Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

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.

NITROMIST (NDA-021780)

(NITROGLYCERIN)

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

Download Data

Expand all

06/24/2022 (SUPPL-8)

Approved Drug Label (PDF)

4 Contraindications

4.5 Circulatory Failure and Shock

Newly added subsection

NitroMist is contraindicated in patients with acute circulatory failure or shock.

5 Warnings and Precautions

5.2 Hypotension

Additions and/or revisions underlined

Severe hypotension, particularly with upright posture, may occur even with small doses of nitroglycerin. Patients who may be volume-depleted or who, for whatever reason, are already hypotensive are at increased risk of symptomatic hypotension. Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris.

…

6 Adverse Reactions

Additions and/or revisions underlined

The following adverse reactions are discussed in more detail elsewhere in the label:

Hypotension [see Warnings and Precautions (5.2)]
Headache [see Warnings and Precautions (5.4)]
Hypersensitivity [see Contraindications (4.4)]

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion

Risk Summary

Limited published data on the use of nitroglycerin are insufficient to determine a drug associated risk of major birth defects or miscarriage. In animal reproduction studies, there were no adverse developmental effects when nitroglycerin was administered intravenously to rabbits or intraperitoneally to rats during organogenesis at doses greater than 64-times the human dose [see Data].

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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 – 4% and 15 – 20%, respectively.

Data

Animal Data

No embryotoxic or postnatal development effects were observed with transdermal application in pregnant rabbits and rats at doses up to 240 mg/kg/day for 13 days, at intraperitoneal doses in pregnant rats up to 20 mg/kg/day for 11 days, and at intravenous doses in pregnant rabbits up to 4 mg/kg/day for 13 days.

8.2 Lactation

PLLR conversion

Risk Summary

Sublingual nitroglycerin has not been studied in lactating women. It is not known if nitroglycerin is present in human milk, or if nitroglycerin has effects on milk production or the breastfed child. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s need for nitroglycerin and any potential adverse effects on the breastfed child from nitroglycerin or from the underlying maternal condition.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined

Advise the patient to read the FDA-approved patient labeling (Instructions for Use)

06/10/2016 (SUPPL-7)

Approved Drug Label (PDF)

4 Contraindications

PDE5 Inhibitor Use

Addition to the end of the paragaragh: Do not use NitroMist in patients who are taking the soluble guanylate cyclase (sGC) stimulator riociguat. Concomitant use can cause hypotension.

7 Drug Interactions

PDE5 Inhibitors

Addition to the end of the first paragraph: Do not use NitroMist in patients who are taking the soluble guanylate cyclase (sGC) stimulator riociguat. Concomitant use may result in severe hypotension, syncope, or myocardial ischemia.