Luvox (Fluvoxamine) Contraindications and Precautions
- abrupt discontinuation
- bipolar disorder
- breast-feeding
- cardiac disease
- children
- dehydration
- driving or operating machinery
- elderly
- electroconvulsive therapy (ECT)
- hepatic disease
- hyponatremia
- mania
- pregnancy
- seizure disorder
- seizures
- suicidal ideation
- tobacco smoking
Luvox Contraindications and Precautions
Fluvoxamine is contraindicated in those patients with a hypersensitivity to the drug or any of the formulation components.
Avoid abrupt discontinuation of any SSRI if possible. Gradual tapering is recommended during discontinuation of any SSRI to decrease or prevent the occurrence of potential withdrawal-like symptoms.
All effective antidepressants can transform depression into mania or hypomania in predisposed individuals. The usual presentation of this switch is the sudden appearance of insomnia. If a patient develops manic symptoms, fluvoxamine should be held and appropriate therapy initiated to treat the manic symptoms. All patients should be adequately screened for bipolar disorder prior to the initiation of fluvoxamine for any indication.
Currently, fluoxetine (i.e., Prozac®) is the only antidepressant that is labeled for use in pediatric depression. The possibility of a suicide attempt is inherent in patients with depressive symptoms, whether these occur in primary depression or in association with another primary disorder such as obsessive-compulsive disorder (OCD). Patients with a history of suicidal ideation and who are at high risk for suicide attempt should be closely supervised during drug therapy with fluvoxamine. In addition, fluvoxamine should be prescribed in the smallest quantity consistent with good patient management in order to reduce the risk of overdose. Caretakers of patients receiving treatment with any antidepressant should talk to their health care provider before stopping the use of these drugs; some antidepressants should not be abruptly discontinued. In October, 2004, the FDA directed manufacturers of all antidepressants to include a Black Box warning detailing the risk of suicide in pediatric patients. A causal role for antidepressants in inducing suicidality has been established in pediatric patients. Although fluvoxamine data were reviewed, it should be noted that it is not approved for the treatment of depression in the US. However, fluvoxamine has been used ‘off-label’ for the treatment of depression. The risk of suicidality for these drugs was identified in a pooled analysis of 24 placebo-controlled trials (n=4400) lasting up to 16 weeks in pediatric patients with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders. The analysis showed a greater risk of suicidality during the first few months of treatment in those receiving antidepressants (SSRIs and others). The average risk of such events on drug was 4% and 2% for placebo; however, no suicides occurred in these trials. Based on these data, FDA has determined that the following points are appropriate for inclusion in the boxed warning: antidepressants increase the risk of suicidal thinking and behavior (suicidality) in pediatric patients with MDD and other psychiatric disorders (OCD, social anxiety disorder); anyone considering the use of an antidepressant in a pediatric patient for any clinical use must balance the risk of increased suicidality with the clinical need; patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior, particularly within the first few months of starting therapy or at the time of dose increases or decreases; such observation would generally include at least weekly face-to-face contact with patients, family members or caregivers during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks; additional contact by telephone may be appropriate between face-to-face visits; adults with MDD or co-morbid depression in the setting of other psychiatric illness being treated with antidepressants should be observed similarly for clinical worsening and suicidality, especially during the initial few months of a course of drug therapy, or at times of dose changes; families and caregivers should be advised to closely observe the patient (adult or child) on a daily basis for the emergence of agitation, irritability, unusual changes in behavior, emergence of suicidality, and to communicate immediately with the prescriber. It is unknown if the suicidality risk in pediatric patients extends to longer-term therapy (i.e., beyond several months) or to adult patients. In patients who exhibit changes in symptoms (see Adverse Events), worsening of depression or emergent suicidality, a decision should be made to change or discontinue treatment. If discontinuing, medication should be tapered as rapidly as possible, but with recognition that abrupt discontinuation can also cause adverse symptoms. A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described represent such a conversion is unknown. Patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder prior to initiating treatment. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that fluvoxamine is not approved for use in treating bipolar depression.
Fluvoxamine is contraindicated for concomitant use in patients receiving MAO inhibitor therapy (see Drug Interactions). Fluvoxamine’s effects during electroconvulsive therapy (ECT) have not been evaluated in clinical studies to date.
Fluvoxamine should be used with caution in patients with a history of seizure disorder. Seizures occurred in a small percentage of patients in clinical trials. If drug-induced seizures occur, the drug should be discontinued.
Fluvoxamine should be used with caution in patients with hepatic disease because metabolism can be delayed. Either lower doses or less frequent dosing may be necessary. Fluvoxamine is also known to inhibit hepatic cytochrome P450 isoenzymes, which may lead to clinically significant drug interactions. The use of certain medications with fluvoxamine is contraindicated (see Drug Interactions).
Tobacco smoking increases the metabolism of fluvoxamine. Smokers have a 25% increase in metabolism over non-smokers.
Fluvoxamine should be used with caution in elderly patients. Pharmacokinetic data indicates that fluvoxamine clearance is reduced by about 50% in the elderly. Although no difference in safety has been recorded, slow titration of initial and subsequent dosage is recommended in the elderly.
Although clinical trial data indicate that fluvoxamine is not associated with the development of clinically significant ECG changes, the use of fluvoxamine has not been systematically evaluated in patients with a recent history of myocardial infarction or unstable cardiac disease. The concurrent use of certain medications, which may cause alter cardiac conduction when combined with fluvoxamine, is contraindicated (see Drug Interactions).
Fluvoxamine can cause a syndrome of inappropriate secretion of antidiuretic hormone (SIADH) that presents as hyposmolarity of serum and urine, and hyponatremia. Elderly patients and those receiving diuretics (i.e., dehydration) appear to be at greatest risk for hyponatremia. Monitor serum electrolytes and other indicators of SIADH periodically during drug therapy.
Fluvoxamine is classified as FDA pregnancy category C. Animal teratology studies with fluvoxamine have failed to show an increased risk of fetal malformations at doses twice the maximum human daily dose on a mg/m2 basis. However, an increase in pup deaths during the first few days after birth has been noted in animal studies where fluvoxamine was initiated in the last trimester of gestation and continued during lactation. Decreased pup birth weight and survival have also been noted. These changes occurred at doses near the normal maximum human dose on a mg/m2 basis. Animal studies have also shown that SSRIs downregulate serotonin receptors in the fetal cortex and that these changes can be present for a period of time after birth. A prospective, human cohort study was conducted to evaluate the outcome of neonates born to 267 women who took an SSRI during pregnancy (of whom 26 took fluvoxamine). Compared with a neonatal control group, SSRI-exposed neonates had similar rates of major malformation, spontaneous and elective abortion, and stillbirth. In addition, mean birth weight and gestational age were similar among the two groups of neonates. The manufacturer recommends the use of fluvoxamine in pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus.
Fluvoxamine should be used with caution in breast-feeding mothers because, although minimal, fluvoxamine is excreted into breast milk. Preliminary studies suggest that roughly 0.5% of the maternal daily dose could be ingested by a breast-feeding infant. Other SSRIs have been reported to induce changes in sleeping or eating patterns in the breast-fed infant. Patients should advise their physician of their intention to breast-feed. The American Academy of Pediatrics has suggested that SSRI use during breast-feeding may be of concern. If breast-feeding is continued, the infant should be observed for evidence of adverse effects, and breast-feeding should be avoided at times of peak serum concentrations. Alternatively, discontinuation of fluvoxamine during lactation or the use of formula for infant feeds may be indicated.
Because any psychoactive drug may impair judgment, thinking, or motor skills, patients should use caution when driving or operating machinery, until they are reasonably certain that fluvoxamine does not affect them adversely. The US olympic committee has only banned the use of the SSRI-type antidepressants in sporting events that involve rifelry.
Fluvoxamine was the first SSRI to receive FDA approval in children for the treatment of obsessive-compulsive disorder (OCD). Safe and effective use in children under 8 years of age has not been established. Decreased appetite and weight loss may occur in children receiving SSRIs; regular monitoring of weight and growth are recommended throughout treatment. The risks of extensive durations of use of fluvoxamine on the growth, development, or maturation of children or adolescents have not been assessed. However, there is no evidence available to date to suggest an adverse effect. However, the absence of data does not necessarily correlate to a lack of adverse effects with chronic use. In October, 2004, the FDA directed manufacturers of all antidepressants to include a Black Box warning detailing the risk of suicide in pediatric patients. A causal role for antidepressants in inducing suicidality has been established in pediatric patients (see Contraindications, suicidal ideation). Pediatric patients should be monitored closely for the risk of suicide with any antidepressant medication. Among the antidepressants, only fluoxetine (i.e., Prozac®) is approved for use in treating depression in pediatric patients. Fluoxetine, sertraline, fluvoxamine, and clomipramine are approved for OCD in pediatric patients. None of the drugs is approved for other psychiatric indications in children. Pediatric patients being treated with antidepressants for any indication should be observed daily by caregivers for clinical worsening, as well as agitation, irritability, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. If concerns arise, contact with health care providers should be made immediately. Antidepressants should be prescribed in the smallest quantity consistent with good patient management in order to reduce the risk of overdose. A patient Medication Guide about using antidepressants in children and adolescents is available. Health care providers should instruct patients and caregivers to read the guide and discuss any questions with them.
[ Last revised: 4/26/2005 12:54:00 PM ]
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