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.

NASCOBAL (NDA-021642)

(CYANOCOBALAMIN)

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

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12/07/2018 (SUPPL-19)

Approved Drug Label (PDF)

4 Contraindications

(additions underlined)

NASCOBAL is contraindicated in patients with hypersensitivity to cobalt and/or vitamin B12 or any of its excipients. Anaphylactic shock and death have been reported after parenteral vitamin B12 administration in sensitive patients.

5 Warnings and Precautions

(PLR conversion; subsections created as below, please see label for complete information)

5.1 Severe Optic Atrophy in Patients with Leber’s Disease

5.2 Anaphylactic Reactions

5.3 Masking of Folate Deficiency with Vitamin B12 Use

5.4 Hypokalemia and Thrombocytosis Due to Intense Treatment of Megaloblastic Anemia

5.5 Unmasking of Polycythemia Vera

6 Adverse Reactions

(subsection revised)

The following serious adverse reactions are described elsewhere in the labeling:

Severe Optic Atrophy in Patients with Leber’s Disease.
Anaphylactic Reactions.
Hypokalemia and Thrombocytosis Due to Intense Treatment of Megaloblastic Anemia.

6.1 Clinical Trials Experience

(PLR conversion; subsection added- please refer to label for complete information)

7 Drug Interactions

(PLR conversion)

Chloramphenicol may decrease the efficacy of NASCOBAL when used for treatment of anemia. If NASCOBAL is used for the treatment of anemia concomitantly with chloramphenicol, monitor for reduced efficacy and if needed, consider an alternative therapy.

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion)

Risk Summary

The limited available data on NASCOBAL in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, vitamin B12 is an essential vitamin and requirements are increased during pregnancy.

Animal reproduction studies have not been conducted with vitamin B12.

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

8.2 Lactation

(PLLR conversion)

Risk Summary

Vitamin B12 is present in the milk of lactating women in concentrations which approximate the mother’s vitamin B12 blood level. Vitamin B12 does not appear to pose more than a minimal risk to breastfeeding children.

8.4 Pediatric Use

(subsection revised, additions underlined)

Safety and effectiveness have not been established in pediatric patients.

8.5 Geriatric Use

(PLR conversion, subsection added)

Clinical studies of NASCOBAL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

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

PATIENT COUNSELING INFORMATION

(subsection added (PLR conversion), please refer to label for complete information)

PATIENT INFORMATION

(PLR conversion, please refer to label for more information)

Other

(PLR and PLLR conversion)