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.

ISOVUE-200 (NDA-020327)

(IOPAMIDOL)

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

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01/13/2026 (SUPPL-28)

Approved Drug Label (PDF)

5 Warnings and Precautions

Following subsections were created to comply with Physician’s Labeling Rule (PLR) requirements:

5.1 Risks Associated with Intrathecal Administration

5.2 Hypersensitivity Reactions

5.3 Acute Kidney Injury

5.4 Cardiovascular Adverse Reactions

5.5 Thromboembolic Events

5.6 Extravasation and Injection Site Reactions

5.7 Thyroid Storm in Patients with Hyperthyroidism

5.8 Thyroid Dysfunction in Pediatric Patients 0 Years to 3 Years of Age

5.9 Hypertensive Crisis in Patients with Pheochromocytoma

5.10 Sickle Cell Crisis in Patients with Sickle Cell Disease

5.11 Severe Cutaneous Adverse Reactions

5.12 Interference with Laboratory Tests

6 Adverse Reactions

Following subsections were created to comply with Physician’s Labeling Rule (PLR) requirements:

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 Drug Interactions

Following subsections were created to comply with Physician’s Labeling Rule (PLR) requirements:

7.1 Drug-Drug Interactions

7.2 Drug-Laboratory Test Interactions

8 Use in Specific Populations

Following subsections were created to comply with Pregnancy and Lactation Labeling Rule (PLLR) requirements:

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

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

PATIENT COUNSELING INFORMATION

This section was created to comply with Physician’s Labeling Rule (PLR) requirements.

04/25/2023 (SUPPL-25)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age:

Additions and/or revisions underlined:

Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast media in pediatric patients 0 to 3 years of age.

Younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with an increased risk of hypothyroidism after ICM exposure. Pediatric patients with congenital cardiac conditions may be at greatest risk given that they often require high doses of contrast during invasive cardiac procedures.

An underactive thyroid during early life may be harmful for cognitive and neurological development and may require thyroid hormone replacement therapy. After exposure to ICM, individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates.

PRECAUTIONS

Pediatric Use

Additions and/or revisions underlined:

…

After exposure to iodinated contrast media, individualize thyroid function monitoring in pediatric patients 0 to 3 years of age based on underlying risk factors, especially in term and preterm neonates (see WARNINGS and ADVERSE REACTIONS).

02/18/2022 (SUPPL-23)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

Information for Patients

Newly added information:

6. Advise parents/caregivers about the risk of developing thyroid dysfunction after ISOVUE administration. Advise parents/caregivers about when to seek medical care for their child to monitor for thyroid function (see WARNINGS).

Pediatric Use

Additions and/or revisions underlined:

Safety and effectiveness in children has been established in pediatric angiocardiography, computed tomography (head and body) and excretory urography. Pediatric patients at higher risk of experiencing adverse events …

Newly added information:

Thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration in pediatric patients, including term and preterm neonates; some patients were treated for hypothyroidism. Monitor pediatric patients 0 to 3 years of age closely, particularly those with one or more potential risk factors, for thyroid dysfunction (see WARNINGS and ADVERSE REACTIONS).

WARNINGS

General

Additions and/or revisions underlined:

Caution must be exercised in patients with severely impaired renal function, those with combined renal and hepatic disease, or anuria, particularly when larger or repeat doses are administered.

Newly added information:

Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast media. Among patients 0 to 3 years of age exposed to iodinated contrast media, thyroid dysfunction has been reported in 1% to 15% depending on the age of the patient and the dose of the iodinated contrast agent.

Younger age, very low birth weight, prematurity, and the presence of other conditions, such as, admission to neonatal or pediatric intensive care units, and cardiac conditions are associated with an increased risk. Pediatric patients with cardiac conditions may be at the greatest risk given that they often require high doses of contrast during invasive cardiac procedures, such as catheterization and computed tomography (CT).

Pediatric patients 0 to 3 years of age warrant closer monitoring because an underactive thyroid during early life may be harmful for motor, hearing, and cognitive development and may require transient T4 replacement therapy. Evaluate thyroid function in all pediatric patients 0 to 3 years of age within 3 weeks following exposure to iodinated contrast media, especially in term and preterm neonates. If thyroid dysfunction is detected, treat and monitor thyroid function as clinically needed.

6 Adverse Reactions

Additions and/or revisions underlined:

General Adverse Reactions to Contrast Media

Additions and/or revisions underlined:

… All hemodynamic disturbances and injuries to organs or vessels perfused by the contrast medium are included in this category.

Experience with iopamidol suggests there is much less discomfort (e.g. pain and/or warmth) with peripheral arteriography. Fewer changes are noted in ventricular function after ventriculography and coronary arteriography.

Idiosyncratic reactions include all other reactions …

In addition to the adverse drug reactions reported for iopamidol, the following additional adverse reactions have been reported with the use of other intravascular contrast agents and are possible with the use of any water-soluble iodinated contrast agent: …

Endocrine: hyperthyroidism, hypothyroidism

02/16/2018 (SUPPL-14)

Approved Drug Label (PDF)

8 Use in Specific Populations

Pediatric Use

(additions underlined)

Safety and effectiveness in children has been established in pediatric angiocardiography and computed tomography (head and body). Pediatric patients at higher risk of experiencing adverse events during contrast medium administration may include those having asthma, a sensitivity to medication and/or allergens, cyanotic heart disease, congestive heart failure, a serum creatinine greater than 1.5 mg/dL or those less than 12 months of age.

04/05/2017 (SUPPL-12)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

(additions underlined)

General

…

Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS). Reaction severity may increase and time to onset may decrease with repeat administration of contrast agent; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions. Avoid administering Isovue to patients with a history of a severe cutaneous adverse reaction to Isovue.

6 Adverse Reactions

(additions underlined)

General Adverse Reactions To Contrast Media

…

Tissue Disorders: Skin necrosis; Reactions range from mild (e.g. rash, erythema, pruritus, urticaria and skin discoloration) to severe: [e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS)].

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

Information for Patients

(addition underlined)

1. Inform your physician if you are pregnant.

2. Inform your physician if you are diabetic or if you have multiple myeloma, pheochromocytoma, homozygous sickle cell disease, or known thyroid disorder.

3. Inform your physician if you are allergic to any drugs, food, or if you had any reactions to previous injections of substances used for x-ray procedures.

4. Inform your physician about any other medications you are currently taking, including nonprescription drugs, before you have this procedure.

5. Advise patients to inform their physician if they develop a rash after receiving Isovue.