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Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications and Warnings |
Abilify (aripiprazole) Tablets and Oral Solution
(click product name to read prescribing information) |
BOXED WARNING
PRECAUTIONS
- Use in Patients with Concomitant Illness
- Safety Experience in Elderly Patients with
Psychosis Associated with Alzheimer's Disease
|
BOXED WARNING
Elderly patients with dementia-related psychosis
treated with atypical antipsychotic drugs are at an increased
risk of death compared to placebo. Analyses of seventeen
placebo-controlled trials (modal duration of 10 weeks) in these
patients revealed a risk of death in the drug-treated patients
of between 1.6 to 1.7 times that seen 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. Abilify is not approved
for the treatment of patients with dementia-related psychosis.
For additional details, see
MedWatch 4/11/05 Safety Alert. |
|
|
|
Fortamet (metformin HCl extended-release
tablets)
(click product name to read prescribing information) |
BOXED WARNING
(added to sample cartons)
|
As with all Metformins there
is a boxed warning associated with this product. Please see
enclosed Full Prescribing Information including the warning
regarding lactic acidosis. |
|
|
|
Tasmar (tolcapone) Tablets
(click product name to read prescribing information)
|
BOXED
WARNING
PRECAUTIONS
ADVERSE REACTIONS
|
.....All 3 cases were reported within the first
six months of initiation of treatment with Tasmar. Analysis of
the laboratory monitoring data in over 3,400 Tasmar-treated
patients participating in clinical trials indicated that
increases in SGPT/ALT or SGOT/AST, when present, generally
occurred within the first 6 months of treatment with Tasmar.
Although a program of periodic laboratory monitoring for evidence of
hepatocellular injury is recommended,
it is not clear that periodic monitoring of liver enzymes will
prevent the occurrence of fulminant liver failure.....
.....In patients determined to be appropriate
candidates for treatment with Tasmar, SGPT/ALT and SGOT/AST
levels should be determined at baseline and periodically (i.e.
every 2 to 4 weeks) for the first 6 months of therapy. After the
first six months, periodic monitoring is recommended at
intervals deemed clinically relevant. Although more frequent
monitoring increases the chances of early detection, the precise
schedule for monitoring is a matter of clinical judgement.....
Tasmar should be discontinued if SGPT/ALT or
SGOT/AST levels exceed 2 times5the
upper limit of normal..... |
|
|
|
Tolectin 600 (tolmetin sodium) Tablets
Tolectin DS (tolemetin sodium) Capsules
(click product name to read labeling
template) |
BOXED
WARNING
- Cardiovascular Risk
- Gastrointestinal Risk
CONTRAINDICATIONS
WARNINGS
- Cardiovascular Effects
- Cardiovascular Thrombotic Events
- Hypertension
- Congestive Heart Failure and Edema
- Gastrointestinal Effects - Risk of
Ulceration, Bleeding, and Perforation
- Renal Effects
- Advanced Renal Disease
- Anaphylactoid Reactions
- Skin Reactions
- Pregnancy
PRECAUTIONS
- General
- Hepatic Effects
- Hematological Effects
- Preexisting Asthma
- Information for Patients
- Laboratory Tests
- Drug Interactions
- ACE-inhibitors
- Aspirin
- Diuretics
- Lithium
- Methotrexate
- Warfarin
- Drug/Laboratory Test Interactions
- Carcinogenesis, Mutagenesis, Impairment
of Fertility
- Pregnancy
- Teratogenic Effects. Pregnancy
Category C
- Nonteratogenic Effects
- Labor and Delivery
- Nursing Mothers
- Pediatric Use
- Geriatric Use
MEDICATION GUIDE |
Please see attached labeling
template.
This labeling
supplement is in response to the Agency’s June 15, 2005 letter
to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs)
to revise the labeling of all NSAIDs to provide more specific
information for practitioners, patients, family members and
caregivers about potential risks of CV (cardiovascular) and GI
(gastrointestinal) adverse effects for patients taking
NSAIDs. Additionally, the label was revised to include a
description of early symptoms associated with Stevens-Johnson
Syndrome.
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. |
|
|
|
Wellbutrin (bupropion hydrochloride) Tablets
(click product name to read prescribing information)
|
BOXED
WARNING
WARNINGS
MEDICATION GUIDE
|
BOXED WARNING
Antidepressants increased the risk of suicidal
thinking and behavior (suicidality) in short-term studies in
children and adolescents with Major Depressive Disorder (MDD)
and other psychiatric disorders. Anyone considering the use of
Wellbutrin or any other antidepressant in a child or adolescent
must balance this risk with the clinical need. Patients who are
started on therapy should be observed closely for clinical
worsening, suicidality, or unusual changes in behavior. Families
and caregivers should be advised of the need for close
observation and communication with the prescriber. Wellburtrin
is not approved for use in pediatric patients.....
WARNINGS
.....In addition, patients with a history of
suicidal behavior or thoughts, those patients exhibiting a
significant degree of suicidal ideation prior to commencement of
treatment, and young adults, are at an increased risk of
suicidal thoughts or suicide attempts, and should receive
careful monitoring during treatment.....
For additional details, see
MedWatch 10/15/04 Safety Alert. |
|
|
|
Wellbutrin SR (bupropion hydrochloride)
Sustained-Release Tablets
(click product name to read prescribing information)
|
BOXED
WARNING
WARNINGS
MEDICATION GUIDE
|
BOXED WARNING
Antidepressants increased the risk of suicidal
thinking and behavior (suicidality) in short-term studies in
children and adolescents with Major Depressive Disorder (MDD)
and other psychiatric disorders. Anyone considering the use of
Wellbutrin SR or any other antidepressant in a child or adolescent
must balance this risk with the clinical need. Patients who are
started on therapy should be observed closely for clinical
worsening, suicidality, or unusual changes in behavior. Families
and caregivers should be advised of the need for close
observation and communication with the prescriber. Wellbutrin
SR
is not approved for use in pediatric patients.....
WARNINGS
.....In addition, patients with a history of
suicidal behavior or thoughts, those patients exhibiting a
significant degree of suicidal ideation prior to commencement of
treatment, and young adults, are at an increased risk of
suicidal thoughts or suicide attempts, and should receive
careful monitoring during treatment.....
For additional details, see
MedWatch 10/15/04 Safety Alert.
|
|
|
|
Wellbutrin XL (bupropion hydrochloride
extended-release tablets)
(click product name to read prescribing information)
|
BOXED
WARNING
WARNINGS
MEDICATION GUIDE
|
BOXED WARNING
Antidepressants increased the risk of suicidal
thinking and behavior (suicidality) in short-term studies in
children and adolescents with Major Depressive Disorder (MDD)
and other psychiatric disorders. Anyone considering the use of
Wellbutrin XL or any other antidepressant in a child or adolescent
must balance this risk with the clinical need. Patients who are
started on therapy should be observed closely for clinical
worsening, suicidality, or unusual changes in behavior. Families
and caregivers should be advised of the need for close
observation and communication with the prescriber. Wellburtrin
XL
is not approved for use in pediatric patients.....
WARNINGS
.....In addition, patients with a history of
suicidal behavior or thoughts, those patients exhibiting a
significant degree of suicidal ideation prior to commencement of
treatment, and young adults, are at an increased risk of
suicidal thoughts or suicide attempts, and should receive
careful monitoring during treatment.....
For additional details, see MedWatch 10/15/04
Safety Alert. |
|
|
|
Zyprexa (olanzapine tablets)
Zyprexa Zydis (olanzapine orally disintegrating
tablets)
Zyprexa IntraMuscular (olanzapine for injection)
(click product name to read prescribing information)
|
BOXED
WARNING
WARNINGS
|
BOXED WARNING
Elderly patients with dementia-related psychosis treated with
atypical antipsychotic drugs are at an increased risk of death
compared to placebo. Analyses of seventeen placebo-controlled
trials (modal duration of 10 weeks) in these patients revealed a
risk of death in the drug-treated patients of between 1.6 to 1.7
times that seen 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. Zyprexa (olanzapine) is not
approved for the treatment of patients with dementia-related
psychosis.
WARNINGS
Elderly patients with dementia-related psychosis
treated with atypical antipsychotic drugs are at an increased
risk of death compared to placebo. Zyprexa is not approved for
the treatment of patients with dementia-related psychosis.....
For additional details, see
MedWatch 4/11/05 Safety Alert. |
MedWatch Home |
Safety Information |
Submit Report | How to
Report | Download
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Back to Summary Page
Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications
and Warnings |
Paxil (paroxetine hydrochloride) Tablets and Oral
Suspension
(click product name to read prescribing information)
|
CONTRAINDICATIONS
WARNINGS
- Usage in Pregnancy: Teratogenic
Effects
- Animal Findings
- Nonteratogenic Effects
PRECAUTIONS
- Drug Interactions
- Pregnancy Category D
MEDICATION GUIDE
|
CONTRAINDICATIONS
Concomitant use in patients taking pimozide is
contraindicated.....
WARNINGS
Usage in Pregnancy: Teratogenic Effects
Epidemiological studies have shown that infants
born to women who had first trimester paroxetine exposure had an
increased risk of cardiovascular malformations, primarily
ventricular and atrial septal defects (VSDs and ASDs).....
Animal Findings
Reproduction studies were performed at doses up to
50 mg/kg/day in rats and 6 mg/kg/day in rabbits administered
during organogenesis. These doses are approximately 8 (rat) and 2
(rabbit) times the MRHD on an mg/m2 basis.
These studies have revealed no evidence of teratogenic effects.
However, in rats, there was an increase in pup deaths during the
first 4 days of lactation when dosing occurred during the last
trimester of gestation and continued throughout lactation.....
Nonteratogenic Effects
Neonates exposed to Paxil and other SSRIs or
serotonin and norepinephrine reuptake inhibitors (SNRIs), late in
the third trimester have developed complications requiring
prolonged hospitalization, respiratory support, and tube feeding.
Such complications can arise immediately upon delivery.....
There have also been postmarketing reports of
premature births in pregnant women exposed to paroxetine or other
SSRIs.....
For additional details, see
MedWatch 12/8/05 Safety Alert. |
|
|
|
Paxil CR (paroxetine hydrochloride) Controlled-Release
Tablets
(click product name to read prescribing information) |
CONTRAINDICATIONS
WARNINGS
- Usage in Pregnancy: Teratogenic
Effects
- Animal Findings
- Nonteratogenic Effects
PRECAUTIONS
- Drug Interactions
- Pregnancy Category D
MEDICATION GUIDE
|
CONTRAINDICATIONS
Concomitant use in patients taking pimozide is
contraindicated.....
WARNINGS
Usage in Pregnancy: Teratogenic
Effects
Epidemiological studies have shown that infants
born to women who had first trimester paroxetine exposure had an
increased risk of cardiovascular malformations, primarily
ventricular and atrial septal defects (VSDs and ASDs).....
Animal Findings
Reproduction studies were performed at doses up to
50 mg/kg/day in rats and 6 mg/kg/day in rabbits administered
during organogenesis. These doses are approximately 8 (rat) and 2
(rabbit) times the MRHD on an mg/m2 basis.
These studies have revealed no evidence of teratogenic effects.
However, in rats, there was an increase in pup deaths during the
first 4 days of lactation when dosing occurred during the last
trimester of gestation and continued throughout lactation.....
Nonteratogenic Effects
Neonates exposed to Paxil CR and other SSRIs or
serotonin and norepinephrine reuptake inhibitors (SNRIs), late in
the third trimester have developed complications requiring
prolonged hospitalization, respiratory support, and tube feeding.
Such complications can arise immediately upon delivery.....
There have also been postmarketing reports of
premature births in pregnant women exposed to paroxetine or other
SSRIs.....
For additional details, see MedWatch 12/8/05 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 |
Summary of Changes to Contraindications
and Warnings |
Acetadote (acetylcysteine) Injection (for
Intravenous Use)
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
- Pediatric Patients
- No adverse effects were noted during I.V.
infusion with acetylcysteine at a mean rate of 4.2 mg/kg/h for
24 hours to 10 preterm newborns ranging in gestational age from
25 to 31 weeks.....
|
For specific treatment information regarding the
clinical management of acetaminophen overdose, please contact
your regional poison center at 1-800-222-1222, or alternatively,
a special health professional assistance line for acetaminophen
overdose at 1-800-525-6115. |
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|
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Advil Allergy Sinus (200 mg ibuprofen/30 mg pseudoephedrine HCl/2 mg chlorpheniramine maleate) Tablets
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. |
|
|
|
Advil Cold & Sinus (200 mg ibuprofen/30 mg pseudoephedrine HCl) Tablets
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. |
|
|
|
Advil
Liqui-Gels (200 mg ibuprofen capsules)
Advil Migraine (200 mg ibuprofen) 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. |
|
|
|
Children’s Motrin (50 mg ibuprofen) Chewable
Tablets
Motrin Junior Strength (100 mg ibuprofen)
Chewable Tablets
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.....
|
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. |
|
|
|
Effexor (venlafaxine hydrochloride) Tablets
(click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
-
Information for Patients
-
Mydriasis
ADVERSE REACTIONS
|
Mydriasis has been reported in association with
venlafaxine; therefore patients with raised intraocular pressure or
at risk of acute narrow-angle glaucoma (angle-closure glaucoma)
should be monitored.
|
|
|
|
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules
(click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
-
Information for Patients
-
Mydriasis
ADVERSE REACTIONS
|
Mydriasis has been reported in association with venlafaxine;
therefore patients with raised intraocular pressure or at risk of
acute narrow-angle glaucoma (angle-closure glaucoma) should be
monitored. |
|
|
|
Junior Strength Motrin (100 mg ibuprofen) Tablets
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. |
|
|
|
Motrin Cold & Sinus (200 mg ibuprofen/30 mg pseudoephedrine HCl)
Tablets
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. |
|
|
|
Motrin IB (200 mg ibuprofen)
Tablets
Motrin Migraine Pain
(200 mg ibuprofen) Tablets
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. |
|
|
|
Motrin Infants’ Drops* (50 mg/1.25 mL ibuprofen
oral suspension)
*Berry (¼ and ½ oz) and Dye-free Berry- (½ and 1
oz) flavored package sizes
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. |
|
|
|
Rituxan (rituximab)
(click product name to read prescribing information)
Note: In February 2006, two new
indications were approved for Rituxan (rituximab). This label
includes Rituxan's new indication for first-line treatment of
diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma in
combination with CHOP or other anthracycline-based chemotherapy
regimens. |
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
- The
overall safety database for Rituxan is based on clinical trial
data.....
- The
following serious adverse reactions, some with fatal outcomes,
have.....
- Except
as noted, adverse events described below occurred in the setting
of.....
- Immunogenicity
- Single Agent Rituxan for
Relapsed or Refractory, Low‑Grade or Follicular, CD20‑Positive,
B‑Cell, NHL
- Risk Factors Associated
with Increased Rates of Adverse Events
- Rituxan in
Combination with Chemotherapy for DLBCL
|
Hepatitis B Reactivation with Related
Fulminant Hepatitis and Other Viral Infections
The following
additional serious viral infections, either new, reactivated or
exacerbated, have been identified in clinical studies or
postmarketing reports. The majority of patients received Rituxan
in combination with chemotherapy or as part of a hematopoietic
stem cell transplant. These viral infections included JC virus
[progressive multifocal leukoencephalopathy (PML)],
cytomegalovirus, herpes simplex virus, parvovirus B19, varicella
zoster virus, West Nile virus, and hepatitis C.....
Severe Mucocutaneous Reactions
.....These
reports include paraneoplastic pemphigus (an uncommon disorder
which is a manifestation of the patient’s underlying
malignancy)..... |
|
|
|
Rituxan (rituximab)
(click product name to read prescribing information)
Note: In February 2006,
two new indications were approved for Rituxan (rituximab). This
label includes the indication for Rituxan in combination with
methotrexate to reduce signs and symptoms in adult patients with
moderately- to severely active rheumatoid arthritis who have had
an inadequate response to one or more TNF antagnoist therapies.
|
WARNINGS
- Severe Infusion Reactions
- Management of Severe Infusion Reactions
- Hypersensitivity Reactions
- Concomitant use with biologic agents and DMARDs
other than Methotrexate in RA
PRECAUTIONS
- Drug/Laboratory Interactions
- Immunization
- Use in Patients with RA Who Had No Prior Inadequate
Response to TNF Antagonists
- Retreatment in Patients with RA
- Geriatric Use
ADVERSE REACTIONS
- Adverse Reactions in Patients with Rheumatoid
Arthritis
- Table 7: Incidence of All Adverse
Events Occurring in ≥2% and at least 1%
greater than placebo among Rheumatoid Arthritis Patients.....
- Infusion Reactions
- Infections
- Cardiac Events
- Immunogenicity
PATIENT PACKAGE INSERT |
Severe Infusion Reactions
The following signs and symptoms were added:
- Urticaria
- Anaphylactic and Anaphylactoid Events
Management of Severe Infusion Reactions
Medications and supportive care measures
including, but not limited to, epinephrine, antihistamines,
glucocorticoids, intravenous fluids, vasopressors, oxygen,
bronchodilators, and acetaminophen, should be available and
instituted as medically indicated for use in the event of a
reaction during administration.
Hypersensitivity Reactions
Glucocorticoids added as a medication for the
treatment of hypersensitivity reactions.
Concomitant use with biologic agents and DMARDs
other than Methotrexate in RA
Limited data are available on the safety of the
use of biologic agents or DMARDs other than methotrexate in
patients exhibiting peripheral B cell depletion following
treatment with rituximab. Patients should be closely observed for
signs of infection if biologic agents and/or DMARDs are used
concomitantly.
|
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 |
Astelin (azelastine hydrochloride) Nasal Spray
(click product name to read prescribing information) |
PRECAUTIONS
-
Activities Requiring Mental Alertness
ADVERSE REACTIONS
- Seasonal Allergic Rhinitis
- Initial Section & Table
- Dermatological
- Digestive
- Musculoskeletal
- Respiratory
- Bronchitis
- Dry
Throat
- Nocturnal
Dyspnea
- Nasopharyngitis
- Nasal
Congestion
- Pharyngolaryngeal Pain
- Sinusitis
- Nasal
Dryness
- Paranasal Sinus
Hypersecretion
- Post
Nasal Drip
- Whole Body
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Betaxolol hydrochloride ophthalmic solution, 0.5%
as base
(click product name to read prescribing information) |
PRECAUTIONS
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Cardura (doxazosin mesylate) Tablets
(click product name to read prescribing information)
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PRECAUTIONS
-
Cataract Surgery
- Geriatric Use
ADVERSE REACTIONS
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Ceredase (alglucerase injection)
(click product name to read prescribing information) |
PRECAUTIONS
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Cystadane (betaine anhydrous for oral solution)
(click product name to read prescribing
information) |
PRECAUTIONS
ADVERSE REACTIONS
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Famvir (famciclovir) Tablets
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Famvir 125 mg, 250 mg and 500 mg tablets contain
lactose.....
- Information for Patients
- There is no evidence that Famvir will affect the
ability of a patient to drive or to use machines.
ADVERSE REACTIONS
- Postmarketing Experience
- Serious Skin Reactions (e.g. Erythema
Multiforme)
- Jaundice
- Thrombocytopenia
- Dizziness
- Somnolence
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Flovent HFA (fluticasone propionate) Inhalation
Aerosol
(click product name to read prescribing information) |
PRECAUTIONS
ADVERSE REACTIONS
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Hytrin (terazosin hydrochloride) Capsules
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Intraoperative Floppy Iris Syndrome (IFIS)
ADVERSE REACTIONS
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Hytrin (terazosin hydrochloride) Tablets
(click product name to read prescribing information)
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PRECAUTIONS
- General
- Intraoperative Floppy Iris Syndrome (IFIS)
ADVERSE REACTIONS
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Lasix (furosemide) Tablets
(click product name to read prescribing information) |
PRECAUTIONS
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Nexium (esomeprazole magnesium) Delayed-Release
Capsules
(click product name to read prescribing information)
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PRECAUTIONS
ADVERSE REACTIONS
- Postmarketing Reports
-
Blood and Lymphatic System
Disorders
- Agranulocytosis
- Pancytopenia
- Eye Disorders
- Immune System Disorders
- Anaphylactic Reaction/Shock
- Psychiatric Disorders
- Skin and Subcutaneous Tissue
Disorders
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Nexium I.V. (esomeprazole
sodium) for Injection
(click product name to read prescribing information)
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PRECAUTIONS
ADVERSE REACTIONS
- Postmarketing Reports
-
Blood and Lymphatic System
Disorders
- Agranulocytosis
- Pancytopenia
-
Eye Disorders
-
Immune System Disorders
- Anaphylactic Reaction/Shock
-
Psychiatric Disorders
-
Skin and Subcutaneous Tissue
Disorders
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Zegerid (omeprazole/sodium
bicarbonate) Capsules and Powder for Oral Suspension
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Information for Patients
ADVERSE REACTIONS
-
A controlled clinical trial was conducted in 359
critically ill patients, comparing Zegerid 40 mg/1680 mg
suspension..... [paragraph after Table 12]
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MedWatch Home |
Safety Information |
Submit Report | How to
Report | Download
Forms | Join the
E-list | Comments
Back to Summary Page
|
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