Drug Safety-related Labeling Changes (SrLC)

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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.

MOVIPREP (NDA-021881)

(ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE)

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

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04/06/2022 (SUPPL-24)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.10 Hypersensitivity Reactions

Additions and/or revisions underlined:

MoviPrep contains polyethylene glycol (PEG) and lemon flavoring (containing citral, lemon and lime oil; maltodextrin; xanthan gum; and vitamin E) and may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus [see Contraindications (4), Adverse Reactions (6.2) and Description (11)]. 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

6.2 Postmarketing Experience

Additions and/or revisions underlined:

Hypersensitivity reactions: anaphylaxis (some of which were severe, including shock), rash, urticaria, pruritus, lip, tongue and facial swelling, dyspnea, chest tightness and throat tightness, rhinorrhea, dermatitis, fever, and chills [see Warnings and Precautions (5.10)].

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

MEDICATION GUIDE

What are the ingredients in MoviPrep?

Additions and/or revisions underlined:

Inactive ingredients:

Pouch A: aspartame, acesulfame potassium, and lemon flavoring including citral, lemon oil and lime oil; maltodextrin; xanthan gum; and vitamin E.

05/14/2021 (SUPPL-23)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.7 Aspiration

Additions and/or revisions underlined:

Patients with impaired gag reflex or other swallowing abnormalities are at risk for regurgitation or aspiration of MoviPrep. Observe these patients during the administration of MoviPrep. Use with caution in these patients.

Do not combine MoviPrep with starch-based thickeners [see Dosage and Administration (2.1)]. Polyethylene glycol (PEG), a component of MoviPrep, when mixed with starch-thickened liquids reduces the viscosity of the starch-thickened liquid. When a PEG-based product used for another indication was mixed in starch-based pre-thickened liquids used in patients with dysphagia, thinning of the liquid occurred and cases of choking and potential aspiration were reported.

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

MEDICATION GUIDE

MoviPrep may affect how other medicines work. Do not take medicines by mouth 1 hour before or after starting each dose of MoviPrep.

Especially tell your healthcare provider if you take:

Newly added:

starch-based thickeners; For patients who have trouble swallowing, do not mix MoviPrep with starch-based thickeners.

12/07/2018 (SUPPL-17)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.10 Hypersensitivity Reactions

(new subsection added)

MoviPrep contains polyethylene glycol (PEG) and may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus. Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs and symptoms occur.

5.2 Cardiac Arrhythmias

(additions underlined)

There have been rare reports of serious arrhythmias (including atrial fibrillation) associated with the use of ionic osmotic laxative products for bowel preparation. These occur predominantly in patients with underlying cardiac risk factors and electrolyte disturbances. Use caution when prescribing MoviPrep for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, cardiomyopathy, or electrolyte imbalance). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.

5.4 Use in Patients with Renal Impairment

(additions underlined)

Use MoviPrep with caution in patients with renal impairment or patients taking concomitant medications that affect renal function (such as diuretics, ACE inhibitors, angiotensin receptor blockers, or nonsteroidal anti-inflammatory drugs. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during, and after use of MoviPrep, and consider performing pre-dose and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.

5.9 Risks in Patients with Phenylketonuria

(additions underlined)

Phenylketonurics can be harmful to patients with phenylketonuria (PKU). MoviPrep contains phenylalanine, a component of aspartame. Each MoviPrep treatment contains 131 mg of phenylalanine (after hydrolysis of the aspartame molecule in vivo to aspartic acid and phenylalanine). Before prescribing MoviPrep to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including MoviPrep.

6 Adverse Reactions

(additions underlined)

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

Serious Fluid and Electrolyte Abnormalities
Cardiac Arrhythmias
Seizures
Patients with Renal Impairment
Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis
Patients with Significant Gastrointestinal Disease
Aspiration
Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency
Risks in Patients with Phenylketonuria
Hypersensitivity Reactions

6.1 Clinical Studies Experience

(additions, please refer to label for more information)

6.2 Postmarketing Experience

(additions underlined)

The following adverse reactions have been identified during post-approval use of MoviPrep or other PEG-based products. 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

Cardiovascular: Tachycardia, palpitations, hypertension, arrhythmia, atrial fibrillation, peripheral edema, asystole, acute pulmonary edema and syncope, and dehydration.

Gastrointestinal: upper gastrointestinal bleeding from a Mallory-Weiss tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)]

…

7 Drug Interactions

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

(additions underlined)

Use caution when prescribing MoviPrep for patients with conditions and/or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizures, arrhythmias, or QT prolongation in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate.

7.2 Potential for Reduced Drug Absorption

(additions underlined)

MoviPrep can reduce the absorption of other co-administered drugs. Administer oral medications at least 1 hour before the start of administration of each dose of MoviPrep

7.3 Stimulant Laxatives

(new subsection added)

Concurrent use of stimulant laxatives and MoviPrep may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking MoviPrep.

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion)

Risk Summary

There are no available data on MoviPrep in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with MoviPrep.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

8.2 Lactation

(PLLR conversion)

Risk Summary

There are no data available on the presence of MoviPrep in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of MoviPrep to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MoviPrep and any potential adverse effects on the breastfed child from MoviPrep or from the underlying maternal condition.

8.5 Geriatric Use

(additions underlined)

Of the 413 patients in clinical trials receiving MoviPrep, 91 (22%) patients were aged 65 or older, while 25 (6%) patients were over 75 years of age. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients. However, elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities.

8.6 Renal Impairment

(new subsection added)

Use MoviPrep with caution in patients with renal impairment 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 MoviPrep, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.

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

Medication Guide

(additions and revisions, please refer to label)

PATIENT COUNSELING INFORMATION

(additions and revisions, please refer to label)

Other

(PLLR conversion)