Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications and Warnings |
Abilify (aripiprazole) Tablets
Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets
Abilify (aripiprazole) Oral Solution
Abilify (aripiprazole) Injection For Intramuscular Use Only
Prescribing Information (in new labeling format)
See MedWatch Safety Alert posted 6/16/2008 notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. |
BOXED WARNING
WARNINGS AND PRECAUTIONS
- Use in Elderly Patients with Dementia-Related Psychosis
- Increased Mortality
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Abilify (aripiprazole) is not approved for the treatment of patients with dementia-related psychosis [see BOXED WARNING].
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BOXED WARNING
WARNINGS: 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 (eg, heart failure, sudden death) or infectious (eg, 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. Abilify (aripiprazole) is not approved for the treatment of patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS (5.1)]. |
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Clozaril (clozapine HCl) Tablets
For current prescribing information, contact Novartis Pharmaceuticals at 1-888-669-6682.
See MedWatch Safety Alert posted 6/16/2008 notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis.
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BOXED WARNING
WARNINGS
- 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. Clozaril is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).
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BOXED WARNING
WARNING: 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. Clozaril is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). |
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FazaClo (clozapine) Orally Disintegrating Tablets
For current prescribing information, contact Azur Pharma, Inc. at 1-877-329-2256.
See MedWatch Safety Alert posted 6/16/2008 notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis.
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BOXED WARNING
WARNINGS
- 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. FazaClo is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).
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BOXED WARNING
WARNING: 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. FazaClo is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). |
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Geodon (ziprasidone HCl) Capsules
Geodon (ziprasidone mesylate) for Injection - For IM Use Only
Prescribing Information
See MedWatch Safety Alert posted 6/16/2008 notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis.
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BOXED WARNING
WARNINGS
- 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. Geodon (ziprasidone) is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).
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BOXED WARNING
WARNING: 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 (see WARNINGS). |
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Haldol (haloperidol injection) For Immediate Release
Prescribing Information
See MedWatch Safety Alert posted 6/16/2008 notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis.
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BOXED WARNING
WARNINGS
- 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. Haldol Injection is not approved for
the treatment of patients with dementia-related psychosis (see BOXED
WARNING).
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BOXED WARNING
WARNING: 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. Haldol Injection is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). |
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Haldol Decanoate (haloperidol) For IM Injection Only
Prescribing Information
See MedWatch Safety Alert posted 6/16/2008 notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. |
BOXED WARNING
WARNINGS
- 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. Haldol Decanoate is not approved for the treatment of patients with dementia-related psychosis (see BOXED
WARNING).
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BOXED WARNING
WARNING: 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. Haldol Decanoate is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). |
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Invega (paliperidone) Extended-Release Tablets
Prescribing Information (in new labeling format)
See MedWatch Safety Alert posted 6/16/2008 notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. |
BOXED WARNING
WARNINGS AND PRECAUTIONS
- 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. Invega (paliperidone) is not approved for the treatment of dementia-related psychosis [see BOXED WARNING].
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BOXED WARNING
WARNING: 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 17 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. Invega (paliperidone) Extended-Release Tablets is not approved for the treatment of patients with dementia- related psychosis [see WARNINGS and PRECAUTIONS (5.1)]. |
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Moban (molindone hydrochloride tablets, USP)
Prescribing Information
See MedWatch Safety Alert posted 6/16/2008 notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. |
BOXED WARNING
WARNINGS
- 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. Moban is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).
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BOXED WARNING
WARNING: 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. Moban is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). |
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Navane (thiothixene capsules)
Navane (thiothixene hydrochloride
concentrate)
Prescribing Information
See MedWatch Safety Alert posted 6/16/2008 notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. |
BOXED WARNING
WARNINGS
- 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. Navane is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).
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BOXED WARNING
WARNING: 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. Navane is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). |
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Risperdal (risperidone) Tablets
Risperdal (risperidone) Oral Solution
Risperdal M-Tab (risperidone) Orally Disintegrating Tablets
For current prescribing information, contact Janssen, L.P. at 1-800-526-7736.
See MedWatch Safety Alert posted 6/16/2008 notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis.
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BOXED WARNING
WARNINGS
- 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. Risperdal (risperidone) is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).
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BOXED WARNING
WARNING: 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. Risperdal (risperidone) is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). |
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Risperdal Consta (risperidone) Long-Acting Injection
For current prescribing information, contact Janssen, L.P. at 1-800-526-7736.
See MedWatch Safety Alert posted 6/16/2008 notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. |
BOXED WARNING
WARNINGS
- 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. Risperdal Consta (risperidone) is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).
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BOXED WARNING
WARNING: 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. Risperdal Consta (risperidone) is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). |
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Seroquel (quetiapine fumarate) Tablets
For current prescribing information, contact AstraZeneca at 1-800-236-9933.
See MedWatch Safety Alert posted 6/16/2008 notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis.
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BOXED WARNING
WARNING
- 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. Seroquel is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).
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BOXED WARNING
WARNING: 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. Seroquel is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). |
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Seroquel XR (quetiapine fumarate) Extended-Release Tablets
For current prescribing information, contact AstraZeneca at 1-800-236-9933.
See MedWatch Safety Alert posted 6/16/2008 notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis.
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BOXED WARNING
WARNING
- 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. Seroquel XR is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).
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BOXED WARNING
WARNING: 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. Seroquel XR is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). |
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Symbyax (olanzapine and fluoxetine HCl capsules)
For current prescribing information, contact Eli Lilly and Company at 1-800-LillyRX.
See MedWatch Safety Alert posted 6/16/2008 notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis.
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BOXED WARNING
WARNING
- 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. Symbyax (olanzapine and fluoxetine HCl) is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).
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BOXED WARNING
WARNING: 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. Symbyax (olanzapine and fluoxetine HCl) is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). |
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Viread (tenofovir disoproxil fumarate) Tablets
Prescribing Information (in new labeling format)
Patient Package Insert
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BOXED WARNING
WARNINGS AND PRECAUTIONS
- Exacerbation of Hepatitis after Discontinuation of Treatment
- Coadministration with Other Products
- Patients Coinfected with HIV-1 and HBV
- Decreases in Bone Mineral Density
- Fat Redistribution
- Immune Reconstitution Syndrome
ADVERSE REACTIONS
- Adverse Reactions from Clinical Trials Experience
- Clinical Trials in Patients with Chronic Hepatitis B
- Treatment-Emergent Adverse Reactions
- Laboratory Abnormailities
- Table 8 (and text following Table 8)
DRUG INTERACTIONS
- Drugs Affecting Renal Function
- In the treatment of chronic hepatitis B, Viread should not be administered in combination with Hepsera (adefovir dipivoxil).
PATIENT COUNSELING INFORMATION
- Information for Patients
- Patients should be advised that:
- The use of Viread has not been shown to reduce the risk of transmission of HIV-1 or HBV to others...
- Viread should not be discontinued without first informing their physician.
- If you have HIV-1 infection, with or without HBV coinfection, it is important to take Viread with combination therapy.
- Severe acute exacerbations of hepatitis have been reported in patients who are infected with HBV or coinfected with HBV and HIV-1...
- In patients with chronic hepatitis B, it is important to obtain HIV antibody testing prior to initiating Viread...
- Viread should not be administered in combination with Hepsera...
- Decreases in bone mineral density have been observed with the use of Viread in patients with HIV...
- In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown. The relationship between response and long-term prevention of outcomes such as hepatocellular carcinoma is not known.
PATIENT PACKAGE INSERT
- What is Viread and how does it work?
- Use in the Treatment of HIV-1 Infection
- Use in the Treatment of Chronic Hepatitis B
- Does Viread cure HIV-1 or AIDS?
- Does Viread reduce the risk of passing HIV-1 or HBV to others?
- Who should not take Viread?
- What should I tell my healthcare provider before taking Viread?
- How should I take Viread?
- What are the possible side effects of Viread?
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BOXED WARNING
WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS
...Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including Viread. Hepatic function should be monitored closely with both clinical and
laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including Viread. If appropriate, resumption of anti-hepatitis B therapy may be warranted [See Warnings and Precautions (5.2)].
WARNINGS AND PRECAUTIONS
Exacerbation of Hepatitis after Discontinuation of Treatment
Discontinuation of anti-HBV therapy, including Viread, may be associated with severe acute exacerbations of hepatitis. Patients infected with HBV who discontinue Viread should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Coadministration with Other Products
...Viread should not be administered in combination with Hepsera (adefovir dipivoxil) [See Drug Interactions (7.4)].
Patients Coinfected with HIV-1 and HBV
Due to the risk of development of HIV-1 resistance, Viread should only be used in HIV-1 and HBV coinfected patients as part of an appropriate antiretroviral combination regimen.
HIV-1 antibody testing should be offered to all HBV-infected patients before initiating therapy with Viread. It is also recommended that all patients with HIV-1 be tested for the presence of chronic hepatitis B before initiating treatment with Viread.
Decreases in Bone Mineral Density
...The bone effects of Viread have not been studied in patients with chronic HBV infection.
Fat Redistribution
In HIV-infected patients redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast
enlargement, and "cushingoid appearance" have been observed in patients receiving combination antiretroviral therapy...
Immune Reconstitution Syndrome
Immune reconstitution syndrome has been reported in HIV-infected patients treated with combination antiretroviral therapy, including Viread... |
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Zyprexa (olanzapine tablets)
Zyprexa Zydis (olanzapine orally disintegrating tablets)
Zyprexa IntraMuscular (olanzapine for injection)
Prescribing Information
See MedWatch Safety Alert posted 6/16/2008 notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. |
BOXED WARNING
WARNINGS
- 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. Zyprexa is not approved for the treatment of patients with
dementia-related psychosis (see BOXED WARNING).
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BOXED WARNING
WARNING: 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. Zyprexa (olanzapine) is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). |
Back to Summary Page | Back to Top
Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications
and Warnings |
Metadate CD (methylphenidate HCl, USP) Extended-Release Capsules
Prescribing Information |
CONTRAINDICATIONS
- Hypersensitivity To Methylphenidate Or Other Excipients
- Halogenated Anesthetics
PRECAUTIONS
- Drug Testing
- Metadate CD contains methylphenidate which may result in a positive result during drug testing.
- Drug Interactions
- Phenylbutazone (added)
- In theory, there is a possibility that the clearance of methylphenidate might be affected by urinary pH...
- Halogenated Anesthetics
ADVERSE REACTIONS
- Postmarketing Experience
- ...peripheral coldness, Raynaud’s phenomenon, reversible ischaemic neurological deficit (added)
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CONTRAINDICATIONS
Hypersensitivity To Methylphenidate Or Other Excipients
...Metadate CD contains sucrose. Therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.
Halogenated Anesthetics
There is a risk of sudden blood pressure increase during surgery. If surgery is planned, Metadate CD should not be taken on the day of the surgery.
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Reyataz (atazanavir sulfate) Capsules
Prescribing Information (in new labeling format)
Patient Package Insert
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CONTRAINDICATIONS
- Table 3: Drugs That Are Contraindicated with Reyataz
DRUG INTERACTIONS
- Potential for Reyataz to Affect Other Drugs
- Established and Other Potentially Significant Drug Interactions
- Table 10
- HIV Antiviral Agents
- Other Agents
- Drugs with No Observed or Predicted Interactions with Reyataz
PATIENT PACKAGE INSERT
- What important information should I know about taking Reytataz with other medicines?
- Midazolam, also known as Versed (used for sedation), when taken by mouth.
- Do not take the following medicines with Reyataz because they may lower the amount of Reyataz in your blood...
- Viramune (nevirapine, used for HIV infection).
- Talk to your healthcare provider about choosing an effective method of contraception...
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CONTRAINDICATIONS
See Table 3: Drugs That Are Contraindicated with Reyataz:
Triazolam and orally administered midazolam are extensively metabolized by CYP3A4. Coadministration of triazolam or orally administered midazolam with
Reyataz may cause large increases in the concentration of these benzodiazepines...
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Rocephin (ceftriaxone sodium)
For Injection
Prescribing Information
See previous MedWatch Safety Alerts originally posted 07/05/2007 notifying healthcare professionals of the potential risks associated with concomitant use of Rocephin with calcium or calcium-containing solutions or products. |
CONTRAINDICATIONS
WARNINGS
- Interaction with Calcium-Containing Products
PRECAUTIONS
- General
- Cases of pancreatitis, possibly secondary to biliary obstruction, have been reported rarely in patients treated with Rocephin...
- The elimination of Rocephin is not altered by probenecid.
- As with other cephalosporins, anaphylactic shock cannot be ruled out...
- Geriatric Use (subsection added)
ADVERSE REACTIONS
- Postmarketing Experience
(subsection added)
- Gastrointestinal
- Genitourinary
- Dermatologic
- Cephalosporin Class Adverse Reactions
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CONTRAINDICATIONS
Neonates ( < 28 days)
...Rocephin must not be co-administered with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition, in neonates because of the risk of precipitation of ceftriaxone-calcium salt. Cases of fatal reactions with ceftriaxone-calcium precipitates in lung and kidneys in neonates have been described. In some cases the infusion lines and the times of administration of ceftriaxone and calcium-containing solutions differed...
WARNINGS
Interaction with Calcium-Containing Products
There are no reports to date of intravascular or pulmonary precipitations in patients, other than neonates, treated with ceftriaxone and calcium-containing IV solutions. However, the theoretical possibility exists for an interaction between
ceftriaxone and IV calcium-containing solutions in patients other than neonates. Therefore, Rocephin and calcium-containing solutions, including continuous calcium-containing infusions such as parenteral nutrition, should not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different sites. As a further theoretical consideration and based on 5 half-lives of ceftriaxone, Rocephin and IV calcium-containing solutions should not be administered within 48 hours of each other in any patient (see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION).
No data are available on potential interaction between ceftriaxone and oral calcium containing products or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral).
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Brand (Generic) Name |
Sections Modified
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Summary of Changes to Contraindications
and Warnings |
Phosphocol P 32 (chromic phosphate P 32 suspension)
Prescribing Information
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WARNINGS
PRECAUTIONS
- Pediatric Use
- Risk of Malignancy
- Acute lymphocytic leukemia has been reported in children following the intra-articular
administration of Phosphocol P32 (See WARNINGS).
ADVERSE REACTIONS
- Postmarketing Experience
- Leukemia in Children (see WARNINGS)
- Radiation injury (necrosis and fibrosis) to the small bowel, cecum, and bladder following administration of P 32 into the peritoneal cavity.
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WARNINGS
Leukemia
Phosphocol P 32 may increase the risk for leukemia in certain situations. Two children (ages 9 and 14) with hemophilia developed acute lymphocytic leukemia approximately 10 months after intra-articular injections of Phosphocol P 32 (0.6 and 1.5 mCi total dose). Phosphocol P 32 is not indicated in the intra-articular treatment of hemarthroses. |
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Retisert (fluocinolone acetonide intravitreal implant)
Prescribing Information (in new labeling format)
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WARNINGS AND PRECAUTIONS
- Cataract Formation
- Increase in Intraocular Pressure
ADVERSE REACTIONS
- Clinical Trials Experience – Ocular
Events
- Clinical Trials Experience – Non-Ocular
Events
PATIENT COUNSELING INFORMATION |
WARNINGS AND PRECAUTIONS
Cataract Formation
Use of corticosteroids may result in posterior subcapsular cataract formation.
Based on clinical trials with Retisert, during the 3-year post implantation period, nearly all phakic eyes are expected to develop cataracts and require cataract surgery.
Increase in Intraocular Pressure
...Based on clinical trials with Retisert, within 3-years post implantation, approximately 77% of patients will require IOP lowering medications to control intraocular pressure and 37% of patients will require filtering procedures to control intraocular pressure... |
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Sustiva (efavirenz) Capsules and Tablets
Prescribing Information |
WARNINGS
- Reproductive Risk Potential: Pregnancy Category D
ADVERSE REACTIONS
- Postmarketing Experience
- Central and Peripheral Nervous System
- Cerebellar coordination and balance disturbances (added)
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WARNINGS
Reproductive Risk Potential: Pregnancy Category D
...Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of Sustiva is recommended...
...As of July 2007, the Antiretroviral Pregnancy Registry has received prospective reports of 373 pregnancies exposed to efavirenz-containing regimens, nearly all of which were first-trimester exposures (359 pregnancies). Birth defects occurred in 7 of 295 live births (first-trimester exposure) and 1 of 26 live births (second/third-trimester exposure). None of these prospectively reported defects were neural tube defects. However, there have been five retrospective reports of findings consistent with neural tube defects, including meningomyelocele. All mothers were exposed to efavirenz-containing regimens in the first trimester... |
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Vidaza (azacitidine for injection) For SC or IV Use
Prescribing Information (in new labeling format)
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WARNINGS AND PRECAUTIONS
- Anemia, Neutropenia and Thrombocytopenia
- Pregnancy: Pregnancy Category D
- Use in Males
ADVERSE REACTIONS
- Overview
- Adverse Reactions Described in Other Labeling Sections
- Adverse Reactions Most Frequently (>2%) Resulting in Clinical Intervention (SC or IV Route)
- Dose Held
- ...thrombocytopenia, pyrexia, pneumonia (added)
- Adverse Reactions in Clinical Trials
- Initial Section
- Table 1
- Table 2
- In clinical studies of either SC or IV Vidaza, the following serious adverse reactions occurring at a rate of < 5% (and not described in Tables 1 or 2) were reported:
- Blood and Lymphatic System Disorders
- Bone marrow failure
- Pancytopenia
- Eye Disorders
- Infections and Infestations
- Cellulitis
- Neutropenic sepsis
- Septic shock
- Nervous System Disorders
- Postmarketing Experience
USE IN SPECIFIC POPULATIONS
- Pregnancy - Pregnancy Category D
- ...Female partners of male patients receiving Vidaza should not become pregnant [see Nonclinical Toxicology (13)]...
- Nursing Mothers
- ...a decision should be made whether to discontinue nursing or to discontinue the drug, taking into consideration the importance of the drug to the mother.
- Geriatric Use
- Gender
- Race
PATIENT COUNSELING INFORMATION
- ...For nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into consideration the importance of the drug to the mother.
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WARNINGS AND PRECAUTIONS
Anemia, Neutropenia and Thrombocytopenia
Treatment with Vidaza is associated with anemia, neutropenia and thrombocytopenia... (anemia added)
Pregnancy: Pregnancy Category D
...Azacitidine caused congenital malformations in animals...[see Use in Specific Populations (8.1)].
Use in Males
...In animal studies, pre-conception treatment of male mice and rats resulted in increased embryofetal loss in mated females [see Nonclinical Toxicology (13)]. |
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Zemuron (rocuronium bromide) Injection Solution For Intravenous Use
Prescribing Information (in new labeling format)
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WARNINGS AND PRECAUTIONS
- Appropriate Administration and Monitoring
- Residual Paralysis
- Long-term Use in an Intensive Care Unit
- QT Interval Prolongation
USE IN SPECIFIC POPULATIONS
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WARNINGS AND PRECAUTIONS
Appropriate Administration and Monitoring
...It is recommended that clinicians administering
neuromuscular blocking agents such as Zemuron employ a peripheral nerve stimulator to monitor drug effect, need for additional doses, adequacy of spontaneous recovery or antagonism, and to decrease the complications of overdosage if additional doses are administered.
Residual Paralysis
In order to prevent complications resulting from residual paralysis, it is recommended to extubate only after the patient has recovered sufficiently from neuromuscular block. Other factors which could cause residual paralysis after extubation in the post-operative phase (such as drug interactions or patient condition) should also be considered. If not used as part of standard clinical practice the use of a reversal agent should be considered, especially in those cases where residual paralysis is more likely to occur.
Long-term Use in an Intensive Care Unit
...Myopathy after long term administration of other non-depolarizing neuromuscular blocking agents in the ICU alone or in combination with corticosteroid therapy has been reported. Therefore, for patients receiving both neuromuscular blocking agents and corticosteroids, the period of use of the neuromuscular blocking agent should be limited as much as possible and only used in the setting where in the opinion of the prescribing physician, the specific advantages of the drug outweigh the risk.
QT Interval Prolongation
The overall analysis of ECG data in pediatric patients indicates that the concomitant use of Zemuron with general anesthetic agents can prolong the QTc interval [see Clinical Studies (14.3)]. |
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Brand
(Generic) Name
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Sections Modified |
Corzide (nadolol and bendroflumethiazide tablets)
Prescribing Information
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PRECAUTIONS
- Drug Interactions
- Nadolol
- Digitalis glycosides—Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
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Glucophage (metformin hydrochloride tablets)
Glucophage XR (metformin hydrochloride extended-release tablets)
Prescribing Information |
PRECAUTIONS
- General
- Macrovascular Outcomes
- There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Glucophage or Glucophage XR or any other anti-diabetic drug.
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Kerlone (betaxolol hydrochloride tablets)
Prescribing Information
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PRECAUTIONS
- Drug Interactions
- Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
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Metaglip (glipizide and metformin HCl) Tablets
Prescribing Information |
PRECAUTIONS
- General
- Macrovascular Outcomes
- There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Metaglip or any other anti-diabetic drug.
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Norvir (ritonavir capsules) Soft Gelatin
Norvir (ritonavir oral solution)
Prescribing Information
Patient Package Insert |
PRECAUTIONS
- PR Interval Prolongation
- Information for Patients
- Patients should be informed that Norvir may produce changes in the electrocardiogram (eg, PR prolongation)...
ADVERSE REACTIONS
- Postmarketing Experience
- Cardiovascular System
- First–degree AV block, second-degree AV block, third-degree AV block, right bundle branch block have been reported (See PRECAUTIONS – PR Interval Prolongation).
PATIENT PACKAGE INSERT
- What Are the Possible Side Effects of Norvir?
- Changes in the electrocardiogram (EKG)...
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Precose (acarbose tablets)
Prescribing Information
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PRECAUTIONS
- General
- Macrovascular Outcomes
- There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Precose or any other anti-diabetic drug.
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Sandostatin (octreotide acetate) Injection
Prescribing Information |
PRECAUTIONS
- General
- Risk of Pregnancy with Normalization of IGF-1 and GH (new subsection)
- Pregnancy Category B
- Nursing Mothers
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Somavert (pegvisomant for injection)
Prescribing Information
Patient Package Insert
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PRECAUTIONS
- Lipohypertrophy
- Lipohypertrophy has been reported in <5% of patients following pegvisomant administration.
ADVERSE REACTIONS
- Postmarketing Experience
- Lipohypertrophy has been reported in <5% of patients following pegvisomant administration.
- Asymptomatic, transient elevations in transaminases up to 15 times ULN have been observed in <2% of patients in the post-marketing experience. These reports were not associated with an increase in bilirubin, and there were no clinical consequences for these patients...
PATIENT PACKAGE INSERT
- INSTRUCTIONS FOR USE
- Giving the Injection
- Choose a different injection site each day so lumps do not develop...
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Brand
(Generic) Name
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Sections Modified |
Cialis (tadalafil) Tablet, Film Coated
Prescribing Information
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ADVERSE REACTIONS
- Postmarketing Experience
- Nervous
- Transient Global Amnesia (added)
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Estring (estradiol vaginal ring)
Prescribing Information
Patient Package Insert
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ADVERSE REACTIONS
- Postmarketing Experience
- A few cases of toxic shock syndrome (TSS) have been reported...
- A few cases of ring adherence to the vaginal wall, making ring removal difficult, have been reported...
- A few cases of bowel obstruction and vaginal ring use have been reported...
PATIENT PACKAGE INSERT
- Who should not use Estring?
- Currently have or have had liver problems.
- What are the possible side effects of Estring?
- What can I do to lower my chances of getting a serious side effect with Estring?
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Femara (letrozole tablets)
Prescribing Information
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ADVERSE REACTIONS
- Postmarketing Experiences
- ...angioedema and anaphylactic reactions (added)
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Megace ES (megestrol acetate oral suspension)
Prescribing Information
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ADVERSE REACTIONS
- Postmarketing
- Deep Vein Thrombosis (added)
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Symlin (pramlintide acetate) Injection
Prescribing Information
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ADVERSE REACTIONS
- Postmarketing Experience (new subsection)
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Synagis (palivizumab) For Intramuscular Administration
Prescribing Information
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ADVERSE REACTIONS
- Postmarketing Experience
- Blood and Lymphatic System Disorders
- Severe Thrombocytopenia (platelet count <50,000/microliter)
- General Disorders and Administration Site Conditions
- Immune System Disorders
- Severe acute hypersensitivity reactions and anaphylaxis...
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Viagra (sildenafil citrate) Tablets
Prescribing Information |
ADVERSE REACTIONS
- Postmarketing Experience
- Other Events
- Nervous
- Transient Global Amnesia (added)
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Zovirax (acyclovir) Capsules and Tablets
Zovirax (acyclovir) Suspension
Prescribing Information |
ADVERSE REACTIONS
- Observed During Clinical Practice
- Renal Pain (may be associated with renal failure)
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Brand (Generic) Name
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Sections Modified |
Omnitrope Pen 10 (somatropin [rDNA origin] injection), For Subcutaneous Use
For use with Omnitrope (somatropin [rDNA origin] injection) 10 mg/1.5 mL
Cartridges
Patient Package Insert
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INSTRUCTIONS FOR USE (new) |
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