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 SelfemraTM 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. SelfemraTM 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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SELFEMRA SUMMARY
SelfemraTM (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).
SelfemraTM 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 SelfemraTM 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 SelfemraTM 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 Selfemra (Fluoxetine)
SSRIs Offer Model For Drug Development Opportunities To Treat Rheumatoid Arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2010.02.26]
A new study found that fluoxetine (Prozac®) and citalopram (Celexa®) treatment significantly inhibited disease progression of collagen-induced arthritis (CIA) in mice. Research led by Sandra Sacre, Ph.D...
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 Selfemra (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 Selfemra (Fluoxetine)
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.
Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS) [Recruiting]
The purpose of this study is to compare the efficacy of calcium carbonate to fluoxetine in
the treatment of moderate to severe PMS. Second, to compare each active agent to a placebo
control. Third, to evaluate the efficacy of each treatment for specific symptom clusters
(i. e. affective and somatic). Fourth, to determine whether the addition of calcium to on
going fluoxetine treatment leads to additional therapeutic benefit.
Predictors of Treatment Response to Fluoxetine in PTSD Following a Recent History of War Zone Stress Exposure [Not yet recruiting]
Three hundred (300) male or female outpatients, over 18 years of age, will be enrolled in
this study to determine whether fluoxetine can be used as a treatment for Posttraumatic
Stress Disorder in soldiers recently returning from combat exposure. There will be two
phases to the study. In Phase I Fluoxetine + usual psychological care will be compared with
Placebo + usual psychological care over a 12-week period. Subsequently, in Phase II all
subjects will be offered the opportunity to enroll in a 20-week open-label trial on
Fluoxetine. If response is inadequate, adjunctive treatment with either buspirone or
buproprion will be offered. The investigational drugs are Fluoxetine, Buspirone and
Bupropion. All are commercially available.
Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment [Recruiting]
This will be a controlled, randomized, double-blind and double-dummy study on the treatment
augmentation strategy for obsessive compulsive disorder (OCD). The investigators will
compare the association of an SSRI (fluoxetine) with quetiapine, Selective serotonin
reuptake inhibitors (SSRI) with clomipramine and SSRI with placebo for 12 weeks.
Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS) [Recruiting]
The purpose of this study is first, to compare the efficacy of calcium carbonate to
fluoxetine in the treatment of moderate to severe PMS. Second, to compare each active agent
to a placebo control. Third, to evaluate the efficacy of each treatment for specific symptom
clusters (i. e. affective and somatic). Fourth, to determine whether the addition of calcium
to on going fluoxetine treatment leads to additional therapeutic benefit.
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Page last updated: 2010-02-26
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