We all worry about what other people think of us, but some people have a deep fear of social situations that might cause embarrassment. For them, occasions such as attending parties or meetings, eating in front of others, having conversations with others, and/or public speaking can trigger intense discomfort.[1][2] People who experience this fear often try to avoid these types of situations, and when they do engage in social activities, they can suffer a great deal, feeling physical symptoms such as gastrointestinal discomfort, sweating, tremors, or heart palpitations.[1]
Patients with SAD often view their fears as a social problem or as shyness.[3] However, intense anxiety in social situations can be a hallmark symptom of social anxiety disorder, or SAD, also known as social phobia. SAD is a chronic, debilitating psychiatric condition in which you experience abnormal fear in social situations.[1] SAD affects approximately 15 million American adults each year, making it one of the most common psychiatric disorders in the U.S., along with major depression, alcohol abuse, and specific phobias.[4][5][6] SAD precedes a comorbid psychiatric condition in up to 77% of cases.[7][8] LUVOX CR® has not been proven in clinical trials to prevent or treat comorbid conditions.
SAD not only keeps people from enjoying being around others, it also affects many aspects of daily life. People with SAD may miss classes at school or meetings at work, or attend but not participate.[1] People with SAD may feel their disease significantly impacts their ability to function in school or at work.[9]
*LUVOX CR has not been shown to improve quality of life.
In one study, SAD was associated with notable disability, impacting physical and mental health, social interaction, and utilization of healthcare resources. This survey of 965 patients from 15 health clinics showed that those patients with SAD (n = 60) had worse health than patients without an anxiety disorder (n = 777). Furthermore, SAD patients experienced almost 3 times as many days with disability and visited their doctor more often than those without an anxiety disorder.[10]
SAD is under-diagnosed and often goes untreated unless other disorders are present.[7] Unfortunately, SAD is frequently not identified and according to one study, 97% of patients go untreated within 1 year of onset.[11]
Once-A-Day LUVOX CR® (fluvoxamine maleate) Extended-Release Capsules are indicated for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD).
The use of alosetron, tizanidine, thioridazine, or pimozide with LUVOX CR Capsules is contraindicated. The use of MAO inhibitors in combination with LUVOX CR Capsules, or within 14 days of discontinuing treatment with LUVOX CR Capsules, is contraindicated (see WARNINGS and PRECAUTIONS). LUVOX CR Capsules are also contraindicated in patients with a history of hypersensitivity to fluvoxamine maleate or any of its excipients.
In clinical trials, the most commonly observed adverse events with an incidence of ≥5% and at least twice that of placebo were nausea, somnolence, asthenia, diarrhea, anorexia, tremor, and sweating. Overall, these side effects were mild to moderate in severity and transient in nature. Other common adverse events (≥5% and at least twice that of placebo) included abnormal ejaculation and anorgasmia.
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 LUVOX CR® (fluvoxamine maleate) Extended-Release Capsules 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. LUVOX CR Capsules are not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)
Please see full prescribing information, including boxed warning, for LUVOX CR.
References:
LUVOX CR is a registered trademark of Solvay Pharmaceuticals, Inc.
© 2008 Jazz Pharmaceuticals, Inc.