Label Changes for:

Pristiq (desvenlafaxine) Extended-Release tablets

November 2009

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009, July 2010, September 2010, October 2010, January 2011

 

March 2011

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

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

MEDICATION GUIDE

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

 

September 2010

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

 

 

 

                                          

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