Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications
and Warnings |
Biaxin Filmtab (clarithromycin tablets)
Biaxin XL Filmtab (clarithromycin
extended-release tablets)
Biaxin Granules (clarithromycin for
oral suspension, USP)
(click product name to read prescribing information)
|
CONTRAINDICATIONS
PRECAUTIONS
- Drug Interactions
- Colchicine
- CYP3A
- Ergotamine/dihydroergotamine
ADVERSE REACTIONS
- Post-marketing
Experience
|
Concomitant administration of
clarithromycin and any of the following drugs is contraindicated:
cisapride, pimozide, astemizole, terfenadine, and ergotamine or
dihydroergotamine....
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Diprolene (augmented
betamethasone dipropionate lotion) Lotion
(click product name to read prescribing information)
|
CONTRAINDICATIONS
PRECAUTIONS
-
Information for Patients
-
Carcinogenesis, Mutagenesis, Impairment of
Fertility
-
Pregnancy: Teratogenic Effects Pregnancy
Category C
-
Pediatric Use
ADVERSE REACTIONS
-
The following additional local adverse
reactions have been reported with topical corticosteroids, and
they may occur more frequently with the use of occlusive
dressings and higher potency corticosteroids.....
|
Diprolene Lotion is
contraindicated in patients who are hypersensitive to
betamethasone dipropionate, to other corticosteroids, or to any
ingredient in this preparation. |
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|
|
Diprolene (augmented
betamethasone dipropionate ointment) Ointment
(click product name to read prescribing information) |
CONTRAINDICATIONS
PRECAUTIONS
- General
- Information for Patients
- Carcinogenesis, Mutagenesis, Impairment of
Fertility
- Pregnancy: Teratogenic Effects Pregnancy
Category C
- Pediatric Use
ADVERSE REACTIONS
- Hypertrichosis
- Systemic absorption of topical
corticosteroids.....
|
Diprolene Ointment is
contraindicated in patients who are hypersensitive to
betamethasone dipropionate, to other corticosteroids, or to any
ingredient in this preparation.
|
|
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Efudex (fluorouracil) Topical Solutions and Cream
(click product name to read prescribing information) |
CONTRAINDICATIONS
WARNINGS
|
CONTRAINDICATIONS
Efudex should not be used in
patients with dihydropyrimidine dehydrogenase (DPD) enzyme
deficiency. A large percentage of fluorouracil is catabolized by the
DPD enzyme. DPD enzyme deficiency can result in shunting of
fluorouracil to the anabolic pathway, leading to cytotoxic activity
and potential toxicities.
WARNINGS
Patients should discontinue
therapy with Efudex if symptoms of DPD enzyme deficiency develop.
Rarely, life-threatening
toxicities such as stomatitis, diarrhea, neutropenia, and
neurotoxicity have been reported with intravenous administration of
fluorouracil in patients with DPD enzyme deficiency..... |
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Imodium (loperamide hydrochloride) Capsules
(click product name to read prescribing information)
|
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
- General
- Information for Patients
- Drug Interactions
- Carcinogenesis, Mutagenesis, Impairment
of Fertility
- Pregnancy
- Teratogenic Effects
- Non-teratogenic Effects
- Nursing Mothers
ADVERSE REACTIONS
- Clinical Trial Data
- Post-marketing Experience
- Skin and Subcutaneous Tissue
Disorders
- Immune System Disorders
- Gastrointestinal Disorders
- Renal and Urinary Disorders
|
CONTRAINDICATIONS
(See prescribing information for contraindications)
WARNINGS
In general, Imodium
should not be used when inhibition of peristalsis is to be avoided
due to the possible risk of significant sequelae including ileus,
megacolon and toxic megacolon. Imodium must be discontinued
promptly when constipation, abdominal distention or ileus develop.
Treatment of diarrhea
with Imodium is only symptomatic. Whenever an underlying etiology
can be determined, specific treatment should be given when
appropriate (or when indicated).
|
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Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications and Warnings |
Avinza (morphine sulfate extended-release
capsules)
(click product name to read prescribing information) |
BOXED WARNING
WARNINGS
PRECAUTIONS
|
BOXED WARNING & WARNINGS
Patients must not consume alcoholic beverages
while on Avinza therapy. Additionally,
patients must not use prescription or non-prescription
medications containing
alcohol while on Avinza therapy. Consumption of alcohol while
taking Avinza may result
in the rapid release and absorption of a potentially fatal dose
of morphine.
WARNINGS
In vitro studies
performed by the FDA demonstrated that when Avinza 30 mg was
mixed with 900 mL of buffer solutions
containing ethanol (20% and 40%), the dose of morphine that
was released was alcohol concentration-dependent, leading to a
more rapid release of morphine. While the
relevance of in vitro lab
tests regarding Avinza to the clinical setting remains
to be determined, this acceleration of release may correlate
with in vivo rapid release of the total morphine dose, which could
result in the absorption of a potentially fatal dose
of morphine.
For additional details, see MedWatch 11/03/2005
Safety Alert. |
MedWatch
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Back to Summary Page
Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications
and Warnings |
Epogen (epoetin alfa) for
Injection
(click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
|
Cases of pure red cell aplasia (PRCA)
and of severe anemia, with or without other cytopenias,
associated with neutralizing antibodies to erythropoietin have
been reported in patients treated with Epogen. This has been
reported predominantly in patients with CRF receiving Epogen by
subcutaneous administration. Any patient who develops a sudden
loss of response to Epogen, accompanied by severe anemia and low
reticulocyte count, should be evaluated for the etiology of loss
of effect, including the presence of neutralizing antibodies to
erythropoietin. If anti-erythropoietin antibody-associated anemia
is suspected, withhold Epogen and other erythropoietic proteins.
For additional details, see MedWatch 12/01/2005
Safety Alert. |
|
|
|
Humira (adalimumab)
(click product name to read prescribing information)
|
WARNINGS
- Serious Infections
- Neurologic Events
- Malignancies
ADVERSE REACTIONS
- Infections
- Malignancies
- Autoantibodies
- Other Adverse Events
- Humira has been studied in 395 patients
with psoriatic arthritis in two placebo-controlled
studies and in an open-label extension study.....
PATIENT PACKAGE INSERT
|
Serious Infections
Serious infections, sepsis, tuberculosis and
rare cases of opportunistic infections, including fatalities,
have been reported with the use of TNF blocking agents including
Humira.
Neurologic Events
Use of TNF blocking agents, including
Humira,
has been associated with rare cases of new onset or exacerbation
of clinical symptoms and/or radiographic evidence of
demyelinating disease.
Malignancies
In the controlled portions of
clinical trials of some TNF-blocking agents, including Humira,
more cases of malignancies have been observed among patients
receiving those TNF blockers compared to control patients..... |
|
|
|
Marcaine (bupivacaine
hydrochloride injection,
USP)
Marcaine with Epinephrine 1:200,000 (as
bitartrate) (bupivacaine hydrochloride and epinephrine
injection, USP)
(click product name to read prescribing information) |
WARNINGS |
The statement, "Warning:
Contains Sulfites" has been added to the container labels
and carton labeling as these products contain the antioxidant,
sodium metatabisulfite. |
|
|
|
Prinivil (lisinopril) Tablets
(click product name to read prescribing information)
|
WARNINGS
- Head and Neck Angioedema
- Hepatic Failure
|
Head and Neck Angioedema
.....Even in those instances
where swelling of only the tongue is involved, without
respiratory distress, patients may require prolonged
observation since treatment with antihistamines and
corticosteroids may not be sufficient. Very rarely, fatalities
have been reported due to angioedema associated with laryngeal
edema or tongue edema. Patients with involvement of the
tongue, glottis or larynx are likely to experience airway
obstruction, especially those with a history of airway
surgery.....
Hepatic Failure
Rarely, ACE inhibitors have
been associated with a syndrome that starts with cholestatic
jaundice or hepatitis and progresses to fulminant hepatic
necrosis, and (sometimes) death..... |
|
|
|
Prinzide (lisinopril-hydrochlorothiazide)
Tablets
(click product name to read prescribing information)
|
WARNINGS
- Head and Neck Angioedema
- Hepatic Failure
|
Head
and Neck Angioedema
.....ACE inhibitors have been
associated with a higher rate of angioedema in Black than in
non-Black patients.....
.....Even in those instances where
swelling of only the tongue is involved, without respiratory
distress, patients may require prolonged observation since
treatment with antihistamines and corticosteroids may not be
sufficient. Very rarely, fatalities have been reported due to
angioedema associated with laryngeal edema or tongue edema.
Patients with involvement of the tongue, glottis or larynx are
likely to experience airway obstruction, especially those with a
history of airway surgery.....
Hepatic Failure
Rarely, ACE inhibitors have
been associated with a syndrome that starts with cholestatic
jaundice or hepatitis and progresses to fulminant hepatic
necrosis, and (sometimes) death..... |
|
|
|
Rapamune
(sirolimus) Tablets and Oral Solution
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
- Other Clinical Experience
- Angioedema
- Hypersensitivity
Vasculitis
- Lymphedema
- Calcineurin
Inhibitor-induced HUS/TTP/TMA
|
..... Hypersensitivity
reactions, including anaphylactic/anaphylactoid reactions,
angioedema, and hypersensitivity vasculitis, have been
associated with the administration of sirolimus.
|
|
|
|
Vytorin (ezetimibe/simvastatin
tablets)
(click product name to read prescribing information) |
WARNINGS
- Myopathy/Rhabdomyolysis
- The
safety and effectiveness of ezetimibe administered with fibrates
have not been established. Therefore,
the concomitant use of Vytorin and fibrates should be avoided.
PRECAUTIONS
- Information for Patients
- Skeletal Muscle
- Other Drug Interactions
ADVERSE REACTIONS
- Post-marketing Experience
|
There is an increased risk of
myopathy when simvastatin is used concomitantly with fibrates (especially
gemfibrozil). The
combined use of simvastatin with gemfibrozil should be avoided, unless the benefits are likely to
outweigh the increased risks of this drug combination. The dose of simvastatin should not exceed 10
mg daily in patients receiving concomitant medication with
gemfibrozil. Therefore,
although not recommended, if Vytorin is used in combination with
gemfibrozil, the dose should not exceed 10/10 mg daily. |
MedWatch
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Back to Summary Page
Brand
(Generic) Name |
Sections Modified |
Allegra (fexofenadine hydrochloride) Tablets
(click product name to read prescribing information) |
PRECAUTIONS
- Information for Patients
- Drug Interaction with
Erythromycin and Ketoconazole
- .....This
observed increase in the bioavailability of fexofenadine
may be due to transport-related effects, such as p-glycoprotein.....
- Interactions with
Fruit Juices
- Carcinogenesis, Mutagenesis,
Impairment of Fertility
- Nursing Mothers
ADVERSE REACTIONS
- Chronic
Idiopathic Urticaria
- Table 3
|
|
|
Aminosyn
II (amino acid injection with electrolytes) with Electrolytes in Dextrose
Injection with Calcium
(click product name to read prescribing information) |
PRECAUTIONS
|
|
|
Aredia (pamidronate
disodium for injection) for Intravenous Infusion
(click product name to read prescribing information) |
PRECAUTIONS
|
|
|
Aromasin (exemestane
tablets)
(click product name to read prescribing information)
|
PRECAUTIONS
ADVERSE REACTIONS
- Adjuvant Treatment of Early Breast Cancer
- Table 8
- Table 9
|
|
|
CellCept (mycophenolate
mofetil capsules and tablets )
CellCept Oral Suspension
(mycophenolate
mofetil for oral suspension)
CellCept Intravenous
(mycophenolate
mofetil hydrochloride for injection)
(click product name to read prescribing
information) |
PRECAUTIONS
ADVERSE REACTIONS
|
|
|
Detrol (tolterodine tartrate tablets)
(click product name to read prescribing information)
|
PRECAUTIONS
- Information for Patients
- Carcinogenesis, Mutagenesis, Impairment
of Fertility
- Pregnancy
- Pediatric Use
|
|
|
Detrol
LA (tolterodine tartrate extended release capsules)
(click product name to read prescribing information)
|
PRECAUTIONS
- Patients with Congenital or Acquired QT
Prolongation
- Drug Interactions
|
|
|
Flomax (tamsulosin hydrochloride) Capsules
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Intraoperative Floppy Iris Syndrome (IFIS)
ADVERSE REACTIONS
- Postmarketing Experience
- Intraoperative Floppy Iris Syndrome (IFIS)
For additional details, see MedWatch 11/22/2005
Safety Alert. |
|
|
Gleevec (imatinib mesylate) Tablets
(click product name to read prescribing information)
|
PRECAUTIONS
ADVERSE REACTIONS
- Chronic Myeloid Leukemia
- Hematologic Toxicity
- Hepatotoxicity
- Gastrointestinal Stromal
Tumors
|
|
|
Kaletra (lopinavir/ritonavir)
Tablets and Oral Solution
(click product name to read prescribing information) |
PRECAUTIONS
- Information for Patients
- Table 10
|
|
|
Levemir (insulin
detemir [rDNA origin] injection)
(click product name to read prescribing information) |
PRECAUTIONS
|
|
|
Nor-QD (norethindrone tablets, USP) Tablets
(click product name to read prescribing information) |
PRECAUTIONS
- Drug Interactions
- Anti-infective Agents and
Anticonvulsants
- Anti-HIV Protease
Inhibitors
- Herbal Products
PATIENT PACKAGE INSERT |
|
|
Norvir (ritonavir capsules) Soft Gelatin and (ritonavir oral solution)
(click product name to read prescribing information) |
PRECAUTIONS
ADVERSE REACTIONS
- Pediatrics
- Treatment-Emergent Adverse Events
- Laboratory Abnormalities
|
|
|
Novolin R (regular, human
insulin injection [recombinant DNA origin], USP)
(click product name to read prescribing information) |
PRECAUTIONS
- Hypoglycemia and Hypokalemia
- Laboratory Tests
|
|
|
NovoLog (insulin aspart [rDNA origin] injection)
(click product name to read prescribing information)
|
PRECAUTIONS
|
|
|
Trileptal (oxcarbazepine)
Tablets and Oral Suspension
(click product name to read prescribing information)
|
PRECAUTIONS
- Cognitive/Neuropsychiatric
Adverse Events
- Pediatric Use
ADVERSE REACTIONS
|
|
|
Truvada (emtricitabine and
tenofovir disoproxil fumarate) Tablets
(click product name to read prescribing information) |
PRECAUTIONS
- Bone Effects
- Tenofovir Disoproxil
Fumarate
- Immune Reconstitution Syndrome
ADVERSE REACTIONS
- Clinical Trials
- Viread
- Lipodystrophy
- Anxiety
- Total Cholesterol
(> 300 mg/dL)
- Post-marketing Experience
- Viread
- Gastrointestinal
Disorders
- Hepatobiliary
Disorders
- Increased Liver
Enzymes
- Hepatitis
- Renal and Urinary
Disorders
- Nephrogenic
Diabetes Insipidus
|
|
|
Venofer (iron sucrose injection,
USP)
(click product name to read prescribing information)
|
PRECAUTIONS
- Hypersensitivity Reactions
- Hypotension
- Geriatric Use
ADVERSE REACTIONS
- Adverse Events Observed in All
Treated Populations
- Adverse Events
Observed in Peritoneal Dialysis Dependent-Chronic Kidney
Disease (PDD-CKD) Patients
- Hypersensitivity
Reactions
|
|
|
Zometa (zoledronic acid) Injection
(click product name to read prescribing information) |
PRECAUTIONS
ADVERSE REACTIONS
- Post-marketing Experience
|
MedWatch
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Back to Summary Page
Brand
(Generic) Name |
Sections Modified |
Arava (leflunomide) Tablets
(click product name to read prescribing information)
|
ADVERSE REACTIONS
- Post-marketing
- Skin and Appendages
- Vasculitis including
Cutaneous Necrotizing Vasculitis
|
|
|
Beconase AQ (beclomethasone
dipropionate monohydrate) Nasal Spray
(click product name to read prescribing information)
|
ADVERSE REACTIONS
- Anaphylactoid/Anaphylactic Reactions
|
|
|
Cubicin (daptomycin for injection)
(click product name to read prescribing information) |
ADVERSE REACTIONS
- Post-Marketing Experience
- Immune System Disorders
- Musculoskeletal System
|
|
|
Emend (aprepitant) Capsules
(click product name to read prescribing information) |
ADVERSE REACTIONS
- Moderately Emetogenic
Chemotherapy
- Highly and Moderately Emetogenic
Chemotherapy
|
|
|
Invanz (ertapenem for injection)
(click product name to read prescribing information) |
ADVERSE REACTIONS
-
Additional Adverse Experiences
- In a clinical
trial for the treatment of diabetic foot infections in which
289 adult diabetic patients were treated with ertapenem, the
adverse experience profile was generally similar to that
seen in previous clinical trials.
- Adverse
Laboratory Changes
- In a clinical trial for
the treatment of diabetic foot infections in which 289 adult
diabetic patients were treated with ertapenem, the
laboratory adverse experience profile was generally similar
to that seen in previous clinical trials.
|
|
|
Mylotarg (gemtuzumab
ozogamicin for injection)
(click product name to read prescribing information)
|
ADVERSE REACTIONS
- Other Clinical Experience
|
|
|
Plavix (clopidogrel bisulfate tablets)
(click product name to read prescribing information) |
ADVERSE REACTIONS
- Post-marketing Experience
-
Body as a Whole
- Hepato-biliary Disorders
- Respiratory, Thoracic and Mediastinal
Disorders
- Skin and Subcutaneous Tissue Disorders
- Toxic Epidermal Necrolysis
- Gastrointestinal Disorders
|
|
|
Trelstar Depot 3.75 mg (triptorelin pamoate for injectable suspension)
(click product name to read prescribing information) |
ADVERSE REACTIONS
|
|
|
Trelstar
LA 11.25 mg (triptorelin pamoate for injectable suspension)
(click product name to read prescribing information) |
ADVERSE REACTIONS
|
|
|
Zoladex
(goserelin acetate implant) 3.6 mg
Please contact AstraZeneca Pharmaceuticals
at 1-800-236-9933 for prescribing information.
|
ADVERSE REACTIONS
During post-marketing
surveillance, rare cases of pituitary apoplexy (a clinical
syndrome secondary to infarction of the pituitary gland) have
been reported after the administration of gonadotropin-releasing
hormone agonists. In a majority of these cases, a
pituitary adenoma was diagnosed. Most of the pituitary apoplexy
cases occurred within 2 weeks of the first dose, and some
occurred within the first hour. In these cases, pituitary
apoplexy has presented as sudden headache, vomiting, visual
changes, ophthalmoplegia, altered mental status, and sometimes
cardiovascular collapse. Immediate medical attention has been
required. |
|
|
Zoladex
(goserelin acetate implant) 10.8 mg -
3 month
Please contact AstraZeneca Pharmaceuticals
at 1-800-236-9933 for prescribing information. |
ADVERSE REACTIONS
During post-marketing
surveillance, rare cases of pituitary apoplexy (a clinical
syndrome secondary to infarction of the pituitary gland) have
been reported after the administration of gonadotropin-releasing
hormone agonists. In a majority of these cases, a
pituitary adenoma was diagnosed. Most of the pituitary apoplexy
cases occurred within 2 weeks of the first dose, and some
occurred within the first hour. In these cases, pituitary
apoplexy has presented as sudden headache, vomiting, visual
changes, ophthalmoplegia, altered mental status, and sometimes
cardiovascular collapse. Immediate medical attention has been
required. |
MedWatch
Home | Safety Information | Submit
Report | How to Report | Download
Forms | Join the E-list | Comments
Back to Summary Page
|
|