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.

E-Z-HD (NDA-208036)

(BARIUM SULFATE)

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

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04/30/2019 (SUPPL-10)

Approved Drug Label (PDF)

4 Contraindications

(additions underlined)

…

high risk of aspiration such as those with known or suspected tracheo-esophageal fistula or obtundation

…

5 Warnings and Precautions

5.1 Hypersensitivity Reactions

(additions underlined)

… A history of bronchial asthma, atopy, food allergies, or a previous reaction to a contrast agent may increase the risk for hypersensitivity reactions.

…

5.3 Delayed Gastrointestinal Transit and Obstruction

(additions underlined)

… Patients with the following conditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired GI motility, electrolyte imbalance, dehydration, on a low residue diet, taking medications that delay GI motility, constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and the elderly. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration after the barium sulfate procedure.

5.4 Aspiration Pneumonitis

(additions underlined)

The use of VARIBAR THIN LIQUID is contraindicated in patients with trachea-esophageal fistula. Oral administration of barium is associated with aspiration pneumonitis, especially in patients with a history of food aspiration or with compromised swallowing mechanism. Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis.

In patients at risk for aspiration, begin the procedure with a small ingested volume of VARIBAR THIN LIQUID. Monitor the patient closely for aspiration, discontinue administration of VARIBAR THIN LIQUID if aspiration is suspected, and monitor for development of aspiration pneumonitis.

8 Use in Specific Populations

8.4 Pediatric Use

(additions underlined)

The efficacy of VARIBAR THIN LIQUID in pediatric patients is based on successful opacification of the pharynx during modified barium swallow examinations. Safety and dosing recommendations in pediatric patients are based on clinical experience.

…

04/07/2017 (SUPPL-5)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.4 Pediatric Use

(additions underlined)

The efficacy of E-Z-PAQUE in pediatric patients from birth to less than 17 years of age is based on successful opacification of the esophagus, stomach, duodenum and small bowel during radiologic examinations. Safety and dosing recommendations in pediatric patients are based on clinical experience.

E-Z-PAQUE is contraindicated in pediatric patients with tracheo-esophageal fistula . Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions. Pediatric patients with cystic fibrosis or Hirschsprung disease should be monitored for bowel obstruction after use .Pediatric patients with hereditary fructose intolerance may develop severe symptoms with administration of E-Z- Paque; assess for this risk and avoid use in patients with hereditary fructose intolerance.

02/08/2017 (SUPPL-6)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Delayed Gastrointestinal Transit and Obstruction

(additions underlined)

Orally administered barium sulfate may accumulate proximal to a constricting lesion of the colon, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, bowel obstruction, or rarely perforation. Patients with the following conditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired GI motility, electrolyte imbalance, dehydration, on a low residue diet, taking medications that delay GI motility, constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and the elderly.

To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration during and in the days following a barium sulfate procedure. Consider the administration of laxatives.

8 Use in Specific Populations

8.4 Pediatric Use

(subsection revised, additions underlined)

Double-contrast radiographic examinations of the esophagus, stomach and duodenum may be used in pediatric patients 12 years older.

E-Z HD is contraindicated in pediatric patients with tracheo-esophageal fistula. Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions. Pediatric patients with cystic fibrosis or Hirschsprung disease should be monitored for bowel obstruction after use.

01/03/2017 (SUPPL-2)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

High risk of GI perforation such as those with a recent prior GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, post GI surgery or biopsy, acute GI injury or burn, or recent radiotherapy to pelvis.

5 Warnings and Precautions

5.3 Delayed Gastrointestinal Transit and Obstruction

Additions and/or revisions underlined:

5.6 Risk with Hereditary Fructose Intolerance

Newly added section:

E-Z-CAT Dry contains sorbitol which may cause severe symptoms if ingested by patients with hereditary fructose intolerance. Severe symptoms may include the following: vomiting, hypoglycemia, jaundice, hemorrhage, hepatomegaly, hyperuricemia, and kidney failure. Before administration of E-Z-CAT Dry assess patients for a history of hereditary fructose intolerance and avoid use in these patients

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The efficacy of E-Z-CAT DRY in pediatric patients from birth to less than 17 years of age is based on successful opacification of the GI tract during computed tomography. Safety and dosing recommendations in pediatric patients above are based on clinical experience.

E-Z-CAT DRY is contraindicated in pediatric patients with tracheo-esophageal fistula. Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions. Pediatric patients with cystic fibrosis or Hirschsprung disease should be monitored for bowel obstruction after use.

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

PATIENT COUNSELING INFORMATION

Revised as below:

Advise the patient to read the FDA-approved patient labeling (Instructions for Use). After administration, advise patients to:

Maintain adequate hydration.
Seek medical attention for worsening for constipation or slow gastrointestinal passage.
Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty.