Citalopram (Page 6 of 10)

ADVERSE REACTIONS

The premarketing development program for citalopram included citalopram exposures in patients and/or normal subjects from 3 different groups of studies: 429 normal subjects in clinical pharmacology/pharmacokinetic studies; 4422 exposures from patients in controlled and uncontrolled clinical trials, corresponding to approximately 1370 patient-exposure years. There were, in addition, over 19,000 exposures from mostly open-label, European postmarketing studies. The conditions and duration of treatment with citalopram varied greatly and included (in overlapping categories) open-label and double-blind studies, inpatient and outpatient studies, fixed-dose and dose-titration studies, and short-term and long-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard World Health Organization (WHO) terminology has been used to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

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

Adverse Events Associated with Discontinuation of Treatment

Among 1063 depressed patients who received citalopram 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 citalopram-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
Body System/Adverse Event Percentage of Patients Discontinuing Due to Adverse Event
Citalopram (N=1063) Placebo (N=446)

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 Citalopram-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 citalopram 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 citalopram and for which the incidence in patients treated with citalopram 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 citalopram 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 *
Body System/Adverse Event (Percentage of Patients Reporting Event)
Citalopram (N=1063) Placebo (N=446)
*
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.
Denominator used was for females only (N=638 citalopram; N=252 placebo).
Primarily ejaculatory delay.
§
Denominator used was for males only (N=425 citalopram; N=194 placebo).

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%

Dysmenorrhea

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 Disorder §

6%

1%

Impotence §

3%

<1%

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