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
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
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
