The agency warned patients that the off-patent drug has been associated with a potentially fatal condition called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), which can cause fever, rash, and swelling of lymph glands, liver, kidney, lungs, heart, or pancreas.
The antipsychotic used to treat schizophrenia and bipolar I disorder was linked to six cases of DRESS, with symptoms occurring in patients between 11 days and one month after first taking ziprasidone.
The FDA Adverse Event Reporting System (FAERS) noted serious outcomes, including hospitalization, but no fatalities.
The FDA said the cases “support an association between ziprasidone and the development of DRESS because of the consistency of the case characteristics to the signs and symptoms of DRESS, the temporal relationship between ziprasidone initiation and the onset of symptoms, and reported cases of positive re-challenge [when the drug is re-administered to see if adverse effects reoccur].”
This is not the first time the FDA has required extra labelling on Geodon.
Since 2005 the drug has borne a black box warning describing the increased risk of death compared to placebo in patients with dementia-related psychosis – an effect shared by other second generation antipsychotic medicines. The packaging insert includes the warning that Geodon is not approved for this indication.
Following the DRESS warning, a spokeswoman for Pfizer told us “Patient safety is of the utmost importance to Pfizer and we continuously monitor the safety and efficacy of our products to ensure that the benefits and risks are accurately described in the product label, as approved by the FDA.”
The company said it had updated the Geodon label to include language about DRESS and added the drug “has been approved as an effective treatment of schizophrenia, for acute and maintenance treatment of mixed or manic episodes in bipolar disorder, and for the adjunctive maintenance treatment of bipolar disorder.
“Geodon has a well-established benefit risk profile for more than 13 years as an effective treatment option for patients diagnosed with Schizophrenia and Bipolar disorders.”
Pfizer did not comment on whether the labelling change could delay manufacturing.