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

continuation is recommended.

Patients being treated with Symbyax should be screened for bipolar disorder and monitored for mania/hypomania.

As with all antipsychotic treatment, prescribing should be consistent with the need to minimize Tardive Dyskinesia (TD). The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Symbyax may induce orthostatic hypotension associated with dizziness, tachycardia, bradycardia, and in some patients, syncope, especially during the initial dose-titration period. Particular caution should be used in patients with known cardiovascular disease, cerebrovascular diseases, or those predisposed to hypotension.

Symbyax should be used cautiously in patients with a history of seizures or with conditions that lower the seizure threshold.

Patients should be cautioned regarding the risk of bleeding associated with the concomitant use of Symbyax with non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, warfarin or other drugs that affect coagulation.

As with other antidepressants, Symbyax has been associated with cases of clinically significant hyponatremia that appeared to be reversible when Symbyax was discontinued.

As with any CNS-active drug, Symbyax has the potential to impair judgment, thinking or motor skills.

As with other drugs that antagonize dopamine receptors, Symbyax elevates prolactin levels, and a modest elevation persists during administration.

Because of the long elimination half-lives of fluoxetine and its major metabolite, changes in dose will not be fully reflected in plasma for several weeks.

Other potentially serious adverse events includ
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SOURCE Eli Lilly and Company
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