Brand (Generic) Name
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Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Fluvoxamine Maleate Tablets
(click product name to read prescribing information)
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CONTRAINDICATIONS
WARNINGS
- Potential Tizanidine Interaction
- Potential Alosetron Interaction
PRECAUTIONS
- Concomitant Medication
- Drug Interactions
- Potential Interactions with Drugs that Inhibit or are
Metabolized by Cytochrome P450 Isozymes
- Other Drugs
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CONTRAINDICATIONS
Co-administration of
thioridazine, terfenadine, astemizole, cisapride, pimozide,
alosetron or tizanidine with fluvoxamine maleate is
contraindicated. Fluvoxamine maleate tablets are contraindicated
in patients with a history of hypersensitivity to fluvoxamine
maleate.
WARNINGS
Potential Tizanidine
Interaction
Fluvoxamine is a potent
inhibitor of CYP1A2 and tizanidine is a CYP1A2 substrate. The
effect of fluvoxamine (100 mg daily for 4 days) on the
pharmacokinetics and pharmacodynamics of a single 4 mg dose of
tizanidine has been studied in 10 healthy subjects. Tizanidine Cmax was increased approximately 12-fold (range 5-fold to
32-fold), elimination half-life was increased by almost 3-fold,
and AUC increased 33-fold (range 14-fold to 103-fold). The mean
maximal effect on blood pressure was a 35 mm Hg decrease in
systolic blood pressure, a 20 mm Hg decrease in diastolic blood
pressure, and a 4 beat/min decrease in heart rate. Drowsiness was
significantly increased and performance on a psychomotor task was
significantly impaired. Fluvoxamine and tizanidine should not be
used together.
Potential Alosetron
Interaction
Fluvoxamine, an inhibitor of several CYP
isozymes, has been shown to increase mean alosetron plasma
concentrations (AUC) approximately 6-fold and prolonged the
half-life by approximately 3-fold. Consequently, it is recommended
that fluvoxamine not be used in combination with alosetron.
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Norvir (ritonavir capsules)
Soft Gelatin
Norvir (ritonavir oral
solution)
(click product name to read prescribing information)
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CONTRAINDICATIONS
- Table 4
- Alpha1-adrenoreceptor Antagonist
WARNINGS
PRECAUTIONS
- Drug Interactions
- Table 6
- Trazodone
- Fluticasone Propionate
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CONTRAINDICATIONS
Alfuzosin HCL as
member of Alpha1-adrenoreceptor
antagonist, is contraindicated with Norvir.
WARNINGS
A drug interaction
study in healthy subjects has shown that ritonavir significantly
increases plasma fluticasone propionate exposures, resulting in
significantly decreased serum cortisol concentrations. Systemic
corticosteroid effects, including Cushing's syndrome and adrenal
suppression have been reported during postmarketing use in
patients receiving ritonavir and inhaled or intranasally
administered fluticasone propionate. Therefore, coadministration
of fluticasone propionate and Norvir is not recommended unless the
potential benefit to the patient outweighs the risk of systemic
corticosteroid side effects.
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Tev-Tropin [somatropin (rDNA
origin) for injection]
(click product name to read prescribing information)
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CONTRAINDICATIONS
WARNINGS
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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, Tev-Tropin 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 obstructions or sleep apnea, or unidentified respiratory
infection. Male patients with one or more of these factors may be
at greater risk than females. Patients with Prader-Willi syndrome
should be evaluated for signs of upper airway obstruction and
sleep apnea before initiation of treatment with growth hormone. If
during treatment with growth hormone, patients show signs of upper
airway obstruction (including onset of or increased snoring)
and/or new onset sleep apnea, treatment should be interrupted. All
patients with Prader-Willi syndrome treated with growth hormone
should also have effective weight control and be monitored for
signs of respiratory infection, which should be diagnosed as early
as possible and treated aggressively.
Unless patients with
Prader-Willi syndrome also have a diagnosis of growth hormone
deficiency, Tev-Tropin is not indicated for the long term
treatment of pediatric patients who have growth failure due to
genetically confirmed Prader-Willi syndrome.
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Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Ellence (epirubicin
hydrochloride injection)
(click product name to read prescribing information)
|
BOXED WARNING
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
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BOXED WARNING
The cumulative risk of
developing treatment-related AML or myelodysplastic syndrome
(MDS), in 7110 patients with breast cancer who received adjuvant
treatment with epirubicin-containing regimens, was estimated as
0.27% at 3 years, 0.46% at 5 years, and 0.55% at 8 years.
WARNINGS
An analysis of 7110
patients who received adjuvant treatment with epirubicin in
controlled clinical trials as a component of polychemotherapy
regimens for early breast cancer, showed a cumulative risk of
secondary acute myelogenous leukemia or myelodysplastic syndrome
(AML/MDS) of about 0.27% (approximate 95% CI, 0.14-0.40) at 3
years, 0.46% (approximate 95% CI, 0.28-0.65) at 5 years and
0.55% (approximate 95% CI, 0.33-0.78) at 8 years. The risk of
developing AML/MDS increased with increasing epirubicin
cumulative doses as shown in Figure 6.
|
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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)
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WARNINGS
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In placebo-controlled
clinical studies (two flexible dose and one fixed dose study) of
dementia-related psychosis, there was an increased incidence of
cerebrovascular adverse events (eg, stroke, transient ischemic
attack), including fatalities, in aripiprazole-treated patients
(mean age: 84 years; range: 78-88 years). In the fixed-dose
study, there was a statistically significant dose response
relationship for cerebrovascular adverse events in patients
treated with aripiprazole. Aripiprazole is not approved for the
treatment of patients with dementia-related psychosis.
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Crestor (rosuvastatin
calcium) Tablets
(click product name to read prescribing information)
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WARNINGS
PRECAUTIONS
- General
- Pregnancy
- Pregnant rats given oral gavage
dosages
ADVERSE REACTIONS
- Clinical Adverse Experiences
- Laboratory Abnormalities
- Elevated Creatine Phosphokinase
- Postmarketing Experience
- Very Rare Cases of Jaundice
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In clinical trials, the
incidence of myopathy and rhabdomyolysis increased at doses of
rosuvastatin above the recommended dosage range (5 to 40 mg). In
postmarketing experience, effects on skeletal muscle, e.g.
uncomplicated myalgia, myopathy and, rarely, rhabdomyolysis have
been reported in patients treated with HMG-CoA reductase
inhibitors including rosuvastatin. As with other HMG-CoA
reductase inhibitors, reports of rhabdomyolysis with
rosuvastatin are rare, but higher at the highest marketed dose
(40 mg). Factors that may predispose patients to myopathy with
HMG-CoA reductase inhibitors include advanced age (≥65
years), hypothyroidism, and renal insufficiency.
Rosuvastatin should be prescribed with
caution in patients with predisposing factors for myopathy, such
as, renal impairment, advanced age, and inadequately treated
hypothyroidism.
The 40 mg dose of
rosuvastatin is reserved only for those patients who have not
achieved their LDL-C goal utilizing the 20 mg dose of
rosuvastatin once daily.
Rosuvastatin therapy should
also be temporarily withheld in any patient with an acute,
serious condition suggestive of myopathy or predisposing to the
development of renal failure secondary to rhabdomyolysis (e.g.,
sepsis, hypotension, dehydration, major surgery, trauma, severe
metabolic, endocrine, and electrolyte disorders, or uncontrolled
seizures).
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Diamox Sequels (acetazolamide
extended-release capsules)
(click product name to read prescribing information)
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WARNINGS
PRECAUTIONS
- Information for Patients
- Drug Interactions
- Drug/Laboratory Test Interactions
- Geriatric Use
ADVERSE REACTIONS
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Fatalities
have occurred, although rarely, due to severe reactions to
sulfonamides including Stevens-Johnson syndrome, toxic epidermal
necrolysis, fulminant hepatic necrosis, anaphylaxis,
agranulocytosis, aplastic anemia, and other blood dyscrasias.
Sensitizations may recur when a sulfonamide is readministered
irrespective of the route of administration. If signs of
hypersensitivity or other serious reactions occur, discontinue
use of this drug. |
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Femring (estradiol acetate vaginal
ring)
(click product name to read prescribing information)
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WARNINGS
- Coronary Heart Disease and Stroke
- Venous Thromboembolism (VTE)
PATIENT PACKAGE INSERT
- What Is The Most Important Information I Should Know About
Femring (an Estrogen Product)?
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Coronary Heart Disease and Stroke
In the Women's Health Initiative (WHI) study, an increase
in the number of strokes was observed in women receiving CE
alone compared to placebo.
Venous Thromboembolism (VTE)
In the Women's Health Initiative (WHI) study, an increased
risk of deep vein thrombosis was observed in women receiving
CE alone compared to placebo.
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Kaletra (lopinavir/ritonavir)
Capsules and Oral Solution
(click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
|
A drug interaction study in
healthy subjects has shown that ritonavir significantly
increases plasma fluticasone propionate exposures, resulting
in significantly decreased serum cortisol concentrations.
Concomitant use of Kaletra and fluticasone propionate is
expected to produce the same effects. Systemic corticosteroid
effects including Cushing's syndrome and adrenal suppression
have been reported during postmarketing use in patients
receiving ritonavir and inhaled or intranasally administered
fluticasone propionate. Therefore, coadministration of
fluticasone propionate and Kaletra is not recommended unless
the potential benefit to the patient outweighs the risk of
systemic corticosteroid side effects.
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Maxaquin (lomefloxacin
hydrochloride tablets)
(click product name to read prescribing information)
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WARNINGS
- Peripheral Neuropathy
- Tendon Effects
PRECAUTIONS
ADVERSE REACTIONS
- Post-Marketing Adverse Events
- Quinolone-Class Adverse Events
- Peripheral Neuropathy
- Torsades de Pointes
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Peripheral Neuropathy
Rare cases of sensory or sensorimotor
axonal polyneuropathy affecting small and/or large axons
resulting in paresthesias, hypoesthesias, dysesthesias and
weakness have been reported in patients receiving quinolones,
including lomefloxacin. Lomefloxacin should be discontinued if
the patient experiences symptoms of neuropathy including pain,
burning, tingling, numbness, and /or weakness, or is found to
have deficits in light touch, pain, temperature, position sense,
vibratory sensation, and/or motor strength in order to prevent
the development of an irreversible condition.
Tendon Effects
Ruptures of the shoulder,
hand, Achilles tendon or other tendons that require surgical
repair or resulted in prolonged disability have been reported in
patients receiving quinolones, including lomefloxacin.
Post-marketing surveillance reports indicate that this risk may
be increased in patients receiving concomitant corticosteroids,
especially the elderly. Lomefloxacin should be discontinued if
the patient experiences pain, inflammation, or rupture of a
tendon. Patients should rest and refrain from exercise until
diagnosis of tendonitis or tendon rupture had been excluded.
Tendon rupture can occur during or after therapy with quinolones,
including lomefloxacin. |
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Temodar
(temozolomide) Capsules
(click product name to read prescribing information)
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WARNINGS
ADVERSE REACTIONS IN
ADULTS
- Newly Diagnosed Glioblastoma Multiforme
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Very rare cases of
myelodysplastic syndrome and secondary malignancies, including
myeloid leukemia have also been observed.
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Trileptal
(oxcarbazepine) Tablets and Oral Solution
(click product name to read prescribing information)
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WARNINGS
- Serious Dermatological Reactions
PRECAUTIONS
- Multi-organ Hypersensitivity
- Information for Patients
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Serious dermatological
reactions, including Stevens-Johnson syndrome (SJS) and toxic
epidermal necrolysis (TEN), have been reported in both children
and adults in association with Trileptal use. The median time of
onset for reported cases was 19 days. Such serious skin
reactions may be life-threatening, and some patients have
required hospitalization with very rare reports of fatal
outcome. Recurrence of the serious skin reactions following
re-challenge with Trileptal has also been reported.
The reporting rate of TEN and
SJS associated with Trileptal use, which is generally accepted
to be an underestimate due to underreporting, exceeds the
background incidence rate estimates by a factor of 3 to 10 fold.
Estimates of the background incidence rate for these serious
skin reactions in the general population range between 0.5 to 6
cases per million person years. Therefore, if a patient develops
a skin reaction while taking Trileptal, consideration should be
given to discontinuing Trileptal use and prescribing another
anti-epileptic medication.
|
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Brand
(Generic) Name |
Sections Modified
|
Boniva (ibandronate sodium)
Tablets
(click product name to read prescribing information)
|
PRECAUTIONS
- General
- Jaw Osteonecrosis
- Musculoskeletal Pain
- Information for Patients
- Drug Interactions
- H2 Blockers and Proton Pump Inhibitors
(PPIs)
- Aspirin/Nonsteroidal
Antiinflammatory Drugs (NSAIDs)
- Carcinogenesis, Mutagenesis,
Impairment of Fertility
- Carcinogenesis
- Impairment of Fertility
- Pregnancy
- Geriatric Use
ADVERSE REACTIONS
- Daily Dosing
- Treatment and Prevention of
Postmenopausal Osteoporosis
- Table 3
- Once Monthly Dosing
- Table 4
- Ocular Adverse Events
- Laboratory Test Findings
PATIENT PACKAGE INSERT
- What Is My Boniva Schedule?
- Common Side Effects With
Boniva Are:
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Children's Advil (100 mg/5
mL ibuprofen) Suspension
(click product name to read prescribing information)
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Ask
A Doctor Before Use If The Child Has
- Not Been Drinking Fluids
- Lost a Lot of Fluid Due to Continued
Vomiting or Diarrhea
- Ulcers
- Bleeding Problems
- Problems or Serious Side Effects from
Taking Fever Reducers or Pain Relievers
- Stomach Problems that Last or Come
Back, such as Heartburn, Upset Stomach or Pain
- High Blood Pressure, Heart or Kidney
Disease or is Taking a Diuretic
Alcohol Free statement added to carton of
the fruit flavored product to maintain consistency with the
grape and blue raspberry products.
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Cialis
(tadalafil) Tablets
(click product name to read prescribing information)
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PRECAUTIONS
- Alpha-blockers
- Information for Patients
- Drug Interactions
- Effects of Cialis on Other
Drugs
- Alpha Blockers
- Tamsulosin
- Doxazosin
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Cosopt (dorzolamide
hydrochloride-timolol maleate ophthalmic solution)
(click product name to read prescribing information)
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PRECAUTIONS
ADVERSE REACTIONS
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Gleevec (imatinib mesylate)
Tablets
(click product name to read prescribing information)
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PRECAUTIONS
- General
- Fluid Retention and Edema
- Hemorrhage
ADVERSE REACTIONS
- Chronic Myeloid Leukemia
- Table 4
- Table 6
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Indocin (Indomethacin)
Capsules, Oral Suspension and Suppositories
(click product name to read prescribing
information)
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PRECAUTIONS
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Levoxyl (levothyroxine
sodium, USP) Tablets
(click product name to read prescribing information)
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PRECAUTIONS
ADVERSE REACTIONS
- Tablet Stuck in Throat & Dysphagia
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Nolvadex
(tamoxifen citrate) Tablets
(click product name to read prescribing information)
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PRECAUTIONS
- Nursing Mothers
- Reduction in Breast Cancer Incidence in High Risk
Women and Women with DCIS
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Rapamune (sirolimus) Oral Solution and Tablets
(click product name to read prescribing information)
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PRECAUTIONS
ADVERSE REACTIONS
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Velcade (bortezomib) for Injection
(click product name to read prescribing information)
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PRECAUTIONS
- Peripheral Neuropathy
- Hypotension
- Cardiac Disorders
- Gastrointestinal Adverse
Events
- Thrombocytopenia
- Tumor Lysis Syndrome
- Patients with Renal Impairment
- Information for Patients
- Drug Interactions
- Pregnancy Category D
- Geriatric Use
ADVERSE REACTIONS
- Randomized Open-Label Phase 3
Clinical Study
- Serious Adverse Events (SAEs)
- Table 6
- Non-randomized Phase 2
Clinical Studies
- Serious Adverse Events (SAEs)
- Table 7
- The Phase 2 Open-Label
Extension Study
- Description of Selected
Adverse Events from the Phase 3 and Phase 2 Studies
- Gastrointestinal
Events
- Thrombocytopenia
- Peripheral Neuropathy
- Hypotension
- Neutropenia
- Asthenic Conditions
(Fatigue, Malaise, Weakness)
- Pyrexia
- Additional Serious
Adverse Events from Clinical Studies and
Post-Marketing
- Cardiac Disorders
- Ear and Labyrinth
Disorders
- Eye Disorders
- Gastrointestinal
Disorders
- General Disorders and
Administration Site Conditions
- Hepatobiliary
Disorders
- Infections and
Infestations
- Metabolism and
Nutrition Disorders
- Nervous System
Disorders
- Psychiatric Disorders
- Renal and
Urinary Disorders
- Respiratory, Thoracic
and Mediastinal Disorders
- Skin and Subcutaneous
Tissue Disorders
- Vascular Disorders
- Post-Marketing Experience
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Vfend I.V. (voriconazole)
for Injection
Vfend (voriconazole)
Tablets
Vfend (voriconazole) for
Oral Suspension
(click product name to read prescribing information)
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PRECAUTIONS
- Drug Interactions
- Table 10
- Methadone
(CYP3A4 Inhibition)
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Vytorin (ezetimibe/simvastatin) Tablets
(click product name to read prescribing information)
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PRECAUTIONS
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Zetia
(ezetimibe) Tablets
(click product name to read prescribing information)
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PRECAUTIONS
- Drug Interactions
- HMG Co-A Reductase Inhibitors
- Cyclosporine
ADVERSE REACTIONS
PATIENT PACKAGE
INSERT
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Zofran (ondansetron hydrochloride) Injection
Zofran (ondansetron hydrochloride)
Injection Premixed
(click product name to read prescribing information) |
PRECAUTIONS
ADVERSE REACTIONS
- Postoperative Nausea and Vomiting
- Pediatric Use
- Table 14
- Table 15
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Zosyn (piperacillin
and tazobactam for injection)
(click product name to read prescribing information)
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SYSTEMIC ANTIBACTERIAL
DRUG PRODUCTS STATEMENT to reduce the development of
drug-resistant bacteria.
PRECAUTIONS
- General
- Information for Patients
- Drug/Laboratory Test Interactions
|
MedWatch
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MedWatch
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Back to Summary Page
|
|