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.

COSYNTROPIN (NDA-022028)

(COSYNTROPIN)

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

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07/01/2024 (SUPPL-7)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:
Cosyntropin Injection is contraindicated in patients with a history of a hypersensitivity to cosyntropin or, synthetic ACTH, or to any excipients of Cosyntropin Injection. Reactions have included anaphylaxis [see Warnings and Precautions (5.1)].

5 Warnings and Precautions

5.2 Diagnostic Inaccuracies

Additions and/or revisions underlined:

Cortisol levels and subsequent diagnosis of adrenocortical insufficiency following Cosyntropin Injection administration may be inaccurate if patients are on certain medications because of their effect on cortisol binding globulins.

Glucocorticoids and spironolactone may result in falsely elevated cortisol levels. Stop these drugs on the day of cosyntropin testing. Long-acting glucocorticoids may need to be stopped for a longer period before cosyntropin testing [see Dosage and Administration (2.1) and Drug Interactions (7)].

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Additions and/or revisions underlined:

The following serious adverse reactions are described below and elsewhere in the labeling:

Hypersensitivity Reactions [see Warnings and Precautions (5.1)]

Diagnostic Inaccuracies [see Warnings and Precautions (5.2)]

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post-approval use of cosyntropin:

anaphylactic reaction
bradycardia
tachycardia
hypertension
peripheral edema
rash

7 Drug Interactions

7.1 Drug Effects on Plasma Cortisol Levels

Newly added subsection title

Additions and/or revisions underlined:

Accuracy of diagnosis can be complicated by concomitant medications. Plasma cortisol levels and subsequent diagnosis of adrenocortical insufficiency following Cosyntropin Injection administration may be inaccurate if patients are on certain medications because of their effect on cortisol or cortisol binding globulin levels [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)].

Glucocorticoids and spironolactone may falsely elevate plasma cortisol levels. Stop these drugs on the day of Cosyntropin Injection testing. Long-acting glucocorticoids may need to be stopped for a longer period before Cosyntropin Injection testing.

…

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion

Additions and/or revisions underlined:

Risk Summary

Available data from case reports over decades of use with cosyntropin during pregnancy have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Unidentified adrenal insufficiency can result in adverse maternal or fetal outcomes (see Clinical Considerations).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk for major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk

Unidentified adrenal insufficiency during pregnancy can result in maternal and/or fetal death; therefore, the diagnosis of suspected adrenal insufficiency during pregnancy should not be delayed.

8.2 Lactation

PLLR conversion

Additions and/or revisions underlined:

Risk Summary

There are no data on the presence of cosyntropin in human milk, the effects on the breastfed infant, or the effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Cosyntropin Injection and any potential adverse effects on the breastfed infant from Cosyntropin Injection or from the underlying maternal condition.

8.4 Pediatric Use

Newly added subsection

Cosyntropin Injection is approved for use in pediatric patients [see Dosage and Administration (2.3)]

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Hypersensitivity Reactions, including Anaphylaxis

Inform patients and/or caregivers of the early signs of hypersensitivity reactions including rash, hives, itching, facial swelling, tightness of the chest, and wheezing [see Contraindications (4) and Warnings and Precautions (5.1)].

Drug Interference with Cosyntropin Injection Testing

Advise patients and/or caregivers to stop taking glucocorticoids and spironolactone on the day of Cosyntropin Injection testing. However, for patients taking long-acting glucocorticoids, advise them to stop for longer periods before Cosyntropin Injection testing. Advise patients to stop taking estrogen-containing drugs four to six weeks before Cosyntropin Injection testing [see Dosage and Administration (2.1), Warnings and Precautions (5.2), and Drug Interactions (7)].

Other

PLLR conversion

05/11/2018 (SUPPL-5)

Approved Drug Label (PDF)

4 Contraindications

Revised as below:

Hypersensitivity to Cosyntropin injection, synthetic ACTH, or to any of the excipients.

5 Warnings and Precautions

PLR conversion: subsections are as follows; please refer to label for complete information:
5.1 Hypersensitivity to Cosyntropin Injection

5.2 Diagnostic Inaccuracies

6 Adverse Reactions

PLR conversion; revised as below:

The following adverse reactions have been identified during post approval use. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Newly added to bulleted listing:

Anaphylactic reaction

7 Drug Interactions

PLR conversion; newly added subsection – please refer to label for complete information:

Drug effects on plasma cortisol levels

8 Use in Specific Populations

PLR conversion; please refer to label for complete information

8.1 Pregnancy

8.3 Nursing Mothers

Newly added information:

It is not known whether Cosyntropin is excreted into human milk …

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

PATIENT COUNSELING INFORMATION

PLR conversion; newly added information:

Hypersensitivity reactions: Inform patients that hypersensitivity reactions can occur with Cosyntropin injection.

Other

PLR conversion