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Pristiq

Generic Name: Desvenlafaxine
Drug Category: SNRI
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 1 year.

Approved Uses

Indicated for the treatment of adult major depressive disorder (MDD).

Do not use MAOIs intended to treat psychiatric disorders with Pristiq or within 7 days of stopping treatment with Pristiq. Do not use Pristiq within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Pristiq in a patient who is being treated with linezolid or intravenous methylene blue.

PRISTIQ is not approved for use in treating bipolar depression.

Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.

The pupillary dilation that occurs following use of many antidepressant drugs including Pristiq may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Cases of seizure have been reported in pre-marketing clinical studies with PRISTIQ.

Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures.

Elevations in fasting serum total cholesterol, LDL (low density lipoproteins) cholesterol, and triglycerides occurred in the controlled studies.

The maximum recommended dose in patients with moderate renal impairment (24-hr creatinine clearance [ClCr] = 30 to 50 mL/min, Cockcroft-Gault [C-G]) is 50 mg per day. The maximum recommended dose in patients with severe renal impairment (ClCr 15 to 29 mL/min, C-G) or end-stage renal disease (ESRD, ClCr < 15 mL/min, C-G) is 25 mg every day or 50 mg every other day. Supplemental doses should not be given to patients after dialysis.

The recommended dose in patients with moderate to severe hepatic impairment (Child-Pugh score 7 to 15) is 50 mg per day. Dose escalation above 100 mg per day is not recommended.

Patients receiving PRISTIQ should have regular monitoring of blood pressure since increases in blood pressure were observed in clinical studies. Pre-existing hypertension should be controlled before initiating treatment with PRISTIQ.

Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including PRISTIQ. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Interstitial lung disease and eosinophilic pneumonia associated with venlafaxine (the parent drug of PRISTIQ) therapy have been rarely reported.

Angioedema has been reported in patients treated with PRISTIQ.

Activation of mania/hypomania has also been reported in a small proportion of patients with major affective disorder who were treated with other marketed antidepressants. As with all antidepressants, PRISTIQ should be used cautiously in patients with a history or family history of mania or hypomania.

Use of SNRIs, including PRISTIQ, may cause symptoms of sexual dysfunction. In male patients, SNRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SNRI use may result in decreased libido and delayed or absent orgasm.

As with all CNS-active drugs, patients should be advised to avoid alcohol consumption while taking PRISTIQ.

SSRIs and SNRIs, including PRISTIQ, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to this risk.

The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including PRISTIQ, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort), and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Do not start PRISTIQ in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered.

Concomitant use of PRISTIQ with drugs primarily metabolized by CYP2D6 which may increase the risk of toxicity of the CYP2D6 substrate drug. Examples include desipramine, atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine and tolterodine.

False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported in patients taking desvenlafaxine.

Based on animal data, Pristiq may cause fetal harm.

Exposure to SNRIs in mid to late pregnancy may increase the risk for preeclampsia, and exposure to SNRIs near delivery may increase the risk for postpartum hemorrhage.

Desvenlafaxine is excreted in human milk.

GoToSource

Off-label Uses

• Use in patients under 18 years of age. GoToSource

• Chemotherapy-induced peripheral neuropathy. GoToSource

• Obsessive-compulsive disorder. GoToSource

• Attention-deficit hyperactivity disorder. GoToSource

• Hot flashes associated with menopause. GoToSource

• Anxiety. GoToSource

• Fibromyalgia and diabetic neuropathy. GoToSource 

• Lupus. GoToSource

Adverse Events

Suicidal thinking and behavior (suicidality). GoToSource

Somnolence (sleepiness), anorexia (appetite loss), constipation, increased blood pressure and sexual dysfunction. GoToSource

Hyponatremia (low sodium). GoToSource 

Nasopharyngitis. GoToSource

Takotsubo cardiomyopathy (heart condition that can be caused by emotional or physical distress). GoToSource

Acquired hemophilia A (bleeding disorder). GoToSource

Episodes of mania. GoToSource

Discontinuation symptoms (dizziness, nausea, headache, irritability, diarrhea, anxiety, abnormal dreams, fatigue and hyperhidrosis). GoToSource

Interstitial lung disease. GoToSource

Increased risk of gastrointestinal bleeding in patients with left ventricular assist device. GoToSource

Increased QT and QTc intervals. GoToSource

Litigation

Lawsuits filed for birth defects and suicide.

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 28, 2024