Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Climara Pro (estradiol/levonorgestrel)
Transdermal System)
(click product name to read prescribing information)
|
CONTRAINDICATIONS
BOXED WARNING
WARNINGS
- Cardiovascular Disorders
- Coronary Heart Disease and
Stroke
- Venous Thromboembolism (VTE)
- Malignant Neoplasms
- Dementia
PRECAUTIONS
ADVERSE REACTIONS
- Miscellaneous
- Urticaria
- Angioedema
- Anaphylactoid/Anaphylactic
Reactions
PATIENT PACKAGE INSERT
|
CONTRAINDICATIONS
Known hypersensitivity to the
ingredients of Climara Pro.
BOXED WARNING
The WHI study reported
increased risks of stroke and deep vein thrombosis in
postmenopausal women (50 to 70 years of age) during 6.8 years of
treatment with oral conjugated estrogens (CE0.625 mg) relative to
placebo.
The Women's Health
Initiative Memory Study (WHIMS), a substudy of WHI, reported
increased risk of developing probable dementia in postmenopausal
women 65 years of age or older during 4 years of treatment with CE
0.625 mg combined with MPA 2.5 mg and during 5.2 years of
treatment with CE 0.625 mg alone, relative to placebo.....
WARNINGS
Cardiovascular Disorders
Coronary Heart Disease and Stroke
In the WHI
estrogen-alone substudy, an increased risk of stroke was observed
in women receiving CE compared to placebo (44 versus 32 per 10,000
women-years). The increase in risk was observed in year 1 and
persisted.
.....Participation in
an open label extension of the original HERS trial (HERS II) was
agreed to by 2,321 women.....
Venous Thromboembolism
(VTE)
In the WHI
estrogen-alone substudy, an increased risk of deep vein thrombosis
was observed in women receiving CE compared to placebo (21 versus
15 per 10,000 women-years). The increase in deep vein thrombosis
risk was observed during the first year.
Malignant Neoplasms
Endometrial Cancer
.....The reported
endometrial cancer risk among unopposed estrogen users is about 2
to 12 times greater than in nonusers, and appears dependent on
duration of treatment and on estrogen dose. Most studies show no
significant increased risk associated with use of estrogens for
less than one year. The greatest risk appears associated with
prolonged use, with increased risks of 15- to 24-fold for 5 to 10
years or more.....
Dementia
.....In the
estrogen-alone substudy, after an average follow-up of 5.2 years,
28 women in the estrogen-alone group and 19 women in the placebo
group were diagnosed with probable dementia. The relative risk of
probable dementia for estrogen alone versus placebo was 1.49 (95
percent CI, 0.83-2.66). The absolute risk of probable dementia for
estrogen alone versus placebo was 37 versus 25 cases per 10,000
women-years.....
|
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Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Advil Cold & Sinus
Liquigels (200 mg ibuprofen/ 30 mg pseudoephedrine HCl capsules)
Over-the-Counter (OTC)
Medication
(click product name to read
labeling template)
|
WARNINGS
- Allergy Alert
- Stomach Bleeding Warning
DO NOT USE.....
ASK A DOCTOR BEFORE USE IF YOU HAVE......
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE.....
WHEN USING THIS PRODUCT.....
STOP USE AND ASK A DOCTOR IF.....
IF PREGNANT OR BREAST-FEEDING.....
|
Please see attached labeling template.
Revisions to the Drug Facts label and
Principal Display Panel include more specific information for
consumers, family members, and caregivers about potential risks of
cardiovascular and gastrointestinal adverse effects associated
with the use of non-prescription NSAIDS (excluding aspirin).
In addition, the "Allergy Alert" has been revised to
include a warning for aspirin sensitive individuals and a
description of early symptoms associated with Stevens-Johnson
Syndrome (SJS). The "Alcohol Warning" has been relocated
to appear as part of the new "Stomach Bleeding Warning".
The labeling template includes the recommended
general changes and not the specific approved product labeling.
For additional details, see MedWatch 6/15/05 Safety Alert.
|
|
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|
Children's Advil (100 mg/5 mL ibuprofen)
Suspension
Over-the-Counter (OTC)
Medication
(click product name to read labeling
template)
|
WARNINGS
- Allergy Alert
- Stomach Bleeding Warning
- Sore Throat Warning
DO NOT USE.....
ASK A DOCTOR BEFORE USE IF THE CHILD HAS.....
ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS.....
WHEN USING THIS PRODUCT.....
STOP USE AND ASK A DOCTOR IF.....
|
Please see attached labeling template.
Revisions to the Drug Facts label and
Principal Display Panel include more specific information for
consumers, family members, and caregivers about potential risks of
cardiovascular and gastrointestinal adverse effects associated
with the use of non-prescription NSAIDS (excluding aspirin).
In addition, the "Allergy Alert" has been revised to
include a warning for aspirin sensitive individuals and a
description of early symptoms associated with Stevens-Johnson
Syndrome (SJS). The "Alcohol Warning" has been relocated
to appear as part of the new "Stomach Bleeding Warning".
The labeling template includes the recommended
general changes and not the specific approved product labeling.
For additional details, see MedWatch 6/15/05 Safety Alert.
|
|
|
|
Children's Motrin (100 mg/5 mL ibuprofen)
Suspension
Over-the-Counter (OTC)
Medication
(click product name to read labeling
template)
|
WARNINGS
- Allergy Alert
- Stomach Bleeding Warning
- Sore Throat Warning
DO NOT USE.....
ASK A DOCTOR BEFORE USE IF THE CHILD HAS.....
ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS.....
WHEN USING THIS PRODUCT.....
STOP USE AND ASK A DOCTOR IF.....
|
Please see attached labeling template.
Revisions to the Drug Facts label and
Principal Display Panel include more specific information for
consumers, family members, and caregivers about potential risks of
cardiovascular and gastrointestinal adverse effects associated
with the use of non-prescription NSAIDS (excluding aspirin).
In addition, the "Allergy Alert" has been revised to
include a warning for aspirin sensitive individuals and a
description of early symptoms associated with Stevens-Johnson
Syndrome (SJS). The "Alcohol Warning" has been relocated
to appear as part of the new "Stomach Bleeding Warning".
The labeling template includes the recommended
general changes and not the specific approved product labeling.
For additional details, see MedWatch 6/15/05 Safety Alert.
|
|
|
|
Children's Motrin
Cold (100 mg/5 mL ibuprofen and 15 mg/5 mL pseudoephedrine HCl)
Suspension
Over-the-Counter (OTC)
Medication
(click product name to read labeling
template)
|
WARNINGS
- Allergy Alert
- Stomach Bleeding Warning
- Sore Throat Warning
DO NOT USE.....
ASK A DOCTOR BEFORE USE IF THE CHILD HAS.....
ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS.....
WHEN USING THIS PRODUCT.....
STOP USE AND ASK A DOCTOR IF.....
|
Please see attached labeling template.
Revisions to the Drug Facts label and
Principal Display Panel include more specific information for
consumers, family members, and caregivers about potential risks of
cardiovascular and gastrointestinal adverse effects associated
with the use of non-prescription NSAIDS (excluding aspirin).
In addition, the "Allergy Alert" has been revised to
include a warning for aspirin sensitive individuals and a
description of early symptoms associated with Stevens-Johnson
Syndrome (SJS). The "Alcohol Warning" has been relocated
to appear as part of the new "Stomach Bleeding Warning".
The labeling template includes the recommended
general changes and not the specific approved product labeling.
For additional details, see MedWatch 6/15/05 Safety Alert.
|
|
|
|
Emla (lidocaine 2.5% and
prilocaine 2.5%) Cream
(click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
- General
- Emla cream should not be applied to
open wounds.
- Care should be taken not
to allow Emla Cream to come in contact with the eye.....
- Information for Patients
- Emla Cream should not
be applied near the eyes.....
- Drug Interactions
- Specific interaction
studies with lidocaine/prilocaine and class III
anti-arrhythmic drugs.....
- Should Emla cream be
used concomitantly with other products containing
lidocaine.....
- Carcinogenesis,
Mutagenesis, Impairment of Fertility
- Labor and Delivery
- Pediatric Use
|
Patients treated with class III
anti-arrhythmic drugs (eg, amiodarone, bretylium, sotalol,
defetilide) should be under close surveillance and ECG
monitoring considered, because cardiac effects may be additive.
.....In these same studies,
animals exposed to Emla Cream only in the external auditory
canal, showed no abnormality. Emla cream should not be used in
any clinical situation when its penetration or migration beyond
the tympanic membrane into the middle ear is possible.
|
|
|
|
Ibuprofen Capsules 200 mg
Over-the-Counter (OTC)
Medication
(click product name to read labeling
template)
|
WARNINGS
- Allergy Alert
- Stomach Bleeding Warning
DO NOT USE.....
ASK A DOCTOR BEFORE USE IF YOU HAVE......
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE.....
WHEN USING THIS PRODUCT.....
STOP USE AND ASK A DOCTOR IF.....
IF PREGNANT OR BREAST-FEEDING.....
|
Please see
attached labeling template.
Revisions to the Drug Facts label and
Principal Display Panel include more specific information for
consumers, family members, and caregivers about potential risks
of cardiovascular and gastrointestinal adverse effects
associated with the use of non-prescription NSAIDS (excluding
aspirin). In addition, the "Allergy Alert" has
been revised to include a warning for aspirin sensitive
individuals and a description of early symptoms associated with
Stevens-Johnson Syndrome (SJS). The "Alcohol Warning"
has been relocated to appear as part of the new "Stomach
Bleeding Warning".
The labeling template includes the recommended
general changes and not the specific approved product labeling.
For additional details, see MedWatch 6/15/05 Safety Alert. |
MedWatch
Home | Safety Information | Submit
Report | How to Report | Download
Forms | Join the E-list | Comments
Back to Summary Page
Brand
(Generic) Name |
Sections Modified |
Avodart (dutasteride) Soft
Gelatin Capsules
(click product name to read prescribing information) |
PRECAUTIONS
- Drug/Laboratory Test Interactions
|
|
|
Clozaril
(clozapine) Tablets
(click product name to read prescribing information) |
PRECAUTIONS
-
Drug Interactions
- Pharmacokinetic-Related
Interactions
|
|
|
Emtriva (emtricitabine)
Capsules and Oral Solution
(click product name to read prescribing information) |
PRECAUTIONS
- Drug Interactions
- Coadministration of Emtricitabine/Zidovudine
- Immune Reconstitution
Syndrome
|
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Enlon-Plus (edrophonium chloride, USP and
atropine sulfate, USP) Injection
(click product name to read prescribing information) |
PRECAUTIONS
|
|
|
Femara (letrozole
tablets)
(click product name to read prescribing information)
|
PRECAUTIONS
- Laboratory Tests
- In the adjuvant
setting, total cholesterol in the Femara arm.....
- Bone Effects
- Geriatric Use
ADVERSE REACTIONS
- Initial Paragraph
- Adjuvant Treatment of Early
Breast Cancer in Postmenopausal women
- Table 13: Patients with
Adverse Events (CTC 1-4 grades Irrespective to Relationship
of Study Drug) in the Adjuvant Study BIG 1-98
-
Extended
Adjuvant Treatment of Early Breast Cancer in Postmenopausal
Women who have Received 5 Years of Adjuvant Tamoxifen
Therapy
-
Table
14: Percentage of Patients with Adverse Events
-
First-Line
Breast Cancer
-
Table
15: Percentage (%) of Patients with Adverse Events
|
|
|
Fosamax
(alendronate sodium) Tablets and Oral Solution
(click product name to read prescribing
information) |
PRECAUTIONS
ADVERSE REACTIONS
|
|
|
Meridia (sibutramine
hydrochloride monohydrate) Capsules
(click product name to read prescribing
information) |
PRECAUTIONS
|
|
|
Prozac (fluoxetine hydrochloride)
(click product name to read prescribing information) |
PRECAUTIONS
-
Carcinogenesis,
Mutagenesis, Impairment of Fertility
- Initial Paragraph
-
Impairment of
Fertility
- Pediatric Use
|
|
|
Rowasa (mesalamine)
Rectal Suspension Enema
(click product name to read prescribing information)
|
PRECAUTIONS
- Worsening of colitis or
symptoms of inflammatory bowel disease, including melena.....
-
Carcinogenesis,
Mutagenesis, Impairment of Fertility
- The
oligospermia and infertility in men associated with
sulfasalazine have.....
ADVERSE REACTIONS
-
Pancytopenia
-
Neutropenia
-
Oligospermia
-
Infertility in Men
|
|
|
Sarafem
(fluoxetine hydrochloride)
(click product name to read prescribing information)
|
PRECAUTIONS
-
Carcinogenesis,
Mutagenesis, Impairment of Fertility
- Initial Paragraph
-
Impairment of
Fertility
- Pediatric Use
|
|
|
Tamiflu (oseltamivir phosphate) Capsules and Oral Suspension
(click product name to read prescribing information)
|
PRECAUTIONS
- General
- Safety and efficacy of repeated
treatment or prophylaxis courses have not been studied.
- Serious Skin/Hypersensitivity Reaction
ADVERSE REACTIONS
- Prophylaxis Studies in Adult Patients
- Table 3: Most
Frequent Adverse Events in Studies in Naturally Acquired
Influenza in Patients 13 Years of Age and Older
- Prophylaxis in Pediatric Patients
- Table
4: Most Frequent Adverse Events Occurring in Children
Aged 1 to 12 Years in Studies in Naturally Acquired
Influenza
PATIENT PACKAGE INSERT |
|
|
Velcade (bortezomib) for
Injection
(click product name to read prescribing information) |
PRECAUTIONS
- Cardiac Disorders
- Hepatic Events
ADVERSE REACTIONS
|
|
|
Zovirax (acyclovir) Capsules,
Tablets and Suspension
(click product name to read prescribing information) |
PRECAUTIONS
- Initial Paragraph
- Maintaining Adequate Hydration
|
MedWatch
Home | Safety Information | Submit
Report | How to Report | Download
Forms | Join the E-list | Comments
Back to Summary Page
Brand
(Generic) Name |
Sections Modified
|
Evoxac (cevimeline hydrochloride)
Capsules
Please contact Daiichi
Pharmaceutical Co., Ltd at 1-877-324-4222 for prescribing
information.
|
ADVERSE REACTIONS
Cevimeline was administered to 1777
patients during clinical trials worldwide, including Sjogren's
patients and patients with other conditions. In
placebo-controlled Sjogren's studies in the U.S. 320 patients
received cevimeline doses ranging from 15 mg tid to 60 mg tid,
of whom 93% were women and 7% were men. Demographic distribution
was 90% Caucasian, 5% Hispanic, 3% Black and 2% of other origin.
In these studies 14.6 % of patient discontinued treatment with
cevimeline due to adverse events.
-
Post-marketing Adverse Events
The following adverse
reaction has been identified during post approval use of
Evoxac. Because post marketing adverse reactions are reported
voluntarily from a population of uncertain size, it is not
always possible to reliably estimate their frequency or
establish a causal relationship to drug exposure.
- Liver and Biliary Systems Disorders
- Cholecystitis
|
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|
Flovent HFA (fluticasone
propionate) Inhalation Aerosol
(click product name to read prescribing information)
|
ADVERSE REACTIONS
- Psychiatry
- Anxiety
- Behavioral changes, including
hyperactivity and irritability, have been reported very
rarely and primarily in children
|
|
|
Prograf (tacrolimus
capsules)
Prograf (tacrolimus
injection) [for intravenous infusion
only]
(click product name to read prescribing information) |
ADVERSE REACTIONS
- Less Frequently Reported Adverse Events
- Nervous System
- Gastrointestinal
- Cardiovascular
- Urogenital
- Hemic/Lymphatic
- Miscellaneous
- Respiratory
- Post-marketing
- Post-marketing Adverse Events
- Other Events Include.....
|
|
|
Spectracef (cefditoren
pivoxil) Tablets
(click product name to read prescribing information)
|
ADVERSE REACTIONS
- Post-marketing Experience
- Erythema Multiforme
- Stevens-Johnson Syndrome
- Toxic Epidermal Necrolysis
|
|
|
Zofran (ondansetron
hydrochloride) Injection
Zofran (ondansetron
hydrochloride) Injection Premixed
(click product name to read prescribing information) |
ADVERSE REACTIONS
- Observed During Clinical Practice
|
|
|
Zofran (ondansetron
hydrochloride) Tablets
Zofran ODT (ondansetron)
Orally Disintegrating Tablets
Zofran (ondansetron
hydrochloride) Oral Solution
(click product name to read prescribing information) |
ADVERSE REACTIONS
- Observed During Clinical Practice
- Special Senses: Eye Disorders.....
|
MedWatch
Home | Safety Information | Submit
Report | How to Report | Download
Forms | Join the E-list | Comments
Back to Summary Page
|
|