Brand (Generic) Name |
Sections Modified
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Summary of Changes to Contraindications and Warnings |
EstroGel 0.06% (estradiol gel)
Prescribing Information
Patient Package Insert
|
BOXED WARNING
- Cardiovascular and Other Risks
WARNINGS
- Cardiovascular Disorders
- Stroke
- Coronary Heart Disease
- Venous Thromboembolism (VTE)
- Malignant Neoplasms
- Endometrial Cancer
- Breast Cancer
- Ovarian Cancer
- Dementia
PRECAUTIONS
- General
- Hypertriglyceridemia
- Alcohol-based Gels are Flammable
- Laboratory Tests
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Pregnancy
- Nursing Mothers
- Pediatric Use
- Geriatric Use
ADVERSE REACTIONS
- Genitourinary System
- Uterine Bleeding/Spotting
- Pelvic Pain
- Central Nervous System
- Miscellaneous
- Glucose Intolerance
- Hypocalcemia (preexisting condition)
PATIENT PACKAGE INSERT
- Initial Paragraph
- What is the most important information I should know about EstroGel (an estrogen hormone)?
- How is EstroGel used?
- Tell your healthcare provider...
- How should I use EstroGel?
- What should I avoid while using EstroGel?
- What are the possible side effects of estrogens?
- What can I do to lower my chances of having an adverse event with EstroGel?
- What are the ingredients in EstroGel?
|
BOXED WARNING
Cardiovascular and Other Risks
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia...
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE 0.625 mg alone and during 4 years of treatment with daily CE 0.625 mg combined with MPA 2.5 mg, relative to placebo...
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins...
WARNINGS
See highlighted text for labeling revisions. |
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Herceptin (trastuzumab) Intravenous Infusion
Prescribing Information (in new labeling format) |
BOXED WARNING
- Cardiomyopathy
- Infusion Reactions; Pulmonary Toxicity
WARNINGS AND PRECAUTIONS
- Cardiomyopathy
- Table 1
- Table 2
- Infusion Reactions
- In postmarketing reports, serious and fatal infusion reactions have been reported...
- HER2 Testing
- Embryo-Fetal Toxicity (Pregnancy Category D)
ADVERSE REACTIONS
- Initial Section
- Adverse reactions requiring interruption or discontinuation of Herceptin treatment include: pulmonary toxicity (added)
PATIENT COUNSELING INFORMATION |
BOXED WARNING
Cardiomyopathy
Herceptin can result in sub-clinical and clinical cardiac failure manifesting as CHF and decreased LVEF...
Infusions Reactions; Pulmonary Toxicity
...Fatal infusion reactions have been reported.
...Discontinue Herceptin for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. [see Warnings and Precautions (5.2, 5.4)]
WARNINGS AND PRECAUTIONS
See highlighted text for labeling revisions. |
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Rituxan (rituximab) Injection For Intravenous Use
Prescribing Information (in new labeling format)
Medication Guide
|
BOXED WARNING
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
- The most common adverse reactions of Rituxan (incidence ≥25%) observed in patients with NHL are infusion reactions, fever, chills, infection, asthenia, and lymphopenia...
- Clinical Trials Experience Non-Hodgkin's Lymphoma
- Infections
- Cytopenias and Hypogammaglobulinemia
- Postmarketing Reports
USE IN SPECIFIC POPULATIONS
- Pregnancy
- Nursing Mothers
MEDICATION GUIDE (new - previously Patient Package Insert) |
BOXED WARNING
Infusion Reactions
Rituxan administration can result in serious, iucluding fatal infusion reactions. Deaths within 24 hours of Rituxan infusion have occurred...
...Carefully monitor patients during infusions. Discontinue Rituxan infusion and provide medical treatment for Grade 3 or 4 infusion reactions...
WARNINGS AND PRECAUTIONS
Infusion Reactions
...Premedicate patients with an antihistamine and acetaminophen prior to dosing. Institute medical management (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion reactions as needed. Depending on the severity of the infusion reaction and the required interventions, consider resumption of the infusion at a minimum 50% reduction in rate after symptoms have resolved... |
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Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications
and Warnings |
Alesse 28 Tablets (levonorgestrel and ethinyl estradiol tablets)
Prescribing Information
Patient Package Insert
|
CONTRAINDICATIONS
WARNINGS
- Thromboembolic Disorders and Other Vascular Problems
- Figure II: Circulatory Disease Mortality Rates Per 100,000 Woman Years By Age, Smoking Status and Oral-Contraceptive Use
- Venous Thrombosis and Thromboembolism
- Carcinoma of the Reproductive Organs and Breasts
PATIENT PACKAGE INSERT:DETAILED PATIENT LABELING
- Who Should Not Take Oral Contraceptives
- Risks of Taking Oral Contraceptives
- Risk of Developing Blood Clots
- Lipid Metabolism and Pancreatitis
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CONTRAINDICATIONS
- Valvular heart disease with thrombogenic complications
WARNINGS
Venous Thrombosis and Thromboembolism
...Since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than four weeks after delivery in women who elect not to breast-feed or after a midtrimester pregnancy termination.
Carcinoma of the Reproductive Organs and Breasts
See highlighted text for labeling revisions. |
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Janumet (sitagliptin/metformin HCl) Tablets
Prescribing Information (in new labeling format)
Patient Package Insert
|
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
- Hypersensitivity Reactions
ADVERSE REACTIONS
- Postmarketing Experience
- ...Hypersensitivity reactions include anaphylaxis, angioedema, rash, urticaria and exfoliative skin conditions including Stevens-Johnson syndrome [see Warnings and Precautions (5.13)]; upper respiratory tract infection.
PATIENT COUNSELING INFORMATION
- Instructions
- Patients should be informed that allergic reactions have been reported during postmarketing use of sitagliptin, one of the components of Janumet...
PATIENT PACKAGE INSERT
- Do not take Janumet if you: ...have had an allergic reaction to Janumet or sitagliptin (Januvia), one of the components of Janumet.
- What should I tell my doctor before and during treatment with Janumet?
- What are the possible side effects of Janumet?
- Allergic reactions, which may be serious...
- Upper respiratory infection
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CONTRAINDICATIONS
Janumet (sitagliptin/metformin HCl) is contraindicated in patients with:
- History of a serious hypersensitivity reaction to Janumet or sitagliptin, (one of the components of Janumet), such as anaphylaxis or angioedema. [See Warnings and Precautions (5.13) and Adverse Reactions (6.2).]
WARNINGS AND PRECAUTIONS: Hypersensitivity Reactions
There have been postmarketing reports of serious hypersensitivity reactions in patients treated with sitagliptin, one of the components of Janumet. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome...
...Onset of these reactions occurred within the first 3 months after initiation of treatment with sitagliptin, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue Janumet, assess for other potential causes for the event, and institute alternative treatment for diabetes. [See Adverse Reactions (6.2).] |
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Mycamine (micafungin sodium) For Injection
Prescribing Information (in new labeling format)
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CONTRAINDICATIONS
ADVERSE REACTIONS
- Clinical Trials Experience
- Candidemia and Other Candida Infections
- Esophageal Candidiasis
- Prophylaxis of Candida Infections in Hematopoietic Stem Cell Transplant Recipients
- Overall Mycamine Safety Experience in Clinical Trials
- Blood and Lymphatic System Disorders
- Gastrointestinal Disorders
- Table 5
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
- Geriatric Use
- Race and Gender
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CONTRAINDICATIONS
Mycamine is contraindicated in persons with known hypersensitivity to micafungin, any component of Mycamine, or other echinocandins. |
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Omnitrope [somatropin (rDNA origin) injection] For Subcutaneous Use
Prescribing Information (in new labeling format)
Patient Package Insert |
CONTRAINDICATIONS
- Acute Critical Illness
- Prader-Willi Syndrome in Children
- Active Malignancy
- Diabetic Retinopathy
- Hypersensitivity
- Benzyl Alcohol Sensitivity
WARNINGS AND PRECAUTIONS
- Acute Critical Illness
- Neoplasms
- Glucose Intolerance
- Intracranial Hypertension (IH)
- Fluid Retention
- Hypothyroidism
- Slipped Capital Femoral Epiphysis in Pediatric Patients
- Local and Systemic Reactions
- Laboratory Tests
ADVERSE REACTIONS
- Most Serious and/or Most Frequently Observed Adverse Reactions
- Clinical Trials Experience
- Clinical Trials in Pediatric GHD Patients
- Postmarketing Surveillance
DRUG INTERACTIONS
- Inhibition of 11ß-Hydroxysteroid Dehydrogenase Type 1 (11ßHSD-1)
- Glucocorticoid Replacement
- Cytochrome P450-Metabolized Drugs
- Oral Estrogen
- Insulin and/or Oral Hypoglycemic Agents
USE IN SPECIFIC POPULATIONS
PATIENT COUNSELING INFORMATION
- If patients are prescribed Omnitrope Cartridge 5 mg/1.5 mL (to be inserted into Omnitrope Pen 5 delivery systems)...
PATIENT PACKAGE INSERT
- Instructions for Use: Omnitrope Pen 5 (new)
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CONTRAINDICATIONS
See highlighted text for labeling revisions.
WARNINGS AND PRECAUTIONS
See highlighted text for labeling revisions. |
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Tysabri (natalizumab) Injection For Intravenous Use
Prescribing Information (in new labeling format)
Medication Guide
|
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
- Progressive Multifocal Leukoencephalopathy (PML)
- Distribution Program for Tysabri
- Hypersensitivity/Antibody Formation
- Immunosuppression/Infections
- Hepatotoxicity
ADVERSE REACTIONS
- Clinical Trials Experience
- Initial Section
- Multiple Sclerosis Clinical Studies
- Crohn's Disease Clinical Studies
- Infections
- Infusion-related Reactions
- Immunogenicity
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
PATIENT COUNSELING INFORMATION
- General Counseling Information
- Progressive Multifocal Leukoencephalopathy
- Immunosuppression/Infections
- Hepatotoxicity
MEDICATION GUIDE |
CONTRAINDICATIONS
Tysabri should not be administered to a patient who has had a hypersensitivity reaction to Tysabri. Observed reactions range from urticara to anaphylaxis [see Warnings and Precautions (5.3)].
WARNINGS AND PRECAUTIONS
See highlighted text for labeling revisions. |
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WelChol (colesevelam hydrochloride) Tablets
Prescribing Information (in new labeling format)
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CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
- General
- Serum Triglycerides (TG)
- Drug Interactions
ADVERSE REACTIONS
- Clinical Studies Experience
- Type 2 Diabetes Mellitus
- Table 2
- Hypertriglyceridemia
- Cardiovascular Adverse Events
- Hypoglycemia
USE IN SPECIFIC POPULATIONS
- Geriatric Use
- Renal Impairment
PATIENT COUNSELING INFORMATION
- Type 2 Diabetes Mellitus
- General
- Hypertriglyceridemia and Cardiovascular Disease
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CONTRAINDICATIONS
WelChol is contraindicated in patients with:
• A history of bowel obstruction
• Serum TG concentrations >500 mg/dL
• A history of hypertriglyceridemia-induced pancreatitis
WARNINGS AND PRECAUTIONS
See highlighted text for labeling revisions.
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Back to Summary Page | Back to Top
Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications
and Warnings |
Azactam (aztreonam for injection, USP)
Prescribing Information
|
WARNINGS
- Clostridium difficile associated disease (CDAD)
PRECAUTIONS
- Information for Patients
- Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic
is discontinued...
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WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Azactam, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
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Azactam (aztreonam injection) in GALAXY Plastic Container (PL 2040) For Intravenous Use
Prescribing Information
|
WARNINGS
- Clostridium difficile associated disease (CDAD)
PRECAUTIONS
- Information for Patients
- Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic
is discontinued...
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WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Azactam, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
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Chantix (varenicline) Tablets
Prescribing Information
See MedWatch Safety Alert posted 11/20/2007 for additional information on Chantix. |
WARNINGS
- Neuropsychiatric Symptoms
PRECAUTIONS
- Information for Patients (see highlighted text for new or revised labeling)
|
WARNINGS: Neuropsychiatric Symptoms
Serious neuropsychiatric symptoms have occurred in patients being treated with Chantix. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking; however, some of these symptoms have occurred in patients who continued to smoke. All patients being treated with Chantix should be observed for neuropsychiatric symptoms including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior. These symptoms, as well as worsening of pre-existing psychiatric illness, have been reported in patients attempting to quit smoking while taking Chantix in the postmarketing experience. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of Chantix and the safety and efficacy of Chantix in such patients has not been established. Patients attempting to quit smoking with Chantix and their families and caregivers should be alerted about the need to monitor for these symptoms and to report such symptoms immediately to the patient’s healthcare provider. |
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Cialis (tadalafil) Tablets
Prescribing Information (in new labeling format)
Patient Package Insert
|
WARNINGS AND PRECAUTIONS
- Potential for Drug Interactions When Taking Cialis for Once Daily Use
- Renal Insufficiency
- Cialis for Once Daily Use
- Hepatic Impairment
- Cialis for Once Daily Use
- Alcohol
- Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)
- Effects on Bleeding
ADVERSE REACTIONS
- Clinical Studies Experience
- Postmarketing Experience
- Nervous
- Seizure and Seizure Recurrence
USE IN SPECIFIC POPULATIONS
- Geriatric Use
- Hepatic Impairment
- Renal Insufficiency
PATIENT COUNSELING INFORMATION
- Potential for Drug Interactions When Taking Cialis for Once Daily Use
- Recommended Administration
PATIENT PACKAGE INSERT
- What Is The Most Important Information I Should Know About Cialis?
- What Is Cialis?
- Can Other Medicines Affect Cialis?
- How Should I Take Cialis?
- Cialis for once daily use...
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WARNINGS AND PRECAUTIONS
Potential for Drug Interactions When Taking Cialis for Once Daily Use
Physicians should be aware that Cialis for once daily use provides continuous plasma tadalafil levels and should consider this when evaluating the potential for interactions with medications (e.g., nitrates, alpha-blockers, anti-hypertensives and potent inhibitors
of CYP3A4) and with substantial consumption of alcohol...
Renal Insufficiency: Cialis for Once Daily Use
Due to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, Cialis for once daily use is not recommended in patients with severe renal insufficiency. No dose adjustment is required in patients with mild or moderate renal insufficiency [see Use in Specific Populations (8.7)].
Hepatic Impairment: Cialis for Once Daily Use
Cialis for once daily use has not been extensively evaluated in patients with mild or moderate hepatic insufficiency. Therefore, caution is advised if Cialis for once daily use is prescribed to these patients. Because of insufficient information in patients with severe hepatic impairment, use of Cialis in this group is not recommended [see Use In Specific Populations (8.6)].
See highlighted text for labeling revisions in WARNINGS AND PRECAUTIONS section.
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E.E.S. (erythromycin ethylsuccinate)
Prescribing Information
|
WARNINGS
- Clostridium difficile associated disease (CDAD)
PRECAUTIONS
- Information for Patients
- Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic
is discontinued...
|
WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all
antibacterial agents, including Ery-Ped, and may range in severity from mild diarrhea to fatal
colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile
may need to be discontinued. Appropriate fluid and electrolyte management, protein
supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be
instituted as clinically indicated. |
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Ery-Ped (erythromycin ethylsuccinate, USP)
Prescribing Information
|
WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Information for Patients
- Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic
is discontinued...
|
WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ery-Ped, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
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Humira (adalimumab) Injection, Solution For Subcutaneous Use
Prescribing Information (in new labeling format)
Medication Guide
|
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
- Immunogenicity
- Plaque Psoriasis Clinical Studies
PATIENT COUNSELING INFORMATION
MEDICATION GUIDE (new) |
WARNINGS AND PRECAUTIONS
See highlighted text for labeling revisions. |
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Lunesta (eszopiclone) Tablets
Prescribing Information
Medication Guide
|
WARNINGS
- First paragraph (second sentence changed to a bold print type):
The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.
- Second paragraph: "Complex behaviors such as "sleep-driving"...
- Severe Anaphylactic and Anaphylactoid Reactions (new subsection)
PRECAUTIONS
- SPECIAL CONCERNS “Sleep-Driving” and Other Complex Behaviors (new subsection)
MEDICATION GUIDE (new) |
WARNINGS (second paragraph)
...Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported. These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons. Although behaviors such as sleep-driving may occur with Lunesta alone at therapeutic doses, the use of alcohol and other CNS depressants with Lunesta appears to increase the risk of such behaviors, as does the use of Lunesta at doses exceeding the maximum recommended dose. Due to the risk to the patient
and the community, discontinuation of Lunesta should be strongly considered for patients who report a “sleep-driving” episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not remember these events. Amnesia and other neuropsychiatric symptoms may occur unpredictably. In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including
completed suicides), have been reported in association with the use of sedative/hypnotics.
Severe Anaphylactic and Anaphylactoid Reactions (new subsection)
Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including Lunesta...
(See highlighted label for revised text.) |
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Ortho Evra
(norelgestromin/ethinyl estradiol transdermal system)
Prescribing Information
Patient Package Insert
See MedWatch Safety Alert posted 1/19/2008 for additional information on Ortho Evra Contraceptive Transdermal Patch. |
WARNINGS
- Epidemiologic, case-control studies...
PATIENT PACKAGE INSERT: DETAILED PATIENT LABELING
- Other Considerations Before Using Ortho Evra
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WARNINGS
Epidemiologic, case-control studies were conducted in the U.S. using electronic healthcare claims data to evaluate the risk of venous thromboembolism (VTE) among
women aged 15-44 who used Ortho Evra compared to women who used oral contraceptives containing 30-35 mcg of ethinyl estradiol (EE) and either norgestimate (NGM) or levonorgestrel (LNG). NGM is the prodrug for norelgestromin, the
progestin in Ortho Evra. These studies (see Table 5) used slightly different designs and reported odds ratios ranging from 0.9 (indicating no increase in risk) to
2.4 (indicating an approximate doubling of risk). One study (i3 Ingenix) included patient chart review to confirm the VTE occurrence... |
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PCE (erythromycin particles in tablets) Dispertab Tablets
Prescribing Information |
WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Information for Patients
- Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic
is discontinued...
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WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including PCE, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
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Rapamune (sirolimus) Oral Solution and Tablets
Prescribing Information (in new labeling format) |
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
- Conversion from Calcineurin Inhibitors to Rapamune in Maintenance Renal
Transplant Population
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WARNINGS AND PRECAUTIONS
Proteinuria
...Patients with the greatest amount of urinary protein excretion prior to Rapamune conversion were those whose protein excretion increased the most after conversion. New onset nephrosis (nephrotic syndrome) was also reported as a treatment emergent adverse event in 2.2% of the Rapamune conversion group patients in comparison to 0.4% in the CNI continuation group of patients... |
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Brand
(Generic) Name
|
Sections Modified |
Byetta (exenatide) injection
Prescribing Information
Patient Package Insert
See MedWatch Safety Alerts posted 10/16/2007 and 2/27/2008 for additional information on Byetta.
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PRECAUTIONS
- General
- Postmarketing cases of acute pancreatitis have been reported...
- Information for Patients
- Patients should be informed that persistent severe abdominal pain, which may be accompanied by vomiting, is the hallmark symptom of acute pancreatitis...
PATIENT PACKAGE INSERT
- What are the possible side effects of Byetta?
- ...Talk to your healthcare provider if you experience the following severe and persistent symptoms, alone or in combination, because they could be signs of a serious medical condition: abdominal pain or vomiting.
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Cipro I.V. (ciprofloxacin) For Intravenous Infusion
Prescribing Information |
PRECAUTIONS
- Photosensitivity/Phototoxicity
- Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions...
- Information for Patients
- Patients should be advised: that photosensitivity/phototoxicity has been reported in patients receiving quinolones...
ADVERSE REACTIONS
- Skin/Hypersensitivity
- Photosensitivity/Phototoxicity Reaction
- Postmarketing Adverse Events
- Photosensitivity/Phototoxicity Reaction
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Cipro (ciprofloxacin hydrochloride) Tablets
Cipro (ciprofloxacin) Oral Suspension
Prescribing Information
Patient Package Insert
|
PRECAUTIONS
- Photosensitivity/Phototoxicity
- Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions...
- Information for Patients
- Patients should be advised: that photosensitivity/phototoxicity has been reported in patients receiving quinolones...
ADVERSE REACTIONS
- Skin/Hypersensitivity
- Photosensitivity/Phototoxicity Reaction
- Postmarketing Adverse Events
- Photosensitivity/Phototoxicity Reaction
PATIENT PACKAGE INSERT
- What are the possible side effects of Cipro?
- Sun sensitivity (photosensitivity), which can appear as skin eruption or severe sunburn, can occur in some patients taking quinolone antibiotics after exposure to sunlight or artificial ultraviolet (UV) light (e.g., tanning beds). Cipro has been infrequently associated with photosensitivity...
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Cipro XR (ciprofloxacin extended-release tablets)
Prescribing Information
Patient Package Insert |
PRECAUTIONS
- Photosensitivity/Phototoxicity
- Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions...
- Information for Patients
- Patients should be advised: that photosensitivity/phototoxicity has been reported in patients receiving quinolones...
ADVERSE REACTIONS
- Skin/Hypersensitivity
- Photosensitivity/Phototoxicity Reactions
- Postmarketing Adverse Experience
- Photosensitivity/Phototoxicity Reaction
PATIENT PACKAGE INSERT
- What are the possible side effects of Cipro XR?
- Sun sensitivity (photosensitivity), which can appear as skin eruption or severe sunburn, can occur in some patients taking quinolone antibiotics after exposure to sunlight or artificial ultraviolet (UV) light (e.g., tanning beds). Cipro XR has been infrequently associated with photosensitivity...
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Effexor (venlafaxine hydrochloride) Tablets
Contact Wyeth Pharmaceuticals, Inc. at 1-800-934-5556 for current prescribing information.
|
PRECAUTIONS
- Drug Interactions
- Drugs that Inhibit Cytochrome P450 Isoenzymes
Ketoconazole: A pharmacokinetic study with ketoconazole 100 mg b.i.d. with a single dose of venlafaxine 50 mg in extensive metabolizers (EM; n = 14) and 25 mg in poor metabolizers (PM; n = 6) of CYP2D6 resulted in higher plasma concentrations of both venlafaxine and O-desmethylvenlafaxine (ODV) in most subjects following administration of ketoconazole. Venlafaxine Cmax increased by 26% in EM subjects and 48% in PM subjects. Cmax values for ODV increased by 14% and 29% in EM and PM subjects, respectively.
Venlafaxine AUC increased by 21% in EM subjects and 70% in PM subjects (range in PMs - 2% to 206%), and AUC values for ODV increased by 23% and 33% in EM and PM (range in PMs - 38% to 105%) subjects, respectively. Combined AUCs of venlafaxine and ODV increased on average by approximately 23% in EMs and 53% in PMs, (range in PMs 4% - 134%).
Concomitant use of CYP3A4 inhibitors and venlafaxine may increase levels of venlafaxine and ODV. Therefore, caution is advised if a patient’s therapy includes a CYP3A4 inhibitor and venlafaxine concomitantly. |
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Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules
Contact Wyeth Pharmaceuticals, Inc. at 1-800-934-5556 for current prescribing information. |
PRECAUTIONS
- Drug Interactions
- Drugs that Inhibit Cytochrome P450 Isoenzymes
Ketoconazole: A pharmacokinetic study with ketoconazole 100 mg b.i.d. with a single dose of venlafaxine 50 mg in extensive metabolizers (EM; n = 14) and 25 mg in poor metabolizers (PM; n = 6) of CYP2D6 resulted in higher plasma concentrations of both venlafaxine and O-desmethylvenlafaxine (ODV) in most subjects following administration of ketoconazole. Venlafaxine Cmax increased by 26% in EM subjects and 48% in PM subjects. Cmax values for ODV increased by 14% and 29% in EM and PM subjects, respectively.
Venlafaxine AUC increased by 21% in EM subjects and 70% in PM subjects (range in PMs - 2% to 206%), and AUC values for ODV increased by 23% and 33% in EM and PM (range in PMs - 38% to 105%) subjects, respectively. Combined AUCs of venlafaxine and ODV increased on average by approximately 23% in EMs and 53% in PMs, (range in PMs 4% - 134%).
Concomitant use of CYP3A4 inhibitors and venlafaxine may increase levels of venlafaxine and ODV. Therefore, caution is advised if a patient’s therapy includes a CYP3A4 inhibitor and venlafaxine concomitantly. |
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Flumadine (rimantadine) Tablets and Syrup
Prescribing Information |
PRECAUTIONS
- Drug Interactions
- Live Attenuated Influenza Vaccine (LAIV)
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Inderide (propranolol hydrochloride [Inderal]
and hydrochlorothiazide) Tablets
Prescribing Information
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PRECAUTIONS
- Drug/Drug Interactions
- Propranolol hydrochloride (Inderal)
- Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
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InnoPran XL (propranolol hydrochloride) Extended Release Capsules
Prescribing Information
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PRECAUTIONS
- Drug Interactions
- Digitalis Glycosides
- Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
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Lopressor (metoprolol tartrate tablets, USP)
Lopressor (metoprolol tartrate injection, USP)
Prescribing Information
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PRECAUTIONS
- Drug Interactions
- Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
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Lopressor HCT (metoprolol tartrate USP and hydrochlorothiazide USP) Tablets
Prescribing Information
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PRECAUTIONS
- Drug/Drug Interactions
- Lopressor
- Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease
heart rate. Concomitant use can increase the risk of bradycardia.
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Seroquel (quetiapine fumarate) Tablets
Prescribing Information
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PRECAUTIONS
- Leukopenia, Neutropenia and Agranulocytosis
- Information for Patients
- Laboratory Tests
ADVERSE REACTIONS
- Vital Signs and Laboratory Studies
- In postmarketing clinical trials, elevations in total cholesterol (predominantly LDL cholesterol) have been observed.
- Postmarketing Experience
- Cardiomyopathy
- Myocarditis
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Sular (nisoldipine) Extended Release Tablets [in new Geomatrix Formulation]
Prescribing Information |
PRECAUTIONS
- Information for Patients
- ...Sular should be taken on an empty stomach (1 hour before or 2 hours after a meal)...
- This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions...
- Drug Interactions
- CYP3A4 Inhibitors and Inducers
- See highlighted label for revised text.
ADVERSE REACTIONS
- See highlighted label for revised text.
- See Adverse Event Table with Sular, dose bioequivalent to...
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Tamiflu (oseltamivir phosphate) Capsules and For Oral Suspension
Prescribing Information
Patient Package Insert
See MedWatch Safety Alert posted 3/04/2008 for additional information on Tamiflu. |
PRECAUTIONS
- Hepatic Impairment
- Neuropsychiatric Events
- Drug Interactions
- ...No pharmacokinetic interactions have been observed when coadministering oseltamivir with amoxicillin, acetaminophen, cimetidine or with antacids (magnesium and aluminum hydroxides and calcium carbonates).
ADVERSE REACTIONS
- Observed During Clinical Practice
- Gastrointestinal Disorders
- Gastrointestinal Bleeding
- Hemorrhagic Colitis
- Psychiatric
- Delirium, including symptoms such as altered level of consciousness, confusion, abnormal behavior, delusions, hallucinations, agitation, anxiety, nightmares...
PATIENT PACKAGE INSERT
- What are the possible side effects of Tamiflu?
- People with the flu, particularly children and adolescents, may be at an increased risk of seizures, confusion, or abnormal behavior early during their illness. These events may occur shortly after beginning Tamiflu or may occur when flu is not treated. These events are uncommon but may result in accidental injury to the patient. Therefore, patients should be observed for signs of unusual behavior and a healthcare professional should be contacted immediately if the patient shows any signs of unusual behavior.
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Triglide (fenofibrate) Tablets
Contact Sciele Pharma, Inc. at 1-800-461-3696 for current prescribing information. |
PRECAUTIONS
- Information for Patients
- Store tablets only in the moisture protective container
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Brand
(Generic) Name
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Sections Modified |
Celebrex (celecoxib) Capsules
Prescribing Information
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ADVERSE REACTIONS
- Adverse reactions from long-term, placebo-controlled polyp prevention studies...
- Some adverse reactions occurred in higher percentages of patients than in the arthritis pre-marketing trials (treatment durations up to 12 weeks...
- The following additional adverse reactions occurred in ≥0.1% and <1% of patients taking Celebrex...
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Climara (estradiol transdermal system)
Prescribing Information
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ADVERSE REACTIONS
- Postmarketing Experience
- The following adverse reactions have been identified during post
approval use of Climara: a few cases in which there were a combination of the symptoms of
generalized hives or rash with swelling of the throat or eyelid edema. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably
estimate their frequency or establish a causal relationship to drug exposure.
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Lotrisone (clotrimazole and betamethasone dipropionate) Cream and Lotion
Prescribing Information
Patient Package Insert
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ADVERSE REACTIONS
- The following local adverse reactions have been reported with topical corticosteroids
and may occur more frequently with the use of occlusive dressings...
- ...capillary fragility (ecchymoses), and sensitization (local reactions upon repeated application of product)...
PATIENT PACKAGE INSERT
- What are the possible side effects of Lotrisone Cream and Lotion?
- ...fragile blood vessels, sensitization (local reactions upon repeated application of product)...
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Brand (Generic) Name
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Sections Modified |
Avandia (rosiglitazone maleate) Tablets
Prescribing Information (in new labeling format)
Patient Package Insert
See MedWatch Safety Alert posted 2/26/2008 for new Avandia Medication Guide. |
PATIENT PACKAGE INSERT
- What is Avandia?
- ...Avandia has not been studied enough in children under 18 years of age to know if it is safe or effective in children.
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Nexium (esomeprazole magnesium) Delayed-Release Capsules
Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension
Patient Package Insert |
PATIENT PACKAGE INSERT (new)
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Tolectin DS (tolmetin sodium) Capsules
Tolectin 600 (tolmetin sodium) Tablets
For Oral Administration
Medication Guide
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MEDICATION GUIDE
- NSAID medicines that need a prescription
- Ibuprofen
(generic name)
- Vicoprofen (tradename) [see footnote]
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