The FDA has recently required that an extra warning be added to the Warnings and Precautions section of the ziprasidone package insert. The new warning is about the development of DRESS. This is an acronym for Drug Reaction with Eosinophilia and Systemic Symptoms.

DRESS consists of three or more of the following:

• Skin reaction e.g. rash, exfoliative dermatitis
• Eosinophilia
• Fever
• Lymphadenopathy
• Systemic symptoms such as hepatitis/nephritis/pneumonitis/myocarditis /pericarditis/ pancreatitis

This recommendation was made after the FDA reviewed information about six patients who developed DRESS between 11 and 30 days after initiating treatment with ziprasidone.

Ziprasidone should be discontinued immediately if DRESS is suspected, as it is potentially fatal.