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Geodon (ziprasidone)

Geodon (ziprasidone)

FDA ALERT Geodon® is a type of medicine called an atypical antipsychotic. FDA has found that older patients treated with atypical antipsychotics for dementia had a higher chance for death than patients who did not take the medicine. This is not an approved use.

What is Geodon® ?

Geodon® (ziprasidone) is an antipsychotic medication—one of a group called “atypical” to distinguish these newer drugs from older medications. The FDA approved Geodon as a treatment for schizophrenia in 2001. It helps manage schizophrenia’s “positive” symptoms, such as auditory hallucinations, delusions, and thought disturbances. Geodon may also help in treating the “negative” symptoms of schizophrenia, which include social withdrawal, apathy, lack of motivation, and an inability to experience pleasure. Geodon is presently being studied for the treatment of bipolar disorder.

How does Geodon work?

As with other atypical antipsychotic medications, Geodon may reduce symptoms of schizophrenia by blocking the action of serotonin and dopamine, two neurotransmitter chemicals, at specific receptors in the brain. Geodon may also inhibit the reuptake of serotonin and norepinephrine into brain cells, which may improve depressive symptoms in people with schizophrenia.

Is Geodon safe?

Several years ago, the FDA became concerned about the possibility that Geodon and a number of other drugs might increase the very small possibility of a specific, potentially fatal heart–rhythm irregularity called torsade de pointes. The FDA did not approve Geodon in 1998 because there was some evidence that it could cause a lengthening of the so–called QT interval of the heart beat, a change associated with torsade. The FDA asked for specific safety data, which were submitted in 1999. Although “QT prolongation” is still a concern, thousands of consumers have been treated without evidence of the heart–rhythm irregularity. And the overall mortality rate during the trials was similar to that of placebo and with other antipsychotic drugs. Since its introduction to US consumers in 2001, there have been no reported fatalities due to Geodon induced torsade.

The FDA labeling does not include a “black box warning”, usually included when there is a significant risk that the doctor and consumer must be aware of and take into account when prescribing/taking such a medication. The FDA labeling for Geodon also does not recommend an EKG prior to or during treatment. However, the labeling warns physicians and consumers about QT prolongation and the possible risk of sudden death. The FDA labeling suggests that doctors use their best judgment , based on the health status of the individual, when considering the use of ziprasidone as a first–line medication or only after other medications have failed. There are no requirements that consumers have regular heart check–ups while taking this medication.

It is important to note that your risk of dangerous heart–rhythm changes can be increased by other medications you may be taking and any other heart conditions you may have. Therefore, you should tell your doctor about all your medications (including dietary supplements, non–prescription medicines, and herbal medicines) and any heart problems you have now or have had. If you faint, lose consciousness, or have heart palpitations while taking Geodon, contact your doctor immediately.

Talk with you doctor about all decisions relating to using medications. All medication decisions should be tailored to the individuals needs and
involve a benefit/risk assessment.

What are the common side effects caused by Geodon?

Some of the most common side effects associated with Geodon are feeling unusually tired, nausea, constipation, dizziness, restlessness, diarrhea, rash, cough and runny nose, and abnormal muscle movements, including tremor, shuffling, and uncontrollable movements. Geodon is associated with little or no weight gain in most consumers. Geodon also appears to infrequently cause increases in glucose, cholesterol, or triglyceride blood levels.

Does Geodon cause tardive dyskinesia?

Tardive dyskinesia (TD) is a disorder characterized by abnormal movements of the mouth, limbs, or body that occur in some people taking antipsychotic drugs. Researchers believe that atypical antipsychotics like Geodon are less likely to cause TD than the older antipsychotics.

Because it may take years until researchers can fully assess the risk of TD when taking Geodon, this drug should be prescribed at the lowest effective dose to minimize that risk. If you develop symptoms of TD while taking Geodon—symptoms such as grimacing, sucking and smacking of your lips, or other abnormal movements of the body or limbs—you and your doctor should consider switching medications. Keep in mind, though, that some people may need to continue taking Geodon to most effectively control their symptoms of schizophrenia despite developing TD.

What should you tell your doctor if you are considering taking Geodon?

Your physician should decide if Geodon is the best treatment for you. If you are thinking about taking Geodon, be sure to tell your doctor if you:

* Have had any problems with your heart, have heart disease or have a family history of heart disease
* Have had any problems with fainting or dizziness
* Have had any liver problems
* Are pregnant or plan to get pregnant
* Are breastfeeding
* Are taking any prescription or non–prescription medications
*
Are allergic to any medications

How does Geodon interact with other medications?

There are some medications that may be unsafe to use when taking Geodon, and there are some that can affect how well Geodon works. Always tell your doctor about all drugs that you are taking, including non–prescription drugs, supplements, and herbal medicines.

• Geodon should not be taken with any drug that affects the QT interval of the heart rhythm, such as Mellaril (thioridazine), Quinidex (quinidine), Avelox (moxifloxicin), Orap (pimozide), and Zagam (sparfloxicin).

• Certain high blood pressure medications that cause low blood levels of potassium or magnesium may increase a person’s risk for QT prolongation.

• Because Geodon has a direct effect on the central nervous system, people taking this drug should be cautious when taking other drugs that affect the central nervous system.

• Studies have shown that carbamazepine (Tegretol; an anticonvulsant commonly used as a mood stabilizer to treat bipolar disorder) can decrease the amount of Geodon in the body. Medications with similar effects to carbamazepine include: Sustiva (efavirenz), Fulvicin (griseofulvin), Mysoline (primidone), Rezulin (troglitazone).

• Studies have shown that ketoconazole (Nizoral; a medication used to treat fungal infections) can increase the amount of Geodon in the body. Medications with similar effects to ketoconazole include: Biaxin (clarithromycin), erythromycin, Cardizem (diltiazem), Luvox (fluvoxamine), Prozac (fluoxetine), Calan (verapamil), Accolate (zafirlukast).

What is the standard dose for Geodon?

The lowest effective dose of any medication should always be used to reduce the risk of troublesome and potentially harmful side effects. The recommended initial dose of Geodon is 20 mg per day, but this dose may be increased to as much as 80 mg twice a day, depending on its effectiveness in each individual. Increasing the dose beyond 80 mg twice a day is not recommended. Your physician should watch for improvement of your symptoms for several weeks before adjusting the dose because it may take that long for the drug to produce its full effect.

What else should I keep in mind when taking Geodon?

Geodon is available in capsules that should be swallowed whole and taken with food. Women who are planning to become pregnant or who are pregnant should discuss both the benefits and risks with their doctor before taking Geodon. Because dizziness caused by a drop in blood pressure can occur while taking Geodon, be careful when standing up and tell your doctor immediately if you feel dizzy.

Updated by Charles F. Caley, Pharm.D., BCPP
(April 2004)

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NAMI wishes to thank the College of Psychiatric and Neurological Pharmacists for producing this fact sheet.

For further information please contact the pharmaceutical company listed below.

Pfizer, Inc.

235 East 42nd St.

New York, NY 10017-5755

800-438-1985

www.pfizer.com

Free or low-cost medications provided by pharmaceutical companies

Some pharmaceutical companies offer medication assistance programs to low-income individuals and families. These programs typically require a doctor’s consent and proof of financial status. They may also require that you have either no health insurance, or no prescription drug benefit through your health insurance. Please contact the pharmaceutical company directly for specific eligibility requirements and application information.

Geodon Rx Assistance Program: 1-866-443-6366

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