The detailed view includes drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections. The prescribing information may be accessed by clicking on the drug name.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Alora (estradiol transdermal system)

(click product name to read prescribing information)

BOXED WARNING

• Cardiovascular and Other Risks

WARNINGS

• Cardiovascular Disorders
  • Coronary Heart Disease and Stroke
  • Venous Thromboembolism (VTE)

PRECAUTIONS

• General
  • Hypertriglyceridemia
  • Ovarian cancer
• Drug/Laboratory Test Interactions
• Geriatric Use

ADVERSE REACTIONS

• Gastrointestinal

  • Enlargement of Hepatic Hemangiomas

     

CONTRAINDICATIONS

Alora should not be used in individuals with any of the following conditions:

• Liver dysfunction or disease.

• Alora should not be used in patients with known hypersensitivity to its ingredients.

• Known or suspected pregnancy. There is no indication for Alora in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.

BOXED WARNING

Arixtra (fondaparinux sodium) injection

(click product name to read prescribing information)

WARNINGS

• Abdominal Surgery
• Thrombocytopenia

PRECAUTIONS

• General
• Geriatric Use

ADVERSE REACTIONS

• Abdominal Surgery
• Table 10
• Table 13

Arixtra prophylactic therapy is contraindicated in patients with body weight <50 kg undergoing hip fracture, hip replacement or knee replacement surgery, and abdominal surgery. During the randomized clinical trials of prophylaxis in the peri-operative period following hip fracture, hip replacement, or knee replacement surgery, occurrence of major bleeding was doubled in patients with a body weight <50 kg compared with those with a body weight ≥50 kg (5.4% versus 2.1%). In the clinical trial in patients undergoing abdominal surgery, the major bleeding rate was also higher in patients with a body weight <50 kg as compared to those with a body weight ≥50 kg (5.3% versus 3.3%), respectively.

WARNINGS

Abdominal Surgery

Major bleeding in patients receiving prophylactic therapy in abdominal surgery occurred in 2.1% (13/606) of patients with normal renal function, in 3.6% (22/613) with mild renal impairment, in 6.7% (12/179) with moderate renal impairment, and in 7.1% (1/14) with severe renal impairment. When Arixtra was used according to the recommended timing of the first injection (6 to 8 hours after surgery), major bleeding occurred in 2.1% (10/467) of patients with normal renal function, in 3.3% (16/481) with mild renal impairment, in 5.8% (8/137) with moderate renal impairment, and in 7.7% (1/13) with severe renal impairment.

Thrombocytopenia can occur with the administration of Arixtra. Moderate thrombocytopenia (platelet counts between 100,000/mm3 and 50,000/mm3) occurred at a rate of 3.0% in patients given Arixtra 2.5 mg in the peri-operative hip fracture, hip replacement or knee replacement surgery and abdominal surgery clinical trials.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Atacand (candesartan cilexetil) Tablets

(click product name to read prescribing information)

• Hypotension in Heart Failure Patients

PRECAUTIONS

• General
  • Impaired Renal Function
  • Drug Interactions
• Geriatric Use
  • Heart Failure

ADVERSE REACTIONS

• Heart Failure

Caution should be observed when initiating therapy in patients with heart failure. Patients with heart failure given Atacand commonly have some reduction in blood pressure. In patients with symptomatic hypotension this may require temporarily reducing the dose of Atacand, or diuretic, or both, and volume repletion. In the CHARM program, hypotension was reported in 18.8% of patients on candesartan versus 9.8% of patients on placebo. The incidence of hypotension leading to drug discontinuation in candesartan-treated patients was 4.1% compared with 2.0% in placebo-treated patients. Monitoring of blood pressure is recommended during dose escalation and periodically thereafter.

Cefuroxime for Injection USP and Dextrose Injection USP

(click product name to read prescribing information)

PRECAUTIONS

• Carcinogenesis, Mutagenesis, Impairment of Fertility
• Pregnancy
• Geriatric Use

.....When the colitis is not relieved by drug discontinuation or when it is severe, oral vancomycin is the treatment of choice for antibiotic-associated pseudomembranous colitis produced by Clostridium difficile. Other causes of colitis should also be considered.

Clozaril (clozapine) Tablets

(click product name to read prescribing information)

Lodine (etodolac capsules and tablets)

(click product name to read prescribing information)

 WARNINGS

• Gastrointestinal (GI) Effects-Risk of GI Ulceration, Bleeding, and Perforation

• Advanced Renal Disease

PRECAUTIONS

• General
• Hepatic Effects
• Renal Effects
• Hematological Effects
• Fluid Retention and Edema
• Information for Patients
• Laboratory Tests
• Drug Interactions
  • ACE-inhibitors
  • Diuretics
  • Glyburide
  • Lithium
  • Phenytoin
  • Warfarin
• Pregnancy
• Labor and Delivery
• Pediatric Use
• Geriatric Use

ADVERSE REACTIONS

• Initial Paragraph
  • Gastrointestinal experiences including
  • Other events including
• Additional Adverse Reactions Reported with NSAIDS
  • Body As a Whole
  • Cardiovascular System
  • Digestive System
  • Hemic and Lymphatic System
  • Nervous System
  • Respiratory System
  • Urogenital System

Gastrointestinal (GI) Effects-Risk of GI Ulceration, Bleeding, and Perforation

Serious GI toxicity, such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, can occur at any time, with or without warning symptoms, in patients treated chronically with NSAIDs.

NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Most spontaneous reports of fatal GI events are in elderly or debilitated patients, and therefore, special care should be taken in treating this population. To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.

Studies have shown that patients with a prior history of peptic ulcer disease, and/or gastrointestinal bleeding, and who use NSAIDs have a greater than 10-fold risk for developing a GI bleed than patients with neither of these risk factors. In addition to a past history of ulcer disease, pharmacoepidemiological studies have identified several other co-therapies or co-morbid conditions that may increase the risk for GI bleeding such as: treatment with oral corticosteroids, treatment with anticoagulants, longer duration of NSAID therapy, smoking, alcoholism, older age, and poor general health status.

In cases with advanced kidney disease, treatment with Lodine is not recommended. However, if NSAID therapy must be initiated, close monitoring of the patient's kidney function is advisable.

Over-the-Counter (OTC) Medication

(click product name to read prescribing information)

• Ask a Doctor or Pharmacist Before Use If You Are
• Under a doctor's care for any serious condition
• Taking Any Other Drug

• Stop Use and Ask a Doctor If

  • Pain Gets Worse Or Last More Than 10 Days

  • Stomach Pain Occurs or Lasts, Even if Symptoms are Mild

  • Redness or Swelling is Present in the Painful Area

  • Any New Symptoms Appear

DIRECTIONS

• Take 1 caplet Every 8 to12 hours While Symptoms Last
• Do Not Exceed  2 caplets in Any 8-12 hours or 3 caplets in 24-hour Period

(click product name to read prescribing information)

• Autoimmune Disorders
  • Thrombotic Thrombocytopenic Purpura

ADVERSE REACTIONS

• Thrombotic Thrombocytopenic Purpura
• ALT Elevations
  • Chronic Hepatitis B

Development or exacerbation of autoimmune disorders including myositis, hepatitis thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, psoriasis rheumatoid arthritis, interstitial nephritis, thyroiditis, and systemic lupus erythematosus have been reported in patients receiving alpha interferon. Pegasys should be used with caution in patients with autoimmune disorders.

Requip (ropinirole hydrochloride) Tablets

(click product name to read prescribing information)

• Falling Asleep During Activities of Daily Living
• Syncope
• Symptomatic Hypotension
• Hallucinations

PRECAUTIONS

• Augmentation and Rebound in RLS
• Information for Patients

ADVERSE REACTIONS

• Restless Leg Syndrome
  • Adverse Event Incidence in Controlled Clinical Studies
  • Table 4
• Other Adverse Events Observed During Phase 2/3 Clinical Trials for RLS

.....In controlled clinical trials, somnolence was a common occurrence in patients receiving Requip and is more frequent in Parkinson's disease (up to 40% Requip, 6% placebo) than in Restless Legs Syndrome (12% Requip, 6% placebo).....

Syncope

Tagamet HB (200mg cimitidine) Tablets

Over-the-Counter (OTC) Medication

(click product name to read prescribing information)

(click product name to read prescribing information)

• Head and Neck Angioedema
• Hepatic Failure

(click product name to read prescribing information)

• Head and Neck Angioedema
• Hepatic Failure

Head and Neck Angioedema

Even in those instances where swelling of only the tongue is involved, without respiratory distress, patients may require prolonged observation since treatment with antihistamines and corticosteroids may not be sufficient. Very rarely, fatalities have been reported due to angioedema associated with laryngeal edema or tongue edema. Patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially those with a history of airway surgery.

Hepatic Failure

Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant hepatic necrosis and (sometimes) death.

Zocor (simvastatin) Tablets

(click product name to read prescribing information)

• Myopathy/Rhabdomyolysis
  • Potent Inhibitors of CYP3A4
    • Telithromycin
  • Other Drugs
    • Danazol

PRECAUTIONS

• Drug Interactions
  • CYP3A4 Interactions
    • Telithromycin
  • Other Drug Interaction
    • Danazol
    • Amiodarone or Verapamil

• Potent Inhibitors of CYP3A4 - (the drug Telithromycin added to the list)
• Danazol particularly with higher doses of simvastatin

Use of simvastatin concomitantly with itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or large quantities of grapefruit juice (>1 quart daily) should be avoided.

The dose of simvastatin should not exceed 10 mg daily in patients receiving concomitant medication with cyclosporine and danazol. The benefits of the use of simvastatin in patients receiving cyclosporine or danazol should be carefully weighed against the risks of these combinations.

0.45% Sodium Chloride Injection

0.9% Sodium Chloride Injection

(click product name to read prescribing information)

• Geriatric Use

Actonel (risedronate sodium) Tablets

(click product name to read prescribing information)

• Pregnancy

ADVERSE REACTIONS

• Postmarketing Experience
  • Very Rare Hypersensitivity and Skin Reactions, Including Angioedema, Generalized Rash and Bullous Skin Reactions, Some Severe

PATIENT PACKAGE INSERT

Cefazolin for Injection USP and Dextrose Injection USP

(click product name to read prescribing information)

• Pregnancy - Teratogenic Effects
• Pediatric Use
• Geriatric Use

ADVERSE REACTIONS

• Hepatic
• Renal

Cipro (ciprofloxacin hydrochloride) Tablets

Cipro (ciprofloxacin) Oral Suspension

(click product name to read prescribing information)

• Information for Patients

• Drug Interactions

ADVERSE REACTIONS

• Post-Marketing Adverse Events

  • Anaphylactic reactions (including life-threatening anaphylactic shock)

  • Toxic Epidermal Necrolysis (Lyell's Syndrome)

Cipro XR (ciprofloxacin extended-release tablets)

(click product name to read prescribing information)

• Information for Patients

• Drug Interactions

ADVERSE REACTIONS

• Anaphylactic reactions (including life-threatening anaphylactic shock)

• Toxic Epidermal Necrolysis (Lyell's Syndrome)

Doryx (doxycycline hyclate) Delayed-Release Capsules

(click product name to read prescribing information)

• General
• Information for Patients
• Geriatric Use

DynaCirc (isradipine) Capsules 

(click product name to read prescribing information)

• Geriatric Use

ADVERSE REACTIONS

• Skin
  • Angioedema

Dynacirc CR (isradipine) Controlled-Release Tablets

(click product name to read prescribing information)

• Geriatric Use

ADVERSE REACTIONS

• Skin
  • Angioedema

Gleevec (imatinib mesylate) Tablets

(click product name to read prescribing information)

• Carcinogenesis, Mutagenesis, Impairment of Fertility

(click product name to read prescribing information)

• Pediatric Use

ADVERSE REACTIONS

• Pediatric Patients
• Adverse Laboratory Changes
  • Pediatric Patients

Leukeran (chlorambucil) Tablets

(click product name to read prescribing information)

• General

  • Administration of live vaccines to immunocompromised patients should be avoided

(click product name to read prescribing information)

• Alpha-Blockers

(click product name to read prescribing information)

• Information for Patients
• Drug Interactions
  • Warfarin
• Geriatric Use

ADVERSE REACTIONS

• Additional NSAID Adverse Experiences Reported Occasionally with NSAIDS or Lodine XL Include

  • Body as a Whole

    • Anaphylactic/Anaphylactoid reactions (including shock)

  • Respiratory System

    • Pulmonary Infiltration with Eosinophilia

(click product name to read prescribing information)

• Hepatic Impairment
• Renal Impairment
• Drug-Drug Interactions

Ortho-Cyclen (norgestimate/ethinyl estradiol) Tablets

(click product name to read prescribing information)

• Pediatric Use

(click product name to read prescribing information)

• Geriatric Use

(click product name to read prescribing information)

PRECAUTIONS

• Geriatric Use

(click product name to read prescribing information)

• Geriatric Use

(click product name to read prescribing information)

• Drug Interactions
• Geriatric Use

ADVERSE REACTIONS

• Initial Paragraph
• Hepatotoxicity
• Other Adverse Reactions
  • Initial Paragraph

Reminyl (galantamine hydrobromide) Tablets, Oral Solution and Extended-Release Capsules

(click product name to read prescribing information)

• Deaths in Subjects with Mild Cognitive Impairment (MCI)

For additional details, see MedWatch 04/01/2005 Safety Alert 

Strattera (atomoxetine hydrochloride) Capsules

(click product name to read prescribing information)

• General
  • Effects on Growth

Please contact GE Healthcare at 1-800-437-1171 for prescribing information.

• Geriatric Use

Clinical studies of Thallous Chloride TI 201 did not include sufficient numbers of subject aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

(click product name to read prescribing information)

• Bone Effects

ADVERSE REACTIONS

• Treatment-Naïve Patients
  • Treatment-Emergent Adverse Events

• Patients with Moderate or Severe Renal Insufficiency

(click product name to read prescribing information)

• Peripheral and Optic Neuropathy
  

ADVERSE REACTIONS

• Postmarketing Experience
  • Peripheral Neuropathy and Optic Neuropathy

Casodex (bicalutamide) Tablets

(click product name to read prescribing information)

• Postmarketing Experience
  • Hypersensitivity Reactions
  • Interstitial Lung Disease

Cipro (ciprofloxacin) I.V. for Intravenous Infusion

(click product name to read prescribing information)

• Adverse Reactions in Adult Patients
  • Skin/Hypersensitivity
    • Life-threatening Anaphylactic Shock
• Post-Marketing Adverse Events

  • Toxic Epidermal Necrolysis (Lyell's Syndrome)

Floxin Otic (Ofloxacin Otic) Solution 0.3%

Please contact Daiichi Pharmaceutical Corporation at 1-877-324-4244  for prescribing information.

• Subjects with Otitis Externa
  • Transient Loss of Hearing

In once daily dosing studies, there were also single reports of nausea, seborrhea, transient loss of hearing, tinnitus, otitis externa, otitis media, tremor, hypertension and fungal infection.

Lidoderm (lidocaine Patch 5%)

(click product name to read prescribing information)

• Events Observed During Postmarketing Surveillance of Lidoderm

FDA/CDER/OCD/Safety Policy and Communication Staff
Web page last revised by jlw August 05, 2005