On Monday, the FDA issued an advisory urging doctors to watch for worsening depression or suicidal thoughts in patients who take any of 10 antidepressants. The FDA advises that patients be monitored especially at the beginning of treatment
or whenever the antidepressant dose is changed.
There does not appear to be sufficient evidence to support such an advisory. The FDA itself admits that they don't know that these drugs are responsible for the behavioral changes indicated in the advisory. I'm wondering if the FDA assumed a cause and effect relationship that doesn't actually exist, or that they have the cause and effect reversed. For example, a change in the behaviors indicated will often prompt the use, or change in dosage, of one or more of these drugs. There is also quite a lag time for these drugs to take effect. It is, therefore, no surprise that these tendencies occur in some patients upon beginning a course of these medications. In addition, many people begin participating in in-depth psychotherapy concurrently with a change in medication, thus making them more vulnerable to their emotions around the same time.
I suspect that liability concerns alone prompted this advisory. My fear is that people will discontinue their medications (although the FDA recommends against doing so) and that others will not get the help they need because of a fear caused by this advisory.
http://content.health.msn.com/content/article/84/98068.htm
. . . and this:
Another article for your information:
http://content.health.msn.com/content/article/84/98069.htm
or whenever the antidepressant dose is changed.
There does not appear to be sufficient evidence to support such an advisory. The FDA itself admits that they don't know that these drugs are responsible for the behavioral changes indicated in the advisory. I'm wondering if the FDA assumed a cause and effect relationship that doesn't actually exist, or that they have the cause and effect reversed. For example, a change in the behaviors indicated will often prompt the use, or change in dosage, of one or more of these drugs. There is also quite a lag time for these drugs to take effect. It is, therefore, no surprise that these tendencies occur in some patients upon beginning a course of these medications. In addition, many people begin participating in in-depth psychotherapy concurrently with a change in medication, thus making them more vulnerable to their emotions around the same time.
I suspect that liability concerns alone prompted this advisory. My fear is that people will discontinue their medications (although the FDA recommends against doing so) and that others will not get the help they need because of a fear caused by this advisory.
http://content.health.msn.com/content/article/84/98068.htm
March 22, 2004 -- The FDA is issuing a warning about the possibility of worsening depression or suicidal thoughts in people, particularly children, who take any of 10 popular antidepressants, especially at the beginning of treatment or when the doses are increased or decreased.
The FDA has sent a letter to drug manufacturers requesting labeling changes on these antidepressants -- warning of possible suicide, worsening depression, anxiety, and panic attacks in adults and children.
Antidepressants involved in this warning label request are:
Prozac (also sold generically as fluoxetine)
Zoloft
Paxil
Luvox
Celexa
Lexapro
Wellbutrin
Effexor
Serzone
Remeron
"We don't know that the drugs are responsible for these behavioral changes, but nonetheless we're telling physicians and families to be aware of this and that if the behaviors do emerge, to get treatment right away," said Russell Katz, a director with the FDA's Center for Drug Evaluation and Research, in a news teleconference today.
. . . and this:
The FDA has been closely reviewing studies of antidepressants in children for the past year after an initial report on studies of Paxil and other drugs suggested an increased risk of suicidal thoughts in children given antidepressants. No suicides occurred in any of the trials, the FDA reports.
The analysis has involved 25 controlled trials with 4,000 children taking antidepressants, said Katz. "Those reviews are ongoing."
Today's action "arose from an unexpected observation in some studies of an apparent excess of emotionability, a catch-all term ... that includes suicidal [thoughts]," said Robert Temple, MD, the FDA's director of medical policy.
However, closer examination has shown that the accounts are unclear -- whether certain behaviors reported were actual suicide attempts or other self-injurious behavior that was not suicide-related.
"As we've gone into the studies in detail, it's become evident that the terms used were highly varied and [the studies] not very well done," Temple said.
Another article for your information:
http://content.health.msn.com/content/article/84/98069.htm