Historical Information on Fluoxetine hydrochloride (marketed as Prozac)
These items are out-of-date.
Previous FDA Alert – Suicidal Thoughts or Actions in Children and Adults [Issued 7/2005]
All patients being treated with any type of antidepressants should be observed closely for clinical worsening and suicidality especially during the first few months of therapy and when the dose is modified.
FDA has concluded that suicidal thinking or behavior may increase in pediatric patients treated with any type of antidepressant, especially early in treatment. Increases in suicidal thinking or behavior due to drug can be expected in about 1 out of 50 treated pediatric patients. Note that fluoxetine is approved for treating pediatric patients who have depression or obsessive-compulsive disorder.
Several recent scientific publications report the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. Even before these reports became available, FDA began 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 any type of antidepressant medication. It is expected that this review will require a year or longer to complete. In the meantime, FDA is highlighting that adults being treated with any type of antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior.
This information reflects FDA’s current analysis of all available data concerning this drug. FDA intends to update this sheet when additional information or analyses become available.
All patients being treated with any type of antidepressant for any indication should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. For pediatric patients, such observation would generally include at least weekly face-to-face contact with patients or their family members or caregivers during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks. Additional contact by telephone may be appropriate between face-to-face visits. Adults whose symptoms worsen while being treated with antidepressant medications, including an increase in suicidal thinking or behavior, should be evaluated by their healthcare professional.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.
Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4 percent, twice the placebo risk of 2 percent. No suicides occurred in these trials; however, the duration of treatment was limited. Spontaneous post-marketing reports of suicide-related events associated with the use of SSRIs, including suicidal ideation, suicide attempt, self-mutilation and completed suicide have been received. Because these events may also be related to underlying psychiatric illness, definitive evaluation of the effects of SSRIs on suicide related events from post-marketing reports alone is not possible, and the data from controlled clinical trials is more informative.
Although there are no similar comprehensive data linking the use of antidepressant medications and an increased risk of suicidality in adults, FDA has initiated a complete review of all available data. FDA has asked the manufacturers of all marketed antidepressants to identify all placebo-controlled clinical trials conducted in adults in their development programs for their antidepressant products, regardless of the indication studied, and to provide information from these trials to FDA. Manufacturers are being asked to use a similar approach to assembling this information as was used in evaluating the risk of suicidality in placebo-controlled trials in pediatric patients treated with antidepressant medications.
This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.
- Regulatory History of fluoxetine from Drugs@FDA
Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.