SERTRALINE HYDROCHLORIDE (Page 10 of 16)

ADVERSE REACTIONS

During its premarketing assessment, multiple doses of sertraline hydrochloride were administered to over 4000 adult subjects as of February 18, 2000. The conditions and duration of exposure to sertraline hydrochloride varied greatly, and included (in overlapping categories) clinical pharmacology studies, open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose and titration studies, and studies for multiple indications, including major depressive disorder, OCD, panic disorder, PTSD, PMDD and social anxiety disorder.

Untoward events associated with this exposure were 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 untoward events into a smaller number of standardized event categories.

In the tabulations that follow, a World Health Organization dictionary of terminology has been used to classify reported adverse events. The frequencies presented, therefore, represent the proportion of the over 4000 adult individuals exposed to multiple doses of sertraline hydrochloride who experienced a treatment-emergent adverse event of the type cited on at least one occasion while receiving sertraline hydrochloride. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. It is important to emphasize that events reported during therapy were not necessarily caused by it.

The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that 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 side effect incidence rate in the population studied.

Incidence in Placebo-Controlled Trials

Table 2 enumerates the most common treatment-emergent adverse events associated with the use of sertraline hydrochloride (incidence of at least 5% for sertraline hydrochloride and at least twice that for placebo within at least one of the indications) for the treatment of adult patients with major depressive disorder/other *, OCD, panic disorder, PTSD, PMDD and social anxiety disorder in placebo-controlled clinical trials. Most patients in major depressive disorder/other *, OCD, panic disorder, PTSD and social anxiety disorder studies received doses of 50 to 200 mg/day. Patients in the PMDD study with daily dosing throughout the menstrual cycle received doses of 50 to 150 mg/day, and in the PMDD study with dosing during the luteal phase of the menstrual cycle received doses of 50 to 100 mg/day. Table 3 enumerates treatment-emergent adverse events that occurred in 2% or more of adult patients treated with sertraline hydrochloride and with incidence greater than placebo who participated in controlled clinical trials comparing sertraline hydrochloride with placebo in the treatment of major depressive disorder/other *, OCD, panic disorder, PTSD, PMDD and social anxiety disorder. Table 3 provides combined data for the pool of studies that are provided separately by indication in Table 2.

TABLE 2 MOST COMMON TREATMENT-EMERGENT ADVERSE EVENTS: INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS
Percentage of Patients Reporting Event
Major Depressive Disorder/Other * OCD Panic Disorder PTSD
Body System/Adverse Event Sertraline hydrochloride(N=861) Placebo(N=853) Sertraline hydrochloride(N=533) Placebo(N=373) Sertraline hydrochloride(N=430) Placebo(N=275) Sertraline hydrochloride(N=374) Placebo(N=376)
*
Major depressive disorder and other premarketing controlled trials.
Primarily ejaculatory delay. Denominator used was for male patients only (N=271 sertraline hydrochloride major depressive disorder/other*; N=271 placebo major depressive disorder/other*; N=296 sertraline hydrochloride OCD; N=219 placebo OCD; N=216 sertraline hydrochloride panic disorder; N=134 placebo panic disorder; N=130 sertraline hydrochloride PTSD; N=149 placebo PTSD; No male patients in PMDD studies; N=205 sertraline hydrochloride social anxiety disorder; N=153 placebo social anxiety disorder).
The luteal phase and daily dosing PMDD trials were not designed for making direct comparisons between the two dosing regimens. Therefore, a comparison between the two dosing regimens of the PMDD trials of incidence rates shown in Table 2 should be avoided.
Autonomic Nervous System Disorders
Ejaculation Failure 7 <1 17 2 19 1 11 1
Mouth Dry 16 9 14 9 15 10 11 6
Sweating Increased 8 3 6 1 5 1 4 2
Center. & Periph. Nerv. System Disorders
Somnolence 13 6 15 8 15 9 13 9
Tremor 11 3 8 1 5 1 5 1
Dizziness 12 7 17 9 10 10 8 5
General
Fatigue 11 8 14 10 11 6 10 5
Pain 1 2 3 1 3 3 4 6
Malaise <1 1 1 1 7 14 10 10
Gastrointestinal Disorders
Abdominal Pain 2 2 5 5 6 7 6 5
Anorexia 3 2 11 2 7 2 8 2
Constipation 8 6 6 4 7 3 3 3
Diarrhea/Loose Stools 18 9 24 10 20 9 24 15
Dyspepsia 6 3 10 4 10 8 6 6
Nausea 26 12 30 11 29 18 21 11
Psychiatric Disorders
Agitation 6 4 6 3 6 2 5 5
Insomnia 16 9 28 12 25 18 20 11
Libido Decreased 1 <1 11 2 7 1 7 2
PMDD Daily Dosing PMDD Luteal Phase Dosing Social Anxiety Disorder
Body System/Adverse Event Sertraline hydrochloride(N=121) Placebo(N=122) Sertraline hydrochloride(N=136) Placebo(N=127) Sertraline hydrochloride (N=344) Placebo(N=268)
Autonomic Nervous System Disorders
Ejaculation Failure N/A N/A N/A N/A 14
Mouth Dry 6 3 10 3 12 4
Sweating Increased 6 <1 3 0 11 2
Center. & Periph. Nerv. System Disorders
Somnolence 7 <1 2 0 9 6
Tremor 2 0 <1 <1 9 3
Dizziness 6 3 7 5 14 6
General
Fatigue 16 7 10 <1 12 6
Pain 6 <1 3 2 1 3
Malaise 9 5 7 5 8 3
Gastrointestinal Disorders
Abdominal Pain 7 <1 3 3 5 5
Anorexia 3 2 5 0 6 3
Constipation 2 3 1 2 5 3
Diarrhea/Loose Stools 13 3 13 7 21 8
Dyspepsia 7 2 7 3 13 5
Nausea 23 9 13 3 22 8
Psychiatric Disorders
Agitation 2 <1 1 0 4 2
Insomnia 17 11 12 10 25 10
Libido Decreased 11 2 4 2 9 3
TABLE 3 TREATMENT-EMERGENT ADVERSE EVENTS: INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS Percentage of Patients Reporting Event Major Depressive Disorder/Other *, OCD, Panic Disorder, PTSD, PMDD and Social Anxiety Disorder combined
Body System/Adverse Event SERTRALINE HYDROCHLORIDE(N=2799) Placebo(N=2394)
*
Major depressive disorder and other premarketing controlled trials.
Included are events reported by at least 2% of patients taking sertraline hydrochloride except the following events, which had an incidence on placebo greater than or equal to sertraline hydrochloride: abdominal pain, back pain, flatulence, malaise, pain, pharyngitis, respiratory disorder, upper respiratory tract infection.
Primarily ejaculatory delay. Denominator used was for male patients only (N=1118 sertraline hydrochloride; N=926 placebo).
Autonomic Nervous System Disorders
Ejaculation Failure 14 1
Mouth Dry 14 8
Sweating Increased 7 2
Center. & Periph. Nerv. System Disorders
Somnolence 13 7
Dizziness 12 7
Headache 25 23
Paresthesia 2 1
Tremor 8 2
Disorders of Skin and Appendages
Rash 3 2
Gastrointestinal Disorders
Anorexia 6 2
Constipation 6 4
Diarrhea/Loose Stools 20 10
Dyspepsia 8 4
Nausea 25 11
Vomiting 4 2
General
Fatigue 12 7
Psychiatric Disorders
Agitation 5 3
Anxiety 4 3
Insomnia 21 11
Libido Decreased 6 2
Nervousness 5 4
Special Senses
Vision Abnormal 3 2

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