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Limited Use
[what does this mean?]
Generic drug name:
olanzapine
(oh LAN za peen)
Brand name(s):
SYMBYAX,
ZYPREXA,
ZYPREXA RELPREVV,
ZYPREXA ZYDIS
GENERIC:
available
FAMILY:
Atypical Antipsychotics
Find the drug label by
searching at DailyMed.
Pregnancy and Breast-feeding Warnings [top]
Pregnancy Warning
Olanzapine (ZYPREXA) was found to cause harm to developing fetuses in animal studies. Fetal death and decreased fetal weight were observed. There were also increases in the length of mothers' pregnancies. Of seven pregnancies in women taking olanzapine in clinical trials, there was one spontaneous abortion, one neonatal death due to a heart defect, three therapeutic abortions and two normal births. Long-term follow-up was not reported for the normal births nor was there any analysis of the fetuses from therapeutic abortions.
The FDA updated the information for this entire class of antipsychotic drugs relating to their potential risk to newborns when used during pregnancy. The drugs’ product labels have been updated to include information stating that when mothers are treated with these drugs during the third trimester of pregnancy, there is a potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in their newborns.
Breast-feeding Warning
Olanzapine was excreted in the breast milk of treated rats. It is very likely that women taking olanzapine would also excrete the drug into their milk. Because of the potential for serious adverse effects, women taking olanzapine should not breast-feed their infants.
Safety Warnings For This Drug [top]
FDA BLACK BOX WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen 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.
ZYPREXA (olanzapine) is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).[1]
Decreased Sweating
This drug may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or in hot weather while you are taking this medication, since overheating may result in heatstroke. Also, hot baths or saunas may make you feel dizzy or faint when you are taking this medication.
Weight Gain
For a variety of reasons, including increased appetite, the newer (so-called “atypical”) antipsychotic drugs commonly cause a significant increase in weight that can be troublesome and dangerous for patients using these drugs. For various drugs in this group, the usual range of weight gain is from 5 to 20 pounds, but there are a large number of reports of people gaining much more than 20 pounds, especially with longer-term use of the drugs. In addition to and related to weight gain are metabolic disorders including elevated blood sugar, the onset of diabetes and abnormalities of fat metabolism such as elevated triglyceride levels. Patients should be informed of these effects to help prevent excessive body weight gain.[2]
Blood Sugar Elevation and Diabetes Mellitus
Elevations in blood sugar (glucose),[3],[4],[5] in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with atypical antipsychotics that include aripiprazole (ABILIFY), clozapine (CLOZARIL), olanzapine (ZYPREXA), quetiapine (SEROQUEL), risperidone (RISPERDAL) and ziprasidone (GEODON).
The relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available.
Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia, including polydipsia (excessive thirst/drinking of liquids), polyuria (excessive urination), polyphagia (excessive eating) and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of the suspect drug.
Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients with Dementia
Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in clinical trials of the atypical antipsychotics in elderly patients with dementia-related psychosis.[6] In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with these drugs than in patients treated with placebo. The atypical antipsychotics are not approved for the treatment of patients with dementia-related psychosis.
Facts About This Drug [top]
Olanzapine (ZYPREXA, ZYPREXA ZYDIS) is an antipsychotic used to treat schizophrenia and related psychoses. This drug is chemically similar to clozapine (CLOZARIL, FAZACLO, FAZACLO ODT) and may work in a similar way.[7] Refer to the drug product label for additional approved uses of olanzapine.
Olanzapine is not approved for the treatment of patients with dementia-related psychosis.
Public Citizen lists olanzapine as a Limited Use drug.
All antipsychotics tend to improve symptoms such...
Olanzapine (ZYPREXA, ZYPREXA ZYDIS) is an antipsychotic used to treat schizophrenia and related psychoses. This drug is chemically similar to clozapine (CLOZARIL, FAZACLO, FAZACLO ODT) and may work in a similar way.[7] Refer to the drug product label for additional approved uses of olanzapine.
Olanzapine is not approved for the treatment of patients with dementia-related psychosis.
Public Citizen lists olanzapine as a Limited Use drug.
All antipsychotics tend to improve symptoms such as hallucinations, agitation, delusions, suspiciousness and disorganized thinking. Atypical antipsychotics are different because they may be better than older antipsychotic drugs at improving the “negative” symptoms of schizophrenia, such as apathy, emotional withdrawal, lack of pleasure and disorientation. However, there is no clear evidence that, overall, atypical antipsychotics are more effective or are better tolerated than the older, conventional antipsychotics, such as haloperidol (HALDOL).[8]
Olanzapine has not been studied in children under age 18. Women who are breast-feeding should not take olanzapine. Long-term effects of this drug are not yet known. Many studies are as yet unpublished.[9]
Adverse effects
Women, the elderly and Asian patients are more prone to the adverse effects of olanzapine.
Drowsiness and weight gain are the most common adverse effects observed with use of olanzapine.
Neuroleptic malignant syndrome (NMS) is a rare but severe adverse effect of antipsychotic drugs. The symptoms of NMS can include fever; confusion; disorientation or other cognitive (thinking) function changes; muscle rigidity; profuse sweating; and unstable blood pressure, heart rate and gastrointestinal function. NMS can be life-threatening; rapid recognition and treatment are important.[10]
In October 2010, Prescrire International published an article reporting sudden cardiac death and urinary incontinence associated with olanzapine use.
There have been rare post-marketing reports of hepatitis.
Very rare cases of cholestasis (blockage of bile flow) or mixed liver injury (flow blockage in addition to direct toxic effects on liver cells) also have been reported in the post-marketing period.[11]
Rare cases of restless legs syndrome (RLS) have been reported as probably associated with olanzapine use. Prescribers and health care professionals should be made aware that this adverse effect may occur, and until further studies are done, patients should be observed for RLS, which can be misdiagnosed for psychotic agitation.[12]
In October 2010, Prescrire International published an article reporting sudden cardiac death and urinary incontinence associated with olanzapine use.[13]
Studies show ...
The results of clinical trials on olanzapine do not suggest that the drug offers much of a unique advantage over other antipsychotic drugs.
Clinical trial data examined in a Prescrire International article on the use of olanzapine for the prevention of bipolar disorder showed that “there is no firm evidence that olanzapine boosts the efficacy of failing lithium therapy, or that olanzapine is any more useful than carbamazepine or valproic acid.”[14]
A randomized, controlled clinical trial compared olanzapine with haloperidol and “found no statistically or clinically significant advantages of olanzapine for schizophrenia on measures of compliance, symptoms, or overall quality of life, nor did it find evidence of reduced inpatient use or total cost.”[15] This trial used a better design than previously published studies that had suggested olanzapine was better than haloperidol.
In April 2011, the Office of Inspector General of the Department of Health and Human Services released a study titled “Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents,” with dismal results. The study was conducted at the request of Sen. Charles Grassley (R-Iowa) and evaluated the extent to which elderly nursing home residents receive newer, more expensive atypical antipsychotic drugs and the associated cost to the Medicare system. It also assessed the extent to which dangerous, off-label prescribing of these drugs was occurring. Click here to read the August 2011 Worst Pills, Best Pills News article on the report.
On May 24, 2013, the Centers for Medicare and Medicaid Services, as part of the National Partnership to Improve Dementia Care in Nursing Homes, issued new guidelines discouraging the use of antipsychotic drugs to treat dementia in nursing home patients. The recommendations belatedly follow the May 2011 report by the Inspector General of the Department of Health and Human Services, which found that 14% of nursing home residents had Medicare claims filed on their behalf for atypical antipsychotic medications, which have never been approved by the Food and Drug Administration (FDA) for managing dementia.
A study published in the British Medical Journal evaluated the risk of death associated with specific antipsychotic medications used in elderly residents in nursing homes. The study reviewed information relating to the risk of death when using different drug therapies and found that the risk of death varied according to the specific drug used. The authors of the study concluded:
“The evidence accumulated so far implies that use of haloperidol in this vulnerable population cannot be justified because of the excess harm. Quetiapine might be somewhat safer than other atypical drugs, but these findings will require replication in other studies.”[16]
A study published in Annals of Internal Medicine in 2014 showed that patients 65 years or older using quetiapine (SEROQUEL, SEROQUEL XR), risperidone (RISPERDAL) and olanzapine have an increased risk of a sudden loss of kidney function known as acute kidney injury.[17]
In 2015, JAMA Internal Medicine published an article showing that use of atypical antipsychotic drugs was associated with an increased risk of falls and fractures in patients 65 and older.[18]
In 2015, a study published in the Journal of Clinical Psychiatry showed that aripiprazole, olanzapine, quetiapine and risperidone had a high risk of adverse effects and a low rate of effectiveness when used in patients older than 40.[19]
In 2015, a study published in JAMA Internal Medicine showed that strong anticholinergic drugs, which include olanzapine, were associated with an increased risk of dementia in older adults. The study also showed that higher doses and longer use of these drugs are associated with higher risk of dementia.[20]
Regulatory actions surrounding olanzapine
2003: In September, the Food and Drug Administration (FDA) ordered that the product labeling for certain antipsychotic drugs warn that patients should be monitored for symptoms of diabetes. The drugs requiring the new warning were olanzapine, aripiprazole, clozapine, quetiapine, risperidone and ziprasidone (GEODON). [21]
2005: The FDA issued a public health advisory on April 11 warning that atypical antipsychotics are associated with an increased risk of death when used to treat dementia in elderly patients.
The atypical antipsychotics affected by the FDA advisory are aripiprazole, olanzapine, quetiapine, risperidone, clozapine and ziprasidone. None of these drugs, however, is approved for the treatment of behavioral disorders in patients with dementia.[22]
2009: The FDA updated the product label of olanzapine to include information stating that the agency had received reports of leukopenia/neutropenia (low white blood cell count). These reports were received in clinical trial and/or post-marketing reports, and the FDA called them short-term events “related to antipsychotic agents.” Agranulocytosis (failure of the bone marrow to make enough white blood cells) also had been reported.[23]
2010: On January 29, the FDA issued a public health advisory informing health care professionals of changes to the prescribing information for olanzapine related to its use in adolescents ages 13-17 years for treatment of schizophrenia and bipolar I disorder (manic or mixed episodes). The FDA stated that prescribers and health care professionals should consider that there are increased risks of weight gain, hyperlipidemia and related long-term risks in adolescents compared with adults using this medication. Effectiveness and safety of olanzapine have not been established in pediatric patients younger than 13 years of age.[24]
2011: The FDA updated the information for all antipsychotic drugs relating to their potential risk to newborns when used during pregnancy. The drugs’ product labels have been updated to state that when mothers are treated with these drugs during the third trimester of pregnancy, there is a potential risk of abnormal muscle movements (extrapyramidal signs, or EPS) and withdrawal symptoms in their newborns.[25]
2016: The FDA issued a safety warning that a rare but serious skin condition known as Drug Reaction with Eosinophilia and Systemic Symptoms has been reported with use of olanzapine. This condition can involve other organs, such as the liver, kidneys, heart and lungs, and it can be fatal.[26]
Health Canada, an agency similar to the FDA, updated the product label of atypical antipsychotics to warn that the drugs are associated with an increased risk of sleep apnea (a disorder that causes breaks in breathing or very shallow breathing during sleep).[27]
2017: The FDA approved a new warning in the product label of olanzapine that stated that the drug may cause excessive sleepiness, low blood pressure upon sitting up or standing (postural hypotension) and problems with balance, all of which may increase the risk of falls and fractures in patients taking the drug.[28]
In 2022, the Journal of Clinical Psychopharmacology published a study showing that antipsychotic drugs that caused a high or medium increase in the level of the hormone prolactin in women, which include olanzapine, were associated with an increased risk of breast cancer . [29] See the July 2022 Worst Pills, Best Pills News article “Some Antipsychotics Elevate Breast Cancer Risk, a Large Study Confirms.”
Before You Use This Drug [top]
Do not use if you have or have had:
Tell your doctor if you have or have had:
When You Use This Drug [top]
How to Use This Drug [top]
Interactions with Other Drugs [top]
The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:
Central nervous system depressant (CNS) drugs, including alcohol, antidepressants, antihistamines, antipsychotics, some blood pressure medications (reserpine, methyldopa, beta-blockers), motion sickness medications, muscle relaxants, narcotics, sedatives, sleeping pills, and tranquilizers.
Other drugs that can interact with olanzapine include: carbamazepine, charcoal, fluvoxamine, LUVOX, NORVIR, RIFADIN, rifampin, RIMACTANE, ritonavir, TEGRETOL.
Adverse Effects [top]
Call your doctor immediately if you experience:
Call your doctor if these symptoms continue:
Signs of overdose:
If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.
Periodic Tests[top]
Ask your doctor which of these tests should be done periodically while you are taking this drug:
last reviewed July 31, 2024
Worst Pills, Best Pills is a project of Public Citizen's Health Research Group Group. As an independent, nonprofit organization, we take no corporate or government contributions and accept no advertising. Copyright © 2024 Public Citizen's Health Research Group. All rights reserved.
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