Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

OSMOPREP (NDA-021892)

(SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

Download Data

Expand all

11/29/2018 (SUPPL-14)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

OsmoPrep is contraindicated in the following conditions:

History of acute phosphate nephropathy

Electrolyte Disorders

Bowel preparations, including OsmoPrep can cause fluid and electrolyte disturbances, which can lead to serious adverse reactions including cardiac arrhythmias, seizures and renal impairment.

Patient Management

OsmoPrep is contraindicated in patients with a history of acute phosphate nephropathy.

Use OsmoPrep with caution in patients with severe renal impairment (creatinine clearance less than 30 mL/minute), with conditions, or who are taking medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of arrhythmias, seizures, or renal impairment. Consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in these patients.

Correct electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia before treatment with OsmoPrep
Avoid additional sodium phosphate-based purgative or enema products
If a patient develops significant vomiting or signs of dehydration while or after taking OsmoPrep, consider performing post-colonoscopy lab tests ([electrolytes, creatinine, and blood urea nitrogen (BUN).

5 Warnings and Precautions

Additions and/or revisions underlined:

5.2 Cardiac Arrhythmias

There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. QT prolongation with sodium phosphate tablets has been associated with electrolyte imbalances, such as hypokalemia and hypocalcemia.

5.5 Colonic Mucosal Ulceration and Inflammatory Bowel Disease

Osmotic laxatives, including OsmoPrep, may induce colonic mucosal aphthous ulcerations. In the OsmoPrep clinical program, aphthous ulcers were observed in 3% of patients who took the recommended OsmoPrep dosing regimen.

Consider the potential for mucosal ulcerations resulting from bowel preparation when interpreting colonoscopic finding should in patients with known or suspected inflammatory bowel disease.

Use OsmoPrep with caution in patients experiencing an acute exacerbation of chronic inflammatory bowel disease as published data suggest that sodium phosphate absorption may be enhanced in such patients.

Addition of the following subsection:

5.7 Hypersenstivity Reactions

OsmoPrep may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and throat tightness. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.

6 Adverse Reactions

Addition of the following:

The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling:

Renal Disease, Acute Phosphate Nephropathy, and Electrolyte Disorders
Cardiac Arrhythmias
Seizures
Use in Patients with Significant Gastrointestinal Disease
Colonic Mucosal Ulceration and Inflammatory Bowel Disease
Aspiration

Hypersensitivity Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

… The safety of OsmoPrep was evaluated in two randomized, investigator-blinded, active controlled trials in 931 adult patients undergoing elective colonoscopy. The mean age of the study population was 60 years (range 20 to 89 years), 88% of patients were Caucasian and 55% were female.

Table 1 shows the most common adverse reactions reported in greater than 3% of patients by treatment group in Study 1. Since diarrhea was considered as a part … as an adverse event in this clinical trial.

Addition of the following:

1 Reported in more than 3% of patients in at least one treatment group

2 Another oral formulation of sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous

Electrolyte Abnormalities in Study 1

Hyperphosphatemia

A total of, 96%, 96%, and 93% of patients who took 60 grams of oral sodium phosphate, 60 grams of OsmoPrep, and 48 grams of OsmoPrep, respectively, developed hyperphosphatemia (defined as phosphate level > 5.1 mg/dL) on the day of the colonoscopy. In this study, patients who took 60 grams of oral sodium phosphate, 60 grams of OsmoPrep, and 48 grams of OsmoPrep had baseline mean phosphate levels of 3.5, 3.5, and 3.6 mg/dL and subsequently developed mean phosphate levels of 7.6, 7.9, and 7.1 mg/dL, respectively, on the day of the colonoscopy.

Hyperkalemia

A total of 20%, 22%, and 18% of patients who took 60 grams of oral sodium phosphate, 60 grams of OsmoPrep, and 48 grams of OsmoPrep, respectively, developed hypokalemia (defined as a potassium level < 3.4 mEq/L) on the day of the colonoscopy. In this study, patients who took 60 grams of oral sodium phosphate, 60 grams of OsmoPrep, and 48 grams of OsmoPrep all had baseline potassium levels of about 4.3 mEq/L and then developed a mean potassium level of 3.7 mEq/L on the day of the colonoscopy …

… The OsmoPrep 60-gram dosage regimen was associated with an increased risk of adverse reactions compared to the 48- gram dosage regimen and a similar overall response rate. Therefore, the OsmoPrep 60-gram dosage is not a recommended regimen

6.2 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identified during post-approval use of OsmoPrep. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity reactions: anaphylaxis, angioedema (swelling of the lips, tongue and face), rash …

7 Drug Interactions

Additions and/or revisions underlined:

7.1 Drugs That May Increase Risks due to Fluid and Electrolyte Abnormalities

… that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizures, arrhythmias, or prolonged QT …

7.2 Potential for Reduced Drug Absorption

OsmoPrep can reduce the absorption of other coadministered oral medications. Administer oral medications at least 1 hour before or 1 hour after starting each OsmoPrep dose.

Newly added subsection:

7.3 Other Sodium Phosphate-Based Laxatives

Administration of additional sodium phosphate-based purgative or enema products with OsmoPrep may increase the risk of acute phosphate nephropathy. Avoid concomitant use.

8 Use in Specific Populations

8.1 Pregnancy

8.2 Lactation

PLLR conversion; extensively changed. Please see label for complete information.

8.5 Geriatric Use

Extensive changes; please refer to label for complete information.

Newly added subsection:

8.6 Renal Impairment

Sodium phosphate is substantially excreted by the kidney. Use OsmoPrep with caution in patients with severe renal impairment (creatinine clearance less than 30 mL/min) or patients taking concomitant medications that may affect renal function. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after the use of OsmoPrep, and consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in these patients.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Newly added; please refer to label for complete information.

PATIENT COUNSELING INFORMATION

Extensive changes; please refer to label for complete information.