FDA Warns of Rare, But Potentially Fatal, Skin Reactions with Ziprasidone
On December 11, 2014, the Food and Drug Administration (FDA) issued a Drug Safety Communication warning that the antipsychotic drug Ziprasidone (brand name, Geodon), which is used to treat schizophrenia and bipolar disorder, is associated with rare, but potentially fatal, serious skin reactions that can affect other parts of the body. The FDA reports that approximately 2.5 million prescriptions for oral formulations of ziprasidone were dispensed in 2013 alone.
Based on information reviewed by the FDA, the FDA required the manufacturer of Geodon to add a new warning to the product label to describe the serious condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). In particular, the FDA reviewed information from six (6) patients where signs and symptoms of DRESS appeared between 11 and 30 days after starting ziprasidone.
The FDA warns as follows: “DRESS may start as a rash that can spread to all parts of the body. It can include fever, swollen lymph nodes, and inflammation of organs such as the liver, kidney, lungs, heart, or pancreas. DRESS also causes a higher-than-normal number of a particular type of white blood cell called eosinophils in the blood. DRESS can lead to death.”
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