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.

MERREM (NDA-050706)

(MEROPENEM)

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

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12/03/2024 (SUPPL-44)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Rhabdomyolysis

Newly added subsection:

Rhabdomyolysis has been reported with the use of meropenem [see Adverse Reactions (6.2)]. If signs or symptoms of rhabdomyolysis such as muscle pain, tenderness or weakness, dark urine or elevated creatine phosphokinase are observed, discontinue MERREM IV and initiate appropriate therapy.

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Rhabdomyolysis [see Warnings and Precautions (5.3)]
6.2 Postmarketing Experience
Additions and/or revisions underlined:
…
Musculoskeletal Disorders: rhabdomyolysis.

04/27/2019 (SUPPL-41)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion; extensive changes. Please refer to label for complete information.

8.2 Lactation

PLLR conversion; additions and/or revisions underlined:

Risk Summary

Meropenem has been reported to be excreted in human milk. No information is available on the effects of meropenem on the breast-fed child or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MERREM IV and any potential adverse effects on the breast-fed child from MERREM IV or from the underlying maternal conditions.

06/05/2018 (SUPPL-40)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Severe Cutaneous Adverse Reactions

Newly added subsection:

Severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme (EM) and acute generalized exanthematous pustulosis (AGEP) have been reported in patients receiving MERREM IV. If signs and symptoms suggestive of these reactions appear, meropenem should be withdrawn immediately and an alternative treatment should be considered.

6 Adverse Reactions

Addition of Severe Cutaneous Adverse Reactions to bulleted line listing

6.2 Postmarketing Experience

Additions and/or revisions underlined:

Skin and Subcutaneous Disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme and acute generalized exanthematous pustulosis.

12/30/2016 (SUPPL-37)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Seizure Potential

(Additions and/or revisions are underlined)

Dosage adjustment is recommended in patients with advanced age and/or adult patients with creatinine clearance of 50 mL/min or less.

5.3 Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid

(Revised subsection title)

5.7 Thrombocytopenia

(Revised subsection title)

5.8 Potential for Neuromotor Impairment

(Additions and/or revisions are underlined)

Alert patients receiving MERREM IV on an outpatient basis regarding adverse events such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. Until it is reasonably well established that MERREM IV is well tolerated, advise patients not to operate machinery or motorized vehicles.

6 Adverse Reactions

(Additions and/or revisions are underlined)

The following are discussed in greater detail in other sections of labeling:

Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid
Thrombocytopenia

6.1 Adverse Reactions from Clinical Trials

(Additions and/or revisions are underlined)

Pediatric Patients:

Systemic and Local Adverse Reactions

Pediatric Patients with Serious Bacterial Infections (excluding Bacterial Meningitis):

MERREM IV was studied in 515 pediatric patients…

Pediatric Patients with Bacterial Meningitis:

MERREM IV was studied in 321 pediatric patients (3 months to less than 17 years of age) with meningitis at a dosage of 40 mg/kg every 8 hours. The types of systemic and local adverse events seen in these patients are similar to the adults…

…The meropenem group had a statistically higher number of patients with transient elevation of liver enzymes.

Pediatric Patients (Neonates and Infants less than 3 months of Age):

MERREM IV was studied in 200 neonates and infants…

Adverse Laboratory Changes in Pediatric Patients:

Laboratory changes seen in the pediatric studies…

6.2 Post-marketing Experience

(Additions and/or revisions are underlined)

Blood and Lymphatic System Disorders: agranulocytosis, neutropenia…

Immune System Disorders: angioedema and drug rash with…

Skin and Subcutaneous Disorders: toxic epidermal necrolysis…

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Patients receiving MERREM IV on an outpatient basis must be alerted of adverse events such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment…

07/27/2016 (SUPPL-36)

Approved Drug Label (PDF)

6 Adverse Reactions

Postmarketing Experience

Addition of DRESS syndrome to listing:

Worldwide postmarketing adverse reactions not otherwise listed…angioedema, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome) and erythema multiforme.