MedWatch - January 2005 Safety-Related Drug Labeling Changes

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Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2005

The detailed view includes drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections. The prescribing information may be accessed by clicking on the drug name.

Summary View

Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Combipatch (estradiol/norethindrone acetate transdermal system) (click product name to read prescribing information)	CONTRAINDICATIONS BOXED WARNING	CONTRAINDICATIONS CombiPatch should not be used in women under any of the following conditions: Known or suspected pregnancy There is no indication for CombiPatch in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy. BOXED WARNING Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia.

Phenergan (promethazine hydrochloride) Tablets and Suppositories (click product name to read prescribing information)	CONTRAINDICATIONS BOXED WARNING WARNINGS General Use in Pediatric Patients	CONTRAINDICATIONS Phenergan Tablets and Suppositories are contraindicated for use in pediatric patients less than two years of age. BOXED WARNING WARNINGS Phenergan should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression......(See prescribing information.) Caution should be exercised when administering Phenergan to pediatric patients 2 years of age and older. It is recommended that the lowest effective dose of Phenergan be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided. Respiratory depression and apnea, sometimes associated with death, are strongly associated with promethazine products and are not directly related to individualized weight-based dosing, which might otherwise permit safe administration......(See prescribing information.)

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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	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

Aventyl (nortriptyline hydrochloride) Oral Solution (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

Desyrel (trazodone hydrochloride) Tablets Please contact Apothecon, a Bristol-Myers Squibb Company, at 1-212-546-4000 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

Doxil (doxorubicin HCl liposome injection) (click product name to read prescribing information)	BOXED WARNING Myocardial Damage WARNINGS Cardiac Toxicity Table 7 Myelosuppression Infusion Reactions Hand-Foot Syndrome (HFS) PRECAUTIONS Information for the Patient ADVERSE REACTIONS Patients with Ovarian Cancer Table 8 Patients with AIDS-Related Kaposi Sarcoma Table 10 Table 11	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/m²every 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.

Femhrt (norethindrone acetate/ethinyl estradiol tablets) (click product name to read prescribing information)	BOXED WARNING WARNINGS Cardiovascular Disorders PRECAUTIONS General Ovarian Cancer Drug/Laboratory Test Interactions Thyroid Replacement Therapy Corticosteroid Binding Globulin (CBG), sex hormone binding globulin (SHBG) HDL₂Subfraction Concentrations Pediatric Use Geriatric Use ADVERSE REACTIONS Genitourinary System	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.

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

Marplan (isocarboxazid) Tablets Please contact Oxford Pharmaceuticals Inc. at 1-973-256-0600 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

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

Pamelor (nortriptyline HCl) Capsules and Solution, USP (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

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

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

Paxil (paroxetine hydrochloride) Tablets and Oral Suspension (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

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

Remeron SolTab (mirtazapine) Orally Disintegrating 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

Remeron (mirtazapine) 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

Serzone (nefazodone hydrochloride) 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

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

Tofranil-PM (imipramine pamoate) 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	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

Wellbutrin (bupropion hydrochloride) 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

Wellbutrin SR (bupropion hydrochloride) Sustained-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

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
Zyban (bupropion hydrochloride) Sustained-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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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Aranesp (darbepoetine alfa) (click product name to read prescribing information)	WARNINGS Thrombotic Events and Increased Mortality PRECAUTIONS Tumor Growth Factor Potential	An increased incidence of thrombotic events has been observed in patients treated with erythropoietic agents. In patients with cancer who received Aranesp, pulmonary emboli, thrombophlebitis and thrombosis occurred more frequently than in placebo controls. Treatment with Epoetin alfa was associated with a higher rate of fatal thrombotic events (1. 1 % Epoetin alfa versus 0.2% placebo) in the first 4 months of the study. Mortality at one year, the primary endpoint of the study. was higher for the Epoetin alfa group (76% Epoetin alfa versus 70% placebo, p = 0.012). Until further information is available. the recommended target hemoglobin should not exceed 12 g/dL in men or women.

Avastin (bevacizumab) (click product name to read prescribing information)	WARNINGS Arterial Thromboembolic Events PRECAUTIONS General Cardiovascular Disease Geriatric Use ADVERSE REACTIONS Initial Paragraph Metastatic Colorectal Cancer and with Other Cancers Venous Thromboembolic Events	Arterial thromboembolic events occurred at a higher incidence in patients receiving Avastin in combination with chemotherapy as compared to those receiving chemotherapy alone. Arterial thromboembolic events included cerebral infarction, transient ischemic attacks (TIAs), myocardial infarction (MI), angina, and a variety of other arterial thromboembolic events. These events were in some instances......(See prescribing information.) The safety of resumption of Avastin therapy after resolution of an arterial thromboembolic event has not been studied. Avastin therapy should be permanently discontinued in patients who experience a severe arterial thromboembolic event during treatment.

Intron A (interferon alfa-2b, recombinant) For Injection (click product name to read prescribing information)	WARNINGS Use with Ribavirin PRECAUTIONS Pediatric Use Chronic Hepatitis C MEDICATION GUIDE	Combination therapy containing Intron A and Rebetol (ribavirin, USP) was associated with hemolytic anemia. Hemoglobin <10 g/dL was observed in approximately 10% of adult and pediatric patients in clinical trials. Anemia occurred within 1 to 2 weeks of initiation of ribavirin therapy. Combination Therapy containing Intron A and Rebetol should not be used in patients with creatinine clearance <50 mL/min.

Novamine 15% Amino Acid Injection Pharmacy Bulk Package (click product name to read prescribing information)	WARNINGS PRECAUTIONS General	This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 ug/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Zometa (zoledronic acid) Injection (click product name to read prescribing information)	WARNINGS Pre-Existing Renal Insufficiency PRECAUTIONS Renal Insufficiency Osteonecrosis of the Jaw	Pre-existing renal insufficiency and multiple cycles of Zometa and other bisphosphonates are risk factors for subsequent renal deterioration with Zometa. Factors predisposing to renal deterioration, such as dehydration or the use of other nephrotoxic drugs, should be identified and managed if possible.

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Brand (Generic) Name	Sections Modified
Ancef (cefazolin for injection) (click product name to read prescribing information)	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients

Avandia (rosiglitazone maleate) Tablets (click product name to read prescribing information)	PRECAUTIONS Drug Interactions CYP2C8 Pediatric Use Geriatric Use ADVERSE REACTIONS Postmarketing Reports Angioedema Urticaria

Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets (click product name to read prescribing information)	PRECAUTIONS Drug Interactions CYP2C8 ADVERSE REACTIONS Postmarketing Reports Angioedema Urticaria

Dopamine Hydrochloride in 5% Dextrose Injection, USP Please contact B. Braun Medical Inc. at 1-866-822-7286 for prescribing information.	PRECAUTIONS Geriatric Use Clinical studies of the dopamine HCL product did not include sufficient number of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Magnevist (brand of gadopentetate dimeglumine) Injection (click product name to read prescribing information)	PRECAUTIONS Laboratory Test Findings Carcinogenesis, Mutagenesis, and Impairment of Fertility Pregnancy Category C Nursing Women

PEG-Intron (peginterferon alfa-2b) Powder for Injection (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Chronic Hepatitis C & Methadone

Zevalin (ibritumomab tiuxetan) (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Growth Factor

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Brand (Generic) Name	Sections Modified
Cipro I.V. (ciprofloxacin) For Intravenous Infusion (click product name to read prescribing information)	ADVERSE REACTIONS Post-Marketing Adverse Events Anthrax Post-Exposure Prophylaxis INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION

Cipro (ciprofloxacin) Oral Suspension and Tablets (click product name to read prescribing information)	ADVERSE REACTIONS Post-Marketing Adverse Events Anthrax Post-Exposure Prophylaxis INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION

Lexapro (escitalopram oxalate) Tablets and Oral Solution (click product name to read prescribing information)	ADVERSE REACTIONS Events Reported Subsequent to the Marketing of Escitalopram Events Reported Subsequent to the Marketing of Racemic Citalopram

Rituxan (rituximab) (click product name to read prescribing information)	ADVERSE REACTIONS Infectious Events HIV-associated lymphoma

Taxotere (docetaxel) Injection Concentrate (click product name to read prescribing information	ADVERSE REACTIONS TAX 313 Trial

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