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.

XYLOCAINE W/ EPINEPHRINE (NDA-006488)

(EPINEPHRINE; LIDOCAINE HYDROCHLORIDE)

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

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10/30/2024 (SUPPL-100)

Approved Drug Label (PDF)

4 Contraindications

PLR conversion; please refer to label for complete information

5 Warnings and Precautions

PLR conversion; please refer to label for complete information

5.1 Dose-Related Toxicity

5.2 Methemoglobinemia

5.3 Antimicrobial Preservatives in Multiple-Dose Vials

5.4 Chondrolysis with Intra-Articular Infusion

5.5 Risk of Adverse Reactions Due to Drug Interactions with Xylocaine/Xylocaine-MPF with Epinephrine

5.6 Allergic-Type Reactions to Sulfites in Xylocaine/Xylocaine-MPF with Epinephrine and Anaphylactic Reactions

5.7 Risk of Systemic Toxicities with Unintended Intravascular or Intrathecal Injection

5.8 Risk of Toxicity in Patients with Hepatic Impairment

5.9 Risk of Use in Patients with Impaired Cardiovascular Function

5.10 Risk of Ischemic Injury or Necrosis in Body Areas with Limited Blood Supply

5.11 Risk of Cardiac Arrhythmias with Concomitant Use of Potent Inhalation Anesthetics

5.12 Risk of Adverse Reactions with Use in the Head and Neck Area

5.13 Familial Malignant Hyperthermia

5.14 Risk of Respiratory Arrest with Use in Ophthalmic Surgery

5.15 Risk of Inadvertent Trauma to Tongue, Lips, and Buccal Mucosa in Dental Applications

5.16 Drug/Laboratory Test Interactions

6 Adverse Reactions

PLR conversion; please refer to label for complete information

7 Drug Interactions

PLR conversion; please refer to label for complete information

7.1 Local Anesthetics

7.2 Monoamine Oxidase Inhibitors and Tricyclic Antidepressants

7.3 Ergot-Type Oxytocic Drugs

7.4 Nonselective Beta-Adrenergic Antagonists

7.5 Drugs Associated with Methemoglobinemia

7.6 Potent Inhalation Anesthetics

7.7 Phenothiazines and Butyrophenones

8 Use in Specific Populations

PLR conversion; please refer to label for complete information

8.1 Pregnancy

PLLR conversion; please refer to label for complete information

8.2 Lactation

PLLR conversion:

Risk Summary

Published data report the presence of lidocaine and its metabolites in human milk in low amounts, along with poor oral bioavailability. There are no data on the effect of lidocaine on the breastfed infant or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Xylocaine Injection and any potential adverse effects on the breastfed child from Xylocaine Injection or from the underlying maternal condition.

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

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

PATIENT COUNSELING INFORMATION

PLR conversion; please refer to label for complete information

17.1 Allergic-Type Reactions

17.2 Temporary Loss of Sensation and Motor Activity After Caudal or Epidural Anesthesia

17.3 Methemoglobinemia

Other

PLR conversion; please refer to label for complete information

11/02/2018 (SUPPL-97)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

(additions underlined)

…

Methemoglobinemia

Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.

Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue XYLOCAINE and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

…

7 Drug Interactions

Clinically Significant Drug Interactions

(additions underlined)

…

Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents:

(please refer to label to view examples)

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

Information for Patients

(additions underlined)

…

Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

…

12/22/2017 (SUPPL-90)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

(Additions and/or revisions are underlined)

Anaphylactic reactions may occur following administration of lidocaine hydrochloride. In the case of severe reaction, discontinue the use of the drug.

6 Adverse Reactions

(Additions and/or revisions are underlined)

Allergic

Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to local anesthetic agents or to the methylparaben used as a preservative in the multiple dose vials. Allergic reactions, including anaphylactic reactions, may occur as a result of sensitivity to lidocaine, but are infrequent. If allergic reactions do occur, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

There have been no reports of cross sensitivity between lidocaine hydrochloride and procainamide or between lidocaine hydrochloride and quinidine.

Hematologic

Methemoglobinemia.