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November 23, 2009

FDA Approves Geodon for Bipolar Disorder

The US Food and Drug Administration (FDA) has approved the atypical antipsychotic Geodon (ziprasidone) for maintenance treatment of bipolar I disorder as an adjunct to lithium or Depakote (valporate) in adults. In 2004, the FDA approved Geodon for treatment of acute manic or mixed episodes in Bipolar 1 Disorder. The additional approval for maintenance treatment, announced by Pfizer on Nov. 20, gives doctors and patients another long-term use drug to help stabilize moods. Geodon was initially FDA approved, in 2001, to treat schizophrenia.

Unlike other atypical antipsychotics, it appears that Geodon may not to be associated with weight gain. In a six-week, head-to-head study between Zyprexa (olanzapine) and Geodon, the Zyprexa patients' median weight gain over the six weeks was ten pounds, while Geodon patients gained less than one pound. In line with this finding, Zyprexa patients saw significant increases in cholesterol and other blood fats, while Geodon patients lipid profiles remained stable. These results suggest that not only is Geodon a healthier alternative, but patients may also be less inclined to stop taking it on their own due to weight gain.

Our readers may recall that Geodon was one of four drugs that Pfizer was found to have illegally promoted for uses which had not been FDA approved. As a result, Pfizer recently agreed to pay $2.3B in the largest healthcare fraud settlement in the history of the Department of Justice.

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