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Prescribing Information
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Side Effects
Adverse Events
Source: [3]
In clinical trials, nausea was the most common adverse event, although typically mild to moderate in severity and transient in nature.[1]
Tolerability
Once-A-Day LUVOX CR provides tolerability in 2 common areas of concern[4][5]
In clinical trials...
- Weight-neutral profile: no significant weight gain or loss vs placebo[2][3][6][7]
- Low incidence of sexual adverse events
Less than 1% of patients treated with LUVOX CR discontinued therapy in clinical trials due to any individual sexual adverse event[2][3][6][7]
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:
- ^ Data on file. Jazz Pharmaceuticals, Inc., Palo Alto, CA.
- ^ Davidson J, Yaryura-Tobias J, DuPont R, et al. fluvoxamine-controlled release formulation for the treatment of generalized social anxiety disorder. J Clin Psychopharmacol. 2004;24:118-125.
- ^ LUVOX CR Prescribing Information. Jazz Pharmaceuticals, Inc., Palo Alto, CA; 2008.
- ^ Hirschfeld RMA. Long-term side effects of SSRIs: sexual dysfunction and weight gain. J Clin Psychiatry. 2003;64(suppl 18):20-24.
- ^ Bruce TJ, Saeed SA. Social anxiety disorder: a common, underrecognized mental disorder. Am Fam Physician. 1999;60:2311-2322.
- ^ Westenberg HGM, Stein DJ, Yang H, et al. A double-blind placebo-controlled study of controlled release fluvoxamine for the treatment of generalized social anxiety disorder. J Clin Psychopharmacol. 2004;24:49-55.
- ^ Hollander E, Koran LM, Goodman WK, et al. A double-blind, placebo-controlled study of the efficacy and safety of controlled-release fluvoxamine in patients with obsessive-compulsive disorder. J Clin Psychiatry. 2003;64:640-647.
LUVOX CR is a registered trademark of Solvay Pharmaceuticals, Inc.
© 2008 Jazz Pharmaceuticals, Inc.
