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.

IOPIDINE (NDA-019779)

(APRACLONIDINE HYDROCHLORIDE)

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

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03/18/2026 (SUPPL-28)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

Additions and/or revisions underlined:

FOR TOPICAL OPHTHALMIC USE ONLY. Not for injection or oral ingestion.

Topical administration of apraclonidine have been reported to cause cardiovascular collapse requiring intubation and ventilation in pediatric patients 6 years and younger, including neonates. Systemic adverse reactions such as prolonged lethargy and unresponsiveness, apnea, hypoxia, respiratory failure, bradycardia, hypertension, hypotension, hypothermia, hypotonia, pallor have also been reported. Appropriate monitoring in a clinical setting should be in place.

6 Adverse Reactions

Additions and/or revisions underlined:

…

Clinical Practice

The following events have been identified during postmarketing use of IOPIDINE 1% Ophthalmic Solution in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to IOPIDINE 1% Ophthalmic Solution, or a combination of these factors, include

Hypersensitivity
Cardiovascular collapse requiring intubation and ventilation, prolonged lethargy and unresponsiveness, apnea, hypoxia, respiratory failure, hypertension, hypotension, hypothermia, hypotonia, and pallor have been reported in pediatric patients 6 years and younger, including neonates, following topical administration of apraclonidine.

8 Use in Specific Populations

Pediatric Use

Additions and/or revisions underlined:

Safety and effectiveness in pediatric patients have not been established.

During postmarketing surveillance, cardiovascular collapse requiring intubation and ventilation, prolonged lethargy and unresponsiveness, apnea, hypoxia, respiratory failure, bradycardia, hypertension, hypotension, hypothermia, hypotonia, and pallor have been reported in pediatric patients 6 years and younger, including neonates, following topical administration of apraclonidine (see WARNINGS).

03/01/2018 (SUPPL-25)

Approved Drug Label (PDF)

6 Adverse Reactions

Newly added information:

Clinical Practice

04/06/2017 (SUPPL-23)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

(additions underlined)

General: Since IOPIDINE® Ophthalmic Solution is a potent depressor of intraocular pressure, patients who develop exaggerated reductions in intraocular pressure should be closely monitored. Although the acute administration of two drops of IOPIDINE Ophthalmic Solution has minimal effect on heart rate or blood pressure in clinical studies evaluating patients undergoing anterior segment laser surgery, the preclinical pharmacologic profile of this drug suggests that caution should be observed in treating patients with severe cardiovascular disease including hypertension. IOPIDINE Ophthalmic Solution should also be used with caution in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease, chronic renal failure, Raynaud’s disease or thromboangiitis obliterans.

…

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

Patient Information

(section added)

Apraclonidine can cause dizziness and somnolence. Patients who engage in hazardous activities requiring mental alertness should be warned of the potential for a decrease in mental alertness on the day of surgery.