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.

FLUORESCITE (NDA-021980)

(FLUORESCEIN SODIUM)

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

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11/17/2021 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Respiratory Reactions

Additions and/or revisions underlined:

Monitor closely when used in patients with a history of allergy or bronchial asthma. An emergency tray should be available in the event of possible reaction to FLUORESCITE® Injection 10%.

6 Adverse Reactions

6.4 Cardiopulmonary Reactions

Additions and/or revisions underlined:

Cardiac arrest, basilar artery ischemia, severe shock and death may occur rarely.

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion; additions and/or revisions underlined

Risk Summary

There is insufficient data with the use of fluorescein in pregnant women to inform a drug-associated risk.

Adequate animal reproduction studies have not been conducted with fluorescein. Fluorescein should only be given to a pregnant woman if clearly needed.

The background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the U.S. general population, the estimated background risk of major birth defects is 2%-4% and of miscarriage is 15%- 20% of clinically recognized pregnancies.

Data

Animal Data

Intravenous administration of a single dose of fluorescein to pregnant rats resulted in rapid distribution into the amniotic fluid and fetus.

8.2 Lactation

PLLR conversion; additions and/or revisions underlined

Risk Summary

Fluorescein injection has been demonstrated to be transferred into human milk for up to 4 days following IV administration.

02/02/2016 (SUPPL-4)

Approved Drug Label (PDF)

4 Contraindications

Hypersensitivity

FLUORESCITE® Injection 10% is contraindicated in patients with known hypersensitivity to fluorescein sodium or any other ingredients in this product. Rare cases of death due to anaphylaxis have been reported. [see Warnings and Precautions (5.1) and Adverse Reactions (6)].
Fluorescein sodium can induce serious intolerance reactions. These reactions of intolerance are always unpredictable but they are more frequent in patients who have previously experienced an adverse reaction after fluorescein injection (symptoms other than nausea and vomiting) or in patients with history of allergy such as food or drug induced urticaria, asthma, eczema, allergic rhinitis. Detailed questioning of each patient is recommended before the angiography to evaluate any prior history of allergy

5 Warnings and Precautions

Respiratory Reactions

Caution is to be exercised in patients with a history of allergy or bronchial asthma. An emergency tray should be available in the event of possible reaction to FLUORESCITE® Injection 10%.
If a potential allergy is suspected, an intradermal skin test may be performed prior to intravenous administration, i.e., 0.05 mL injected intradermally to be evaluated 30 to 60 minutes following injection. Given the sensitivity and specificity of skin testing, a negative skin test is not proof that a patient is not allergic to fluorescein.

Severe Local Tissue Damage

Care must be taken to avoid extravasation during injection as the high pH of fluorescein solution can result in severe local tissue damage. The following complications resulting from extravasation of fluorescein have been noted to occur: severe pain in the arm for several hours, sloughing of the skin, superficial phlebitis, subcutaneous granuloma, and toxic neuritis along the median curve in the antecubital area. When significant extravasation occurs, the injection should be discontinued and conservative measures to treat damaged tissue and to relieve pain should be implemented. [see Administration (2.3) and Adverse Reactions (6)].

Nausea and/or Vomiting

Nausea and/or vomiting and gastrointestinal distress occur commonly within the first few minutes following injection. These reactions usually subside within 10 minutes.

6 Adverse Reactions

Skin and Urine Discoloration

The most common reaction is temporary yellowish discoloration of the skin and urine. Urine may attain a bright yellow color. Discoloration of the skin usually fades in 6 to 12 hours and usually fades in urine in 24 to 36 hours.

Gastrointestinal Reactions

Nausea, vomiting, and gastrointestinal distress are common adverse events. A strong taste may develop after injection.

Hypersensitivity Reactions

Symptoms and signs of hypersensitivity have occurred. Generalized hives and itching, bronchospasm and anaphylaxis have been reported. Rare cases of death have been reported. [see Contraindications 4.1 and Warnings and Precautions (5.1)].

Cardiopulmonary Reactions

Cardiac arrest, basilar artery ischemia, severe shock may occur rarely.

Neurologic Reactions

Headache may occur. Convulsions and syncope may rarely occur following injection.

Thrombophlebitis

Thrombophlebitis at the injection site has been reported. Extravasation of the solution at the injection site causes intense pain at the site and a dull aching pain in the injected arm.

Safety Information

Safety Alerts for Human Medical Products

Drug Safety Labeling Changes

Resources for You

Fluorescite (fluorescein injection) Prescribing Information, February 2016