The FDA’s Second Antidepressant Warning;
Adults Also at an Increased Risk of
Suicide
A year after the FDA acknowledged the link between antidepressants
and the increased risk of suicide in children and adolescents, it now posted a
new warning; adults are also at risk for suicidal thoughts and actions while
taking SSRI (selective serotonin reuptake inhibitor) antidepressants.
As I read this recent news, I thought back to a woman I met two years ago. She
was in a daze, like she had not slept in days. Sentences trailed off without an
ending. She appeared to have trouble remaining focused on our conversation. Her
eyes wandered off into space. With little fight or emotion left in her, she
quietly said, " My husband killed himself three days before
Christmas."
Her husband became increasingly stressed with the increasing
demands of his growing business. Insomnia set in. His weight dropped. Suspecting
depression, his doctor put him on antidepressants. Then the real trouble began,
this woman said. Her normally mild-mannered husband became violent. One night,
about a week after he began taking antidepressants, she called 911 after he
threw her against a wall. His behavior became increasingly erratic until, a week
after the 911 call, she found him dead in the garage with the car running.
There was no doubt in her mind that the medication he took caused his Dr.
Jekyll/Mr. Hyde transformation that quickly led to his death. She told me this
story as she was in the process of losing her house to foreclosure, running back
and forth to therapy with her two teenage boys and facing the prospect of moving
back home with mother until she could pull herself out of her own depression
enough to find a job. It was a tragic story told by a woman with vacant eyes.
Within months of meeting this woman the FDA issued it
first warning (in 2004) stating the link between antidepressant drugs and
increased risk of suicide in adolescents. Published and unpublished studies
concluded that two to three percent of young people treated with antidepressant
drugs are at an increased risk of suicidal thoughts or behavior.
That warning has now spread to all age groups. Last month (July 2005) the FDA
issued a Public Health Advisory (PHA) calling for an update to health care
providers and patients about the recent scientific research and publications
that there is an increased risk of suicidal thought and behaviors in adults
taking antidepressant medication.
The FDA, using a similar approach that was used in the evaluation of the risks
of increased suicidal thoughts and behaviors in their pediatric studies,
requested that manufacturers of antidepressants drugs provide doctors with
information from their drug trials.
In accordance with the 2nd FDA warning the Public Health Advisory advises
patients and health care providers be aware of the following:
- Adults being treated with antidepressant medicines, particularly those being
treated for depression, should be watched closely for worsening of depression
and for increased suicidal thinking or behavior.
- Close observation of adults may be especially important when antidepressant
medications are started for the first time or when doses for the specific drugs
prescribed have been changed.
- Adults whose symptoms worsen while being treated with antidepressants,
including an increase in suicidal thinking or behavior, should be evaluated by
their health care professional.
The above recommendations are also consistent with the existing warnings that
are in the approved labeling, or package insert, for antidepressant medications.
It should be noted that SSRIs are not the only antidepressants causing suicidal
thoughts and actions. In August of 2004, Eli Lilly and Co. introduced Cymbalta
to the U.S. Market. Unlike the Selective Serotonin Reuptake Inhibitors, or
SSRI’s that we are used to, Cymbalta is an antidepressant that targets both
serotonin and no epinephrine to help combat depression. The FDA promises deeper
scrutiny of this drug since, during a study aimed at finding the drug’s
effectiveness against Stress Urinary Incontinence, the patients taking Cymbalta
attempted suicide at a rate more than double the rate of similar patients.
Antidepressants have their place but it is our belief that
other options should be exercised before resorting to the potentially dangerous
drugs. There are many options in between the wide gap between doing nothing and
taking antidepressant medication. In dealing with depression,
diet and
exercise changes are highly beneficial.
Herbal and
homeopathic remedies like
Deprex are also valuable in the battle
against depression.
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