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.

NIASPAN (NDA-020381)

(NIACIN)

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

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05/02/2022 (SUPPL-55)

Approved Drug Label (PDF)

6 Adverse Reactions

Additions underlined

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Mortality and Coronary Heart Disease Morbidity [see Warnings and Precautions (5.1)]
Skeletal Muscle (rhabdomyolysis) [see Warnings and Precautions (5.2)]
Liver Dysfunction [see Warnings and Precautions (5.3)]
Laboratory Abnormalities [see Warnings and Precautions (5.4)]
6.2 Postmarketing Experience
Addition underlined
…
Skin and subcutaneous tissue disorders: maculopapular rash, dry skin, sweating, burning sensation/skin burning sensation, skin discoloration, acanthosis nigricans
…

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

PATIENT INFORMATION

Additions underlined

…

Call your doctor right away if you have any of the side effects listed above.

The most common side effects of NIASPAN include:

…

itching
…

09/09/2020 (SUPPL-54)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

PLLR Conversion; additions and/or revisions underlined:
Risk Summary

Discontinue NIASPAN when pregnancy is recognized in patients receiving the drug for the treatment of hyperlipidemia. Assess the individual risks and benefits of continuing NIASPAN during pregnancy in patients receiving the drug for the treatment of hypertriglyceridemia. Advise patients to inform their healthcare provider of a known or suspected pregnancy.

The potential for embryofetal toxicity with the doses of niacin in NIASPAN is unknown. The available data on NIASPAN use in pregnant women are insufficient to evaluate for a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Animal reproduction studies have not been conducted with niacin or with NIASPAN. Treatment of hypercholesterolemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia for most patients.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

8.2 Lactation

PLLR Conversion; additions and/or revisions underlined:

Risk Summary

Niacin is present in human milk and the amount of niacin increases with maternal supplementation. There is no information on the effects of the doses of niacin in NIASPAN on the breastfed infant or the effects on milk production. Because of the potential for serious adverse reactions in breastfeeding infants, including hepatotoxicity, advise patients not to breastfeed during treatment with NIASPAN.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Pregnancy

Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if NIASPAN should be discontinued [see Use in Specific Populations (8.1)].

Lactation

Advise patients not to breastfeed during treatment with NIASPAN.