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U.S. Department of Health and Human Services

Safety

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Viibryd (Vilazodone HCL) Tablets

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

 

April 2014

Summary View

5 WARNINGS AND PRECAUTIONS

5.2 Serotonin Syndrome
  • The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including VIIBRYD, alone ..... Symptoms of serotonin syndrome were noted in 0.1% of MDD patients treated with VIIBRYD in premarketing clinical trials

6 ADVERSE REACTIONS

6.2 Post-Marketing Experience
  • new section added .... cumulative review of spontaneous events

 

December 2013

Summary View

ADVERSE REACTIONS

DRUG INTERACTIONS

Inducers of CYP3A4 
  • Based on clinical response, consider increasing the dose of VIIBRYD up to 2-fold when concomitantly used with strong CYP3A4 inducers (e.g., carbamazepine) for greater than 14 days. The maximum daily dose should not exceed 80 mg. Concomitant use of VIIBRYD with strong inducers of CYP3A4 (e.g., carbamazepine) can decrease vilazodone systemic exposure by approximately 45% (see Figure 1). If CYP3A4 inducers are discontinued, reduce the VIIBRYD dose to the original level in 14 days [see Dosage and Administration (2.3)].

USE IN SPECIFIC POPULATIONS

Hepatic Impairment
  • Vilazodone is eliminated primarily by hepatic metabolism. In mild, moderate, and severe hepatic impairment, no dose adjustment is necessary

 

 

December 2012

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

CONTRAINDICATIONS

Serotonin Syndrome and MAOIs:
  • Starting Viibryd in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome
 

WARNINGS AND PRECAUTIONS

Serotonin Syndrome
  • The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Viibryd, 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)…

 

 

Summary View