BlackBoxRX
 
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Paroxetine

Suicidal Thoughts and Behaviors

Suicidal Thoughts

  • Antidepressants, including selective serotonin reuptake inhibitors (SSRIs), have been shown to increase the risk of suicidal thoughts and behavior in pediatric and young adult patients when used to treat major depressive disorder and other psychiatric disorders.
  • Because paroxetine capsules are an SSRI, monitor patients closely for worsening and for emergence of suicidal thoughts and behaviors.
  • Advise families and caregivers of the need for close observation and communication with the prescriber

Sexual Dysfunction

  • Use of SNRIs may cause symptoms of sexual dysfunction. In male patients, SNRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SNRI use may result in decreased libido and delayed or absent orgasm.
  • It is important for prescribers to inquire about sexual function prior to initiation of SNRI's and to inquire specifically about changes in sexual function during treatment, because sexual function may not be spontaneously reported. When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including the underlying psychiatric disorder. Discuss potential management strategies to support patients in making informed decisions about treatment.


MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • Close observation for suicidal thinking or unusual changes in behavior

FDA and Industry Communications

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts

Paroxetine

Additional Information

Updated October 2021