Drug Safety Warnings and Updates: January-March 2018

Shannon Thor, PharmD, MS

Disclosures

May 23, 2018

Editorial Collaboration

Medscape &

In This Article

Tranylcypromine sulfate (Parnate)

For more on this Drug Safety Labeling Change, click here.

For full prescribing information, click here.

Updated Boxed Warning

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE

Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. PARNATE is not approved for use in pediatric patients.

Hypertensive Crisis With Significant Tyramine Use

Excessive consumption of foods or beverages with significant tyramine content or the use of certain drugs with PARNATE or after PARNATE discontinuation can precipitate hypertensive crisis. Monitor blood pressure and allow for medication-free intervals between administration of PARNATE and interacting drugs. Instruct patients to avoid ingestion of foods and beverages with high tyramine content.

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