The US Food and Drug Administration is warning the public that the antipsychotic medication ziprasidone “is associated with a rare but serious skin reaction that can progress to affect other parts of the body” and can potentially be fatal. The widely used antipsychotic appears in generic forms and is also marketed under the brand name Geodon. A warning has been added to the drug’s label.
The condition, called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), “may start as a rash that can spread to all parts of the body,” states an FDA safety announcement. “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,” states the safety announcement. “Health care professionals should immediately stop treatment with ziprasidone if DRESS is suspected.”
According to Patient Drug News, “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 ziprasidone’s manufacturer to add a new warning for DRESS for the capsule, oral suspension, and injection forms of the drug.”
FDA Drug Safety Communication: FDA reporting mental health drug ziprasidone (Geodon) associated with rare but potentially fatal skin reactions (US Food and Drug Administration Safety Announcement, December 11, 2014)
Safety Update – Ziprasidone (Geodon) Associated with Fatal Skin Reaction (Patient Drug News, December 14, 2014)