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Ird study of major depressive disorder, which focused on elderly patients (60 to 88 years), is presented separately as is the information from the panic disorder studies and the information from the PMDD studies. Information on additional adverse events associated with PAXIL CR and the immediate-release formulation of paroxetine hydrochloride is included in a separate subsection (see Other Events). Adverse Findings Observed in Short-Term, Placebo-Controlled Trials With PAXIL CR Adverse Events Associated With Discontinuation of Treatment: Major Depressive Disorder: Ten percent (21 212) of patients treated with PAXIL CR discontinued treatment due to an adverse event in a pool of 2 studies of patients with major depressive disorder. The most common events (& 179; 1%) associated with discontinuation and considered to be drug related (i.e., those events associated with dropout at a rate approximately twice or greater for PAXIL CR compared to placebo) included the following: PAXIL CR Placebo (n = 212) (n = 211) Nausea 3.7% 0.5% Asthenia 1.9% 0.5% Dizziness 1.4% 0.0% Somnolence 1.4% 0.0% In a placebo-controlled study of elderly patients with major depressive disorder, 13% (13 104) of patients treated with PAXIL CR discontinued due to an adverse event. Events meeting the above criteria included the following: PAXIL CR Placebo (n = 104) (n = 109) Nausea 2.9% 0.0% Headache 1.9% 0.9% Depression 1.9% 0.0% LFT’s abnormal 1.9% 0.0% Panic Disorder: Eleven percent (50 444) of patients treated with PAXIL CR in panic disorder studies discontinued treatment due to an adverse event. Events mee

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