US FDA issues warning on Pfizer’s Geodon

The US Food and Drug Administration is warning that the antipsychotic drug ziprasidone (marketed under the brand name Geodon by pharma giant Pfizer [NYSE: PFE], and its generics) is associated with a rare but serious skin reaction that can progress to affect other parts of the body.

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). Patients who have a fever with a rash and/or swollen lymph glands should seek urgent medical care. Health care professionals should immediately stop treatment with ziprasidone if DRESS is suspected. Last year, 2.5 million prescriptions for oral formulations of ziprasidone were dispensed, the agency said.

Ziprasidone is an antipsychotic drug used to treat the serious mental health disorders schizophrenia and bipolar I disorder. Ziprasidone helps restore certain natural substances in the brain and can decrease hallucinations, delusions, other psychotic symptoms, and mania. To work properly, ziprasidone should be taken every day as prescribed. Patients should not stop taking their medicine or change their dose without first talking to their health care professional.