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.

RETISERT (NDA-021737)

(FLUOCINOLONE ACETONIDE)

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

Download Data

04/04/2025 (SUPPL-26)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

PLLR Conversion:

Risk Summary

Adequate and well-controlled studies with RETISERT have not been conducted in pregnant women to inform drug- associated risk. Animal reproduction studies have not been conducted with RETISERT. It is not known whether RETISERT can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. RETISERT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In the US 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 on the presence of RETISERT in human milk, the effects on the breastfed infant, or the effects on milk production. Systemically administered corticosteroids are present in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. Clinical or nonclinical lactation studies have not been conducted with RETISERT.

It is not known whether intravitreal treatment with RETISERT could result in sufficient systemic absorption to produce detectable quantities of fluocinolone acetonide in human milk, or affect breastfed infants or milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RETISERT and any potential adverse effects on the breastfed child from RETISERT or from the underlying maternal condition.