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.

COLCRYS (NDA-022352)

(COLCHICINE)

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

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05/14/2020 (SUPPL-26)

Approved Drug Label (PDF)

6 Adverse Reactions

Postmarketing Experience

(Additions and/or revisions underlined)

The following adverse reactions have been identified with colchicine. These have been

generally reversible upon temporarily interrupting treatment or lowering the dose of

colchicine. 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.

8 Use in Specific Populations

Females and Males of Reproductive Potential

(PLLR conversion. Please refer to label for complete information.)

Lactation

(PLLR conversion. Please refer to label for complete information.)

Pediatric Use

(Newly added information)

Safety and effectiveness of colchicine in pediatric patients with gout has not been established.

Pregnancy

(PLLR conversion. Please refer to label for complete information.)

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

Medication Guide

(Additions and/or revisions underlined)

• Talk to your healthcare provider or pharmacist before taking any new medicine.

• Especially tell your healthcare provider if you take:

o darunavir (Prezista)

Before you take COLCRYS, tell your healthcare provider about all your medical conditions, including if you:

• are a male with a female partner who can become pregnant. Receiving treatment with COLCRYS may be related to infertility in some men that is reversible when treatment is stopped.

For more information, go to www.COLCRYS.com or call 1-877-TAKEDA-7 (1-877-825-3327).

Patient Counseling Information

Infertility

(Newly added information)

Advise males of reproductive potential that COLCRYS may rarely and transiently impair fertility [see Use in Specific Populations (8.3)].