People with schizophrenia now have available another drug treatment, although approval of the medication comes with a strong warning about a serious health risk and requires that the manufacturer change the drug's brand name.
The Food and Drug Administration approved Geodon (ziprasidone) to treat schizophrenia, a lifelong mental illness that affects a person's behavior, thinking, and emotions. The product will carry a warning on its labeling about possible heart problems associated with its use. The antipsychotic medication may cause a heart rhythm irregularity, and even death. People with significant heart disease should not use the drug.
Schizophrenia affects about 1 percent of the world's population. Typically, the illness strikes men and women in adolescence or young adulthood. Schizophrenia is chronic, often with multiple relapses and impaired daily functioning. People with schizophrenia may experience hallucinations and delusions.
The drug's manufacturer, Pfizer Inc., of New York, planned to market the medication under the name Zeldox, but the FDA believed it sounded too similar to other medications and had the potential to cause confusion. Pfizer settled on the alternative name Geodon.
The most common side effects reported with the drug, which was approved in February, included sleepiness and abnormal movements. Pfizer has agreed to continue studying the drug's effects on the heart.
Serious Product Problem? Report It
Health professionals can report serious adverse reactions or other product problems to FDA's MedWatch program by:
* Mail: Use the postage-paid MedWatch form, available from the FDA Web site or by calling the toll-free number below.
* Phone: 1-800-FDA-1088 (1-800-332-1088)
* Fax: 1-800-FDA-0178 (1-800-332-0178)
* Internet: www.fda.gov/medwatch/
Call the 800 number or visit the Web site for further assistance.
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