[Posted 12/11/2014] ISSUE: FDA is warning that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction that can progress to affect other parts of the body. A new warning has been added to the ziprasidone drug label to describe the serious condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). See the FDA Drug Safety Communication at: http://www.fda.gov/Drugs/DrugSafety/ucm426391.htm for a Data Summary and additional information.
DRESS may start as a rash that can spread to all parts of the body. It can include fever, swollen lymph nodes, and inflammation of organs such as the liver, kidney, lungs, heart, or pancreas. DRESS also causes a higher-than-normal number of a particular type of white blood cell called eosinophils in the blood. DRESS can lead to death.
BACKGROUND: Ziprasidone is an atypical antipsychotic drug used to treat schizophrenia and bipolar I disorder.
FDA reviewed information from six patients in whom the signs and symptoms of DRESS appeared between 11 and 30 days after ziprasidone treatment was started. None of these patients died (see Data Summary in the Drug Safety Communication at: http://www.fda.gov/Drugs/DrugSafety/ucm426391.htm). Based on this information, FDA required the manufacturer of ziprasidone to add a new warning for DRESS to the Warnings and Precautions section of the drug labels for the capsule, oral suspension, and injection formulations.
RECOMMENDATION: 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. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as ziprasidone have an increased risk of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or mini-stroke during treatment.
Ziprasidone is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking ziprasidone. For more information visit the FDA website: http://www.fda.gov/Drugs
Ziprasidone is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). It is also used to treat episodes of mania (frenzied, abnormally excited or irritated mood) or mixed episodes (symptoms of mania and depression that happen together) in patients with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Ziprasidone is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
Ziprasidone comes as a capsule to take by mouth. It is usually taken twice a day with food. Take ziprasidone at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ziprasidone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may start you on a low dose of ziprasidone and gradually increase your dose.
Ziprasidone may help control your symptoms but will not cure your condition. Continue to take ziprasidone even if you feel well. Do not stop taking ziprasidone without talking to your doctor.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.
Be sure to drink plenty of water every day while you are taking this medication.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
loss of appetite
runny nose, sneezing
unusual movements of your face or body that you cannot control
fast, irregular, or pounding heartbeat
rash or hives
painful erection of the penis that lasts for hours
Ziprasidone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
sudden movements that you cannot control
uncontrollable shaking of a part of the body
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to ziprasidone.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 12/11/2014
AHFS® Consumer Medication Information. © Copyright, 2015. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.