What the FDA changed in 2016

Dosage and administration

1 entry reworded without a change of meaning.

Warnings and precautions

Removed in this revision

• -Removed: Serological testing (e.g.
• -Removed: Concomitant Use of NEXIUM with St.

4 entries reworded without a change of meaning.

Drug interactions

2 entries reworded without a change of meaning.

Warnings

Added in this revision

• +Added: Warnings Allergy alert Do not use if you are allergic to famotidine or other acid reducers

Removed in this revision

• -Removed: Warnings Allergy alert

Do not use

1 entry reworded without a change of meaning.

Warnings and precautions

Added in this revision

• +Added: Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI.
• +Added: In older patients, also consider an endoscopy.
• +Added: Cutaneous and Systemic Lupus Erythematosus Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including pantoprazole.
• +Added: These events have occurred as both new onset and an exacerbation of existing autoimmune disease.
• +Added: The majority of PPI-induced lupus erythematous cases were CLE.
• +Added: The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly.
• +Added: Generally, histological findings were observed without organ involvement.
• +Added: Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs.
• +Added: PPI associated SLE is usually milder than non-drug induced SLE.
• +Added: Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly.
• +Added: The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.
• +Added: Avoid administration of PPIs for longer than medically indicated.
• +Added: If signs or symptoms consistent with CLE or SLE are noted in patients receiving PROTONIX, discontinue the drug and refer the patient to the appropriate specialist for evaluation.
• +Added: Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks.
• +Added: Serological testing (e.g.
• +Added: ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations.

Removed in this revision

• -Removed: Atrophic Gastritis Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with PROTONIX, particularly in patients who were H. pylori positive.

1 entry reworded without a change of meaning.

Adverse reactions

Added in this revision

• +Added: The following serious adverse reactions are described below and elsewhere in labeling: Acute Interstitial Nephritis Clostridium difficile- Associated Diarrhea Bone Fracture Cutaneous and Systemic Lupus Erythematosus Cyanocobalamin (Vitamin B-12) Deficiency Hypomagnesemia Clinical Trials Experience The adverse reaction profiles for PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets are similar.

Removed in this revision

• -Removed: The adverse reaction profiles for PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets are similar.

2 entries reworded without a change of meaning.

Approved uses

1 entry reworded without a change of meaning.

Dosage and administration

Added in this revision

• +Added: PREVACID is available as a capsule and as an orally disintegrating tablet (SoluTab).
• +Added: Both are available in 15 mg and 30 mg strengths.
• +Added: PREVACID capsule and SoluTab SHOULD NOT BE CRUSHED OR CHEWED.
• +Added: Important Administration Information Administration Options PREVACID Capsules - Oral Administration PREVACID capsules should be swallowed whole.
• +Added: Alternatively, for patients who have difficulty swallowing capsules, PREVACID capsules can be opened and administered as follows: Open capsule.
• +Added: PREVACID SoluTab PREVACID SoluTab should not be broken or cut.
• +Added: PREVACID SoluTab should not be chewed.
• +Added: PREVACID SoluTab - Oral Syringe For administration via oral syringe, PREVACID SoluTab can be administered as follows: Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water.
• +Added: Shake gently to allow for a quick dispersal.
• +Added: After the tablet has dispersed, administer the contents within 15 minutes.
• +Added: Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents.
• +Added: Shake gently to allow for a quick dispersal.
• +Added: After the tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes.
• +Added: Refill the syringe with approximately 5 mL of water, shake gently, and flush the nasogastric tube.

Removed in this revision

• -Removed: PREVACID is available as a capsule and an orally disintegrating tablet, and is available in 15 mg and 30 mg strengths.
• -Removed: PREVACID products SHOULD NOT BE CRUSHED OR CHEWED.
• -Removed: Important Administration Information Administration Options PREVACID Delayed-Release Capsules - Oral Administration • PREVACID Delayed-Release Capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, PREVACID Delayed-Release Capsules can be opened and administered as follows: Open capsule.;
• -Removed: Swallow immediately.;
• -Removed: PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets • PREVACID SoluTab should not be broken or cut. • PREVACID SoluTab should not be chewed.;
• -Removed: PREVACID SoluTab - Oral Syringe For administration via oral syringe, PREVACID SoluTab can be administered as follows: • Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water. • Shake gently to allow for a quick dispersal. • After the tablet has dispersed, administer the contents within 15 minutes. • Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any...

4 entries reworded without a change of meaning.

Contraindications

2 entries reworded without a change of meaning.

Warnings and precautions

Added in this revision

• +Added: Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI.
• +Added: In older patients, also consider an endoscopy.
• +Added: Cutaneous and Systemic Lupus Erythematosus Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including lansoprazole.
• +Added: These events have occurred as both new onset and an exacerbation of existing autoimmune disease.
• +Added: The majority of PPI-induced lupus erythematosus cases were CLE.
• +Added: The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly.
• +Added: Generally, histological findings were observed without organ involvement.
• +Added: Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs.
• +Added: PPI associated SLE is usually milder than non-drug induced SLE.
• +Added: Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly.
• +Added: The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.
• +Added: Avoid administration of PPIs for longer than medically indicated.
• +Added: If signs or symptoms consistent with CLE or SLE are noted in patients receiving PREVACID, discontinue the drug and refer the patient to the appropriate specialist for evaluation.
• +Added: Most patients improve with discontinuation of the PPI alone in four to 12 weeks.
• +Added: Serological testing (e.g., ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations.

3 entries reworded without a change of meaning.

Adverse reactions

Added in this revision

• +Added: The following serious adverse reactions are described below and elsewhere in labeling: Acute Interstitial Nephritis Clostridium difficile -Associated Diarrhea Bone Fracture Cutaneous and Systemic Lupus Erythematosus Cyanocobalamin (Vitamin B-12) Deficiency Hypomagnesemia Clinical Trials Experience 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...

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 clinical practice.

5 entries reworded without a change of meaning.

Drug interactions

1 entry reworded without a change of meaning.

Warnings and precautions

Added in this revision

• +Added: The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly.
• +Added: Generally, histological findings were observed without organ involvement.
• +Added: Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly.
• +Added: Serological testing (e.g.

Removed in this revision

• -Removed: The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE).
• -Removed: Onset of CLE occurred up to 2 years after continuous drug therapy (range from 1 to 104 weeks).
• -Removed: CLE occurred primarily in older patients, although cases were reported in patients as young as 7 months of age.
• -Removed: Generally, positive antinuclear antibodies (ANA) and histological findings were observed, consistent with a diagnosis of CLE.
• -Removed: Organ involvement was not typically seen.
• -Removed: Complete recovery generally has occurred within 12 weeks after discontinuation of the drug.
• -Removed: Onset of SLE typically occurred within 30 days after initiating PPI treatment, but some cases occurred days or years after initiating treatment.
• -Removed: SLE occurred primarily in older patients, although cases also occurred in young adults.
• -Removed: Antibody testing for lupus, including ANA and antihistone antibodies, may be positive.
• -Removed: Clinical signs and symptoms of SLE associated with PPI use were usually reversible once the PPI was discontinued.
• -Removed: Clinical symptoms generally resolved within 8 weeks.

2 entries reworded without a change of meaning.

Adverse reactions

Added in this revision

• +Added: Gastrointestinal: pancreatitis; stomatitis; microscopic colitis;
• +Added: Musculoskeletal and Connective Tissue: muscular weakness, myalgia, bone fracture;

4 entries reworded without a change of meaning.

Contraindications

1 entry reworded without a change of meaning.

Warnings and precautions

1 entry reworded without a change of meaning.

Adverse reactions

Added in this revision

• +Added: Adverse reactions reported in greater than or equal to 2% of Saxenda-treated patients and more frequently than in placebo-treated patients are shown in Table 3.

2 entries reworded without a change of meaning.

Do not use

Added in this revision

• +Added: Do not use if you have: trouble or pain swallowing food, vomiting with blood, or bloody or black stools heartburn with lightheadedness, sweating or dizziness chest pain or shoulderpain with shortnessof breath; sweating; pain spreading to arms, neck, or shoulders; or lightheadedness frequent chest pain These may be signs of a serious condition.

Removed in this revision

• -Removed: Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools.
• -Removed: These may be signs of a serious condition.

Stop use and ask a doctor

1 entry reworded without a change of meaning.

Warnings and precautions

Added in this revision

• +Added: Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI.
• +Added: In older patients, also consider an endoscopy.
• +Added: Cutaneous and Systemic Lupus Erythematosus Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including esomeprazole.
• +Added: These events have occurred as both new onset and an exacerbation of existing autoimmune disease.
• +Added: The majority of PPI-induced lupus erythematosus cases were CLE.
• +Added: The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE).
• +Added: Onset of CLE occurred up to 2 years after continuous drug therapy (range from 1 to 104 weeks).
• +Added: CLE occurred primarily in older patients, although cases were reported in patients as young as 7 months of age.
• +Added: Generally, positive antinuclear antibodies (ANA) and histological findings were observed, consistent with a diagnosis of CLE.
• +Added: Organ involvement was not typically seen.
• +Added: Complete recovery generally has occurred within 12 weeks after discontinuation of the drug.
• +Added: Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs.
• +Added: PPI associated SLE is usually milder than non-drug induced SLE.
• +Added: Onset of SLE typically occurred within 30 days after initiating PPI treatment, but some cases occurred days or years after initiating treatment.
• +Added: SLE occurred primarily in older patients, although cases also occurred in young adults.
• +Added: The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.
• +Added: Antibody testing for lupus, including ANA and antihistone antibodies, may be positive.
• +Added: Clinical signs and symptoms of SLE associated with PPI use were usually reversible once the PPI was discontinued.
• +Added: Clinical symptoms generally resolved within 8 weeks.
• +Added: Elevated serological test results may take longer to resolve than clinical manifestations.
• +Added: Avoid administration of PPIs for longer than medically indicated.
• +Added: If signs or symptoms consistent with CLE or SLE are noted in patients receiving NEXIUM, discontinue the drug and refer the patient to the appropriate specialist for evaluation.
• +Added: Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks.

Removed in this revision

• -Removed: Atrophic Gastritis Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which esomeprazole is an enantiomer.

1 entry reworded without a change of meaning.

Adverse reactions

Added in this revision

• +Added: The following serious adverse reactions are described below and elsewhere in labeling: • Acute Interstitial Nephritis • Clostridium difficile Associated Diarrhea • Bone Fracture • Cutaneous and Systemic Lupus Erythematosus • Cyanocobalamin (Vitamin B-12) Deficiency • Hypomagnesemia Clinical Trials Experience 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...

Removed in this revision

• -Removed: Clinical Trials Experience 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.

Stop use and ask a doctor

Added in this revision

• +Added: This may be a sign of a serious medical condition. • you are taking medicine for seizures and your seizures happen more often or get worse

Removed in this revision

• -Removed: This may be a sign of a serious medical condition.

Dosage and administration

Added in this revision

• +Added: Important Administration Instructions • Inspect visually prior to each injection.
• +Added: Only use if solution is clear, colorless, and contains no particles. • Inject VICTOZA subcutaneously in the abdomen, thigh or upper arm.
• +Added: No dose adjustment is needed if changing the injection site and/or timing. • When using VICTOZA with insulin, administer as separate injections.
• +Added: General Dosing and Administration • Inject VICTOZA subcutaneously once-daily at any time of day, independently of meals. • Initiate VICTOZA with a dose of 0.6 mg per day for one week.
• +Added: Do not administer an extra dose or increase in dose to make up for the missed dose. • If more than 3 days have elapsed since the last VICTOZA dose, reinitiate VICTOZA at 0.6 mg to mitigate any gastrointestinal symptoms associated with reinitiation of treatment.
• +Added: Dosage in Patients with Renal Impairment No dose adjustment is recommended for patients with renal impairment.

Removed in this revision

• -Removed: Victoza can be administered once daily at any time of day, independently of meals, and can be injected subcutaneously in the abdomen, thigh or upper arm.
• -Removed: The injection site and timing can be changed without dose adjustment.
• -Removed: For all patients, Victoza should be initiated with a dose of 0.6 mg per day for one week.
• -Removed: When using Victoza with insulin, administer as separate injections.
• -Removed: Victoza solution should be inspected prior to each injection, and the solution should be used only if it is clear, colorless, and contains no particles.
• -Removed: An extra dose or increase in dose should not be taken to make-up for the missed dose.
• -Removed: Based on the elimination half-life, patients should be advised to reinitiate Victoza at 0.6 mg if more than 3 days have elapsed since the last Victoza dose.
• -Removed: This approach will mitigate any gastrointestinal symptoms associated with reinitiation of treatment.

4 entries reworded without a change of meaning.

Forms and strengths

1 entry reworded without a change of meaning.

Contraindications

Removed in this revision

• -Removed: Victoza is contraindicated in patients with a prior serious hypersensitivity reaction to Victoza or to any of the product components.

1 entry reworded without a change of meaning.

Adverse reactions

This section was substantially rewritten in this revision: 17 entries added, 22 removed. A change this large is usually a reorganization of the document rather than a set of individual edits, so the wording is not quoted line by line.

2 entries reworded without a change of meaning.