Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications and Warnings |
Arthrotec
(diclofenac sodium/misoprostol) Tablets
(click product name to read prescribing information)
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CONTRAINDICATIONS
PRECAUTIONS
- Information for Patients
- Special Note for Women
- Pregnancy
- Nursing Mothers
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Arthrotec should not be taken by pregnant women. |
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Celebrex (celecoxib capsules)
(click product name to read prescribing information)
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CONTRAINDICATIONS
BOXED WARNING
- Cardiovascular Risk
- Gastrointestinal Risk
WARNINGS
- Cardiovascular Effects
- Cardiovascular Thrombotic Events
- Hypertension
- Congestive Heart Failure and Edema
- Gastrointestinal (GI) Effects — Risk of GI Ulceration, Bleeding, and Perforation
- Renal Effects
- Advanced Renal Disease
- Skin Reactions
PRECAUTIONS
- Information for Patients
- Laboratory Tests
- Drug Interactions
ADVERSE REACTIONS
- Adverse Events from Celebrex Premarketing Controlled Arthritis Trials
- Other Serious Adverse Reactions which occur Rarely (estimated <0.1%), Regardless of Causality
- Adverse Events from Ankylosing Spondylitis Studies
MEDICATION GUIDE |
CONTRAINDICATIONS
Celebrex is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
BOXED WARNING
Cardiovascular Risk
Celebrex may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs may have a similar risk. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.....
Gastrointestinal Risk
NSAIDs, including Celebrex, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
WARNINGS
Cardiovascular Effects
Cardiovascular Thrombotic Events
Chronic use of Celebrex may cause an increased risk of serious adverse cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.....
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and Celebrex does increase the risk of serious GI events.....
Hypertension
As with all NSAIDS, Celebrex can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events.....
Congestive Heart Failure and Edema
Fluid retention and edema have been observed in some patients taking NSAIDs, including Celebrex.....
Celebrex should be used with caution in patients with fluid retention or heart failure.
Gastrointestinal (GI) Effects — Risk of GI Ulceration, Bleeding, and Perforation
.....NSAIDs should be prescribed with extreme caution in patients with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors.....
Renal Effects
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.....
Advanced Renal Disease
No information is available from controlled clinical studies regarding the use of Celebrex in patients with advanced renal disease. Therefore, treatment with Celebrex is not recommended in these patients with advanced renal disease. If Celebrex therapy must be initiated, close monitoring of the patient's renal function is advisable.
Skin Reactions
Celebrex is a sulfonamide and can cause serious skin adverse events such as exfoliative dermatitis, Stevens Johnson syndrome (SJS), and toxic epidermal necrolysis (TENS), which can be fatal. These serious events can occur without warning and in patients without prior known sulfa allergy..... |
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NuvaRing (etonogestrel/ethinyl estradiol vaginal ring)
(click product name to read prescribing information)
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CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
- Tampon Use
- Toxic Shock Syndrome (TSS)
- Drug Interactions
- Changes in Contraceptive Effectiveness Associated with Co-Administration of Other Drugs
- Increase in Plasma Hormone Levels Associated with Co-Administered Drugs
- Expulsion
- Disconnected Ring
PATIENT PACKAGE INSERT |
CONTRAINDICATIONS
NuvaRing should not be used in women who currently have the following conditions:
- Valvular heart disease with thrombogenic complications.
WARNINGS
Bleeding patterns were evaluated in three large clinical studies. In the US-Canadian study (N = 1177), the percentages of subjects with breakthrough bleeding/spotting ranged from 7.2 to 11.7% during cycles
1-13..... |
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Pipracil (piperacillin sodium)
Please contact Wyeth Pharmaceuticals at 1-800-934-5556 for prescribing information.
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CONTRAINDICATIONS
PRECAUTIONS
- General
- Leukopenia or Neutropenia
- Drug Interactions
- Drug/Laboratory Test Interactions
ADVERSE REACTIONS
- Dermatologic Adverse Events
- Urticaria
- Toxic Epidermal
Necrolysis
- Renal Adverse Events
- Hemic and Lymphatic Adverse
Events
- Hemolytic Anemia
- Agranulocytosis
- Pancytopenia
- Prolonged Bleeding Time
- Serum Electrolytes Adverse
Events
- Other Adverse Events
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CONTRAINDICATIONS
Pipracil is contraindicated in patients with a history of allergic reactions to any of the betalactams, including penicillins and/or cephalosporins.
PRECAUTIONS
General
Leukopenia or neutropenia may
occur during therapy.
Drug Interactions
Limited data suggests that
co-administration of methotrexate and piperacillin may reduce the
clearance of methotrexate due to competition for renal secretion.
If concurrent therapy is necessary, serum concentrations of
methotrexate as well as the signs and symptoms of methotrexate
toxicity should be frequently monitored.
Drug/Laboratory Test Interactions
There have been reports of
positive test results using the Bio-Rad Laboratories Platelia
Aspergillus EIA test in patients receiving piperacillin/tazobactam
injection who were subsequently found to be free of Aspergillus
infection. Crossreactions with non-Aspergillus polysaccharides and
polyfuranoses with the Bio-Rad Laboratories Platelia Aspergillus
EIA test have been reported. Therefore, positive test results in patients receiving
piperacillin should be interpreted cautiously and
confirmed by other diagnostic methods.
ADVERSE REACTIONS
Anaphylactic/anaphylactoid
reactions (some leading to shock and fatalities have been
reported.
Piperacillin therapy has been
associated with an increased incidence of fever and rash in cystic
fibrosis patients. |
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Pravachol (pravastatin sodium) Tablets
(click product name to read prescribing information)
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CONTRAINDICATIONS
WARNINGS
ADVERSE REACTIONS
- Postmarketing Experience
- Hypersensitivity
- Laboratory Abnormalities
- Liver Function Test Abnormalities
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CONTRAINDICATIONS
Active liver disease or unexplained, persistent elevations of serum transaminases.
WARNINGS
Myopathy, defined as muscle aching or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values to greater than 10 times the upper limit of normal, was rare (<0.1%) in pravastatin clinical trials. |
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Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications and Warnings |
Mifeprex (mifepristone) Tablets
(click product name to read prescribing information)
|
BOXED WARNING
WARNINGS
MEDICATION GUIDE |
BOXED WARNING
Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifeprex use.....
Patients with serious bacterial infections (e.g. Clostridium sordellii) and sepsis can present without fever, bacteremia or significant findings on pelvic examination following an abortion. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise.....
WARNINGS
As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of Mifeprex. No causal relationship between these events and the use of Mifeprex and misoprostol has been established. Physicians evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare event. In particular, a sustained fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection.
A high index of suspicion is needed to rule out sepsis (from e.g. Clostridium sordellii) if a patient reports abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea) more than 24 hours after taking misoprostol.....
For additional details, see MedWatch 07/19/2005 Safety Alert. |
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Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications and Warnings |
Enbrel (etanercept) For Subcutaneous Injection
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
PATIENT PACKAGE INSERT |
The use of Enbrel in patients with Wegener’s granulomatosis receiving immunosuppressive agents is not recommended. The use of Enbrel in patients receiving concurrent cyclophosphamide therapy is not recommended. |
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Flovent Diskus (fluticasone propionate inhalation powder)
(click product name to read prescribing information) |
WARNINGS
- Ritonavir Drug Interaction Study
PRECAUTIONS
- Information for Patients
- Drug Interactions
- Inhibitors of Cytochrome P450
- Pregnancy: Teratogenic Effects
- Pediatric Use
ADVERSE REACTIONS
- Observed During Clinical Practice
- Ear, Nose, and Throat
- Facial and Oropharyngeal Edema
- Non-Site Specific
- Very Rare Anaphylactic Reaction
- Very Rare Anaphylactic Reaction in Patients with Severe Milk Protein Allergy
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A drug interaction study in healthy subjects has shown that ritonavir (a highly potent cytochrome P450 3A4 inhibitor) can significantly increase plasma fluticasone propionate concentration, resulting in significantly reduced serum cortisol concentrations. During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing syndrome and adrenal suppression. Therefore, coadministration of fluticasone propionate and ritonavir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects. |
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Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) Modified
Neoral Oral Solution (cyclosporine oral solution, USP) Modified
(click product name to read prescribing information) |
WARNINGS: ALL PATIENTS
- Kidney, Liver and Heart Transplant
PRECAUTIONS
- Drugs That May Potentiate Renal Dysfunction
- Antibiotics
- Other Drugs
- Fibric Acid Derivatives (e.g., bezafibrate, fenofibrate)
- Drugs That Increase Cyclosporine Concentrations
- Drugs/Dietary Supplements That Decrease Cyclosporine Concentrations
- Other Drugs/Dietary Supplements
- Sulfinpyrazone
- Terbinafine
- Other Drug Interactions
- Potassium-sparing Diuretics
- Sirolimus
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Another rare manifestation of cyclosporine-induced neurotoxicity, occurring in transplant patients more frequently than in other indications, is optic disc edema including papilloedema, with possible visual impairment, secondary to benign intracranial hypertension. |
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Norplant System (levonorgestrel implants)
(click product name to read prescribing information) |
WARNINGS
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Numerous epidemiological studies have examined the association between the use of oral contraceptives and the incidence of breast and cervical cancer.
The risk of having breast cancer diagnosed may be slightly increased among current and recent users of combination oral contraceptives. However, this excess risk appears to decrease over time after combination oral contraceptive discontinuation and by 10 years after cessation the increased risk
disappears.....
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Reytaz (atazanavir sulfate) Capsules
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
- Drug Interactions
- Table 11
- Trazodone
- Inhaled Nasal Steriod
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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 Reyataz with ritonavir and fluticasone propionate is expected to produce the same effects.
.... |
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Sandimmune Soft Gelatin Capsules (cyclosporine capsules, USP)
Sandimmune Oral Solution (cyclosporine oral solution, USP)
Sandimmune Injection (cyclosporine injection, USP) FOR INFUSION ONLY
(click product name to read prescribing information)
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WARNINGS
PRECAUTIONS
- Drugs That May Potentiate Renal Dysfunction
- Antibiotics
- Other Drugs
- Fibric Acid Derivatives (e.g., Bezafibrate, Fenofibrate)
- Drugs That Increase Cyclosporine Concentrations
- Drugs/Dietary Supplements That Decrease Cyclosporine Concentrations
- Other Drugs/Dietary Supplements
- Sulfinpyrazone
- Terbinafine
- Other Drug Interactions
- Potassium Sparing Drugs
- Potassium Containing Drugs
- Potassium Rich Diet
- Sirolimus
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Another rare manifestation of cyclosporine-induced neurotoxicity is optic disc edema including papilloedema, with possible visual impairment, secondary to benign intracranial hypertension.
Rarely (approximately 1 in 1000), patients receiving Sandimmune Injection (cyclosporine injection, USP) have experienced anaphylactic reactions. Although the exact cause of these reactions is unknown, it is believed to be due to the Cremophor EL (polyoxyethylated castor oil) used as the vehicle for the I.V. formulation. These reactions can consist of flushing of the face and upper thorax, and non-cardiogenic pulmonary edema, with acute respiratory distress, dyspnea, wheezing, blood pressure changes, and tachycardia. One patient died after respiratory arrest and aspiration pneumonia. In some cases, the reaction subsided after the infusion was stopped. |
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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