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.

LIBRIUM (NDA-012249)

(CHLORDIAZEPOXIDE HYDROCHLORIDE)

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

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12/16/2016 (SUPPL-49)

Approved Drug Label (PDF)

Boxed Warning

(New section added)

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory

depression, coma, and death [see Warnings, Drug Interactions].

• Reserve concomitant prescribing of these drugs for use in patients for whom alternative

treatment options are inadequate.

• Limit dosages and durations to the minimum required.

• Follow patients for signs and symptoms of respiratory depression and sedation.

5 Warnings and Precautions

WARNINGS

(additions underlined)

Concomitant use of benzodiazepines, including Librium, and opioids may result in profound

sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant

prescribing of these drugs for use in patients for whom alternative treatment options are

inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and

benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If

a decision is made to prescribe Librium concomitantly with opioids, prescribe the lowest

effective dosages and minimum durations of concomitant use, and follow patients closely for

signs and symptoms of respiratory depression and sedation. In patients already receiving an

opioid analgesic, prescribe a lower initial dose of Librium than indicated in the absence of an

opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking

Librium, prescribe a lower initial dose of the opioid and titrate based upon clinical response.

Advise both patients and caregivers about the risks of respiratory depression and sedation when

Librium is used with opioids. Advise patients not to drive or operate heavy machinery until the

effects of concomitant use with the opioid have been determined.

7 Drug Interactions

(additions underlined)

The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression

because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines

interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines

and opioids are combined, the potential for benzodiazepines to significantly worsen opioidrelated

respiratory depression exists. Limit dosage and duration of concomitant use of

benzodiazepines and opioids, and monitor patients closely for respiratory depression and

sedation.

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

MEDICATION GUIDE

(Newly added; please refer to label)