FDA Approves Geodon (Ziprasidone) for The Treatment of Schizophrenia
For Immediate Release, February 12, 2001
Contact: Chris Marshall
On February 5, The Food and Drug Administration (FDA) approved ziprasidone, a new antipsychotic medication for the treatment of schizophrenia. Ziprasidone will be available in pharmacies in March under the brand name Geodon.
Developed by Pfizer Inc., ziprasidone has shown to be effective in treating the positive and negative symptoms of schizophrenia, including visual and auditory hallucinations, delusions, motivation difficulties and social withdrawal. Large clinical trials have shown that ziprasidone is associated with little or no weight gain, thus distinguishing it from most other antipsychotic drugs. The most common side effects reported for ziprasidone are headache, somnolence, and abnormal movements.
Over the past several years, the FDA has been concerned with the possibility that ziprasidone and a number of other drugs might increase the very low possibility of a specific, potentially fatal heart-rhythm irregularity, torsade de pointes. The FDA did not approve ziprasidone in 1998 due to evidence that the drug can cause a lengthening of the so-called QT interval of the heartbeat, a change known to predispose to torsade, and asked that specific safety data be gathered. The safety data were submitted to the FDA last year. Although "QT prolongation" predisposing to torsade is still a theoretical concern, over 4000 patients were treated in clinical trials without evidence of the heart-rhythm irregularity. In addition, the overall mortality rate during the trials was similar to that seen with placebo and with other antipsychotic drugs.
NAMI representatives were the only public witnesses to testify at the FDA Advisory Committee meeting, and asked the Committee to take into account the full range of benefits and risks in making a decision. The NAMI witnesses, including NAMI Consumer Council member Shannon Flynn, noted risks of treatments associated with weight gain, the possible effects of weight gain on adherence to treatment, and the desirability for NAMI members of having a full range of therapeutic options. The FDA concluded that the drug should be available to patients and physicians, in part because of its different profile of benefits, side effects, and risks.
The FDA labeling does not include a so-called "black-box warning" and does not require an EKG prior to or during treatment. The labeling does warn physicians and patients about QT prolongation and the possible risk of sudden death. The FDA labeling suggests that doctors use their best judgment, based on the health status of the individual, as to whether to use ziprasidone as a first line medication or only after other available medications have failed. There are no requirements that patients have regular heart check-ups while taking this medication.
NAMI members may also recognize Geodon (ziprasidone) by its former proposed brand name, Zeldox.
For more information on the serious brain disorder schizophrenia, including medication treatments, click here.