The antipsychotic medicine Geodon (ziprasidone) and generic versions of the drug can cause a rare, dangerous skin reaction that can progress to affect other parts of the body, the U.S. Food and Drug Administration says.
physicians and patients will be advised with a new label warning that six cases of "drug reaction with eosinophilia and systemic symptoms," or DRESS have been seen worldwide with the use of ziprasidone. FDA says that DRESS has led to death with other agents though none of those cases were fatal and mortality rates can go up to 10%
In most cases, DRESS begins with the formation of rashes on the body, and soon after that happens, it causes inflammation of the lymph nodes and of the internal organs including lungs, pancreas, kidneys, liver and heart. The condition is also known to produce high counts of eosinophil in the blood as the name of the condition suggests. Any of the following four: eosinophilia, lymphadenopathy, fever, skin reaction and one or more than one systemic complications, such as nephritis, myocarditis, pancreatitis, pericarditis, pneumonitis and hepatitis are the main attributes that show the presence of the severe condition.
Ziprasidone was involved in the six cases reported because the serious condition followed within a few weeks after starting treatment with the medication. In a few cases withdrawal of the medication led to the reoccurrence of the symptoms. In three of the cases no other drugs were reported to have been used alongside ziprasidone.
The FDA said that if clinicians believe that drug reaction with eosinophilia and systemic symptoms is occurring the health care professionals must immediately stop the treatment with ziprasidone.
There is no known treatment for DRESS, said the FDA. The ways of managing the condition is by recognizing it early on and discontinuing the harmful product. If extensive organ involvement occurs, then a treatment with systemic corticosteroids may be considered, as claimed by the United States Food and Drug Administration.
Ziprasidone is an antipsychotic drug currently being used to decrease delusions, mania, hallucinations and other psychotic symptoms in bipolar disorders and schizophrenia.
