• FDA Warns of Potentially Fatal Skin Reaction From Geodon
  • March 10, 2015 | Author: Stephen J. Burg
  • Law Firm: Burg Simpson Eldredge Hersh & Jardine, P.C. - Englewood Office
  • The U.S. Food and Drug Administration issued a drug safety communication regarding ziprasidone, which has the brand name Geodon. Ziprasidone is an antipsychotic medication used to treat schizophrenia and bipolar disorder, and which has been found to cause a rare skin response known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

    DRESS is a drug-induced hypersensitivity response. It can begin as a rash, but other symptoms include fever, swollen lymph nodes and inflammation of internal organs. It also increases the count of a type of a white blood cell known as eosinophils. DRESS usually lasts between two to eight weeks, but in severe cases, it can be fatal.

    The administration reviewed information regarding six patients who had the signs of DRESS after being treated with ziprasidone for 11 to 30 days. None of the patients died. Based on this information, the FDA required the drug's manufacturer, Pfizer Inc., to add a new warning to the medication's Warnings and Precautions label regarding the risk of the skin reaction.

    The new warning is important to physicians considering prescribing ziprasidone. The medication is a popular choice, as it was prescribed 2.5 million times in 2013, according to the FDA. Common side effects of the drug are dizziness, fast heartbeat, fever, sweating, white patches in or around the mouth, restless muscles or tremors, RxList reported.