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The U.S. Food and Drug Administration (FDA) is warning that ziprasidone, an antipsychotic that Pfizer sells under the brand name Geodon, can cause a serious, potentially fatal skin reaction known as “drug reaction with eosinophilia and systemic symptoms,” or DRESS.
Diabetes Insider reports that a new warning label will include information about the risk of DRESS, including six recorded cases that have been associated with the drug.
According to the FDA, DRESS may start out as a skin rash. It can also lead to inflammation in the lymph nodes and internal organs including the heart, lungs, kidneys, liver or pancreas. The potentially fatal skin reaction can also increase cosinophil levels in the blood. In addition to cosinophila, patients may suffer lymphadenopathy, skin reaction, fever, and at least one other systemic complication (which might include hepatitis, nephritis, pancreatitis, pneumonitis, myocarditis, or pericarditis), according to Diabetes Insider.
Given that Geodon is used to treat serious mental illnesses, this information has important implications. The FDA has approved the antipsychotic drug to treat schizophrenia and bipolar I disorder. It is also used off-label to treat aggression, anxiety, attention deficit hyperactivity disorder (ADHD), autism, bipolar disorder maintenances, dementia, depression, mood disorders, post-traumatic stress disorder (PTSD) and obsessive compulsive disorder (OCD).