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.

MIVACRON (NDA-020098)

(MIVACURIUM CHLORIDE)

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

Download Data

07/26/2018 (SUPPL-19)

Approved Drug Label (PDF)

5 Warnings and Precautions

(Additions and/or revisions are underlined)

WARNINGS

Risk of Death Due to Medication Errors

Administration of MIVACRON results in paralysis, which may lead to respiratory arrest and death; this progression may be more likely to occur in a patient for whom it is not intended. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. If another healthcare provider is administering the product, ensure that the intended dose is clearly labeled and communicated.

PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term studies in animals to evaluate carcinogenic potential of mivacurium have not been completed.

Mutagenesis

Mivacurium was non-mutagenic in the in vitro bacterial reverse mutation assay (Ames assay), the in vitro mouse lymphoma assay, the in vitro human lymphocyte assay, and the in vivo rat bone marrow cytogenetic assay.

Impairment of Fertility

Studies to evaluation the effects of mivacurium on fertility have not been completed.

Pregnancy

Risk Summary

There are no adequate and well-controlled studies of MIVACRON in pregnant women. In animal studies, subcutaneous administration of mivacurium to pregnant rats and mice during organogenesis at doses 0.16 and 0.52 times the human dose of 0.25 mg/kg did not result in any malformations or embryo toxic effects.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data

Animal Data

There was no evidence of malformations or embryo toxicity when pregnant mice were administered 0.25 or 0.5 mg/kg mivacurium during organogenesis (0.08 and 0.16 times the human dose of 0.25 mg/kg based on body surface area). These doses were not associated with maternal toxicity.

There was no evidence of malformations or embryo toxicity when pregnant rats were administered 0.4 or 0.8 mg/kg mivacurium during organogenesis (0.26 and 0.52 times the human dose of 0.25 mg/kg based on body surface area). These doses were not associated with maternal toxicity.