling with depression, get treatment. Untreated bipolar disorder and major
depression kill people every year; their threat to your health is significant and should never be
ignored or glossed over.
"Where science, psychology and spirituality meet in a way
that makes a difference to your reality."
that makes a difference to your reality."
Posted in John Hopkins Health Alerts, Depression and Anxiety on September 26, 2007
(a free service of University Health Publishing and John Hopkins Medicine)
(a free service of University Health Publishing and John Hopkins Medicine)
| US Drug advisories & drug guides visit the FDA Center for Drug and Evaluation Research |
Health Canada issues increased health warnings on SSRI's
Advisory
2004-31
June 3, 2004
Health Canada is advising Canadians that Selective Serotonin Re-uptake Inhibitors (SSRIs) and
other newer anti-depressants, now carry stronger warnings indicating that patients of all ages
taking these drugs may experience behavioural and/or emotional changes that may put them at
increased risk of self-harm or harm to others.
The drugs with new warnings include:
Bupropion (Wellbutrin® and Zyban®)
Note that both of these drugs share the same active ingredient. Zyban, a smoking cessation drug,
now carries an appropriately modified version of the above warning.
Citalopram (Celexa®)
Fluoxetine (Prozac®)
Fluvoxamine (Luvox®)
Mirtazapine (Remeron®)
Paroxetine (Paxil®)
Sertraline (Zoloft®)
Venlaflaxine (Effexor®)
Advisory
2004-44
August 9, 2004
This advisory applies to the following anti-depressants: bupropion (whether used for depression or
for smoking cessation), citalopram, fluoxetine, fluvoxamine, mirtazapine, paroxetine, sertraline and
venlafaxine.
International and Canadian reports reveal that some newborns whose mothers took these
medications during pregnancy have developed complications at birth requiring prolonged
hospitalization, breathing support and tube feeding. Reported symptoms include: feeding and/or
breathing difficulties, seizures, muscle rigidity, jitteriness and constant crying. In most cases, the
newer anti-depressant was taken during the third trimester of pregnancy. These symptoms are
consistent with either a direct adverse effect of the anti-depressant on the baby, or possibly a
discontinuation syndrome caused by sudden withdrawal from the drug.
When treating depression in pregnant women, physicians and patients should carefully consider the
potential risks and benefits of the various treatment options for both the mother and the unborn baby.
To date, there is little evidence-based information on how best to treat depression during pregnancy.
Background: In February 2004, a scientific advisory panel set up by Health Canada was asked to
provide the clinical practice perspective on the pediatric clinical trial safety data, and the
spontaneous post-marketing reports for SSRIs and other newer antidepressants. The panel agreed
that a contraindication was not warranted for these medications, and supported Health Canada's
recommendation for stronger warnings, while providing suggestions and comments. The record of
proceedings, and other information about the panel, can be found on Health Canada's website.
Advisory
2004-31
June 3, 2004
Health Canada is advising Canadians that Selective Serotonin Re-uptake Inhibitors (SSRIs) and
other newer anti-depressants, now carry stronger warnings indicating that patients of all ages
taking these drugs may experience behavioural and/or emotional changes that may put them at
increased risk of self-harm or harm to others.
The drugs with new warnings include:
Bupropion (Wellbutrin® and Zyban®)
Note that both of these drugs share the same active ingredient. Zyban, a smoking cessation drug,
now carries an appropriately modified version of the above warning.
Citalopram (Celexa®)
Fluoxetine (Prozac®)
Fluvoxamine (Luvox®)
Mirtazapine (Remeron®)
Paroxetine (Paxil®)
Sertraline (Zoloft®)
Venlaflaxine (Effexor®)
Advisory
2004-44
August 9, 2004
This advisory applies to the following anti-depressants: bupropion (whether used for depression or
for smoking cessation), citalopram, fluoxetine, fluvoxamine, mirtazapine, paroxetine, sertraline and
venlafaxine.
International and Canadian reports reveal that some newborns whose mothers took these
medications during pregnancy have developed complications at birth requiring prolonged
hospitalization, breathing support and tube feeding. Reported symptoms include: feeding and/or
breathing difficulties, seizures, muscle rigidity, jitteriness and constant crying. In most cases, the
newer anti-depressant was taken during the third trimester of pregnancy. These symptoms are
consistent with either a direct adverse effect of the anti-depressant on the baby, or possibly a
discontinuation syndrome caused by sudden withdrawal from the drug.
When treating depression in pregnant women, physicians and patients should carefully consider the
potential risks and benefits of the various treatment options for both the mother and the unborn baby.
To date, there is little evidence-based information on how best to treat depression during pregnancy.
Background: In February 2004, a scientific advisory panel set up by Health Canada was asked to
provide the clinical practice perspective on the pediatric clinical trial safety data, and the
spontaneous post-marketing reports for SSRIs and other newer antidepressants. The panel agreed
that a contraindication was not warranted for these medications, and supported Health Canada's
recommendation for stronger warnings, while providing suggestions and comments. The record of
proceedings, and other information about the panel, can be found on Health Canada's website.
| Off-Site Link to: Health Canada Drug and Health Products Warnings and Advisories |
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