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FDA warns Geodon associated with potentially fatal skin reaction

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The U.S. Food and Drug Administration has issued a safety announcement warning that the antipsychotic drug ziprasidone is associated with a potentially fatal skin reaction known as Drug Reaction with Eosinophilia and Systemic Symptoms.

Ziprasidone (Geodon, Pfizer) is indicated for the treatment of schizophrenia and bipolar I disorder. Its drug label has been updated to describe Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) which begins as a rash that may spread to the entire body. Symptoms can also include fever, swollen lymph nodes, and inflammation to the liver, kidney, lungs, heart or pancreas.

This reaction can also cause an atypical number of eosinophils in the blood.

Information from six patients who exhibited symptoms of DRESS indicated that the reaction began 11 to 30 days after treatment began, according to the FDA. There were no deaths.

Pfizer is now required to add a new warning for the reaction to all drug formulations.

Health care providers are advised to immediately stop treatment in patients presenting symptoms of DRESS, and notify the FDA MedWatch program.

For more information:

http://www.fda.gov/Drugs/DrugSafety/ucm426391.htm