Brand (Generic) Name
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Sections Modified |
Summary of Changes to Contraindications and Warnings
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Novantrone (mitoxantrone for
injection concentrate)
(click product name to read prescribing information)
For additional details, see MedWatch 05/24/2005 Safety Alert
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BOXED WARNING
- Cardiotoxicity
- Secondary Leukemia (AML)
WARNINGS
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BOXED WARNING - CARDIOTOXICITY
Use of Novantrone has been
associated with cardiotoxicity. Cardiotoxicity can occur at any
time during Novantrone therapy, and the risk increases with
cumulative dose. Congestive heart failure (CHF), potentially
fatal, may occur either during therapy with Novantrone or months
to years after termination of therapy. All patients should be
carefully assessed for cardiac signs and symptoms by history and
physical examination prior to start of Novantrone therapy.
..... (See prescribing information)
BOXED WARNING - SECONDARY
LEUKEMIA (AML)
Secondary acute myelogenous
leukemia (AML) has been reported in multiple sclerosis and
cancer patients treated with mitoxantrone. In a cohort of
mitoxantrone treated MS patients followed for varying periods of
time, an elevated leukemia risk of 0.25% (2/802) has been
observed. Postmarketing cases of secondary AML have also been
reported. .....(See prescribing information)
CARDIAC EFFECTS WARNINGS
LVEF should be evaluated by
echocardiogram or MUGA prior to administration of the initial
dose of Novantrone. Multiple sclerosis patients with a baseline
LVEF of <50% should not be treated with Novantrone.
Subsequent LVEF evaluations are recommended if signs or symptoms
of congestive heart failure develop, and prior to all doses
administered to multiple sclerosis patients. NOVANTRONE should
not be administered to multiple sclerosis patients with an LVEF
of <50%, with a clinically significant reduction in LVEF, or
to those who have received a cumulative lifetime dose of >1
40 mg/m2.
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Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Mevacor (lovastatin) Tablets
(click product name to read prescribing information)
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WARNINGS
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It is recommended that liver function
tests be performed prior to initiation of therapy in patients
with a history of liver disease, or when otherwise clinically
indicated. It is recommended that liver function tests be
performed in all patients prior to use of 40 mg or more daily
and thereafter when clinically indicated.
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Nitro-Dur (nitroglycerin) Transdermal Infusion
System
(click product name to read prescribing information) |
WARNINGS
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Amplification
of the vasodilatory effects of the Nitro-Dur patch by
phosphodiesterase inhibitors, e.g., sildenafil can result in
severe hypotension. |
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Plavix (clopidogrel bisulfate
tablets)
(click product name to read prescribing information)
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WARNINGS
- Thrombotic Thrombocytopenic Purpura (TTP)
PRECAUTIONS
ADVERSE REACTIONS
- Post-Marketing Experience
- Skin and Subcutaneous Tissue Disorders
- Stevens-Johnson Syndrome
- Lichen Planus
- Vascular Disorders
- Gastrointestinal Disorders
- Musculoskeletal, Connective Tissue and Bone Disorders
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TTP is a serious condition
and requires urgent referral to a hematologist for prompt
treatment.
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Prevpac (lansoprazole/amoxicillin/clarithromycin tablets)
(click product name to read prescribing information)
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WARNINGS
- Amoxicillin
- Amoxicillin and/or Clarithromycin
PRECAUTIONS
- Amoxicillin
- Drug/Laboratory Test Interactions
- Nursing Mothers
ADVERSE REACTIONS
- Amoxicillin
- Gastrointestinal
- Hemorrhagic/pseudomembranous
Colitis
- Hypersensitivity Reactions
- Serum Sickness Like Reactions,
- Exfoliative Dermatitis,
- Acute Generalized Exanthematous
Pustulosis,
- Hypersensitivity Vasculitis
- Liver
- Hepatic Dysfunction
- Cholestatic Jaundice
- Hepatic Cholestasis
- Acute Cytolytic Hepatitis
- Renal
- Hemic and Lymphatic Systems
- Miscellaneous
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After the diagnosis of
pseudomembranous colitis has been established, appropriate
therapeutic measures should be initiated. Mild cased of
pseudomembranous colitis usually respond to drug
discontinuation of the drug alone.
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Sustiva (efavirenz) Capsules and Tablets
(click product name to read prescribing information)
For additional details, see MedWatch 06/10/2005 Safety Alert
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WARNINGS
- Reproductive Risk Potential
- Category D
- Antiretroviral Pregnancy Registry
PRECAUTIONS
- Information for Patients
- Pregnancy
ADVERSE REACTIONS
PATIENT PACKAGE INSERT
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Efavirenz may cause fetal harm when
administered during the first trimester to a pregnant woman.
Pregnancy should be avoided in women receiving Sustiva. .....(See Prescribing Information)
There are no adequate and
well-controlled studies in pregnant women. Sustiva should be
used during pregnancy only if the potential benefit justifies
the potential risk to the fetus, such as in pregnant women
without other therapeutic options. As of July 2004, the
Antiretroviral Pregnancy Registry has received prospective
reports of 237 pregnancies exposed to efavirenz-containing
regimens, nearly all of which were first-trimester exposures
(232 pregnancies). Birth defects occurred in 5 of 188 live
births (first trimester exposure) and 0 of 13 live births
(second/third trimester exposure). None of these prospectively
reported defects were neural tube defects. However, there have
been four retrospective reports of findings consistent with
neural tube defects, including meningomyelocele. All mothers
were exposed to efavirenz-containing regimens in the first
trimester. Although a causal relationship of these events to the
use of Sustiva has not been established, similar defects have
been observed in preclinical studies of efavirenz.
|
MedWatch
Home | Safety Information | Submit
Report | How to Report | Download
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Back to Summary Page
MedWatch
Home | Safety Information | Submit
Report | How to Report | Download
Forms | Join the E-list | Comments
Back to Summary Page
MedWatch
Home | Safety Information | Submit
Report | How to Report | Download
Forms | Join the E-list | Comments
Back to Summary Page
|
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