FDA forces Pfizer to put another warning on antipsychotic Geodon
- The FDA has warned the public that Geodon (ziprasidone) has been associated with a condition known as DRESS (Drug Reaction with Eisinophilia and Systemic Symptoms), which can cause fever, rash, swelling of lymph glands, liver, kidney, lungs, heart, or pancreas.
- Geodon is indicated for the treatment of schizophrenia and bipolar 1 disorder.
- This is the second time the FDA has required additional labeling in the form of a warning since 2005.
In 2005, the FDA required that Pfizer attach a black box warning to Geodon citing increased risk of death compared to placebo in patients with dementia-related psychosis. Geodon has been around for 13 years and is part of an older class of antipsychotics, known as second-generation antipsychotics.
Yet, despite the fact that there are many side effects associated with Geodon and others in this class, and there are indeed newer 'third-generation' treatment options, Geodon and others in this class continue to be used in the clinical setting. The reality in treating patients with antipsychotics is that certain drugs work in certain people, so having a treatment option with 13 years of data is not a bad thing—but the warnings are important.