Lineaz Warnings

Hematologic effect: reversible myelosuppression (e.g. anemia, leukopenia, pancytopenia, thrombocytopenia) has been reported in patient receiving Linezolid. In cases where the outcome is known, when Linezolid was discontinued, the affected hematologic parameters have risen toward pretreatment levels. Complete blood cell counts (CBCs) should be monitored weekly during Linezolid treatment, especially in patients receiving the drug for more than two weeks and in those who have preexisting myelosuppression, are receiving concomitant drugs that produce bone marrow suppression, or have a chronic infection that was or is being treated with concomitant anti-infective therapy.
Discontinuation of therapy with Linezolid should be considered in patients who develop or have worsening myelosuppression. Thrombocytopenia is the most frequently observed blood dyscrasia. The platelet counts for most patients returned to the normal range/baseline during the follow-up period.
Peripheral and optic neuropathy: Peripheral and optic neuropathies have been reported in adults and children receiving Linezolid; these events have occurred principally in patients receiving the drug for longer than the maximum recommended duration of treatment (28 days). All patients receiving Linezolid for extended periods of time (i.e. 3 months or longer) should have their visual function monitored.
Serotonin Syndrome: Serotonin syndrome (including some fatalities) has been reported in patients receiving Linezolid concomitantly with serotonergic drugs. Sign and symptoms of serotonin syndrome include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering, shaking, diarrhea, loss of coordination, and/or fever.
Linezolid should not be used in patients with carcinoid syndrome or in patients receiving SSRIs, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine, bupropion, or buspirone unless concomitant therapy is considered clinically appropriate and patients can be carefully monitored for signs and/or symptoms of serotonin syndrome or neuroleptic malignant syndrome-like reactions.
Superinfection/Clostridium difficile-associated diarrhea and colitis: Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile, C. Difficile infection (CDI) and C. Difficile-associated diarrhea and colitis (CDAD) have been reported with nearly all anti-infectives, including Linezolid, and may range in severity from mild diarrhea to fatal colitis. Therefore, If CDAD is suspected or confirmed, anti-infective therapy not directed against C. Difficile should be discontinued whenever possible.