The FDA warned 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 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).
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. 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.
Ziprasidone is an atypical antipsychotic drug used to treat schizophrenia and bipolar I disorder. During 2013, approximately 2.5 million prescriptions for oral formulations of ziprasidone were dispensed, and approximately 353,000 patients received a prescription for an oral formulation of ziprasidone through U.S. outpatient retail pharmacies.
The FDA reviewed information from six patients in whom the signs and symptoms of DRESS appeared between 11 and 30 days after ziprasidone treatment was started. None of these patients died. Based on this information, the 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.
See the FDA Safety Alert
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Law Perspectives, December 2014 Report: Beyond the Holiday Blues: When Depression Leads to Liability