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Clinical Trials Experience: The most commonly observed adverse reactions in PRISTIQ treated MDD patients in short-term fixed-dose studies (incidence ≥5% and at least twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders.
Adverse reactions leading to discontinuation of therapy: Combined across 8-week placebo-controlled pre-marketing studies for MDD, 12% of the 1,834 patients who received PRISTIQ (50-400 mg) discontinued treatment due to an adverse event, compared with 3% of the 1,116 placebo-treated patients in those studies. At the recommended dose of 50 mg, the discontinuation rate due to an adverse event for PRISTIQ (4.1%) was similar to the rate for placebo (3.8%). For the 100 mg dose of PRISTIQ the discontinuation rate due to an adverse event was 8.7%.
The most common adverse reactions leading to discontinuation in at least 2% of the PRISTIQ treated patients in the short-term trials, up to 12 weeks, were: nausea (2%); in the long-term studies, up to 11 months, no events lead to discontinuation in at least 2% of the patients and at a rate greater than placebo in the double-blind phase.
Patient exposure: The safety of desvenlafaxine was established in a total of 8,453 patients who were exposed to at least one dose of desvenlafaxine ranging from 10 to 400 mg/day in MDD clinical trials or from post-marketing experience. Long-term safety was evaluated in 2,140 patients who were exposed to PRISTIQ for at least 6 months and with 421 patients exposed for 1 year. In general, the adverse reactions were most frequent in the first week of treatment. Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Adverse drug reactions (ADRs) by System Organ Class (SOC) and CIOMS frequency category listed in order of decreasing medical seriousness within each frequency category and SOC. (See Table 3.)
Click on icon to see table/diagram/imageSexual function adverse reactions: Table 4 shows the incidence of sexual function adverse reactions that occurred in ≥2% of PRISTIQ treated MDD patients in any fixed-dose group (8-week, placebo-controlled, fixed and flexible-dose, pre-marketing clinical studies). (See Table 4.)
Click on icon to see table/diagram/imageOther adverse reactions observed in clinical studies: Other infrequent adverse reactions, not described elsewhere in Clinical Trials Experience, occurring at an incidence of <2% in MDD patients treated with PRISTIQ were: Psychiatric disorders - Bruxism.
In clinical studies, there were uncommon reports of ischemic cardiac adverse events, including myocardial ischemia, myocardial infarction, and coronary occlusion requiring revascularization; these patients had multiple underlying cardiac risk factors. More patients experienced these events during PRISTIQ treatment as compared to placebo [see Cardiovascular/Cerebrovascular Disorders under Precautions].
Discontinuation symptoms: Adverse events reported in association with abrupt discontinuation, dose reduction or tapering of treatment in MDD clinical studies at a rate of ≥2% include: dizziness, withdrawal syndrome, nausea, headache, irritability, insomnia, diarrhea, anxiety, abnormal dreams, fatigue, and hyperhidrosis. In general, discontinuation events occurred more frequently with longer duration of therapy [see Discontinuing PRISTIQ under Dosage & Administration and Discontinuation of Treatment with PRISTIQ under Precautions].
Laboratory, ECG and vital sign changes observed in MDD clinical studies: The following changes were observed in placebo-controlled, short-term, pre-marketing MDD studies with PRISTIQ.
Serum Lipids: Dose-related elevations in fasting serum total cholesterol, LDL (low density lipoproteins) cholesterol, and triglycerides were observed in controlled trials. Measurement of serum lipids should be considered during treatment with desvenlafaxine [see Serum Cholesterol and Triglyceride Elevation under Precautions].
The percentage of patients who exceeded a predetermined threshold value is shown in Table 5. (See Table 5.)
Click on icon to see table/diagram/imageProteinuria: Proteinuria, greater than or equal to trace, was observed in the fixed-dose controlled studies (see Table 6). This proteinuria was not associated with increases in BUN or creatinine and was generally transient. (See Table 6.)
Click on icon to see table/diagram/imageECG changes: Electrocardiograms were obtained from 1,492 PRISTIQ treated patients with MDD and 984 placebo-treated patients in clinical studies lasting up to 8 weeks. No clinically relevant differences were observed between PRISTIQ treated and placebo-treated patients for QT, QTc, PR, and QRS intervals. In a thorough QTc study with prospectively determined criteria, desvenlafaxine did not cause QT prolongation. No difference was observed between placebo and desvenlafaxine treatments for the QRS interval.
Vital sign changes: Table 7 summarizes the changes that were observed in placebo-controlled, short-term, pre-marketing studies with PRISTIQ in patients with MDD (doses 50-400 mg). (See Table 7.)
Click on icon to see table/diagram/imageAt the final on-therapy assessment in the 6-month, double-blind, placebo-controlled phase of a long-term study in patients who had responded to PRISTIQ during the initial 12-week, open-label phase, there was no statistical difference in mean weight change between PRISTIQ and placebo-treated patients.
Orthostatic hypotension: In the short-term, placebo-controlled clinical studies with doses of 50-400 mg, systolic orthostatic hypotension (decrease ≥30 mm Hg from supine to standing position) occurred more frequently in patients ≥65 years of age receiving PRISTIQ (8.0%, 7/87) versus placebo (2.5%, 1/40), compared to patients <65 years of age receiving PRISTIQ (0.9%, 18/1,937) versus placebo (0.7%, 8/1,218).
Adverse Reactions Identified During Post-approval Use: The following adverse reaction has been identified during post-approval use of PRISTIQ. Because post-approval reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, toxic epidermal necrosis, and/or erythema multiforme.
Adverse Reactions Reported with Other SNRIs: Although gastrointestinal bleeding is not considered adverse reaction for PRISTIQ, it is an adverse reaction for other SNRIs and may also occur with PRISTIQ.
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