FDA Issues Warning Over Antipsychotic Drug Geodon

Tuesday, December 16, 2014

The FDA issued a new warning last week for a popular antipsychotic drug used by millions of patients for bipolar disorder or schizophrenia after studies showed it may cause a deadly skin disease.

Geodon is the best-known version of the drug Ziprasidone, sold by Pfizer. It is also marketed under the brand names Zeldox and Zipwell by Actavis. It has been on the market since 2001 and is still prescribed to around 2.5 million people.

The trouble, according to the FDA, comes from studies showing a high percentage of patients using the developed Drug Reaction with Eosinophilia and Systemic Symptoms, or DRESS.

DRESS is a condition that can start as a skin rash, but then intensify to inflammation of the kidneys, heart, lungs, liver and pancreas. It also causes elevated levels of eosinophil white blood cells. In rare cases, it can cause death.

Anyone taking Geodon is urged to see a doctor immediately if they notice common symptoms of DRESS, which can include:

  • Fever
  • Rash
  • Swollen lymph nodes
  • Swollen face

However, patients should not stop taking the drug unless told to do so by a doctor, according to the FDA.

The FDA disclosed that six patients being monitored developed DRESS within 11 to 30 days after starting Geodon. Fortunately, none of them died.

The agency has required that Pfizer add warnings to the label of Geodon, and the warning takes effect immediately.

Although it is only approved for schizophrenia and bipolar disorder, Geodon is often also prescribed off-label for depression, anxiety, dementia, ADHD, autism and post-traumatic stress disorder.

There is no word yet on whether a Geodon lawsuit will be initiated for those patients injured or hospitalized. However, DrugNews will continue to monitor for any additional information and those affected are urged to speak with a lawyer about their options.



FDA Drug Safety Communication: FDA reporting mental health drug ziprasidone (Geodon) associated with rare but potentially fatal skin reactions. (December 11, 2014). Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm426391.htm



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