Prozac-type drugs being investigated by FDA
Several recent scientific publications suggest the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. The issue has been raised off and on but the drug companies have either suppressed the evidence or simply not let it come out. Late last year, there was a big controversy regarding Prozac, but nothing much happened. (Related article: Prozac lawsuits)
Looks like FDA is now acting on thse complaints from consumer groups. FDA has begun a complete review of all available data to determine whether there is an increased risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications. It is expected that this review will take a year or longer to complete. In the meantime, FDA is highlighting that:
Celexa (citalopram)
Cymbalta (duloxetine)
Effexor (venlafaxine)
Lexapro (escitalopram)
Fluvoxamine
Paxil (paroxetine)
Prozac (fluoxetine)
Remeron (mirtazapine)
Serzone (nefazodone)
Wellbutrin (bupropion)
Zoloft (sertraline)
FDA’s comprehensive review will involve many hundreds of individual clinical trials and many thousands of adult patients. It is expected that this review will require a year or more to complete (likely completion mid-2006) because of the large number of trials and the thousands of adverse events that must be checked for possible evidence of suicidality. The FDA announced that it will make the results of its review available to the public once its analyses are complete, and will update this advisory in the meantime if more definitive information becomes available.
Recommended article: Eli Lilly claims that Prozac is a safe drug
Looks like FDA is now acting on thse complaints from consumer groups. FDA has begun a complete review of all available data to determine whether there is an increased risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications. It is expected that this review will take a year or longer to complete. In the meantime, FDA is highlighting that:
- Adults being treated with antidepressant medications, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior. Close watching may be especially important early in treatment, or when the dose is changed, either increased or decreased.
- Adults whose symptoms worsen while being treated with antidepressant drugs, including an increase in suicidal thinking or behavior, should be evaluated by their health care professional.
Celexa (citalopram)
Cymbalta (duloxetine)
Effexor (venlafaxine)
Lexapro (escitalopram)
Fluvoxamine
Paxil (paroxetine)
Prozac (fluoxetine)
Remeron (mirtazapine)
Serzone (nefazodone)
Wellbutrin (bupropion)
Zoloft (sertraline)
FDA’s comprehensive review will involve many hundreds of individual clinical trials and many thousands of adult patients. It is expected that this review will require a year or more to complete (likely completion mid-2006) because of the large number of trials and the thousands of adverse events that must be checked for possible evidence of suicidality. The FDA announced that it will make the results of its review available to the public once its analyses are complete, and will update this advisory in the meantime if more definitive information becomes available.
Recommended article: Eli Lilly claims that Prozac is a safe drug
posted by eCreativa Media | 5:53 PM
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