WARNING
Suicidality and Antidepressant Drugs — Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short–term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of SARAFEM or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short–term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SARAFEM is not approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD). (See WARNINGS, PRECAUTIONS, Information for Patients, and PRECAUTIONS, Pediatric Use.)
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SARAFEM SUMMARY
SARAFEM®
fluoxetine hydrochloride
SARAFEM® (fluoxetine hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) for oral administration; fluoxetine was initially developed and marketed as an antidepressant (Prozac®, fluoxetine capsules, USP). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p -tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NO•HCl.
SARAFEM is indicated for the treatment of premenstrual dysphoric disorder (PMDD).
The efficacy of fluoxetine in the treatment of PMDD was established in 3 placebo–controlled trials (see CLINICAL TRIALS).
The essential features of PMDD, according to the DSM–IV, include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating, and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant.
The effectiveness of SARAFEM in long-term use, that is, for more than 6 months, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use SARAFEM for extended periods should periodically reevaluate the long–term usefulness of the drug for the individual patient.
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NEWS HIGHLIGHTSMedia Articles Related to Sarafem (Fluoxetine)
Prozac improves learning and memory in Huntington's disease
Source: The Doctors Lounge - Neurology
Scientists in Melbourne found that fluoxetine improves depression, learning and memory in Huntington's disease.
Published Studies Related to Sarafem (Fluoxetine)
Randomized, controlled clinical trial of the efficacy of fluoxetine for treatment of compulsive disorders in dogs. [2009.09.15]
OBJECTIVE: To evaluate efficacy of fluoxetine hydrochloride for treatment of compulsive disorders in dogs... The present study did not examine whether fluoxetine was more efficacious than or synergistic with behavioral and environment modifications.
A randomized double-blind clinical trial on analgesic efficacy of fluoxetine for persistent somatoform pain disorder. [2009.09.04]
OBJECTIVES: To verify the efficacy and safety of fluoxetine in treating patients with persistent somatoform pain disorder (PSPD)... CONCLUSIONS: Fluoxetine has a better analgesic effect than a placebo in treating persistent somatoform pain disorder, and is considered a safe treatment; its analgesic effect may be related to an antidepressant effect.
Homeopathic Individualized Q-potencies versus Fluoxetine for Moderate to Severe Depression: Double-blind, Randomized Non-inferiority Trial. [2009.08.17]
Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies)] in acute depression, using fluoxetine as active control... This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of outpatients with moderate to severe depression.
Combination of acupuncture and fluoxetine for depression: a randomized, double-blind, sham-controlled trial. [2009.08]
BACKGROUND AND OBJECTIVE: The current pharmacological management of depression remains limited. The aim of this study was to assess the efficacy and safety of acupuncture in combination with fluoxetine as an intervention for major depressive disorder (MDD). SUBJECTS AND INTERVENTIONS: A total of 80 patients with MDD (DSM-IV) were randomized to two groups: VA group received verum acupuncture, 10 mg/day fluoxetine and placebo; SA group received sham acupuncture and 20-30 mg/day fluoxetine. Acupuncture was applied 5 times a week over a period of 6 weeks... CONCLUSIONS: Additionally applied standardized acupuncture to low-dose fluoxetine for depression is as effective as a recommended dose of fluoxetine treatment. Depressive patients with severe anxious symptoms and/or intolerable side-effects of antidepressants can benefit from it.
Effectiveness and safety of the combination of fluoxetine and olanzapine in outpatients with bipolar depression: an open-label, randomized, flexible-dose study in Puerto Rico. [2009.08]
We studied the effectiveness of olanzapine/fluoxetine combination (OFC) treatment of bipolar depressive episode (7 weeks, study period 1 [SP1]). Study period 1 responders (mean modal daily OFC dosage, 10.8/27.8 mg) were randomized to OFC continuation treatment or olanzapine (OLZ) monotherapy starting at 10 mg (12 weeks, SP2)...
Clinical Trials Related to Sarafem (Fluoxetine)
The Study of Olanzapine Plus Fluoxetine in Combination for Treatment of Treatment Resistant Depression [Completed]
The purposes of this study are to determine:
- Whether olanzapine plus fluoxetine in combination will help patients with
treatment-resistant major depression.
- The safety of olanzapine plus fluoxetine in combination, plus and any side effects that
might be associated with the combination.
- The effectiveness of olanzapine plus fluoxetine compared to olanzapine and fluoxetine
alone.
Olanzapine/Fluoxetine Combination Versus Comparator in the Treatment of Bipolar I Depression [Completed]
Effect of Fluoxetine (Prozac) on Domestic Violence [Active, not recruiting]
This study will evaluate whether fluoxetine (Prozac), used together with traditional
psychotherapy, can reduce aggression in people who are physically violent towards their
spouses or significant others. Treatment for domestic violence has centered on behavioral
therapies, such as anger management and self-control exercises. Recent studies have shown
that fluoxetine-a drug commonly used to treat depression and panic disorder-can decrease acts
of aggression.
Men and women between the ages of 18 and 65 who have a history of inflicting physical
aggression on a spouses or significant others in the past year (with at least one episode
occurring not under the influence of alcohol) may be eligible for this study. Participants
spouses or significant others will also be asked to participate. All potential participants
will be screened with a medical and psychiatric evaluation and history, breath alcohol
analysis, blood tests, urine drug screen and electrocardiogram.
Those enrolled will undergo the following procedures:
Perpetrator
- Interview and questionnaires - Participants will be interviewed by a social worker about
past and current mental health and use of alcohol and illicit drugs and will complete
questionnaires assessing emotional state and personality, depression, anxiety,
aggression and alcohol consumption. Some of the questionnaires will be repeated at
monthly intervals.
- Physical performance testing - Performance and speed will be measured in three separate
training sessions that involve repeatedly pressing a button on a button box console,
earning points worth money.
- Dyadic interaction paradigm - Participants will interact with their spouse/significant
other in a small room, first discussing a neutral topic, such as the day's events, and
then a subject that has been a source of conflict.
- Fluoxetine administration - Participants will be randomly assigned to receive either 10
mg. of fluoxetine or placebo (identical capsules with no active ingredients) once a day
for 3 days, then twice a day, increasing up to four capsules a day if there are no
serious side effects. Blood will be drawn once a month to measure drug levels. At the
end of 3 months, participants taking placebo may remain in the study and receive
fluoxetine.
- Clinic visits - Participants are followed in the clinic weekly for the first month, then
twice a month for the next 2 months for adjustment of number of pills, evaluation of
aggressive behavior and alcohol consumption, and therapy for issues of self-esteem,
anger management and communication skills. Couples therapy aimed at conflict resolution
and improving communication skills will be offered.
- Genetic tests (optional) - Blood will be drawn to determine if there is a relationship
between genes involved in a chemical process (serotonin reuptake) that is influenced by
fluoxetine and the participant's response to the drug.
Spouse/Significant other:
Spouses/significant others will complete several questionnaires once a month (total 4 times)
to rate their partners' behavior while in the study. They will also participate in the
dyadic interaction paradigm described above at the beginning and end of the study.
Fluoxetine Vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD) [Completed]
The purpose of this study is to compare two treatments for post-traumatic stress disorder
(PTSD): fluoxetine (an antidepressant) and Eye Movement Desensitization and Reprocessing
(EMDR, a psychological treatment in which the patient is led through the memory of a
traumatic experience in order to heal him/herself).
There are a variety of therapies used to treat PTSD, but the effectiveness of medication
alone vs an exposure treatment, such as EMDR, has not been tested.
Patients will be assigned randomly (like tossing a coin) to one of three groups for 8 weeks
of treatment. Group 1 will receive fluoxetine; Group 2 will receive EMDR; and Group 3 will
receive inactive placebo. Patients will then stop treatment and have evaluations, including
psychological tests, at the time treatment is stopped, 8 weeks later, and at 6 months.
An individual may be eligible for this study if he/she:
Has PTSD and is 18 to 65 years old.
Efficacy of Fluoxetine in Reducing Ictal Hypoventilation in Patients With Partial Epilepsy [Recruiting]
The purpose of this study is to determine the effects of fluoxetine on breathing mechanisms
during seizures. Patients with partial epilepsy commonly have changes in their breathing
mechanisms during seizures. These changes may increase the risk of serious side effects
from seizures, including sudden unexplained death in epilepsy (SUDEP), which affects 2-10
per 1000 patients with epilepsy each year. Fluoxetine (Prozac) may help to stimulate
breathing through its actions in the brain and has been shown to improve breathing changes
seen with seizures in certain animals. Fluoxetine is in a class of medications called
selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of
serotonin, a natural substance in the brain, at synapses, the junctions at which nerve cells
in the brain communicate. Fluoxetine is currently approved by the United States Food and
Drug Administration (FDA) for the treatment of patients with Major Depressive Disorder,
Obsessive Compulsive Disorder, Bulimia Nervosa, Panic Disorder and Premenstrual Dysphoric
Disorder.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 6 ratings/reviews, Sarafem has an overall score of 8.33. The effectiveness score is 8.33 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Sarafem review by 59 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | 40 mg taken once daily for the period of 13 years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | stabilized mood, allowed for clearer thinking, improved sleep pattern, felt less anxious, made world look bright again. |
| Side effects: | | none -- no weight loss unfortunately |
| Comments: | | Started with 20 mg once daily. This worked for several years. When spouse endured 3 years of life-threatening illness, the dosage was increased to 40 mg taken as 2 20mg pills. |
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| | Sarafem review by care giver of 18 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Obsessive Compulsive Disorder |
| Dosage & duration: | | 60 mgs taken once a day for the period of ongoing for 3 years |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | Significant reduction in perseveration; increased flexibility; reduction in obsessions such as the weather leading to ability to cope better with daily events, unexpected changes, disappointments etc.and increased ability to interact more appropriately socially |
| Side effects: | | Some initial impact to sleep patterns, some weight gain |
| Comments: | | Initial dosage of 20 mgs, increased gradually to 60 mgs and maintained at that level have helped significantly with obsessions and impact of adolescence. |
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| | Sarafem review by 27 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | 40 mg taken once per day for the period of 4 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Releived moderate depression initially, and helped with anger and irritability control. |
| Side effects: | | Sleeping too much, night sweats, vivid dreams, felt emotionally numb, cravings for carbohydrates and overeating, and had decreased libido. |
| Comments: | | Started on 20 mg dose for 2 weeks, then increased to 40 mg. After 4 months the benefits decreased dramatically so switched to another drug, bupropion, but still taking 20 mg of fluoxetine daily. |
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Page last updated: 2009-10-20
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