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.

DAPTOMYCIN (NDA-210282)

(DAPTOMYCIN)

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

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04/30/2025 (SUPPL-4)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

Metabolic and Nutritional Disorders: hyperkalemia

…

08/08/2022 (SUPPL-1)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.12 Development of Drug-Resistant Bacteria

Subsection title revised

7 Drug Interactions

7.1 HMG-CoA Reductase Inhibitors

Additions and/or revisions underlined:

…

Experience with the co-administration of HMG-CoA reductase inhibitors and daptomycin in patients is limited; therefore, consideration should be given to suspending use of HMG-CoA reductase inhibitors temporarily in patients receiving Daptomycin for Injection.

7.2 Drug-Laboratory Test Interactions

Additions and/or revisions underlined:

…

If confronted with an abnormally high PT/INR result in a patient being treated with daptomycin, it is recommended that clinicians:

Repeat the assessment of PT/INR, requesting that the specimen be drawn just prior to the next Daptomycin for Injection dose (i.e., at trough concentration). If the PT/INR value obtained at trough remains substantially elevated above what would otherwise be expected, consider evaluating PT/INR utilizing an alternative method.
Evaluate for other causes of abnormally elevated PT/INR results.

8 Use in Specific Populations

8.2 Lactation

Additions and/or revisions underlined:

…

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Daptomycin for Injection and any potential adverse effects on the breastfed infant from Daptomycin for Injection 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:

Allergic Reactions

Advise patients that allergic reactions, including serious skin, kidney, lung, or other organ reactions, could occur and that these serious reactions require immediate treatment. Patients should report any previous allergic reactions to daptomycin [see Warnings and Precautions (5.1, 5.4, 5.5)].

Muscle Pain or Weakness (Myopathy and Rhabdomyolysis, Peripheral Neuropathy)

Advise patients to report muscle pain or weakness, especially in the forearms and lower legs, as well as tingling or numbness [see Warnings and Precautions (5.2, 5.6)].

Cough, Breathlessness or Fever (Eosinophilic Pneumonia)

Advise patients to report any symptoms of cough, breathlessness, or fever [see Warnings and Precautions (5.3)].

C. difficile-Associated Diarrhea (CDAD)

Advise patients that diarrhea is a common problem caused by antibacterials, including Daptomycin for Injection that usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, including Daptomycin for Injection, patients can develop watery and bloody stools (with or without stomach cramps and fever), even as late as 2 or more months after having received the last dose of the antibacterial. If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions (5.8)],

Antibacterial Resistance

Patients should be counseled that antibacterial drugs, including Daptomycin for Injection, should be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Daptomycin for Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be administered exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Daptomycin for Injection or other antibacterial drugs in the future.