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.

BICILLIN L-A (NDA-050141)

(PENICILLIN G BENZATHINE)

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

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12/10/2020 (SUPPL-238)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

Newly added information (following Anaphylaxis):

Severe cutaneous adverse reactions

Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic

epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS),

and acute generalized exanthematous pustulosis (AGEP) have been reported in patients taking

beta-lactam antibiotics. When SCAR is suspected, Bicillin L-A should be discontinued

immediately and an alternative treatment should be considered.

12/08/2020 (SUPPL-239)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

Method of Administration

Injection into or near a nerve may result in permanent neurological damage.

Additions and/or revisions underlined:

Inadvertent intravascular administration, including inadvertent direct intra-arterial injection or injection

immediately adjacent to arteries, of Bicillin L-A and other penicillin preparations has resulted in severe

neurovascular damage, including transverse myelitis with permanent paralysis, gangrene requiring

amputation of digits and more proximal portions of extremities, and necrosis and sloughing at and

surrounding the injection site consistent with the diagnosis of Nicolau syndrome. Such severe effects …

6 Adverse Reactions

Additions and/or revisions underlined:

Body as a Whole: Hypersensitivity reactions including allergic vasculitis, pruritus, fatigue,

asthenia, and pain; aggravation of existing disorder; headache, Nicolau syndrome.

04/30/2019 (SUPPL-237)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

(additions underlined)

…

Method of Administration

…

FOR DEEP INTRAMUSCULAR INJECTION ONLY. There have been reports of inadvertent intravenous administration of penicillin G benzathine which has been associated with cardiorespiratory arrest and death. Therefore, do not inject intravenously or admix with other intravenous solutions.

Administer by DEEP INTRAMUSCULAR INJECTION ONLY in the upper, outer quadrant of the buttock (dorsogluteal) or the ventrogluteal site. Quadriceps femoris fibrosis and atrophy have been reported following repeated intramuscular injections of penicillin preparations into the anterolateral thigh. Therefore, administration in the anterolateral thigh is not recommended.