Antipsychotic Drug | Zyprexa | Possible Cause Of Death

Antipsychotic Drug | Zyprexa | Possible Cause Of Death

Posted By The Maher Law Firm || 20-Jun-2013

Antipsychotic Drug Zyprexa

Zyprexa (Olanzapine or Fluoxetine Symbyax) is an antipsychotic medication manufactured by Eli Lilly & Co. It was approved by the FDA (Food and Drug Administration) for the treatment of schizophrenia and bipolar disorder.

Schizophrenia is a “mental disorder” characterized by a breakdown of thought processes and deficiencies of emotional responses.

Bipolar Disorder is a mood disorder in which an individual experiences episodes of mania (irritable mood, high and/or low energy levels, arousal) and depression.

Zyprexa can be administered as a tablet, a short-acting injection or a long-acting injection. When administered as a tablet, it is taken once per day, generally beginning with a 5mg tablet with a target dose of 10mg within several days. Zyprexa is not indicated for use in doses above 20mg per day. Clinical trials demonstrated desired results in schizophrenic patients with a dose of 10mg to 15mg per day.

When Zyprexa is administered as a short-acting injection (Zyprexa IntraMuscular), it is administered in 10mg vial doses and should not be confused with Zyprexa Relprevv – a long-acting injection. Zyprexa Relprevv should only be administered by a healthcare professional every 2 to 4 weeks by deep intramuscular gluteal injection. Patients receiving Zyprexa Relprevv are required to remain in the clinic for 3 hours post injection to be monitored. Patients are then escorted home due to a possible risk of delirious or loss of consciousness shortly after receiving the injection. These adverse events are known as PDSS, or Post-Injection Delirium Sedation Syndrome.

Two patients recently died 3 to 4 days after receiving Zyprexa Relprevv (long-acting injection), causing the FDA to investigate. “At this time, FDA is continuing to evaluate these deaths and will provide an update when more information is available.” it said in a statement.

Zyprexa Prescription Information Warning:

WARNING: POST-INJECTION DELIRIUM/SEDATION SYNDROME AND INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Post-Injection Delirium/Sedation Syndrome - Adverse events with signs and symptoms consistent with olanzapine overdose, in particular, sedation (including coma) and/or delirium, have been reported following injections of ZYPREXA RELPREVV. ZYPREXA RELPREVV must be administered in a registered healthcare facility with ready access to emergency response services. After each injection, patients must be observed at the healthcare facility by a healthcare professional for at least 3 hours. Because of this risk, ZYPREXA RELPREVV is available only through a restricted distribution program called ZYPREXA RELPREVV Patient Care Program and requires prescriber, healthcare facility, patient, and pharmacy enrollment [see Dosage and Administration (2.1), Warnings and Precautions (5.1, 5.2), Overdosage (10.2), and Patient Counseling Information (17.2)].

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 drugtreated 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 3 characteristic(s) of the patients is not clear. ZYPREXA RELPREVV is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.3, 5.16) and Patient Counseling Information (17.3)].

As a consumer and patient, you have the right to trust that your medication is safe. This is not always the case. When a pharmaceutical company acts negligently, its actions can result in serious side effects. Well-versed in the product liability laws that protect consumers, our dangerous drug attorneys have handled countless claims on behalf of victims nationwide. To discuss your claim, contact a Maher Law Firm lawyer today.

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