Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Lovenox (enoxaparin sodium injection)
(click product name to read prescribing information)
|
CONTRAINDICATIONS
|
Patients with known hypersensitivity to benzyl
alcohol should not be treated using the multi-dose formulation of
Lovenox. |
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Lupron (leuprolide acetate) Injection
(click product name to read prescribing information)
|
CONTRAINDICATIONS WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
PATIENT PACKAGE INSERT
|
CONTRAINDICATIONS
Lupron Injection is contraindicated in
patients known to be hypersensitive to GnRH, GnRH agonist
analogs or any of the excipients in Lupron Injection. Reports
of anaphylactic reactions to synthetic GnRH (Factrel) or GnRH
agonist analogs have been reported in the medical literature.
Lupron is contraindicated in women who are or
may become pregnant while receiving the drug. Lupron may cause
fetal harm when administered to a pregnant woman.
WARNINGS
Initially, Lupron, like other LH-RH agonists,
causes increases in serum levels of testosterone. Transient
worsening of symptoms, or the occurrence of additional signs
and symptoms of prostate cancer, may occasionally develop
during the first few weeks of Lupron treatment. A small number
of patients may experience a temporary increase in bone pain,
which can be managed symptomatically. As with other LH-RH
agonists, isolated cases of ureteral obstruction and spinal
cord compression have been observed, which may contribute to
paralysis with or without fatal complications.
Periodic
monitoring of serum testosterone and PSA levels is
recommended, especially if the anticipated clinical or
biochemical response to treatment has not been achieved. It
should be noted that results of testosterone determinations
are dependent on assay methodology. It is advisable to be
aware of the type and precision of the assay methodology to
make appropriate clinical and therapeutic decisions. |
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Nutropin Depot (somatropin [rDNA origin] for injectable
suspension)
(click product name to read prescribing information)
|
CONTRAINDICATIONS
WARNINGS |
CONTRAINDICATIONS
Growth hormone is contraindicated in patients with
Prader-Willi syndrome who are severely obese or have severe
respiratory impairment. Unless patients with Prader-Willi syndrome
also have a diagnosis of growth hormone deficiency, Nutropin Depot
is not indicated for the long term treatment of pediatric patients
who have growth failure due to genetically confirmed Prader-Willi
syndrome.
WARNINGS
There have been reports of fatalities after
initiating therapy with growth hormone in pediatric patients with
Prader-Willi syndrome who had one or more of the following risk
factors: severe obesity, history of upper airway obstruction or
sleep apnea, or unidentified respiratory infection. Male patients
with one or more of these factors may be at greater risk than
females..... (See prescribing information.) |
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Roferon-A (interferon alfa-2a,
recombinant)
(click product name to read prescribing information)
|
CONTRAINDICATIONS
WARNINGS
- Neuropsychiatric Disorders
- Cardiovascular Disorders
- Hypersensitivity
- Hepatic Disorders
- Gastrointestinal Disorders
- Bone Marrow Toxicity
- Endocrine Disorders
- Pulmonary Disorders
PRECAUTIONS
- General
- Renal Impairment
- Autoimmune Disease
- Information for Patients
- Laboratory Tests
- Drug Interactions
ADVERSE REACTIONS
- In Other Investigational Studies of Roferon-A
- Postmarketing
MEDICATION GUIDE
|
CONTRAINDICATIONS
Roferon-A is contraindicated
in patients with:
·
Hypersensitivity
to Roferon-A or any of its components
·
Autoimmune
hepatitis
·
Hepatic
decompensation (Child-Pugh class B and C) before or during
treatment
Roferon-A
is contraindicated in neonates and infants because it contains
benzyl alcohol. Benzyl
alcohol is associated with an increased incidence of neurologic
and other complications in neonates and infants, which are
sometimes fatal.
WARNINGS
Roferon-A
should be used with extreme caution in patients who report a
history of depression.
Cases of
cardiomyopathy have been observed on rare occasions in patients
treated with alpha interferons.
(See
prescribing information for additional warnings.) |
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Tikosyn (dofetilide) Capsules
(click product name to read prescribing information)
|
CONTRAINDICATIONS
WARNINGS
-
Hypokalemia and Potassium-Depleting Diuretics
-
Use with Drugs that Prolong QT Interval and
Antiarrhythmic Agents
PRECAUTIONS
-
Information for
Patients
-
Drug-Drug Interactions
- Hydrochlorothiazide (HCTZ) Alone or in Combination
with Triamterene
PATIENT PACKAGE INSERT
|
CONTRAINDICATIONS
The concomitant use of hydrochlorothiazide (alone
or in combinations such as with triamterene) with Tikosyn is
contraindicated
because this has been shown to significantly increase dofetilide plasma
concentrations and QT interval prolongation.
WARNINGS
Hypokalemia or hypomagnesemia may occur with
administration of potassium-depleting diuretics, increasing the
potential for torsade de pointes. Potassium levels should be
within the normal range prior to administration of Tikosyn and
maintained in the normal range during administration of Tikosyn.
The use of Tikosyn in conjunction with other drugs that prolong
the QT interval has not been studied and is not recommended. Such
drugs include phenothiazines, cisapride, bepridil, tricyclic
antidepressants, certain oral macrolides, and certain
fluoroquinolones. |
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Vesanoid (tretinoin) Capsules
(click product name to read prescribing information)
|
CONTRAINDICATIONS
BOXED WARNING
- Experienced Physician and Institution
- Retinoic Acid-APL Syndrome
WARNINGS
PRECAUTIONS
- General
- Drug Interactions
- Drugs Metabolized By the Hepatic P450 System
- Agents Known to Cause Pseudotumor Cerebri/Intracranial
Hypertension (Such as Tetracyclines)
- Vitamin A
- Antifibrinolytic Agents (Such as Tranexamic
Acid, Aminocaproic Acid,or Aprotinin)
ADVERSE REACTIONS
- RA-APL Syndrome
- Additional Adverse Reactions Reported With
Vesanoid
- Cardiovascular
- Hematologic
- Skin
- Miscellaneous Adverse Event
|
CONTRAINDICATIONS
Vesanoid is contraindicated in patients with a
known hypersensitivity to Vesanoid, any of its components,
or other retinoids.
BOXED WARNING
Patients with acute promyelocytic leukemia (APL)
are at high risk in general and can have severe adverse reactions
to Vesanoid (tretinoin). Vesanoid should therefore be administered
only to patients with APL under the strict supervision of a
physician who is experienced in the management of patients with
acute leukemia and in a facility with laboratory and supportive
services sufficient to monitor drug tolerance and protect and
maintain a patient compromised by drug toxicity, including
respiratory compromise.
About 25% of patients with APL treated with
Vesanoid have experienced a syndrome called the retinoic acid-APL (RA-APL) syndrome characterized by fever, dyspnea, acute
respiratory distress, weight gain, radiographic pulmonary
infiltrates, pleural and pericardial effusions, edema, and
hepatic, renal, and multi-organ failure.
(See prescribing information for
additional warnings.)
WARNINGS
The concomitant use of other agents known to cause
pseudotumor cerebri/intracranial hypertension, such as
tetracyclines, might increase the risk of this condition. |
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Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Doxil (doxorubicin HCl) Liposome Injection
(click product name to read prescribing information)
|
BOXED WARNING
WARNINGS
- Cardiac Toxicity
- Myelosuppression
- Infusion Reactions
- Hand-Foot Syndrome (HFS)
PRECAUTIONS
- Information for the Patient
|
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 (doxorubicin HCl) liposome injection, may lead
to cardiac toxicity...... (See prescribing information.)
WARNINGS
(Extensive changes to the WARNINGS section. Please see prescribing information.) |
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Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Altace (ramipril) Capsules
(click product name to read prescribing information)
|
WARNINGS PRECAUTIONS ADVERSE REACTIONS |
Intestinal angioedema has been reported in
patients treated with ACE inhibitors. These patients presented
with abdominal pain (with or without nausea or vomiting); in
some cases there was no prior history of facial angioedema and
C-1 esterase levels were normal. The angioedema was diagnosed by
procedures including abdominal CT scan or ultrasound, or at
surgery, and symptoms resolved after stopping the ACE inhibitor.
Intestinal angioedema should be included in the differential
diagnosis of patients on ACE inhibitors presenting with
abdominal pain. |
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Axid AR (nizatidine)
Over-the-Counter Drug
Please contact
Wyeth Consumer Healthcare at 1-800-322-3129 for prescribing
information. |
WARNINGS |
Allergy alert: Do not use if you
are allergic to nizatidine or other acid reducers. Do not use if
you have trouble or pain swallowing food, vomiting with blood, or
bloody or black stools. These may be signs of a serious condition.
See your doctor. Do not use with other acid reducers. |
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Concerta (methylphenidate HCl) Extended-release Tablets
(click product name to read prescribing information) |
WARNINGS
- Long-Term Suppression of Growth
- Hypertension and Other Cardiovascular Conditions
ADVERSE REACTIONS
- Initial Paragraph
- Adverse Findings in Clinical Trials with Concerta
- Treatment-Emergent Adverse Events Among Concerta-Treated
Patients
PATIENT PACKAGE INSERT |
Data are inadequate to determine whether chronic
use of stimulants in children, including amphetamine, may cause
suppression of growth. Therefore, growth should be monitored
during treatment, and patients who are not growing or gaining
weight as expected should have their treatment interrupted. Caution is indicated in treating patients whose
underlying medical conditions might be compromised by increases in
blood pressure or heart rate, eg, those with preexisting
hypertension, heart failure, recent myocardial infarction, or
hyperthyroidism. Blood pressure should be monitored at appropriate
intervals in patients taking Concerta, especially patients with
hypertension. |
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Cuprimine (penicillamine) Capsules
(click product name to read prescribing information)
|
WARNINGS PRECAUTIONS
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Geriatric Use
|
Penicillamine can cause fetal harm when
administered to a pregnant woman. If this drug is used during
pregnancy, or if the patient becomes pregnant while taking this
drug, the patient should be apprised of the potential hazard to
the fetus. |
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Enbrel (etanercept)
(click product name to read prescribing information)
|
WARNINGS ADVERSE REACTIONS
- Adverse Reactions in Adult Patients with RA, Psoriatic
Arthritis, Ankylosing Spondylitis, or Plaque Psoriasis
- Malignancies
PATIENT PACKAGE INSERT |
Concurrent therapy with Enbrel and Anakinra is not
recommended. During the controlled portions
of Enbrel trials, 3 lymphomas were observed among 4509
Enbrel -treated patients versus 0 among
2040 control patients (duration of controlled treatment
ranged from 3 to 24 months). In the
controlled and open-label portions of clinical trials of
Enbrel, 9 lymphomas were observed in 5723
patients over approximately 11201 patient-years of therapy.
This is 3-fold higher than that expected in the general
population.
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Fuzeon
(enfuvirtide) for Injection
(click product name to read prescribing information)
|
WARNINGS
- Local Injection Site Reactions
- Hypersensitivity Reactions
PRECAUTIONS
- Information for Patients
- Carcinogenesis, Mutagenesis, Impairment of
Fertility
- Pediatric Use
ADVERSE REACTIONS
- Initial Paragraph
- Local Injection Site Reactions
- Other Adverse Events
- Less Common Events
- Renal and Urinary Disorders
- Tubular Necrosis
- Renal Insufficiency
- Blood and Lymphatic Disorders
- Infections
- Nervous System Disorder
- Taste Disturbance
- Peripheral Neuropathy
- Cardiac Disorders
- Gastrointestinal Disorders
- General
- Hepatobiliary Disorders
- Investigations
- Psychiatric Disorders
- Respiratory, Thoracic and Mediastinal Disorders
- Skin and Subcutaneous Tissue Disorders
- Laboratory Abnormalities
- Adverse Events in Pediatric Patients
PATIENT PACKAGE INSERT |
The majority of patients (98%) receiving
Fuzeon in the Phase 3 clinical trials had at least one local
injection site reaction; ISRs occurred throughout treatment
with Fuzeon. Systemic hypersensitivity reactions have been
associated with Fuzeon therapy and may recur on re-challenge.
Hypersensitivity reactions have occurred in <1% of patients
studied and have included combinations of: rash, fever, nausea
and vomiting, chills, rigors, hypotension, and/or elevated
serum liver transaminases. |
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Kaletra (lopinavir/ritonavir) Capsules and Oral
Solution
(click product name to read prescribing information)
|
WARNINGS PRECAUTIONS
- Immune Reconstitution Syndrome
- Information for Patients
- Drug Interactions
- Table 9
- Nucleoside Reverse Transcriptase Inhibitor: Tenofovir
- HIV-Protease Inhibitors: Fosamprenavir
- Antigungals: Ketoconazole, Itraconazole,
Voriconazole
- PDE5 Inhibitors: Sildenafil, Tadalafil, Vardenafil
- Oral Contraceptive: Ethinyl Estradiol
- Carcinogenesis, Mutagenesis and Impairment of Fertility
- Pregnancy
ADVERSE REACTIONS
- Adults
- Table 10
- Cardiovascular System
- Cerebral Infarct
- Deep Thrombophlebitis
- Digestive System
- Musculoskeletal System
- Nervous System
- Hypertonianervousness
- Vertigo
- Urogenital System
- Post-Marketing Experience
- Skin and Appendages
- Stevens Johnson Syndrome
- Erythema Multiforme
- Table 11
|
Particular caution should be used when
prescribing sildenafil, tadalafil, or vardenafil in patients receiving Kaletra. Co-administration
of Kaletra with these drugs is expected to substantially increase their concentrations
and may result in an increase in associated adverse events
including hypotension, syncope, visual changes and prolonged
erection. |
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Levaquin (levofloxacin) Tablets, Oral Solution and Injection
Levaquin (levofloxacin in 5% dextrose) Injection
(click product name to read prescribing information) |
WARNINGSPRECAUTIONS
|
In immature rats and dogs, the oral and
intravenous administration of levofloxacin resulted in
increased osteochondrosis. Histopathological examination of
the weightbearing joints of immature dogs dosed with
levofloxacin revealed persistent lesions of the cartilage.
Other fluoroquinolones also produce similar erosions in the
weight bearing joints and other signs of arthropathy in
immature animals of various species. The relevance of these
findings to the clinical use of levofloxacin is unknown. |
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Pepcid AC (famotidine) Chewable Tablets
Over-the-Counter Drug
(click product name to read prescribing information) |
WARNINGS |
DO NOT USE:
- If you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
- With other acid reducers
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Pepcid Complete (famotidine, calcium carbonate & magnesium
hydroxide) Over-the-Counter Drug
(click product name to read prescribing information) |
WARNINGS |
DO NOT USE:
- If you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
- With other acid reducers
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Pepcid AC (famotidine) Gelcaps
Over-the-Counter Drug
(click product name to read prescribing information) |
WARNINGS |
DO NOT USE:
- If you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
- With other acid reducers
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Pepcid AC (famotidine) Maximum Strength Film Coated Tablets Over-the-Counter Drug
(click product name to read prescribing information) |
WARNINGS |
DO NOT USE:
- If you have trouble or pain swallowing food,
vomiting with blood, or bloody or black stools. These may be
signs of a serious condition. See your doctor.
- With other acid reducers
|
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Pepcid AC (famotidine) Original Strength Film Coated Tablets
Over-the-Counter Drug
(click product name to read prescribing information) |
WARNINGS |
DO NOT USE:
- If you have trouble or pain swallowing food,
vomiting with blood, or bloody or black stools. These may be
signs of a serious condition. See your doctor.
- If you have kidney disease, except under the
advice and supervision of a doctor
- With other acid reducers
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Wellbutrin XL (bupropion hydrochloride)
Extended-Release Tablets
(click product name to read prescribing information)
|
WARNINGS ADVERSE REACTIONS
|
As Wellbutrin XL is bioequivalent to
both the immediate-release formulation of bupropion and to the
sustained-release formulation of bupropion, the seizure
incidence with Wellbutrin XL, while not formally evaluated in
clinical trials, may be similar to that presented below for
the immediate-release and sustained-release formulations of
bupropion...... (See prescribing information.) |
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Brand
(Generic) Name |
Sections Modified
|
Diflucan (fluconazole) Tablets, Injection and
Powder for Oral Suspension
(click product name to read prescribing information)
|
PRECAUTIONS
General
Drug Interactions
- Coumarin-type Anticoagulants
- Cisapride
- Short-acting Benzodiazepines
Geriatric Use
ADVERSE REACTIONS
Post-marketing Experience
-
Immunologic
-
Cardiovascular
-
Central Nervous Syste
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Imitrex (sumatriptan) Nasal Spray
(click product name to read prescribing information)
|
PRECAUTIONS
Pediatric Use
|
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Plavix (clopidogrel bisulfate) Tablets
(click product name to read prescribing information)
|
PRECAUTIONS
General
Information for Patients
Geriatric Use
ADVERSE REACTIONS
Table 3
|
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Propecia (finasteride) Tablets
(click product name to read prescribing information)
|
PRECAUTIONS
- Information for Patients
- Carcinogenesis, Mutagenesis, Impairment of
Fertility
- Pregnancy
- Teratogenic Effects: Pregnancy Category X
ADVERSE REACTIONS
-
Clinical Studies for Propecia (finasteride 1 mg)
in the Treatment of Male Pattern Hair Loss
-
Controlled Clinical Trials and Long-Term Open
Extension Studies for Proscar (finasteride 5 mg) in the
Treatment of Benign Prostatic Hyperplasia
PATIENT PACKAGE INSERT |
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Reyataz (atazanavir sulfate) Capsules
(click product name to read prescribing information)
|
PRECAUTIONS
|
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Sustiva
(efavirenz) Tablets and Capsules
(click product name to read prescribing
information)
|
PRECAUTIONS
Pregnancy
|
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Brand
(Generic) Name |
Sections Modified
|
Femara (letrozole tablets)
(click product name to read prescribing information) |
ADVERSE REACTIONS
- Initial Paragraph
- Extended Adjuvant Treatment of Early Breast
Cancer in Postmenopausal Women who have Received 5 Years of
Adjuvant Tamoxifen Therapy
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Geodon (ziprasidone HCl) Capsules
Geodon (ziprasidone mesylate)
for Injection
(click product name to read prescribing information)
|
ADVERSE REACTIONS
- Adverse Findings Observed in Short-Term,
Placebo-Controlled Trials with Oral Ziprasidone
- Adverse Events Associated with Discontinuation
of Treatment in Short-Term, Placebo-Controlled Trials of Oral
Ziprasidone
- Commonly Observed Adverse Events in Short-Term,
Placebo-Controlled Trials
- Adverse Events Occurring at an Incidence of 2%
or More Among Ziprasidone-Treated Patients in Short-Term, Oral,
Placebo-Controlled Trials
|
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Keppra (levetiracetam) Tablets and Oral
Solution
(click product name to read prescribing information)
|
ADVERSE REACTIONS
|
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Kineret (anakinra)
(click product name to read prescribing information)
|
ADVERSE REACTIONS
- Infections
- Malignancies
- Immunogenicity
|
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Xenical (orlistat) Capsules
(click product name to read prescribing information)
|
ADVERSE REACTIONS
-
Incidence
in Controlled Clinical Trials
|
MedWatch
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Report | How to Report | Download
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Back to Summary Page
|
|