Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

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.

ASACOL (NDA-019651)

(MESALAMINE)

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

Download Data

Expand all

10/01/2020 (SUPPL-28)

Approved Drug Label (PDF)

5 Warnings and Precautions

Renal Impairment

(Additions and/or revisions underlined)

Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure, has been reported in patients taking products such as Asacol that contain mesalamine or are converted to mesalamine [see Adverse Reactions (6.2)]. In animal studies, the kidney was the principal organ of mesalamine toxicity [see Adverse Reactions (6.2), Nonclinical Toxicology (13.2)].

Mesalamine-Induced Acute Intolerance Syndrome

(Additions and/or revisions underlined)

Symptoms include cramping, abdominal pain, bloody diarrhea, and sometimes fever, headache, malaise, pruritis, rash, and conjunctivitis. Monitor patients for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with Asacol.

Photosensitivity

(Newly added subsection)

Patients treated with mesalamine or sulfasalazine who have pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Advise patients to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors.

Nephrolithiasis

(Newly added subsection)

Cases of nephrolithiasis have been reported with the use of mesalamine, including stones of 100% mesalamine content. Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure adequate fluid intake during treatment with Asacol.

Interference with Laboratory Tests

(Newly added subsection)

Use of Asacol may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection because of the similarity in the chromatograms of normetanephrine and the main metabolite of mesalamine, N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). Consider an alternative, selective assay for normetanephrine.

6 Adverse Reactions

(Additions and/or revisions underlined)

The following serious or clinically significant adverse described elsewhere in labeling are:

Renal Impairment [see Warnings and Precautions (5.1)]
Mesalamine-Induced Acute Intolerance Syndrome [see Warnings and Precautions (5.2)]
Hypersensitivity Reactions [see Warnings and Precautions (5.3)]
Hepatic Failure [see Warnings and Precautions (5.4)]
Photosensitivity [see Warnings and Precautions (5.5)]
Nephrolithiasis [see Warnings and Precautions (5.6)]

6.2 Postmarketing Experience

(Additions and/or revisions underlined)

Renal: Renal failure, interstitial nephritis, minimal change disease, nephrolithiasis [see Warnings and Precautions (5.1), (5.6)].

7 Drug Interactions

Interference With Urinary Normetanephrine Measurements

(Newly added information)

Use of Asacol may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection [see Warnings and Precautions (5.7)]. Consider an alternative, selective assay for normetanephrine.

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

Patient Counseling Information

(Additions and/or revisions underlined)

Drink an adequate amount of fluids.
Renal Impairment
- Inform patients that Asacol may decrease their renal function, especially if they have known renal impairment or are taking nephrotoxic drugs, including NSAIDS, and periodic monitoring of renal function will be performed while they are on therapy. Advise patients to complete all blood tests ordered by their physician.

Mesalamine-Induced Acute Intolerance Syndrome and other Hypersensitivity Reactions

(Section title revised)

Inform patients of the signs and symptoms of hypersensitivity reactions. Instruct patients to stop taking Asacol and report to their healthcare provider if they experience new or worsening symptoms of Acute Intolerance Syndrome ( cramping, abdominal pain, bloody diarrhea, and sometimes fever, headache, malaise, conjunctivitis and rash) or other symptoms suggestive of mesalamine-induced hypersensitivity [see Warnings and Precautions (5.2, 5.3)].

Photosensitivity

Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors [see Warnings and Precautions (5.5)].

Nephrolithiasis

Instruct patients to maintain an adequate fluid intake in order to minimize the risk of kidney stone formation and to contact their healthcare provider if they experience signs or symptoms of a kidney stone (e.g., severe side or back pain, blood in the urine) [see Warnings and Precautions (5.6)].

07/27/2017 (SUPPL-27)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions underlined)

…

Endocrine: Nephrogenic diabetes insipidus.

…

Nervous: Depression, somnolence, emotional lability, hyperesthesia, vertigo, confusion, tremor, peripheral neuropathy, transverse myelitis, Guillain-Barré syndrome, intracranial hypertension.

…