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U.S. Department of Health and Human Services

Safety

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Paxil (Paroxetine Hydrochloride) Tablets and Oral Suspension

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

 

December 2012

Summary View

 

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

 

CONTRAINDICATIONS

  • Starting Paxil 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

Serotonin Syndrome
  • The development of a potentially life-threatening serotonin syndrome 469 has been reported with SNRIs and SSRIs, including Paxil, 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)…
 

PRECAUTIONS

Serotonin Drugs
  • The concomitant use of Paxil with MAOIs (including Linezolid and intravenous Methylene Blue) is contraindicated…

 

April 2012

Summary View

 

ADVERSE REACTIONS

Postmarketing Reports
Voluntary reports of adverse events in patients taking Paxil that have been received since market introduction…
  • Stevens-Johnson syndrome (added)