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Geodon

Geodon: Medication News

Levemir
May 12, 2012 12:51AM

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Apr 07, 2012 12:09PM

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Apr 03, 2012 08:36PM

Pregnant Diabetics and Taking Levemir

The insulin drug Levemir, whose generic name is detemir, has been moved from a riskier category of medications for pregnant women to a less risky category by the FDA.

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FDA Black Box Warning

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INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. GEODON (ziprasidone) is not approved for the treatment of patients with Dementia-Related Psychosis

What Is GEODON?

GEODON is a type of prescription medicine called a psychotropic, also known as an atypical antipsychotic. GEODON can be used to treat symptoms of schizophrenia and acute manic or mixed episodes associated with bipolar disorder. GEODON can also be used as maintenance treatment of bipolar disorder when added to lithium or valproate.

Who Should Take GEODON?

Only your doctor can know if GEODON is right for you. GEODON may be prescribed for you if you have schizophrenia or bipolar disorder. Symptoms of schizophrenia may include:
  • hearing voices, seeing things, or sensing things that are not there (hallucinations)
  • beliefs that are not true (delusions)
  • unusual suspiciousness (paranoia)
  • becoming withdrawn from family and friends
Symptoms of manic or mixed episodes of bipolar disorder may include:
  • extremely high or irritable mood
  • increased energy, activity, and restlessness
  • racing thoughts or talking very fast
  • easily distracted
  • little need for sleep

Possible Side Effects

Because these problems could mean you're having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you: 
  • Faint or lose consciousness
  • Feel a change in the way that your heart beats (palpitations)
Common side effects of GEODON include the following and should also be discussed with your doctor if they occur:
  • Feeling unusually tired or sleepy
  • Nausea or upset stomach
  • Constipation
  • Dizziness
  • Restlessness
  • Abnormal muscle movements, including tremor, shuffling, and uncontrolled involuntary movements
  • Diarrhea
  • Rash
  • Increased cough / runny nose

Other Important Safety Information

  • A serious condition called neuroleptic malignant syndrome (NMS) can occur with all antipsychotic medications including GEODON. Signs of NMS include very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. NMS is a rare but serious side effect that could be fatal. Therefore, tell your doctor if you experience any of these signs.
  • Adverse reactions related to high blood sugar (hyperglycemia), sometimes serious, have been reported in patients treated with atypical antipsychotics. There have been few reports of hyperglycemia or diabetes in patients treated with GEODON, and it is not known if GEODON is associated with these reactions. Patients treated with an atypical antipsychotic should be monitored for symptoms of hyperglycemia.
  • Dizziness caused by a drop in your blood pressure may occur with GEODON, especially when you first start taking this medication or when the dose is increased. If this happens, be careful not to stand up too quickly, and talk to your doctor about the problem.
  • Before taking GEODON, tell your doctor if you are pregnant or plan on becoming pregnant. It is advised that you don't breast feed an infant if you are taking GEODON.
  • Because GEODON can cause sleepiness, be careful when operating machinery or driving a motor vehicle. Since medications of the same drug class as GEODON may interfere with the ability of the body to adjust to heat, it is best to avoid situations involving high temperature or humidity.
  • It is best to avoid consuming alcoholic beverages while taking GEODON.
  • Call your doctor immediately if you take more than the amount of GEODON prescribed by your doctor.
  • GEODON has not been shown to be safe or effective in the treatment of children and teenagers under the age of 18 years old.
Reviewed by:
Review Date:
Joseph V. Madia, MD
Friday, June 17, 2011

Source: FDA