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Seizures During premarketing testing, seizures occurred in 0.1% of patients treated with PAXIL, a rate similar to that associated with other drugs effective in the treatment of major depressive disorder. PAXIL should be used cautiously in patients with a history of seizures. It should be discontinued in any patient who develops seizures. Suicide Text Continues Below
The possibility of a suicide attempt is inherent in major depressive disorder and may persist until significant remission occurs. Close supervision of high-risk patients should accompany initial drug therapy. 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. Because of well-established comorbidity between major depressive disorder and other psychiatric disorders, the same precautions observed when treating patients with major depressive disorder should be observed when treating patients with other psychiatric disorders. Discontinuation of Treatment With PAXIL Recent clinical trials supporting the various approved indications for PAXIL employed a taper-phase regimen, rather than an abrupt discontinuation of treatment. The taper-phase regimen used in GAD and PTSD clinical trials involved an incremental decrease in the daily dose by 10 mg/ day at weekly intervals. When a daily dose of 20 mg/ day was reached, patients were continued on this dose for 1 week before
treatment was stopped. With this regimen in those studies, the following adverse events were reported at an incidence of 2% or greater for PAXIL and were at least twice that reported for placebo: Abnormal dreams (2.3% versus 0.5%), paresthesia (2.0% versus 0.4%), and dizziness (7.1% versus 1.5%). In the majority of patients, these events were mild to moderate and were self-limiting and did not require medical intervention. During marketing of PAXIL, there have been spontaneous reports of similar adverse events, which may have no causal relationship to the drug, upon the discontinuation of PAXIL (particularly when abrupt), including the following: Dizziness, sensory disturbances (e. g., paresthesias such as electric shock sensations), agitation, anxiety, nausea, and sweating. These events are generally self-limiting. Similar events have been reported for other selective serotonin reuptake inhibitors. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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