FDA: Antipsychotic Drug Could Cause Fatal Skin Reactions

The FDA has released a warning that the antipsychotic drug ziprasidone could cause serious skin reactions that could damage internal organs.

The drug has a new safety warning on its label that explains risk of the Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). According to the FDA, DRESS may start as a rash and induce inflammation of the organs including the lungs, heart, pancreas, and liver, and could cause swollen lymph nodes and fever.
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Further, DRESS could cause proliferation of eosinophils (a type of white blood cell) in the blood or lead to death.

The FDA based their warning on 6 patients who manifested DRESS symptoms between 11 and 30 days after ziprasidone treatment was initiated. Despite the condition’s 10% mortality rate, the FDA noted that none of the patients died.

Moving forward, the FDA suggested for clinicians to educate their patients about the signs and symptoms of DRESS.

The complete safety alert is published on the FDA’s website.

-Michelle Canales

Reference:

US Food and Drug Administration. Ziprasidone (marketed as Geodon and generics): drug safety communication-rare but potentially fatal skin reactions. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm426624.htm. Published December 11, 2014. Accessed December 12, 2014.