Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications and Warnings |
Anafranil (clomipramine hydrochloride capsules)
(click product name to read prescribing information) |
BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
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Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Aventyl (nortriptyline hydrochloride) Oral Solution
(click product name to read prescribing information)
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BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
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Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Desyrel (trazodone hydrochloride) Tablets
Please contact Apothecon, a Bristol-Myers Squibb Company, at 1-212-546-4000 for prescribing information.
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BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Doxil (doxorubicin HCl liposome injection)
(click product name to read prescribing information)
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BOXED WARNING
WARNINGS
- Cardiac Toxicity
- Myelosuppression
- Infusion Reactions
- Hand-Foot Syndrome (HFS)
PRECAUTIONS
- Information for the Patient
ADVERSE REACTIONS
- Patients with Ovarian Cancer
- Patients with AIDS-Related Kaposi Sarcoma
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BOXED WARNING
Myocardial damage may lead to congestive heart failure and may be encountered as the total cumulative dose of doxorubicin HCl approaches 550 mg/m2. The use of Doxil liposome injection, may lead to cardiac toxicity.....(see prescribing information)
WARNINGS
Cardiac Toxicity
Special attention must be given to the myocardial damage that may be associated with cumulative doses of doxorubicin HCl. Acute left ventricular failure may occur with doxorubicin, particularly in patients who have received a total cumulative doxorubicin of dosage exceeding the currently recommended limit of 550 mg/m2.
Congestive heart failure or cardiomyopathy may be encountered after discontinuation of anthracycline therapy.
Myelosuppression
In patients with relapsed ovarian cancer, myelosuppression was generally moderate and reversible.
In patients with relapsed ovarian cancer, 4.6% received G-CSF (or GM-CSF) to support their blood counts.
Infusion Reactions
In clinical studies, six patients with AIDS-related Kaposi Sarcoma patients (0.9%) and 13 (1.7%) solid tumor patients discontinued Doxil therapy because of infusion-related reactions.
Hand-Foot Syndrome
In the randomized study, 50.6% of patients treated with Doxil at 50 mg/m2 every 4 weeks experienced HFS (developed palmar-plantar skin eruptions characterized by swelling, pain, erythema and, for some patients, desquamation of the skin on the hands and the feet), with 23.8% of the patients reporting HFS Grade 3 or 4 events. Ten subjects (4.2%) discontinued treatment due to HFS or other skin toxicity. |
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Femhrt (norethindrone acetate/ethinyl estradiol tablets)
(click product name to read prescribing information) |
BOXED WARNING
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
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BOXED WARNING
Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia.
WARNINGS
Risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.
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Limbitrol (chlordiazepoxide and amitriptyline hydrochloride) Tablets
Please contact Valeant Pharmaceuticals at 1-800-556-1937 for prescribing information. |
BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Marplan (isocarboxazid) Tablets
Please contact Oxford Pharmaceuticals Inc. at
1-973-256-0600 for prescribing information.
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BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Norpramin (desipramine hydrochloride) Tablets
Please contact Aventis Pharmaceuticals Inc. at 1-800-981-2491 for prescribing information. |
BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Pamelor (nortriptyline HCl) Capsules and Solution, USP
(click product name to read prescribing information)
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BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Parnate (tranylcypromine sulfate) Tablets
(click product name to read prescribing information) |
BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS TO PHYSICIANS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Paxil (paroxetine hydrochloride) Controlled-Release Tablets
(click product name to read prescribing information) |
BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Paxil (paroxetine hydrochloride) Tablets and Oral Suspension
(click product name to read prescribing information)
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BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Pexeva [paroxetine (as mesylate)] Tablets
Please contact Synthon Pharmaceuticals, Ltd at 1-919-493-6006 for prescribing information. |
BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Remeron SolTab (mirtazapine) Orally Disintegrating Tablets
(click product name to read prescribing information)
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BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Remeron (mirtazapine) Tablets
(click product name to read prescribing information)
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BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Serzone (nefazodone hydrochloride) Tablets
(click product name to read prescribing information)
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BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Surmontil (trimipramine maleate) Capsules
Please contact Odyssey Pharmaceuticals at 1-877-427-9068 for prescribing information. |
BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Tofranil-PM (imipramine pamoate) Capsules
(click product name to read prescribing information)
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BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Wellbutrin (bupropion hydrochloride) Tablets
(click product name to read prescribing information)
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BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets
(click product name to read prescribing information)
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BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Wellbutrin XL (bupropion hydrochloride extended-release tablets)
(click product name to read prescribing information) |
BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
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Zyban (bupropion hydrochloride) Sustained-Release Tablets
(click product name to read prescribing information)
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BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
- Clinical Worsening and Suicide Risk
PRECAUTIONS
- Information for Patients
- Clinical Worsening and Suicide Risk
- Pediatric Use
MEDICATION GUIDE
- About Using Antidepressants in Children and Teenagers
|
Please see prescribing information. Class labeling changes for all of the drugs approved to treat major depressive disorder (MDD) and to caution practitioners, patients, family members or caregivers about an increased risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders who are taking antidepressant medications.
See FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
|