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and facts about LUVOX CR.
What Is Obsessive Compulsive Disorder (OCD)?
Obsessive compulsive disorder (OCD) is a common psychiatric disorder, affecting approximately 2.2 million American adults each year.[1][2]
OCD causes afflicted individuals marked distress, occupies much of their time, and interferes with normal routines, productivity at work or school, and social relationships.[3] People with OCD often go several years without treatment. One recent study found that it took on average more than 17 years after first experiencing OCD symptoms for people to receive treatment.[4]
OCD causes people to experience unwanted, intrusive thoughts (obsessions) that can prompt them to carry out repeated actions (compulsions) to reduce the anxiety produced by those thoughts.[3] Common obsessions include excessive fear of contamination, repeated doubts (such as thinking you've harmed someone while driving), a need for ordering and symmetry, and aggressive or horrific impulses. Common compulsions include repeated cleaning (such as hand-washing), repeated checking (such as checking to see if doors are locked), and counting.[3]
Even though it may feel like an extension of normal worries, OCD is a serious, chronic and debilitating anxiety disorder.[3][5] One difference between normal worries and OCD is how much time these behaviors or rituals take out of your day, and how much distress they cause you. People with OCD recognize that their thoughts are irrational, but can't stop them.[3] Treatment with medication and specific types of behavior modification may help reduce some OCD symptoms.[5]
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).
Important Safety Information
CONTRAINDICATIONS
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.
ADVERSE EVENTS
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.
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 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:
- ^ National Institute of Mental Health. The Numbers Count: Mental Disorders in America. Available at: http://www.nimh.nih.gov/health/publications/the-numbers-count-mental-disorders-in-america.shtml. Accessed January 10, 2008.
- ^ Kessler RC, et al. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication (NCS-R). Archives of General Psychiatry. 2005;62:617-27.
- ^ American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision. Washington, DC: American Psychiatric Association; 2000.
- ^ Pinto A, et al. The Brown Longitudinal Obsessive Compulsive Study: clinical features and symptoms of the sample at intake. Journal of Clinical Psychiatry. 2006;67:703-11.
- ^ American Psychiatric Association; Koran LM, et al. Practice guideline for the treatment of patients with obsessive-compulsive disorder. American Journal of Psychiatry. 2007;164(suppl):1-56.
LUVOX is a registered trademark of Solvay Pharmaceuticals, Inc.
© 2008 Jazz Pharmaceuticals, Inc.
