Friday, August 05, 2005

FDA in Desperate Arse Covering Mode

FDA Issues Second Warning: Antidepressants May Increase Suicide Risk

Antidepressants are often prescribed by healthcare providers who are not qualified to monitor depression, says one behavioral medicine expert. 'You don't really know who has been giving these drugs, at what doses, or for how long and why.' The US Food and Drug Administration on Friday issued a second warning that people taking antidepressant drugs be monitored for signs of suicidal thoughts and deepening depression.

The new advisory follows concern about a link between antidepressant use and suicide among children. And it also follows action taken in March 2004, when the FDA said there was a small, but real, increased risk of suicidal behavior in adults and children taking these drugs.

It then ordered manufacturers to place a warning on the labels of all antidepressants detailing those heightened risks.

Those revised labels applied to both pediatric and adult usage of bupropion (Wellbutrin), citalopram (Celexa), fluoxetine (Prozac), fluvoxamine (Luvox), mirtazapine (Remeron), nefazodone (Serzone), paroxetine (Paxil), sertraline (Zoloft), escitalopram (Lexapro), and venlafaxine (Effexor).

Prozac is the only drug approved for use in children with major depressive disorder, yet doctors are at liberty to -- and do -- prescribe many others for pediatric use.

Increase in Suicidal Thinking or Behavior

The FDA said Friday's warning was in response to recent studies that point to the possibility of an increased risk of suicidal behavior in adults taking antidepressants. The agency said it was in the process of reviewing data from drug manufacturers to determine the extent and seriousness of the risk, a review it said could take more than a year.
In the meantime, the agency recommended 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 healthcare professional.

In its statement Friday, the FDA did not cite the published studies that the agency said prompted the renewed warning about antidepressant use among adults.


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