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.

CYKLOKAPRON (NDA-019281)

(TRANEXAMIC ACID)

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

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08/29/2025 (SUPPL-48)

Approved Drug Label (PDF)

Boxed Warning

Newly added section:

WARNING: RISK OF MEDICATION ERRORS DUE TO INCORRECT ROUTE OFADMINISTRATION

CYKLOKAPRON is for intravenous use only. Serious, including fatal, adverse reactions including seizures and cardiac arrythmias have occurred when CYKLOKAPRON was inadvertently administered via the neuraxial route [see Warnings and Precautions (5.1)].

4 Contraindications

Additions and/or revisions underlined:

CYKLOKAPRON Injection is contraindicated:

As a neuraxial (i.e., intrathecal, epidural) injection [see Warnings and Precautions (5.1)].
In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by CYKLOKAPRON in such patients.
In patients with active intravascular clotting [see Warnings and Precautions (5.2)].
In patients with hypersensitivity to tranexamic acid or any of the ingredients [see Warnings and Precautions (5.4)].

5 Warnings and Precautions

5.3 Seizures

Additions and/or revisions underlined:

CYKLOKAPRON may cause seizures, including focal and generalized seizures. The most common setting for tranexamic acid-induced seizures has been during cardiovascular surgery (a setting in which CYKLOKAPRON is not FDA-approved and which uses doses of up to 10-fold higher than the recommended human dose and in patients inadvertently given tranexamic acid via the neuraxial route). CYKLOKAPRON is contraindicated for neuraxial administration (i.e., epidural, intrathecal). Consider dose reduction during surgery and dose adjustments for patients with clinical conditions such as renal dysfunction. Closely monitor the patient during surgery. Consider electroencephalogram (EEG) monitoring for patients with history of seizures or who experience myoclonic movements, twitching, or show evidence of focal seizures. Discontinue CYKLOKAPRON if seizures occur.

6 Adverse Reactions

Additions and/or revisions underlined:

The following clinically significant adverse reactions are described elsewhere in the labeling:

Risk of Medication Errors Due to Incorrect Route of Administration [see Warnings and Precautions (5.1)]
Thromboembolic Risk [see Warnings and Precautions (5.2)]
Seizures [see Warnings and Precautions (5.3)]
Hypersensitivity Reactions [see Warnings and Precautions (5.4)]
Visual Disturbances [see Warnings and Precautions (5.5)]
Dizziness [see Warnings and Precautions (5.6)]

02/04/2021 (SUPPL-47)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Risk of Medication Errors Due to Incorrect Route of Administration

(Newly added section)

CYKLOKAPRON is for intravenous use only. Serious adverse reactions including seizures and cardiac arrythmias have occurred when CYKLOKAPRON was inadvertently administered intrathecally instead of intravenously.

Confirm the correct route of administration for CYKLOKAPRON and avoid confusion with other injectable solutions that might be administered at the same time as CYKLOKAPRON. Syringes containing CYKLOKAPRON should be clearly labeled with the intravenous route of administration.

06/07/2020 (SUPPL-44)

Approved Drug Label (PDF)

Other

(Physicians Labeling Rule (PLR) conversion: please refer to label)

(Pregnancy and Lactation Labeling Rule (PLLR) conversion: please refer to label)

11/21/2017 (SUPPL-41)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

(Additions and/or revisions are underlined)

Cases of allergic reaction with use of intravenous tranexamic acid, including anaphylaxis or anaphylactoid reaction have been reported that are suggestive of a causal relationship.

6 Adverse Reactions

(Additions and/or revisions are underlined)

Anaphylaxis or anaphylactoid reaction have been reported that are suggestive of a causal relationship.