The Food and Drug Administration is warning that the atypical antipsychotic ziprasidone (Geodon) may be associated with a rare but potentially fatal skin reaction.
The agency issued the communication on Dec. 11, saying that it had reviewed six worldwide cases of the condition, known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), that were associated with ziprasidone use. All six cases were reported through the FDA Adverse Event Reporting System. Symptoms began within 11-30 days after ziprasidone therapy was started. In three cases, symptoms recurred – and began more quickly – with discontinuation and reinitiation.
There were no deaths, but DRESS is potentially fatal, with a mortality rate of up to 10%, the FDA noted in a safety announcement. DRESS consists of at least three of the following symptoms: cutaneous reaction, eosinophilia, fever, and lymphadenopathy; and at least one systemic complication, such as hepatitis, nephritis, pneumonitis, myocarditis, pericarditis, and pancreatitis.
The pathogenesis of the condition is unclear, the agency said, but it added that a combination of genetic and immunologic factors are thought to be at play. The FDA said the six cases it reviewed seem to be associated with ziprasidone use because of the signs and symptoms, the temporal relationship between initiation and onset of symptoms, and the cases of positive rechallenge.
There is no specific treatment for DRESS, said the agency, adding that early recognition, quick discontinuation of the offending agent, and supportive care are all crucial to managing the condition.
The FDA said that patients should not stop taking ziprasidone or change the dose without talking with their physician, but noted that those who have a fever with a rash and/or swollen lymph glands should seek urgent medical care.
Clinicians should immediately stop treatment if DRESS is suspected. Adverse reactions involving ziprasidone should be reported to the FDA’s MedWatch program.
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