Geodon® Approved for Bipolar I Disorder
The Food and Drug Administration has approved Geodon (Ziprasidone) as a maintenance treatment for bipolar I disorder.
After a six month double-blind, randomized, placebo-controlled trial of 240 patients, results showed that Geodon with lithium or valporate was superior to placebo plus lithium or valporate. In the six months of treatment, 20 per cent of patients in the Geodon trial needed treatment intervention compared with 32 per cent taking placebo.
Geodon has previously been approved for the treatment of acute manic and mixed episodes, with or without psychotic features. It is not approved for the treatment of elderly patients with dementia-related psychosis.
The most frequently reported side effect was drowsiness. Dizziness, akathisia (restlessness) and disturbances with vision.
A potentially fatal condition known as neuroleptic malignant syndrome (NMS) has been reported with Geodon. This is a rare complication of antipsychotic medication. If signs and symptoms including tachycardia, irregular blood pressure, cardiac dysrhythmia and altered mental status are observed, monitoring and discontinuation of treatment is advised.
A number of precautions and contradictions associated with Geodon have been provided. The medical news site Medpage Today lists these as:
- Not approved for patients with a known history of QT prolongation, recent acute myocardial infarction, or uncompensated heart failure, and should not be used with QT-prolonging drugs.
- Should be avoided in elderly patients with dementia-related psychosis.
- Should probably be discontinued in patients showing signs of tardive dyskinesia.
- Treatment should be stopped in patients showing signs of NMS (see above).
- Patients and clinicians should be alert for hyperglycemia, rash, seizures, and orthostatic hypotension with ziprasidone.
Gever, J. (2009). Ziprasidone okayed for bipolar disorder. MedPage Today, Retrieved from http://www.medpagetoday.com/tbprint.cfm?tbid=17144
Pfizer Inc. (2009) Pfizer Receives FDA Approval for Geodon® (Ziprasidone HCI) Capsules For the Adjunctive Maintenance Treatment of Bipolar Disorder In Adults. Press Release. http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID.