Label Changes for:

Paxil (paroxetine HCl) tablets, oral solution and Paxil CR tablets

October 2010

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

 

July 2011

CONTRAINDICATIONS

  • Do not start PAXIL in a patient who is being treated with a reversible MAOI such as linezolid or methylene blue because of an increased risk of serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions (see WARNINGS).
  • Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS).

PRECAUTIONS

Drug Interactions
  • new pimezole drug interaction information added

 

March 2011

PRECAUTIONS

Tamoxifen
  • Some studies have shown that the efficacy of tamoxifen, as measured by the risk of breast cancer relapse/mortality, may be reduced when co-prescribed with paroxetine as a result of paroxetine’s irreversible inhibition of CYP2D6 (see Drug Interactions). However, other studies have failed to demonstrate such a risk. It is uncertain whether the co-administration of paroxetine and tamoxifen has a significant adverse effect on the efficacy of tamoxifen. One study suggests that the risk may increase with longer duration of coadministration. When tamoxifen is used for the treatment or prevention of breast cancer, prescribers should consider using an alternative antidepressant with little or no CYP2D6 inhibition.

 

October 2010

 

PRECAUTIONS

Bone fracture
  • Epidemiological studies on bone fracture risk following exposure to some antidepressants, including SSRIs, have reported an association between antidepressant treatment and fractures. There are multiple possible causes for this observation and it is unknown to what extent fracture risk is directly attributable to SSRI treatment. The possibility of a pathological fracture, that is, a fracture produced by minimal trauma in a patient with decreased bone mineral density, should be considered in patients treated with paroxetine who present with unexplained bone pain, point tenderness, swelling, or bruising.
Drug Interactions/Serotonergic Drugs
  • Interaction with fentanyl
Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Impairment of Fertility: Some clinical studies have shown that SSRIs (including paroxetine) may affect sperm quality during SSRI treatment, which may affect fertility in some men.

ADVERSE REACTIONS

Postmarketing Reports
  • Restless legs syndrome

 

July 2011

Hide
(web3)