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U.S. Department of Health and Human Services

Safety

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Pristiq (desvenlafaxine) Extended-Release tablet

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

 

December 2013

Summary View

ADVERSE REACTIONS

Clinical Studies Experience

Patient exposure

  • PRISTIQ was evaluated for safety in 8,394 patients diagnosed with major depressive disorder who participated in multiple-dose pre-marketing studies, representing 2,784 patient-years of exposure. Of the total 8,394 patients exposed to at least one dose of PRISTIQ; 2,116 were exposed to PRISTIQ for 6 months, representing 1,658 patient-years of exposure, and 421 were exposed for one year, representing 416 patient-years of exposure…

DRUG INTERACTIONS

Monoamine Oxidase Inhibitors (MAOI)
  • Do not use MAOIs intended to treat psychiatric disorders with desvenlafaxine or within 7 days of stopping treatment with desvenlafaxine. Do not use desvenlafaxine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start desvenlafaxine in a patient who is being treated with linezolid or intravenous methylene blue
Serotonergic Drugs
  • Based on the mechanism of action of desvenlafaxine and the potential for serotonin syndrome, caution is advised when desvenlafaxine is co-administered with other drugs that may affect the serotonergic neurotransmitter systems
Potential for Other Drugs to Affect Desvenlafaxine
  • Based on in vitro data, no dose adjustment is required for PRISTIQ when used concomitantly with inhibitors of CYP3A4 and CYP1A1, 1A2, 2A6, 2D6, 2C8, 2C9, 2C19, 2E1, and the Pglycoprotein transporter. Clinical studies have demonstrated no clinically significant pharmacokinetic interaction between PRISTIQ and strong CYP 3A4 inhibitors
Potential for Desvenlafaxine to Affect Other Drugs
  • Clinical studies have shown that desvenlafaxine does not have a clinically relevant effect on CYP2D6 metabolism at the dose of 100 mg daily (Figure 2). Substrates primarily metabolized by CYP2D6 (e.g., desipramine , atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine) should be dosed at the original level when co-administered with PRISTIQ 100 mg or lower or when PRISTIQ is discontinued. Reduce the dose of these substrates by up to one-half if co-administered with 400 mg of PRISTIQ….
Drug-Laboratory Test Interactions
  • False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported in patients taking desvenlafaxine. This is due to lack of specificity of the screening tests. False positive test results may be expected for several days following discontinuation of desvenlafaxine therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish desvenlafaxine from PCP and amphetamine.

 

February 2013

Summary View

ADVERSE REACTIONS

Clinical Studies Experience
Patient exposure
  • Pristiq was evaluated for safety in 4,158 patients diagnosed with major depressive disorder who participated in multiple-dose pre-marketing studies, representing 1,677 patient-years of exposure. Among these 4,158 Pristiqtreated patients; 1,834 patients were exposed to Pristiq in 8-week, placebo-controlled studies at doses ranging from 50 to 400 mg/day. Out of the 1,834 patients, 687 Pristiq treated patients continued into a 10-month open-label study. Of the total 4,158 patients exposed to at least one dose of Pristiq; 1,320 were exposed to Pristiq for 6 months, representing 1058 patient-years of exposure, and 274 were exposed for one year, representing 241 patient-years of exposure.
Adverse reactions reported as reasons for discontinuation of treatment
  • In the pooled 8-week placebo-controlled studies in patients with MDD, 12% of the 1,834 patients who received Pristiq (50 to 400 mg) discontinued treatment due to an adverse reaction, compared with 3% of the 1,116 placebo-treated patients. At the recommended dose of 50 mg, the discontinuation rate due to an adverse reaction for Pristiq (4.1%) was similar to the rate for placebo (3.8%). For the 100 mg dose of Pristiqthe discontinuation rate due to an adverse reaction was 8.7%....
 
...safety data updates to entire Section 6 Adverse Reactions
  • Suicidal Thoughts and Behaviors in Adolescents and Young Adults...
  • Hyponatremia...
  • Interstitial Lung Disease and Eosinophilic Pneumonia...
  • Serotonin Syndrome...
  • Elevated Blood Pressure...
  • Abnormal Bleeding...
  • Narrow-Angle Glaucoma...
  • Activation of Mania/Hypomania...
  • Discontinuation Syndrome...
  • Seizure...
  • Hyponatremia...
  • Interstitial Lung Disease and Eosinophilic Pneumonia…

 

December 2012

Summary View

 

(Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)

 

CONTRAINDICATIONS

Monoamine Oxidase Inhibitors
  • The use of MAOIs intended to treat psychiatric disorders with Pristiq or within 7 days of stopping treatment with Pristiq is contraindicated because of an increased risk of serotonin syndrome…
 

WARNINGS AND PRECAUTIONS

Special Populations
  • Pregnant women during the third trimester: Neonates exposed to SNRIs or SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. When treating pregnant women with PRISTIQ during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.
Serotonin Syndrome
  • 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, 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)…
 

PATIENT COUNSELING INFORMATION

Serotonin Syndrome:
  • Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of Pristiq with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort)

 

March 2012

Summary View

ADVERSE REACTIONS

Clinical Studies Experience
  • Bruxism

DRUG INTERACTIONS

Drug-Laboratory Test Interactions
  • False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported in patients taking desvenlafaxine. This is due to lack of specificity of the screening tests. False positive test results may be expected for several days following discontinuation of desvenlafaxine therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish desvenlafaxine from PCP and amphetamine.

 

March 2011

Summary View

MEDICATION GUIDE

What should I tell my healthcare provider before taking PRISTIQ

  • patients should inform their healthcare provider if they have or had depression, suicidal thoughts or behaviors 

 

January 2011

Summary View

ADVERSE REACTIONS

6.1 Clinical Studies Experience
  • Table 3: Common Adverse Reactions: Percentages of Patients (> 2% in any Fixed-Dose Group) in  MDD 8-Week Placebo-Controlled Studies
    • "vertigo" added

 

October 2010

Summary View

MEDICATION GUIDE

Revisions
  • Serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions

 

September 2010

Summary View

MEDICATION GUIDE

Prestiq may also cause other serious side effects, including:
  • Allergic Reactions. Some Reactions can be severe, such as swelling beneath skin.

 

July 2010

Summary View

ADVERSE REACTIONS

Adverse Reactions Reported With Other SNRIs
  • ...severe cutaneous reactions (such as Stevens-Johnson Syndrome, toxic epidermal necrolysis, and/or erythema multiforme)

 

November 2009

Summary View

ADVERSE REACTIONS

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 – Angioedema.

MEDICATION GUIDE

  • modifications to inform prescribers of reported discontinuation symptoms for patients who switch from other antidepressants to Pristiq, and to recommend tapering of the initial antidepressant to minimize discontinuation symptoms