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.

CEFOBID (NDA-050551)

(CEFOPERAZONE SODIUM)

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

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03/03/2025 (SUPPL-48)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

Additions and/or revisions underlined:

…

Encephalopathy

Encephalopathy (including decreased consciousness, delirium, seizures) has been reported with the use of CEFOBID. Most cases occurred in patients with renal impairment. The adverse reactions resolved after discontinuation of CEFOBID and/or hemodialysis/continuous

veno-venous hemofiltration. If encephalopathy occurs, consider discontinuing CEFOBID and institute supportive measures.

6 Adverse Reactions

Post-Marketing Experience

Additions and/or revisions underlined:

…

Nervous System Disorders: Encephalopathy (including decreased consciousness, delirium, seizures) (see WARNINGS)

12/17/2024 (SUPPL-47)

Approved Drug Label (PDF)

6 Adverse Reactions

Post-Marketing Experience

Additions and/or revisions underlined:

. . .

Immune System disorders: Anaphylactic reaction including shock and fatal cases (see WARNINGS), acute myocardial ischemia with or without myocardial infarction may occur as part of an allergic reaction.

. . .

09/18/2020 (SUPPL-46)

Approved Drug Label (PDF)

4 Contraindications

(Additions underlined)

CEFOBID is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated severe hypersensitivity to beta-lactams (see WARNINGS).

5 Warnings and Precautions

PRECAUTIONS

(Additions underlined)

…

As with other antibacterial drugs, vitamin K deficiency resulting in coagulopathy has occurred in patients treated with CEFOBID. The mechanism is probably related to the suppression of gut flora which normally synthesize this vitamin. Those at risk include patients with a poor nutritional status, malabsorption states (e.g., cystic fibrosis), alcoholism, and patients on prolonged hyper-alimentation regimens (administered either intravenously or via a naso-gastric tube). Hypoprothrombinemia with or without bleeding has been reported. Prothrombin time should be monitored in these patients, and patients receiving anticoagulant therapy, and exogenous vitamin K administered as indicated.

…

8 Use in Specific Populations

Usage in Pregnancy

(Additions underlined)

Reproduction studies have been performed in mice, rats, and monkeys at doses up to 10 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to

CEFOBID. Cefoperazone crosses the placental barrier. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

09/28/2017 (SUPPL-45)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

(Additions and/or revisions are underlined)

…

As with other antibacterial drugs, vitamin K deficiency resulting in coagulopathy has occurred in patients treated with CEFOBID…

WARNINGS

(Additions and/or revisions are underlined)

Severe and occasionally fatal skin reactions such as toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome (SJS), and exfoliative dermatitis have been reported in patients on CEFOBID therapy. If a severe skin reaction occurs CEFOBID should be discontinued and appropriate therapy should be initiated.

6 Adverse Reactions

(Additions and/or revisions are underlined)

Post-Marketing Experience

Blood and Lymphatic System Disorders: Coagulopathy, thrombocytopenia, hypoprothrombinaemia

Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens Johnson syndrome, exfoliative dermatitis, pruritus