"The US Food and Drug Administration (FDA) has approved another atypical antipsychotic for the treatment of pediatric patients with bipolar I disorder.
According to a release issued by the drug's manufacturer, Actavis, asenapine (Sa"...
Symbyax Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Symbyax (olanzapine and fluoxetine hydrochloride) is a combination of a thienobenzodiazepine, a type of atypical antipsychotic, and a type of antidepressant called a selective serotonin reuptake inhibitor (SSRI) used to treat depression caused by bipolar disorder (manic depression). Symbyax may also be used to treat depression when other medications have not worked. Common side effects of Symbyax include:
- feeling tired,
- dry mouth,
- increased appetite,
- weight gain,
- blurred vision,
- swelling in your hands or feet, or
- trouble sleeping.
Antidepressants such as Symbyax can increase the risk of suicidal thoughts and behaviors. Tell your doctor if this occurs. There may be an increased risk of serious or fatal side effects (e.g., stroke, heart failure) when Symbyax is used in elderly patients with dementia. Tell your doctor if you have unlikely but serious side effects of Symbyax including:
- unusual or severe mental/mood changes (e.g., confusion, nervousness, trouble concentrating, restlessness),
- shaking (tremor),
- inability to keep still,
- decreased interest in sex,
- changes in sexual ability, or
- trouble urinating.
Symbax is taken once/day in the evening, in a 6-mg/25-mg capsule dose. Discuss with your doctor all medications you are taking as Symbax may interact adversely with many different drugs, including: MAO inhibitors, sibutramine, thioridazine, carbamazepine, cimetidine, phenytoin, drugs for anxiety, antipsychotics, antiarrhythmics, antidepressants, fosamprenavir/ritonavir, metoprolol, diuretics, aspirin, antiplatelet drugs, NSAIDs, blood thinners, drugs for high blood pressure, medicines for Parkinson's disease, drugs that increase serotonin, SSRIs, SNRIs, tryptophan, St. John's wort, amphetamines, alcohol, antihistamines, drugs for sleep, muscle relaxants, and narcotic pain relievers. During pregnancy, this medication should be used only when prescribed by a doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may develop muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice these symptoms in your newborn, tell your doctor. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding is not recommended. Do not stop taking this medication without consulting your doctor. Some conditions may worsen when this drug is abruptly stopped.
Our Symbyax Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Symbyax in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have a serious side effect such as:
- sudden and severe headache, chest pain, numbness, and problems with vision, speech, or balance;
- increased thirst, frequent urination, excessive hunger, or weakness;
- agitation, hallucinations, fever, fast heart rate, overactive reflexes, vomiting, diarrhea, loss of coordination;
- very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
- jerky muscle movements you cannot control, seizure (convulsions);
- feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
- flu symptoms, easy bruising, sores in your mouth and throat; or
- seizure (convulsions);
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- dry mouth, increased appetite, weight gain;
- feeling drowsy or tired;
- blurred vision; or
- swelling in your hands or feet.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Symbyax (Olanzapine and fluoxetine)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Symbyax Overview - Patient Information: Side Effects
Dizziness, drowsiness, diarrhea, dry mouth, constipation, increased appetite, weight gain, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual or severe mental/mood changes (e.g., confusion, nervousness, trouble concentrating, rare thoughts of suicide), swelling hands/ankles/feet, restlessness, shaking (tremor), inability to keep still, decreased interest in sex, changes in sexual ability, trouble urinating.
Tell your doctor immediately if any of these rare but very serious side effects occur: black stools, vomit that looks like coffee grounds, easy bruising/bleeding, muscle spasm, yellowing eyes/skin, severe stomach/abdominal pain, slow heartbeat, signs of infection (such as fever, persistent sore throat).
Get medical help right away if any of these rare but serious side effects occur: fainting, severe headache, seizures, eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision).
This drug may infrequently make your blood sugar level rise, an effect that may cause or worsen diabetes. This high blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst/urination or unexplained weakness. If you already have diabetes, be sure to check your blood sugars regularly and share the results with your doctor. Your doctor may need to adjust your medication, diet, and exercise program when you start or stop this medication.
This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels, especially in teenagers. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.)
This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.
This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.
Olanzapine may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any unusual/uncontrolled movements (especially of the face/lips/tongue).
In rare cases, this medication may increase your blood level of a certain hormone (prolactin). For females, this rare increase in prolactin levels may result in unwanted breast milk, irregular/stopped menstrual periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.
For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Symbyax (Olanzapine and fluoxetine)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Symbyax FDA Prescribing Information: Side Effects
The following adverse reactions are discussed in more detail in other sections of the labeling:
- Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
- Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see WARNINGS AND PRECAUTIONS]
- Neuroleptic Malignant syndrome (NMS) [see WARNINGS AND PRECAUTIONS]
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see WARNINGS AND PRECAUTIONS]
- Hyperglycemia [see WARNINGS AND PRECAUTIONS]
- Dyslipidemia [see WARNINGS AND PRECAUTIONS]
- Weight Gain [see WARNINGS AND PRECAUTIONS]
- Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
- Angle-Closure Glaucoma [see WARNINGS AND PRECAUTIONS]
- Allergic Reactions and Rash [see WARNINGS AND PRECAUTIONS]
- Activation of Mania/Hypomania [see WARNINGS AND PRECAUTIONS]
- Tardive Dyskinesia [see WARNINGS AND PRECAUTIONS]
- Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
- Leukopenia, Neutropenia, and Agranulocytosis [see WARNINGS AND PRECAUTIONS]
- Dysphagia [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Abnormal Bleeding [see WARNINGS AND PRECAUTIONS]
- Hyponatremia [see WARNINGS AND PRECAUTIONS]
- Potential for Cognitive and Motor Impairment [see WARNINGS AND PRECAUTIONS]
- Body Temperature Dysregulation [see WARNINGS AND PRECAUTIONS]
- QT Prolongation [see WARNINGS AND PRECAUTIONS]
- Hyperprolactinemia [see WARNINGS AND PRECAUTIONS]
- Discontinuation Adverse Reactions [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice.
The data in the tables represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
Adults - The information below is derived from a clinical study database for SYMBYAX consisting of 2547 patients with treatment resistant depression, depressive episodes associated with Bipolar I Disorder, Major Depressive Disorder with psychosis, or sexual dysfunction with approximately 1085 patient-years of exposure. The conditions and duration of treatment with SYMBYAX varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, fixed-dose and dose-titration studies, and short-term or long-term exposure.
Adverse Reactions Associated with Discontinuation of Treatment in Short-Term, Controlled Studies Including Depressive Episodes Associated with Bipolar I Disorder and Treatment Resistant Depression - Overall, 11.3% of the 771 patients in the SYMBYAX group discontinued due to adverse reactions compared with 4.4% of the 477 patients for placebo. Adverse reactions leading to discontinuation associated with the use of SYMBYAX (incidence of at least 1% for SYMBYAX and greater than that for placebo) using MedDRA Dictionary coding were weight increased (2%) and sedation (1%) versus placebo patients which had 0% incidence of weight increased and sedation.
Commonly Observed Adverse Reactions in Controlled Studies Including Depressive Episodes Associated with Bipolar I Disorder and Treatment Resistant Depression - In short-term studies, the most commonly observed adverse reactions associated with the use of SYMBYAX (incidence ≥ 5% and at least twice that for placebo in the SYMBYAX-controlled database) using MedDRA Dictionary coding were: disturbance in attention, dry mouth, fatigue, hypersomnia, increased appetite, peripheral edema, sedation, somnolence, tremor, vision blurred, and weight increased. Adverse reactions reported in clinical trials of olanzapine and fluoxetine in combination are generally consistent with treatment-emergent adverse reactions during olanzapine or fluoxetine monotherapy.
In a 47-week maintenance study in adults with treatment resistant depression, adverse reactions associated with SYMBYAX use were generally similar to those seen in short-term studies. Weight gain, hyperlipidemia, and hyperglycemia were observed in SYMBYAX-treated patients throughout the study.
Adverse Reactions Occurring at an Incidence of 2% or More in Short-Term Controlled Studies Including Depressive Episodes Associated with Bipolar I Disorder and Treatment Resistant Depression - Table 16 enumerates the treatment-emergent adverse reactions associated with the use of SYMBYAX (incidence of at least 2% for SYMBYAX and twice or more than for placebo). The SYMBYAX-controlled column includes patients with various diagnoses while the placebo column includes only patients with bipolar depression and major depression with psychotic features.
Table 16: Adverse Reactions: Incidence in the
Short-Term Controlled Clinical Studies in Adults
|System Organ Class||Adverse Reaction||Percentage of Patients Reporting Event|
|Eye disorders||Vision blurred||5||2|
|Gastrointestinal disorders||Dry mouth||15||6|
|General disorders and administration site conditions||Fatigue||12||2|
|Infections and infestations||Sinusitis||2||1|
|Metabolism and nutrition disorders||Increased appetite||20||4|
|Musculoskeletal and connective tissue disorders||Arthralgia||4||1|
|Pain in extremity||3||1|
|Nervous system disorders||Somnolenceb||27||11|
|Disturbance in attention||5||1|
|Reproductive system and breast disorders||Erectile dysfunction||2||1|
|a Includes edema, edema peripheral, pitting
edema, generalized edema, eyelid edema, face edema, gravitational edema,
localized edema, periorbital edema, swelling, joint swelling, swelling face,
and eye swelling.
b Includes somnolence, sedation, hypersomnia, and lethargy.
Dystonia, Class Effect for Antipsychotics - Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, the frequency and severity are greater with high potency and at higher doses of first generation antipsychotic drugs. In general, an elevated risk of acute dystonia may be observed in males and younger age groups receiving antipsychotics; however, events of dystonia have been reported infrequently ( < 1%) with the olanzapine and fluoxetine combination.
Additional Findings Observed in Clinical Studies
Sexual Dysfunction - In the pool of controlled SYMBYAX studies in patients with bipolar depression, there were higher rates of the treatment-emergent adverse reactions decreased libido, anorgasmia, erectile dysfunction and abnormal ejaculation in the SYMBYAX group than in the placebo group. One case of decreased libido led to discontinuation in the SYMBYAX group. In the controlled studies that contained a fluoxetine arm, the rates of decreased libido and abnormal ejaculation in the SYMBYAX group were less than the rates in the fluoxetine group. None of the differences were statistically significant.
Sexual dysfunction, including priapism, has been reported with all SSRIs. While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.
There are no adequate and well-controlled studies examining sexual dysfunction with SYMBYAX or fluoxetine treatment. Symptoms of sexual dysfunction occasionally persist after discontinuation of fluoxetine treatment.
Difference Among Dose Levels Observed In Other Olanzapine Clinical Trials
In a single 8-week randomized, double-blind, fixed-dose study comparing 10 (N=199), 20 (N=200), and 40 (N=200) mg/day of olanzapine in patients with Schizophrenia or Schizoaffective Disorder, statistically significant differences among 3 dose groups were observed for the following safety outcomes: weight gain, prolactin elevation, fatigue, and dizziness. Mean baseline to endpoint increase in weight (10 mg/day: 1.9 kg; 20 mg/day: 2.3 kg; 40 mg/day: 3 kg) was observed with significant differences between 10 vs 40 mg/day. Incidence of treatment-emergent prolactin elevation > 24.2 ng/mL (female) or > 18.77 ng/mL (male) at any time during the trial (10 mg/day: 31.2%; 20 mg/day: 42.7%; 40 mg/day: 61.1%) with significant differences between 10 vs 40 mg/day and 20 vs 40 mg/day; fatigue (10 mg/day: 1.5%; 20 mg/day: 2.1%; 40 mg/day: 6.6%) with significant differences between 10 vs 40 and 20 vs 40 mg/day; and dizziness (10 mg/day: 2.6%; 20 mg/day: 1.6%; 40 mg/day: 6.6%) with significant differences between 20 vs 40 mg, was observed.
Other Adverse Reactions Observed In Clinical Studies
Following is a list of treatment-emergent adverse reactions reported by patients treated with SYMBYAX in clinical trials. This listing is not intended to include reactions (1) already listed in previous tables or elsewhere in labeling, (2) for which a drug cause was remote, (3) which were so general as to be uninformative, (4) which were not considered to have significant clinical implications, or (5) which occurred at a rate equal to or less than placebo.
Reactions are classified by body system using the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; and rare reactions are those occurring in fewer than 1/1000 patients.
Body as a Whole - Frequent: chills, neck rigidity, photosensitivity reaction; Rare: death1.
Cardiovascular System - Frequent: vasodilatation; Infrequent: QT-interval prolonged.
Digestive System - Frequent: diarrhea; Infrequent: gastritis, gastroenteritis, nausea and vomiting, peptic ulcer; Rare: gastrointestinal hemorrhage, intestinal obstruction, liver fatty deposit, pancreatitis.
Metabolic and Nutritional - Frequent: generalized edema, weight loss; Rare: bilirubinemia, creatinine increased, gout.
Musculoskeletal System - Rare: osteoporosis.
Nervous System - Frequent: amnesia; Infrequent: ataxia, buccoglossal syndrome, coma, depersonalization, dysarthria, emotional lability, euphoria, hypokinesia, movement disorder, myoclonus; Rare: hyperkinesia, libido increased, withdrawal syndrome.
Special Senses - Frequent: taste perversion; Infrequent: abnormality of accommodation, dry eyes.
Urogenital System - Frequent: breast pain, menorrhagia2, urinary frequency, urinary incontinence; Infrequent: amenorrhea2, female lactation2, hypomenorrhea2, metrorrhagia2, urinary retention, urinary urgency, urination impaired; Rare: breast engorgement2.
Other Adverse Reactions Observed With Olanzapine Or Fluoxetine Monotherapy
The following adverse reactions were not observed in SYMBYAX-treated patients during premarketing clinical studies but have been reported with olanzapine or fluoxetine monotherapy: aplastic anemia, bruxism, cholestatic jaundice, diabetic coma, dysuria, eosinophilic pneumonia3, erythema multiforme, esophageal ulcer, gynecological bleeding, headache, hypotension, jaundice, neutropenia, sudden unexpected death3, sweating, and violent behaviors3. Random triglyceride levels of ≥ 1000 mg/dL have been reported.
Children And Adolescent Patients (aged 10 to 17 years) With A Diagnosis Of Bipolar Depression
The information below is derived from a single, 8-week, randomized, placebo-controlled clinical trial investigating SYMBYAX for the treatment of bipolar I depression in patients 10 to 17 years of age.
Adverse Reactions Associated with Discontinuation of Treatment in the single pediatric study - Overall, 14.1% of the 170 patients in the SYMBYAX group discontinued due to adverse reactions compared with 5.9% of the 85 patients for placebo. Adverse reactions leading to discontinuation associated with the use of SYMBYAX (incidence of at least 1% for SYMBYAX and greater than that for placebo) using MedDRA Dictionary coding were weight increased (2.9%), suicidal ideation (1.8%), bipolar disorder (1.2%), and somnolence (1.2%) versus placebo patients which had 0% incidence of weight increased, bipolar disorder, and somnolence, and a 1.2% incidence of suicidal ideation.
Adverse Reactions Occurring at an Incidence of 2% or more and greater than placebo - Table 17 enumerates the treatment-emergent adverse reactions associated with the use of SYMBYAX (incidence of at least 2% for SYMBYAX and twice or more than for placebo).
Table 17: Treatment-Emergent Adverse Reactions:
Incidence in a 8-week randomized, double-blind, placebo-controlled clinical
trial in pediatric bipolar I depression.
|System Organ Class||Adverse Reaction||Percentage of Patients Reporting Event|
|Nervous system disorders||Somnolencea||24||2|
|Blood triglycerides increased||7||2|
|Blood cholesterol increased||4||0|
|Hepatic enzyme increasedb||9||1|
|Metabolism and nutrition disorders||Increased appetite||17||1|
|Musculoskeletal and connective tissue disorders||Back pain||2||1|
|Injury, poisoning and procedural complications||Accidental overdose||3||1|
|Reproductive system and breast disorders||Dysmenorrhea||2||0|
|a Includes somnolence, sedation, and
hypersomnia. No lethargy was reported.
b Includes alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased, liver function test abnormal, gamma-glutamyltransferase increased, and transaminases increased.
Vital Signs And Laboratory Studies
Vital Signs - Tachycardia, bradycardia, and orthostatic hypotension have occurred in SYMBYAX-treated patients [see WARNINGS AND PRECAUTIONS]. The mean standing pulse rate of SYMBYAX-treated patients was reduced by 0.7 beats/min.
Laboratory Changes - In SYMBYAX clinical studies (including treatment resistant depression, depressive episodes associated with Bipolar I Disorder, Major Depressive Disorder with psychosis, or sexual dysfunction), SYMBYAX was associated with statistically significantly greater frequencies for the following treatment-emergent findings in laboratory analytes (normal at baseline to abnormal at any time during the trial) compared to placebo: elevated prolactin (28% vs 5%); elevated urea nitrogen (3% vs 0.8%); elevated uric acid (3% vs 0.5%); low albumin (3% vs 0.3%); low bicarbonate (14% vs 9%); low hemoglobin (3% vs 0%); low inorganic phosphorus (2% vs 0.3%); low lymphocytes (2% vs 0%); and low total bilirubin (15% vs 4%).
As with olanzapine, asymptomatic elevations of hepatic aminotransferases [ALT, AST, and GGT] and alkaline phosphatase have been observed with SYMBYAX. In the SYMBYAX-controlled database, clinically significant ALT elevations (change from < 3 times the upper limit of normal [ULN] at baseline to ≥ 3 times ULN) were observed in 5% (38/698) of patients exposed to SYMBYAX compared with 0.5% (2/378) of placebo-treated patients and 4% (33/751) of olanzapine-treated patients. ALT elevations ≥ 5 times ULN were observed in 2% (11/701) of SYMBYAX-treated patients, compared to 0.3% (1/379) of placebo-treated patients and 1% (11/760) of olanzapine-treated patients. No patient with elevated ALT values experienced jaundice or liver failure, or met the criteria for Hy's Rule. ALT values returned to normal, or were decreasing, at last follow-up in the majority of patients who either continued treatment with SYMBYAX or discontinued SYMBYAX.
Rare postmarketing reports of hepatitis have been received in patients treated with olanzapine. Very rare cases of cholestatic or mixed liver injury have also been reported in the postmarketing period in patients treated with olanzapine.
Caution should be exercised in patients with signs and symptoms of hepatic impairment, in patients with preexisting conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic drugs.
An increase in creatine phosphokinase has been reported very rarely in SYMBYAX-treated patients and infrequently in clinical trials of olanzapine-treated patients.
QT Interval Prolongation - The mean increase in QTc interval for SYMBYAX-treated patients (4.4 msec) in clinical studies was significantly greater than that for placebo-treated (-0.8 msec), olanzapine-treated (-0.3 msec) patients, and fluoxetine-treated (1.7 msec) patients. There were no significant differences between patients treated with SYMBYAX, placebo, olanzapine, or fluoxetine in the incidence of QTc outliers ( > 500 msec).
Children And Adolescents (aged 10 to 17 years)
In a single 8-week randomized, placebo-controlled clinical trial investigating SYMBYAX for treatment of bipolar I depression in patients 10 to 17 years of age, the following was observed:
Vital Signs - In the SYMBYAX-treated patients compared with placebo-treated patients, the mean orthostatic blood pressure and standing pulse rate were not significantly different between treatment groups.
Body Weight: An increase in weight greater than or equal to 7% occurred in 52.4% of the SYMBYAX group and 3.6% of the placebo group. Weight gain greater than or equal to 15% occurred in 14.1% of the SYMBYAX group and none of the placebo group.
Laboratory Changes - SYMBYAX was associated with statistically significantly greater frequencies for the following treatment-emergent findings in laboratory analytes (normal or low at baseline to abnormal at any time during the trial) compared to placebo: elevated ALT (45.9% vs 2.5%); elevated AST (33.7% vs 7.6%); high fasting total cholesterol (28.9% vs 8.2%); high fasting LDL cholesterol (19.7% vs 6.5%); high fasting triglycerides (52.3% vs 27.3%), and elevated prolactin (85% vs 36%). No patient with elevated hepatic enzyme values experienced jaundice or liver failure, or met the criteria for Hy's Rule. Five patients experienced an adverse event potentially associated with elevated prolactin; these events included dysmenorrhoea, galactorrhoea, and ovulation disorder.
QT Interval Prolongation - SYMBYAX was associated with a statistically significantly greater mean increase in QTcF interval (8.2 msec [95% CI 6.2, 10.2]) compared with placebo. No patients developed QTc increases ≥ 60 msec or QTc ≥ 480 msec [see WARNINGS AND PRECAUTIONS].
The following adverse reactions have been identified during post-approval use of SYMBYAX. Because these reactions are reported voluntarily from a population of uncertain size, it is difficult to reliably estimate their frequency or evaluate a causal relationship to drug exposure.
Adverse reactions reported since market introduction that were temporally (but not necessarily causally) related to SYMBYAX therapy include the following: rhabdomyolysis and venous thromboembolic events (including pulmonary embolism and deep venous thrombosis).
1 This term represents a serious adverse event but does not meet the definition for adverse drug reactions. It is included here because of its seriousness.
2 Adjusted for gender.
3 These terms represent serious adverse events but do not meet the definition for adverse drug reactions. They are included here because of their seriousness
Read the entire FDA prescribing information for Symbyax (Olanzapine and fluoxetine)
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