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.

CARNEXIV (NDA-206030)

(CARBAMAZEPINE)

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

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12/13/2019 (SUPPL-2)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5Hypersensitivity

(additions underlined)

Cases of anaphylaxis and angioedema involving the larynx, glottis, lips, and eyelids have been reported in patients after taking the first or subsequent doses of oral carbamazepine. Angioedema associated with laryngeal edema can be fatal. If a patient develops any of these reactions after treatment with CARNEXIV, the drug should be discontinued and an alternative treatment started. These patients should not be rechallenged with the drug.

…

6 Adverse Reactions

(addition underlined)

…

Hypersensitivity

…

7 Drug Interactions

7.1 Effects of CARNEXIV on Other Drugs

(addition of eslicarbazepine to table 5 and addition of Direct acting oral anticoagulants (e.g., rivaroxaban, apixaban, dabigatran, and edoxaban) to table 6, please refer to label for complete information)

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion, please refer to label for complete information)

8.2 Lactation

(PLLR conversion)

Risk Summary

Carbamazepine and its epoxide metabolite are excreted in human milk. There are no data to assess the effects of carbamazepine or its metabolites on milk production, or on the breastfed infant, of mothers taking CARNEXIV. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CARNEXIV and any potential adverse effects on the breastfed infant from CARNEXIV or from the underlying maternal condition.

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

PATIENT COUNSELING INFORMATION

(additions underlined)

…

Anaphylaxis and Angioedema

Advise patients that anaphylactic reactions and angioedema may occur during treatment with CARNEXIV and that they should immediately report signs and symptoms suggesting angioedema (swelling of the face, eyes, lips, or tongue, or difficulty in swallowing or breathing) to their healthcare provider. Advise patients who experience signs or symptoms suggesting anaphylaxis or angioedema to stop taking the drug until they have consulted with their healthcare provider.

…

Pregnancy

Advise women of childbearing potential that CARNEXIV may cause fetal harm. Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy. Advise patients that there is a pregnancy exposure registry that collects information about the safety of antiepileptic drugs during pregnancy.