U.S. geriatric clinical studies of sertraline in major depressive disorder included 663 sertraline-treated subjects ≥ 65 years of age, of those, 180 were ≥ 75 years of age. No overall differences in the pattern of adverse reactions were observed in the geriatric clinical trial subjects relative to those reported in younger subjects (see ADVERSEREACTIONS), and other reported experience has not identified differences in safety patterns between the elderly and younger subjects. As with all medications, greater sensitivity of some older individuals cannot be ruled out. There were 947 subjects in placebo-controlled geriatric clinical studies of sertraline in major depressive disorder. No overall differences in the pattern of efficacy were observed in the geriatric clinical trial subjects relative to those reported in younger subjects.
In 354 geriatric subjects treated with sertraline in placebo-controlled trials, the overall profile of adverse events was generally similar to that shown in Tables 2 and 3. Urinary tract infection was the only adverse event not appearing in Tables 2 and 3 and reported at an incidence of at least 2% and at a rate greater than placebo in placebo-controlled trials.
SSRIs and SNRIs, including sertraline, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event (see PRECAUTIONS, Hyponatremia).
During its premarketing assessment, multiple doses of sertraline were administered to over 4000 adult subjects as of February 18, 2000. The conditions and duration of exposure to sertraline 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 who experienced a treatment-emergent adverse event of the type cited on at least one occasion while receiving sertraline. 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.
Table 2 enumerates the most common treatment-emergent adverse events associated with the use of sertraline (incidence of at least 5% for sertraline 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 and with incidence greater than placebo who participated in controlled clinical trials comparing sertraline 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.
(1) Primarily ejaculatory delay. Denominator used was for male patients only (N=271 sertraline major depressive disorder/other*; N=271 placebo major depressive disorder/other*; N=296 sertraline OCD; N=219 placebo OCD; N=216 sertraline panic disorder; N=134 placebo panic disorder; N=130 sertraline PTSD; N=149 placebo PTSD; No male patients in PMDD studies; N=205 sertraline social anxiety disorder; N=153 placebo social anxiety disorder).
* Major depressive disorder and other premarketing controlled trials. (2) 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.
(1) Primarily ejaculatory delay. Denominator used was for male patients only (N=1118 sertraline; N=926 placebo).
* Major depressive disorder and other premarketing controlled trials. ** Included are events reported by at least 2% of patients taking sertraline except the following events, which had an incidence on placebo greater than or equal to sertraline: abdominal pain, back pain, flatulence, malaise, pain, pharyngitis, respiratory disorder, upper respiratory tract infection.
Table 4 lists the adverse events associated with discontinuation of sertraline hydrochloride treatment (incidence at least twice that for placebo and at least 1% for sertraline in clinical trials) in major depressive disorder/other* , OCD, panic disorder, PTSD, PMDD and social anxiety disorder.
(1) Primarily ejaculatory delay. Denominator used was for male patients only (N=271 major depressive disorder/other* ; N=296 OCD; N=216 panic disorder; N=130 PTSD; No male patients in PMDD studies; N=205 social anxiety disorder).* Major depressive disorder and other premarketing controlled trials.
Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that selective serotonin reuptake inhibitors (SSRIs) can cause such untoward sexual experiences. Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling, are likely to underestimate their actual incidence.
Table 5 below displays the incidence of sexual side effects reported by at least 2% of patients taking sertraline in placebo-controlled trials.
Ejaculation failure*(primarily delayed ejaculation)
* Denominator used was for male patients only (N=1118 sertraline; N=926 placebo)
** Denominator used was for male and female patients (N=2799 sertraline; N=2394 placebo)
There are no adequate and well-controlled studies examining sexual dysfunction with sertraline treatment.
Priapism has been reported with all SSRIs.
While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.
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