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U.S. Department of Health and Human Services


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Pexeva (paroxetine mesylate) tablets

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)



Somnolence/Sedation and Dizziness
  • During the 12-week, controlled study in patients with PHN, somnolence was reported in 10% of patients treated with 1,200 mg of Horizant per day compared with 8% of patients receiving placebo…
Discontinuation of Horizant
  • In patients with PHN receiving Horizant twice daily, the dose should be reduced to once daily for 1 week prior to discontinuation to minimize the potential of withdrawal seizure


January 2010 

Summary View



Usage in Pregnancy
  • Teratogenic Effects: Epidemiological studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations. The findings from these studies are summarized...