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.

FLAREX (NDA-019079)

(FLUOROMETHOLONE ACETATE)

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

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09/23/2025 (SUPPL-41)

Approved Drug Label (PDF)

4 Contraindications

4.1 Viral, Mycobacterial, and Fungal Infections

Newly added subsection, please refer to label for complete information.

4.2. Hypersensitivity

Newly added subsection, please refer to label for complete information.

5 Warnings and Precautions

The following subsections created to comply with Physician Labeling Rule (PLR) format, please refer to label for complete information.

5.1 Intraocular Pressure (IOP) Increase

5.2 Cataracts

5.3 Delayed Healing

5.4 Corneal and Scleral Melting

5.5 Bacterial Infections

5.6 Viral Infections

5.7 Fungal Infections

5.8 Temporary Blurred Vision

5.9 Risk of Contamination

5.10 Contact Lens Use

6 Adverse Reactions

Additions and/or revisions underlined:

The following clinically significant adverse reactions are described elsewhere in the labeling:

Intraocular Pressure (IOP) Increase [see Warnings and Precautions (5.1)]
Cataracts [see Warnings and Precautions (5.2)]
Delayed Healing [see Warnings and Precautions (5.3)]
Corneal and Scleral Melting [see Warnings and Precautions (5.4)]
Bacterial Infections [see Warnings and Precautions (5. 5.5)]
Viral Infections [see Warnings and Precautions (5.6)]
Fungal Infections [see Warnings and Precautions (5.7)]

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion:

Risk Summary

There are no adequate and well controlled studies of fluorometholone in pregnant women to inform a drug-associated risk. Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6 to 18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed.

8.2 Lactation

PLLR conversion:

Risk Summary

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLAREX is administered to a nursing patient. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for FLAREX and any potential adverse effects on the breastfed child from FLAREX.

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

PATIENT COUNSELING INFORMATION

Newly created section to comply with Physician Labeling Rule (PLR):

Temporary Blurred Vision

Advise patients that vision may be temporarily blurred following dosing with FLAREX. Advise patients to exercise care in operating machinery or driving a motor vehicle [see Warnings and Precautions (5.8)].

Risk of Contamination

Instruct patients to not touch dropper tip to the eye, eyelids, or any surface, as this may contaminate the ophthalmic suspension [see Warnings and Precautions (5.9)].

Contact Lens Use

Advise patients to remove contact lenses during instillation of FLAREX. Contact lenses may be reinserted 15 minutes after instillation [see Warnings and Precautions (5.10)].

Other

Physician Labeling Rule (PLR) conversion.

08/02/2022 (SUPPL-33)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

Additions and/or revisions underlined:

General: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.

Prescription Guidelines: The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re- evaluated.

Not more than one bottle should be prescribed initially, and the prescription should not be refilled without further evaluation.

Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the suspension. The preservative in FLAREX® (fluorometholone acetate ophthalmic suspension) 0.1%, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% but may be reinserted 15 minutes after instillation.

Patients should be advised that their vision may be temporarily blurred following dosing with FLAREX® (fluorometholone acetate ophthalmic suspension) 0.1%. Care should be exercised in operating machinery or driving a motor vehicle.

…

Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLAREX (fluorometholone acetate ophthalmic suspension) 0.1%, is administered to a nursing woman.

…

WARNINGS

Additions and/or revisions underlined:

…

If these products are used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored even though it may be difficult in children and uncooperative patients.

6 Adverse Reactions

Additions and/or revisions underlined:

…

Postmarketing Experience: The following reaction has been identified during post-marketing use of FLAREX® (fluorometholone acetate ophthalmic suspension) 0.1% in clinical practice. Because reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reaction, which has been chosen for inclusion due to either its seriousness, frequency of reporting, possible causal connection to FLAREX, or a combination of these factors, includes: dysgeusia.

The following rare adverse reactions have been reported: Cushing’s syndrome and adrenal suppression may occur after very frequent use of topical ophthalmic corticosteroids, particularly in very young children.

10/24/2016 (SUPPL-30)

Approved Drug Label (PDF)

4 Contraindications

Contraindicated in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases; acute purulent untreated infections, which like other diseases caused by microorganisms …

5 Warnings and Precautions

… Acute purulent infections of the eye may be masked or exacerbated by presence of steroid medication. Topical ophthalmic corticosteroids may slow corneal wound healing. In those diseases causing…

Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the suspension. The preservative in FLAREX® (fluorometholone acetate ophthalmic suspension), benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of FLAREX (fluorometholone acetate ophthalmic suspension) but may be reinserted 15 minutes after instillation.

Patients should be advised that their vision may be temporarily blurred following dosing with FLAREX (fluorometholone acetate ophthalmic suspension). Care should be exercised in operating machinery or driving a motor vehicle.

6 Adverse Reactions

Postmarketing Experience (added subsection)

The following reaction has been identified during post-marketing use of FLAREX® (fluorometholone acetate ophthalmic suspension) in clinical practice. Because reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reaction, which has been chosen for inclusion due to either its seriousness, frequency of reporting, possible causal connection to FLAREX, or a combination of these factors, includes: dysgeusia.