There are 10 types of childhood trauma measured in the ACE Study. Five are personal — physical abuse, verbal abuse, sexual abuse, physical neglect, and emotional neglect. Five are related to other family members:
There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, 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.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia psychomotor restlessnesshypomania, and mania, 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.
Discontinuation of Treatment With Paxil, for a description of the risks of discontinuation of Paxil. Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers.
Such monitoring should include daily observation by families and caregivers. Prescriptions for Paxil should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
Screening Patients for Bipolar Disorder: A major depressive episode may be the initial presentation of bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
It should be noted that Paxil is not approved for use in treating bipolar depression. The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Paxil, alone but particularly with concomitant use of other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St.
Serotonin syndrome symptoms may include mental status changes e. Patients should be monitored for the emergence of serotonin syndrome. Paxil should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue.
No reports involved the administration of methylene blue by other routes such as oral tablets or local tissue injection or at lower doses.
There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Paxil.
If concomitant use of Paxil with certain other serotonergic drugs, i. Treatment with Paxil and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated. Potential Interaction With Thioridazine: Thioridazine administration alone produces prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsade de pointes—type arrhythmias, and sudden death.
This effect appears to be dose related.
An in vivo study suggests that drugs which inhibit CYP2D6, such as paroxetine, will elevate plasma levels of thioridazine. Epidemiological studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations.
The findings from these studies are summarized below: No increase in the risk of overall congenital malformations was seen in the paroxetine-exposed infants.
The cardiac malformations in the paroxetine-exposed infants were primarily ventricular septal defects VSDs and atrial septal defects ASDs. Septal defects range in severity from those that resolve spontaneously to those which require surgery.
This study showed a trend towards an increased risk for cardiovascular malformations for paroxetine risk of 1. Of the 12 paroxetine-exposed infants with cardiovascular malformations, 9 had VSDs. In one study the odds ratio was 2.Hepatotoxicity: The Adverse Effects of Drugs and Other Chemicals on the Liver [Hyman J.
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Subgroup analyses did not indicate that there were any differences in treatment outcomes as a function of age or gender. The long‑term maintenance effects of Paxil in OCD were demonstrated in a long‑term extension to Study 1.