Linezolid (ZYVOX) Linked to Drug Interactions With Serotonergic and Adrenergic Agents
On June 20, the FDA approved safety labeling revisions for linezolid (ZYVOX tablets, oral suspension, and injection; Pfizer, Inc) to advise of contraindications to its use with monoamine oxidase inhibitors, serotonergic drugs, and agents that may increase blood pressure.
Linezolid is a reversible nonselective inhibitor of monoamine oxidase and therefore has the potential to interact with serotonergic and adrenergic agents.
Use of linezolid is therefore contraindicated in patients taking any medicinal product that inhibits monoamine oxidases A or B (eg, phenelzine and isocarboxazid) or within 2 weeks of taking any such medicinal product.
Although not observed in clinical studies, postmarketing cases of serotonin syndrome have been reported in patients who were coadministered linezolid with serotonergic agents, the FDA warned.
Unless patients are carefully observed for signs of the condition (cognitive dysfunction, hyperpyrexia, hyperreflexia, and incoordination), linezolid therapy should be avoided in patients who have carcinoid syndrome and/or are taking serotonergic agents such as serotonin reuptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine, and buspirone.
Because of potential increases in pressor response, linezolid therapy in the absence of careful blood pressure monitoring is likewise contraindicated in patients with uncontrolled hypertension, pheochromocytoma, and thyrotoxicosis, and in patients receiving treatment with directly and indirectly acting sympathomimetic agents (eg, pseudoephedrine), vasopressive agents (eg, epinephrine and norepinephrine), or dopaminergic agents (eg, dopamine and dobutamine).
Linezolid is approved for the treatment of infections caused by designated strains of susceptible microorganisms. Specific indications include vancomycin-resistant Enterococcus faecium infections, nosocomial pneumonia, community-acquired pneumonia, and complicated and uncomplicated skin or skin structure infections.
Linezolid is a reversible nonselective inhibitor of monoamine oxidase and therefore has the potential to interact with serotonergic and adrenergic agents.
Use of linezolid is therefore contraindicated in patients taking any medicinal product that inhibits monoamine oxidases A or B (eg, phenelzine and isocarboxazid) or within 2 weeks of taking any such medicinal product.
Although not observed in clinical studies, postmarketing cases of serotonin syndrome have been reported in patients who were coadministered linezolid with serotonergic agents, the FDA warned.
Unless patients are carefully observed for signs of the condition (cognitive dysfunction, hyperpyrexia, hyperreflexia, and incoordination), linezolid therapy should be avoided in patients who have carcinoid syndrome and/or are taking serotonergic agents such as serotonin reuptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine, and buspirone.
Because of potential increases in pressor response, linezolid therapy in the absence of careful blood pressure monitoring is likewise contraindicated in patients with uncontrolled hypertension, pheochromocytoma, and thyrotoxicosis, and in patients receiving treatment with directly and indirectly acting sympathomimetic agents (eg, pseudoephedrine), vasopressive agents (eg, epinephrine and norepinephrine), or dopaminergic agents (eg, dopamine and dobutamine).
Linezolid is approved for the treatment of infections caused by designated strains of susceptible microorganisms. Specific indications include vancomycin-resistant Enterococcus faecium infections, nosocomial pneumonia, community-acquired pneumonia, and complicated and uncomplicated skin or skin structure infections.