Celexa (Page 6 of 10)

Adverse Findings Observed in Short-Term, Placebo-Controlled Trials

Adverse Events Associated with Discontinuation of Treatment

Among 1063 depressed patients who received Celexa at doses ranging from 10 to 80 mg/day in placebo-controlled trials of up to 6 weeks in duration, 16% discontinued treatment due to an adverse event, as compared to 8% of 446 patients receiving placebo. The adverse events associated with discontinuation and considered drug-related (i.e., associated with discontinuation in at least 1% of Celexa-treated patients at a rate at least twice that of placebo) are shown in TABLE 2. It should be noted that one patient can report more than one reason for discontinuation and be counted more than once in this table.

TABLE 2 Adverse Events Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled, Depression Trials
Percentage of Patients Discontinuing
Due to Adverse Event
Citalopram Placebo
(N=1063) (N=446)
Body System/Adverse Event
General
Asthenia 1% <1%
Gastrointestinal Disorders
Nausea 4% 0%
Dry Mouth 1% <1%
Vomiting 1% 0%
Central and Peripheral
Nervous System Disorders
Dizziness 2% <1%
Psychiatric Disorders
Insomnia 3% 1%
Somnolence 2% 1%
Agitation 1% <1%

Adverse Events Occurring at an Incidence of 2% or More Among Celexa -Treated Patients

Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred among 1063 depressed patients who received Celexa at doses ranging from 10 to 80 mg/day in placebo-controlled trials of up to 6 weeks in duration. Events included are those occurring in 2% or more of patients treated with Celexa and for which the incidence in patients treated with Celexa was greater than the incidence in placebo-treated patients.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

The only commonly observed adverse event that occurred in Celexa patients with an incidence of 5% or greater and at least twice the incidence in placebo patients was ejaculation disorder (primarily ejaculatory delay) in male patients (see TABLE 3).

TABLE 3 Treatment-Emergent Adverse Events: Incidence in Placebo-Controlled Clinical Trials*

*Events reported by at least 2% of patients treated with Celexa are reported, except for the following events which had an incidence on placebo ≥ Celexa: headache, asthenia, dizziness, constipation, palpitation, vision abnormal, sleep disorder, nervousness, pharyngitis, micturition disorder, back pain.

1 Denominator used was for females only (N=638 Celexa; N=252 placebo).

2 Primarily ejaculatory delay.

3 Denominator used was for males only (N=425 Celexa; N=194 placebo).

(Percentage of Patients Reporting Event)
Body System/Adverse Event Celexa Placebo
(N=1063) (N=446)
Autonomic Nervous System
Disorders
Dry Mouth 20% 14%
Sweating Increased 11% 9%
Central & Peripheral Nervous
System Disorders
Tremor 8% 6%
Gastrointestinal Disorders
Nausea 21% 14%
Diarrhea 8% 5%
Dyspepsia 5% 4%
Vomiting 4% 3%
Abdominal Pain 3% 2%
General
Fatigue 5% 3%
Fever 2% <1%
Musculoskeletal System
Disorders
Arthralgia 2% 1%
Myalgia 2% 1%
Psychiatric Disorders
Somnolence 18% 10%
Insomnia 15% 14%
Anxiety 4% 3%
Anorexia 4% 2%
Agitation 3% 1%
Dysmenorrhea1 3% 2%
Libido Decreased 2% <1%
Yawning 2% <1%
Respiratory System Disorders
Upper Respiratory Tract Infection 5% 4%
Rhinitis 5% 3%
Sinusitis 3% <1%
Urogenital
Ejaculation Disorder2,3 6% 1%
Impotence3 3% <1%

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