Potentially Fatal Skin Reactions associated with Ziprasidone-Manufacturer required to add new label by US FDA

Ziprasidone is an atypical antipsychotic drug used to treat schizophrenia and bipolar I disorder. A warning has been issued by US FDA that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction that can affect other parts of the body also. A new warning has been added to the Geodon drug label to describe the serious condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

The disease progression of DRESS starts with a rash and then leads to fever, swollen lymph nodes, and inflammation of organs such as the liver, kidney, lungs, heart, or pancreas and finally death.

Based on the Data Summary in the Drug Safety Communication it was found that in six patients the signs and symptoms of DRESS appeared between 11 and 30 days after the administration of Ziprasidone treatment although none of the patients died. On the basis of this information FDA required the manufacturer of Geodon to add a new warning for DRESS to the Warnings and Precautions section of the drug labels for the capsule, oral suspension, and injection formulations.