The U.S. Food and Drug Administration (FDA) has required a new warning label for the antipsychotic drug Geodon (ziprasidone) to include the risk of a potentially fatal skin reaction. Up to 2.5 million Americans prescribed the drug may experience Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Patients with DRESS may experience a rash that spreads throughout the entire body, swollen lymph nodes, fever and damage to organs such as heart, liver, pancreas or kidneys. Some patients taken Geodon were hospitalized, although no deaths have yet been reported, the FDA said. DRESS symptoms appeared from 11 days to one month after taking Geodon.
The agency warned that “Patients who have a fever with a rash and/or swollen lymph glands should seek urgent medical care. Health care professionals should immediately stop treatment with ziprasidone if DRESS is suspected,” Although DRESS seems to occur infrequently, the potentially fatal effects prompted the need for an updated warning label.
Geodon is approved to treat schizophrenia and bipolar disorder. It belongs to a class of drugs known as second-generation atypical antipsychotics. The drug has also been used off-label in children and seniors, although evidence has shown that this can be unsafe. Geodon has a black box warning for increased risk of death in seniors. Geodon’s other potential side effects include dyskinesia, weight gain, high cholesterol, diabetes, dizziness, seizures and suicidal thoughts.
In 2009, the Department of Justice sued Pfizer and alleged that the company illegally marketed Geodon for off-label use in children. The company paid a fine of $2.3 billion, one of the largest in DOJ history, to settle the case. The DOJ alleged that Pfizer hired 250 child psychiatrists to promote the drug’s use in children.
In 2010, a whistleblower lawsuit was filed alleging that Pfizer marketed Geodon off-label to improve cognition. In 2014, U.S. District Judge Douglas P. Woodstock denied the company’s motion to dismiss the case.