What the FDA changed in 2013

Dosage and administration

1 entry reworded without a change of meaning.

Contraindications

Added in this revision

• +Added: ALDACTONE is contraindicated for patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, hyperkalemia, Addison's disease or other conditions associated with hyperkalemia, and with concomitant use of eplerenone.

Removed in this revision

• -Removed: ALDACTONE is contraindicated for patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, or hyperkalemia.

Warnings

Added in this revision

• +Added: Concomitant administration of ALDACTONE with the following drugs or potassium sources may lead to severe hyperkalemia: other potassium-sparing diuretics ACE inhibitors angiotensin II antagonists aldosterone blockers non-steroidal anti-inflammatory drugs (NSAIDs), e.g., indomethacin heparin and low molecular weight heparin other drugs known to cause hyperkalemia potassium supplements diet rich in potassium salt substitutes containing potassium ALDACTONE should not be administered concurrently...

Removed in this revision

• -Removed: ALDACTONE should not be administered concurrently with other potassium-sparing diuretics.

Adverse reactions

Added in this revision

• +Added: Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia.
• +Added: Metabolism: Hyperkalemia, electrolyte disturbances (see Warnings and Precautions).
• +Added: Musculoskeletal: Leg cramps.
• +Added: Nervous system /psychiatric: Lethargy, mental confusion, ataxia, dizziness, headache, drowsiness.

Removed in this revision

• -Removed: Hematologic: Agranulocytosis.
• -Removed: Metabolism: Hyperkalemia (see Warnings and Precautions).
• -Removed: Nervous system /psychiatric: Mental confusion, ataxia, headache, drowsiness, lethargy.

2 entries reworded without a change of meaning.

Drug interactions

Added in this revision

• +Added: Angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparin, and other drugs known to cause hyperkalemia Concomitant administration may lead to severe hyperkalemia.
• +Added: Cholestyramine Hyperkalemic metabolic acidosis has been reported in patients given ALDACTONE concurrently with cholestyramine.

Adverse reactions

Removed in this revision

• -Removed: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• -Removed: Adverse Reactions in Clinical Trials of ORACEA: In controlled clinical trials of adult subjects with mild to moderate rosacea, 537 subjects received ORACEA or placebo over a 16-week period.
• -Removed: The following table summarizes selected adverse reactions that occurred in the clinical trials at a rate of > 1% for the active arm: Note: Percentages based on total number of study participants in each treatment group.
• -Removed: Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines at higher, antimicrobial doses: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region.
• -Removed: Hepatotoxicity has been reported rarely.
• -Removed: Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline-class.
• -Removed: Most of the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down.
• -Removed: Skin: maculopapular and erythematous rashes.
• -Removed: Exfoliative dermatitis has been reported but is uncommon.
• -Removed: Photosensitivity is discussed above.
• -Removed: Renal toxicity: Rise in BUN has been reported and is apparently dose-related.
• -Removed: Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.
• -Removed: Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

Approved uses

Added in this revision

• +Added: Victoza is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise.
• +Added: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza.
• +Added: Victoza has not been studied in patients with a history of pancreatitis.
• +Added: It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza.
• +Added: Other antidiabetic therapies should be considered in patients with a history of pancreatitis.
• +Added: Victoza is not a substitute for insulin.
• +Added: The concurrent use of Victoza and prandial insulin has not been studied.

Removed in this revision

• -Removed: Victoza is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. • In clinical trials of Victoza, there were more cases of pancreatitis with Victoza than with comparators.
• -Removed: Victoza has not been studied sufficiently in patients with a history of pancreatitis to determine whether these patients are at increased risk for pancreatitis while using Victoza.
• -Removed: Use with caution in patients with a history of pancreatitis. • Victoza is not a substitute for insulin.

1 entry reworded without a change of meaning.

Warnings and precautions

Added in this revision

• +Added: Pancreatitis Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza.
• +Added: If pancreatitis is suspected, Victoza should promptly be discontinued and appropriate management should be initiated.
• +Added: Consider antidiabetic therapies other than Victoza in patients with a history of pancreatitis.

Removed in this revision

• -Removed: There are no conclusive data establishing a risk of pancreatitis with Victoza treatment.
• -Removed: If pancreatitis is suspected, Victoza and other potentially suspect medications should be discontinued promptly, confirmatory tests should be performed and appropriate management should be initiated.
• -Removed: Use with caution in patients with a history of pancreatitis.

2 entries reworded without a change of meaning.

Adverse reactions

1 entry reworded without a change of meaning.

Forms and strengths

1 entry reworded without a change of meaning.

Warnings and precautions

Added in this revision

• +Added: Pseudomembranous Colitis Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including doxycycline, and may range in severity from mild to fatal colitis.
• +Added: Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
• +Added: C. difficile produces toxins A and B which contribute to the development of CDAD.
• +Added: Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
• +Added: CDAD must be considered in all patients who present with diarrhea following antibiotic use.
• +Added: Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
• +Added: If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
• +Added: Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Removed in this revision

• -Removed: Pseudomembranous Colitis Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening.
• -Removed: Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
• -Removed: Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia.
• -Removed: Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated colitis".
• -Removed: If a diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated.
• -Removed: Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone.
• -Removed: In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.

2 entries reworded without a change of meaning.