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FDA Approves Symbyax(R) as First Medication for Treatment-Resistant Depression
Date:3/23/2009

ith an established diagnosis of diabetes mellitus, or having borderline increased blood glucose level. Patients taking Symbyax should be monitored regularly for worsening of glucose control. Patients starting treatment with Symbyax should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, palyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment should undergo fasting blood glucose testing.

Undesirable alterations in lipids have been observed with Symbyax use. Clinical monitoring, including baseline and follow-up lipid evaluations in patients using Symbyax, is advised. Clinically significant, and sometimes very high, elevations in triglyceride levels have been observed with Symbyax use. Clinically meaningful increases in total cholesterol have also been seen with Symbyax use.

Potential consequences of weight gain should be considered prior to starting Symbyax. Patients receiving Symbyax should receive regular monitoring of weight.

Development of a potentially life-threatening serotonin syndrome or NMS-like reactions have been reported with serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs) alone, including Symbyax treatment, but particularly with concomitant use of serotonergic drugs, including triptans, with drugs which impair serotonin metabolism, including MAOIs, or with antipsychotics or other dopamine antagonists. If these events occur, treatment with Symbyax and any concomitant serotonergic or antidopaminergic agents should be discontinued immediately and supportive symptomatic treatment should be initiated.

If rash or other possibly allergic phenomena appear for which an alternative etiology cannot be determined, immediate dis
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SOURCE Eli Lilly and Company
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