Zoloft Contraindications and Precautions
Zoloft (Sertraline) Contraindications / Precautions
- abrupt discontinuation
- anorexia nervosa
- bipolar disorder
- bleeding
- breast-feeding
- cardiac disease
- children
- dehydration
- diabetes mellitus
- driving or operating machinery
- elderly
- electroconvulsive therapy (ECT)
- hepatic disease
- hyponatremia
- mania
- neonates
- pregnancy
- renal failure
- seizure disorder
- seizures
- suicidal ideation
Sertraline Contraindications/Precautions
Sertraline is contraindicated in those patients with a hypersensitivity to sertraline 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. The optimal timing of switching from other SSRIs or serotonergic agents to sertraline is not known. Use caution when switching drugs, especially if an agent with a long half-life has been utilized previously.
All effective antidepressants can transform depression into mania or hypomania in predisposed individuals (i.e., patients with bipolar disorder). If a patient develops manic symptoms, sertraline should be held and appropriate therapy initiated to treat the manic symptoms.
Sertraline is not FDA-approved for the treatment of depression in pediatric patients. 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 OCD. Patients with suicidal ideation, including both adult and pediatric patients, should be closely supervised, whether or not they are taking an antidepressant. In addition, all antidepressants should be prescribed in the smallest quantity consistent with good patient management in order to reduce the risk of overdose. 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. 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, 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 sertraline is not approved for use in treating bipolar depression.
Sertraline is contraindicated for concomitant use in patients receiving MAO inhibitor therapy. Sertraline should not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI.
Sertraline should be used with caution in patients with a history of seizure disorder. Seizures have been reported rarely in patients taking SSRIs; however, they have occurred primarily in cases of overdose. Sertraline’s effects during electroconvulsive therapy (ECT) have not been evaluated in clinical studies to date. Some clinicians have reported that in rare instances the ECT-induced seizure was prolonged in the presence of another SSRI (e.g., fluoxetine).
Although clinical trial data indicate that sertraline is not associated with the development of clinically significant ECG abnormalities, the use of sertraline has not been systematically evaluated in patients with a recent history of myocardial infarction or unstable cardiac disease.
Sertraline is extensively metabolized by the liver. In patients with chronic hepatic disease, sertraline clearance was reduced. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dosage should be used.
Sertraline is extensively metabolized and renal excretion of unchanged drug is only a minor route of elimination. No dosage adjustments have been recommended in patients with renal failure. Sertraline is associated with a mean decrease in serum uric acid of approximately 7%. The clinical significance of this weak uricosuric effect is unknown.
Sertraline can rarely precipitate a syndrome of inappropriate secretion of antidiuretic hormone (SIADH) that presents as hyposmolarity of serum and urine, and hyponatremia. The majority of these occurrences have been in elderly individuals, some in patients taking diuretics or who were otherwise volume depleted (i.e., dehydration).
Patients with diabetes mellitus should be treated with caution because sertraline can dysregulate glucose control. Dose adjustments of hypoglycemics may be necessary.
Because sertraline can cause weight loss, it should be used with caution in patients with anorexia nervosa or in other patients where weight loss is undesirable.
Sertraline is classified as FDA pregnancy category C. Animal teratology studies with sertraline have failed to show an increased risk of fetal malformations, however, an increase in stillbirths and pup deaths during the first few days after birth has been noted in animal studies where sertraline was initiated in the last trimester of gestation. 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; the effect on neurological development is unknown. The applicability of any of these findings to humans is also unknown. A prospective, cohort study was conducted to evaluate the outcome of infants born to 267 women who took an SSRI during pregnancy (of whom 147 took sertraline). Compared with a neonatal control group, SSRI-exposed infants 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 newborns. The manufacturer recommends the use of sertraline in pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus.
Neonates exposed to SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Symptoms have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome. When treating a pregnant woman with an SSRI or SNRI during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. If clinically feasible, and taking the half-life into consideration, tapering of the serotonergic agent prior to delivery may be considered.
Sertraline should be used with caution in breast-feeding mothers because of the excretion of the drug into breast milk. Patients should advise their physician of their intention to breast-feed. Because of its slow elimination, consideration should be given to the possible presence of the drug for a prolonged period after discontinuation of therapy. Other SSRIs (e.g., fluoxetine) have been observed to cause increased irritability, colic, vomiting, and decreased sleep in infants. The effects of sertraline on a breast-feeding infant are unknown. A few case reports of sertraline use in lactation are available and although low sertraline blood concentrations were detected, no adverse events in infants have been noted. 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.
The effectiveness of sertraline in pediatric patients with depression, panic disorder, or post-traumatic stress (PTSD) has not been systematically evaluated. Sertraline is efficacious for the treatment of OCD in children ages 6—18 years. Safety and effectiveness below the age of 6 years have not been established. The adverse event profile observed in children with OCD was generally similar to that observed in adult studies. 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 (> 1 year) of use of sertraline 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. 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, suicidal ideation). Pediatric patients should be monitored closely for the risk of suicide with any antidepressant medication. Among the antidepressants, only fluoxetine 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.
There have been several reports of abnormal bleeding (mostly ecchymosis and purpura) associated with sertraline treatment, including reports of impaired platelet aggregation. While a causal relationship to sertraline has not been established, impaired platelet aggregation may result from platelet serotonin depletion and may contribute to abnormal bleeding.
Because any psychoactive drug may impair judgement, thinking, or motor skills, patients should use caution when driving or operating machinery, until they are reasonably certain that sertraline 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.
[ Last revised: 5/27/2005 3:16:00 PM ]
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