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U.S. Department of Health and Human Services

Safety

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Venlafaxine Extended Release Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2012

Summary View

 

CONTRAINDICATIONS

Monoamine Oxidase Inhibitors (MAOIs)
  • The use of MAOI’s intended to treat psychiatric disorders with Venlafaxine Extended Release Tablets or within 7 days of stopping treatment with Venlafaxine Extended Release Tablets is 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 Venlafaxine Extended Release Tablets, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, busipirone, 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)…