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PRISTIQ: ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the label;

  • Hypersensitivity
  • Effects on blood pressure
  • Abnormal bleeding
  • Mydriasis
  • Hypomania and mania
  • Serum cholesterol and triglyceride elevation
  • Seizure

    Clinical Studies Experience

    The most commonly observed adverse reactions in Pristiq (Desvenlafaxine) 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: dizziness, insomnia, nausea, hyperhidrosis, somnolence, decreased appetite, constipation, anxiety, and specific male sexual function disorders.

    Adverse reactions reported as reasons for discontinuation of treatment

    Combined across 8-week placebo-controlled pre-marketing studies for major depressive disorder, 12% of the 1,834 patients who received Pristiq (Desvenlafaxine) (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 this medicine (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 Desvenlafaxine (Pristiq) treated patients in the short-term studies, up to 8 weeks, were: nausea (4%); dizziness, headache and vomiting (2% each); in the long-term study, up to 9 months, the most common was vomiting (2%).

    Patient exposure

    This medication was evaluated for safety in 3,292 patients diagnosed with major depressive disorder who participated in multiple-dose pre-marketing studies, representing 1,289 patient-years of exposure. Among these 3,292 Pristiq treated patients, 1,834 patients were exposed to Desvenlafaxine in 8-week, placebo-controlled studies at doses ranging from 50 to 400 mg per day. Out of the 1,834 patients, 687 this drug treated patients continued into a 10-month open-label study. Of the total 3,292 patients exposed to at least one dose of Pristiq (Desvenlafaxine), 1,070 were exposed to this medicine for 6 months, representing 842 patient-years of exposure, and 274 were exposed for one year, representing 241 patient-years of exposure.

    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.

    Other adverse reactions observed in pre-marketing clinical studies

    Other infrequent adverse reactions, not described elsewhere in section 6.1, occurring at an incidence of < 2% in MDD patients treated with Pristiq (Desvenlafaxine Succinate) were:

    Immune system disorders: Hypersensitivity.
    Investigations: Weight increased, blood prolactin increased, liver function test abnormal.
    Nervous system disorders: Convulsion, extrapyramidal disorder, syncope.
    Musculoskeletal and connective tissue disorders: Musculoskeletal stiffness.
    Psychiatric disorders: Hypomania, depersonalization.
    Respiratory, thoracic and mediastinal disorders: Epistaxis.
    Vascular disorders: Orthostatic hypotension.

    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 Desvenlafaxine (Pristiq) treatment as compared to placebo.

    Discontinuation events

    Adverse events reported in association with abrupt discontinuation, dose reduction or tapering of treatment in MDD clinical studies at a rate of >= 5% include: dizziness, nausea, headache, insomnia, diarrhea, irritability, anxiety, abnormal dreams, fatigue, and hyperhidrosis. In general, discontinuation events occurred more frequently with longer duration of therapy.

    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 (Desvenlafaxine). Lipids

    Elevations in fasting serum total cholesterol, LDL (low density lipoproteins) cholesterol, and triglycerides occurred in the controlled studies. Some of these abnormalities were considered potentially clinically significant.

    Proteinuria

    Proteinuria, greater than or equal to trace, was observed in the fixed-dose controlled studies. This proteinuria was not associated with increases in BUN or creatinine and was generally transient.

    ECG changes

    Electrocardiograms were obtained from 1,492 Pristiq (Desvenlafaxine) treated patients with major depressive disorder and 984 placebo-treated patients in clinical studies lasting up to 8 weeks. No clinically relevant differences were observed between this drug 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

    At 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 (Desvenlafaxine) during the initial 12-week, open-label phase, there was no statistical difference in mean weight change between this medicine 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 (Desvenlafaxine Succinate) (8.0%, 7/87) versus placebo (2.5%, 1/40), compared to patients < 65 years of age receiving this medication (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 (Desvenlafaxine). 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: angioedema.

    Adverse Reactions Reported with other SNRIs

    Although the following are not considered adverse reactions for Pristiq (Desvenlafaxine Succinate), they are adverse reactions for other SNRIs and may also occur with this drug: gastrointestinal bleeding, photosensitivity reactions, hallucinations and severe cutaneous reactions (such as Stevens-Johnson Syndrome, toxic epidermal necrolysis, and / or erythema multiforme).



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