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)
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.