Luvox Adverse Reactions
- agitation
- akathisia
- amblyopia
- amnesia
- anorexia
- anxiety
- asthenia
- blurred vision
- chills
- constipation
- depression
- diaphoresis
- diarrhea
- dizziness
- drowsiness
- dysmenorrhea
- dyspepsia
- dyspnea
- edema
- ejaculation dysfunction
- elevated hepatic enzymes
- fatigue
- flatulence
- flushing
- headache
- hyperkinesis
- hypertension
- hyponatremia
- hypotension
- impotence
- increased urinary frequency
- insomnia
- malaise
- mania
- myoclonia
- nausea/vomiting
- palpitations
- priapism
- psychosis
- rash (unspecified)
- rhinitis
- seizures
- serotonin syndrome
- SIADH
- sinus tachycardia
- sinusitis
- suicidal ideation
- syncope
- tremor
- urinary retention
- weakness
- weight gain
- weight loss
- withdrawal
- xerostomia
- yawning
Luvox (Fluvoxamine) Adverse Reactions
In general, adverse events occurring with fluvoxamine are similar, even when used for different clinical uses. Also, adverse event rates are similar between the adult and pediatric populations in most cases. The most commonly observed events associated with the use of fluvoxamine and which occur at an incidence of >= 5% in both adults and children and at least twice the rate of placebo include: asthenia/weakness; diaphoresis (sweating); dyspepsia; insomnia; nausea/vomiting; somnolence (sedation and/or drowsiness); nervousness; and tremor. In men, ejaculation dysfunction (mostly as delayed ejaculation) is noted in >= 8% of males receiving fluvoxamine vs. 1% on placebo. In patients with obsessive-compulsive disorder (OCD), the following additional events occur in >= 5% fluvoxamine-treated patients: dysgeusia; xerostomia; libido decrease; orgasm dysfunction; rhinitis; and increased urinary frequency. Additional common side effects noted in >= 5% of children receiving fluvoxamine for OCD included: agitation; depression; dysmenorrhea (females only); flatulence; hyperkinesis; and rash (unspecified).
Treatment emergent adverse events associated with fluvoxamine and occurring at a rate greater versus placebo, respectively, for the body as a whole included: headache (22% vs. 20%); asthenia (14% vs. 6%), flu-like symptoms (3% vs. 2%) and chills (2% vs. 1%).
Gastrointestinal complaints are commonly reported during fluvoxamine therapy. Nausea and vomiting are the most common GI side effects of fluvoxamine, as mentioned above, and occur in about 40% and 5% of patients, respectively. Nausea usually subsides after a few weeks of therapy but may be severe enough to necessitate discontinuation of the drug in roughly 9% of patients. The following GI events may occur with fluvoxamine versus placebo, respectively, at the following incidences: constipation (10% vs. 8%), diarrhea (11% versus 7%), dyspepsia (10% versus 5%), flatulence (4% versus 3%), tooth disorders (3% versus 1%) and anorexia (6% versus 2%).
Adverse CNS reactions may occur in patients receiving fluvoxamine. Drowsiness (somnolence) is the most commonly reported CNS effect. According to the manufacturer’s product literature, somnolence occurred in 22% of subjects taking fluvoxamine versus 8% of patients taking placebo. Some CNS effects may diminish with continued therapy. Sedation is generally less of a problem with fluvoxamine than with tricyclic antidepressants, but is more common than with other SSRIs (e.g., fluoxetine, sertraline). Patients should exercise caution during activities requiring mental alertness until the effects of the drug are known. Other CNS events may occur with fluvoxamine versus placebo, respectively, at the following incidences: insomnia (21 % vs. 10%); xerostomia (14% vs. 10%); nervousness (12 % vs. 5%); dizziness (11 % vs. 6%); tremor (5% vs. 1%); anxiety (5% vs. 3%); and vasodilatation, reported as flushing or feeling hot/warm (3% vs. 1%). In addition, the following adverse events are reported in 2% of those receiving fluvoxamine versus 1% receiving placebo: hypertonia, agitation, libido decrease, depression, and CNS stimulation.
Fluvoxamine is substantially less cardiotoxic than the tricyclic antidepressants. The only cardiovascular side effects reported during controlled clinical trials include palpitations (3% vs. 2% for placebo). Fluvoxamine has not demonstrated clinically important changes in blood pressure, heart rate, or ECG changes in controlled clinical trials.
During initial clinical trials impotence was reported in 2% of male patients receiving fluvoxamine vs. 1% of those receiving placebo. Priapism has been reported rarely with all of the SSRIs. Similar to the experience with other SSRIs, it is possible that a higher incidence of sexual dysfunction will be reported during post-marketing experience with fluvoxamine. Other urogenital adverse events reported include urinary retention and increased urinary frequency.
Respiratory adverse events reported with fluvoxamine, relative to placebo, include upper respiratory tract infection ( 9% vs. 5%); dyspnea (2% vs. 1%); and increased yawning (2% vs. 0%). Disorders of the special senses due to fluvoxamine, relative to placebo, include amblyopia, mostly as blurred vision (3% vs. 2%), and dysgeusia or other taste perversion (3% vs. 1%). Skin reactions include diaphoresis (increased sweating) in 7% vs. 3%.
The following adverse events have also been reported to occur in 1% of fluvoxamine treated patients suffering from OCD or major depressive disorder, but without regard to causality: The following events are listed by body system. Body as a whole: accidental injury (falls, etc.) and malaise. Cardiovascular system: hypertension, hypotension, sinus tachycardia, syncope. Gastrointestinal: fluvoxamine-induced elevated hepatic enzymes. Metabolic and nutritional: edema, weight gain, weight loss. Nervous system: amnesia, apathy, hyperkinesia, hypokinesis, manic reaction, myoclonia, and psychosis. Respiratory: increased cough, sinusitis. Additional reported infrequent side effects (0.1 - 1% of patients) and rare events (<= 0.1% of patients) in which a causal relationship to fluvoxamine has not been established are listed in the manufacturer’s prescribing information.
A rarely reported adverse reaction associated with use of fluvoxamine is the syndrome of inappropriate secretion of antidiuretic hormone (SIADH). SIADH presents as hyposmolarity of serum and urine, and hyponatremia. Drug-induced SIADH is a potential side effect of any SSRI. The effect is usually reversible with drug discontinuation.
During pre-marketing studies with fluvoxamine, seizures occurred in roughly 0.2% of patients. Fluvoxamine should be discontinued in any patient who develops seizures while on fluvoxamine therapy.
Withdrawal symptoms have been reported with abrupt or rapid discontinuation of short-acting SSRIs such as fluvoxamine. The most commonly reported withdrawal symptoms include fatigue, abdominal pain or nausea, dizziness/light-headedness, tremor, chills, diaphoresis, and incoordination. Other reported symptoms include impaired memory, insomnia, shock sensations, headache, and agitation or aggression. Withdrawal symptoms usually begin 1 - 3 days after abrupt discontinuation of the SSRI and remit within 1 - 2 weeks. Gradual tapering is recommended during discontinuation of any SSRI to decrease or prevent the occurrence of withdrawal symptoms.
Serotonin syndrome has been reported when SSRIs are administered concomitantly with other medications known to increase CNS or peripheral serotonin levels or during SSRI overdose. In overdose, fluvoxamine may induce lethargy, mydriasis, bradycardia, coma, seizures, abnormal ECG changes, liver function abnormalities, tachycardia, and vomiting. The symptoms seen may be dependent upon concomitant ingestion of other substances. Close monitoring of the patient is essential in the initial stages of therapy. Initiate therapy with a low dose and titrate dose upwards as clinically indicated.All effective antidepressants can transform depression into mania or hypomania in predisposed individuals (including those with depression or bipolar disorder). With fluvoxamine, manic reactions occur in roughly 1/100 patients. If a manic reaction occurs, the antidepressant should be held and appropriate therapy to treat the manic symptoms initiated.
Suicidal ideation has been reported in antidepressant clinical trials. The symptoms of aggressiveness, akathisia (psychomotor restlessness), agitation, anxiety, insomnia, irritability, hostility, mania, hypomania, impulsivity, and panic attacks have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidal ideation. A change or discontinuation of the therapeutic regimen should especially be considered if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Many of these adverse symptoms have been reported in clinical trials and have not always been associated with suicidality. Rapid discontinuation of SSRIs may also result in many of these adverse CNS events.
[ Last revised: 11/10/2005 4:44:00 PM ]
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