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.

ADRENACLICK (NDA-020800)

(EPINEPHRINE)

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

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02/04/2021 (SUPPL-40)

Approved Drug Label (PDF)

6 Adverse Reactions

Addition of section headings:

Cardiovascular Reactions

Accidental Injection and/or Improper Technique

Skin and Soft Tissue Infections

7 Drug Interactions

Addition of section headings:

Cardiac Glycosides, Diuretics, and Anti-arrhythmics

Antidepressants, Monoamine Oxidase Inhibitors, Levothyroxine, and Antihistamines

Beta-Adrenergic Blockers

Alpha-Adrenergic Blockers

Ergot Alkaloids

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion. Please refer to label for complete information.)

8.2 Lactation

(PLLR conversion. Please refer to label for complete information.)

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

Patient Counseling Information

(Extensive changes; please refer to label)

Patient Information

(Newly added information)

Throw away (dispose of) expired, unwanted, or unused epinephrine injections in an FDA-cleared sharps disposal container. Do not throw away epinephrine injection in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

o Made of heavy-duty plastic,

o Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

o Upright and stable during use,

o Leak-resistant, and

o Properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposalVisit the FDA’s website (https://www.fda.gov/drugs/safe-disposal-medicines/disposal- unused-medicines-what-you-should-know) for more information about how to throw away (dispose of) unused, unwanted or expired medicines.

08/29/2018 (SUPPL-35)

Approved Drug Label (PDF)

6 Adverse Reactions

Newly added information:

Rare cases of stress cardiomyopathy have been reported in patients treated with epinephrine.

Other

Epinephrine injection, USP auto-injector replaces Adrenaclick throughout label.

05/18/2016 (SUPPL-34)

Approved Drug Label (PDF)

5 Warnings and Precautions

Injection-Related Complications

Hold leg firmly during injection.

Lacerations, bent needles, and embedded needles have been reported when epinephrine has been injected into the thigh of young children who are uncooperative and kick or move during an injection. To minimize the risk of injection related injury when administering {insert product name} to young children, instruct caregivers to hold the child’s leg firmly in place and limit movement prior to and during injection.

Serious Infections at the Injection Site

Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Clostridium spores can be present on the skin and introduced into the deep tissue with subcutaneous or intramuscular injection. While cleansing with alcohol may reduce presence of bacteria on the skin, alcohol cleansing does not kill Clostridium spores. To decrease the risk of Clostridium infection, do not inject {insert product name} into the buttock [see Warnings and Precautions (5.2)]. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site.

6 Adverse Reactions

Lacerations, bent needles, and embedded needles have been reported when Adrenaclick has been injected into the thigh of young children who are uncooperative and kick or move during an injection.
Injection into the buttock has resulted in cases of gas gangrene.
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh.