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.

IMITREX (NDA-020626)

(SUMATRIPTAN)

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

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12/09/2025 (SUPPL-29)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

Reproductive System and Breast Disorders

Breast pain [see Use in Specific Populations (8.2)].

8 Use in Specific Populations

8.2 Lactation

Additions and/or revisions underlined:

Risk Summary

Sumatriptan is excreted in human milk following subcutaneous administration. There is no information regarding sumatriptan concentrations in milk from lactating women following administration of IMITREX nasal spray. There are no data on the effects of sumatriptan on the breastfed infant or the effects of sumatriptan on milk production. Use of sumatriptan may be associated with transient breast pain [see Adverse Reactions (6.2)].

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for IMITREX nasal spray and any potential adverse effects on the breastfed infant from sumatriptan or from the underlying maternal condition.

Clinical Considerations

Infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with IMITREX nasal spray.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Lactation

Advise breastfeeding women that they may develop transient breast pain when taking IMITREX. Advise breastfeeding women that avoiding breastfeeding for 12 hours after treatment with IMITREX can minimize their infant’s exposure to sumatriptan [see Use in Specific Populations (8.2)].

…

IMITREX is a trademark owned by or licensed to the GSK group of companies. The other brand listed is a trademark owned by or licensed to its owner and is not owned by or licensed to the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.

12/14/2017 (SUPPL-27)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.9 Local Irritation

(new subsection added)

Local irritative symptoms such as burning, numbness, paresthesia, discharge, and pain or soreness were reported in approximately 5% of patients in controlled clinical trials and were noted to be severe in about 1%. The symptoms were transient and generally resolved in less than 2 hours. Limited examinations of the nose and throat did not reveal any clinically noticeable injury in these patients. The consequences of extended and repeated use of IMITREX nasal spray on the nasal and/or respiratory mucosa have not been systematically evaluated in patients.

6 Adverse Reactions

(addition underlined)

…

Local irritation

...

6.1 Clinical Trials Experience

(additions underlined)

…

The incidence of adverse reactions in controlled clinical trials was not affected by gender, weight, or age of the patients; use of prophylactic medications; or presence of aura. There were insufficient data to assess the impact of race on the incidence of adverse reactions.

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion, please refer to label)

8.2 Lactation

(PLLR conversion, additions underlined)

Risk Summary

Sumatriptan is excreted in human milk following subcutaneous administration (see Data). There is no information regarding sumatriptan concentrations in milk from lactating women following administration of IMITREX nasal spray. There are no data on the effects of sumatriptan on the breastfed infant or the effects of sumatriptan on milk production.

Clinical Considerations

Infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with IMITREX nasal spray.

Data

Following subcutaneous administration of a 6 mg dose of IMITREX injection in 5 lactating volunteers, sumatriptan was present in milk.

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

PATIENT COUNSELING INFORMATION

(additions underlined)

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant.

Lactation

Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed.

…

Local Irritation

Inform patients that they may experience local irritation of their nose and throat. The symptoms will generally resolve in less than 2 hours.

How to Use IMITREX Nasal Spray

Provide patients instruction on the proper use of IMITREX nasal spray. Caution patients to avoid spraying the contents of the device in their eyes.

Patient Information

(additions underlined)

…

Before taking IMITREX, tell your healthcare provider about all of your medical conditions, including if you:

…

are pregnant or plan to become pregnant. It is not known if IMITREX can harm your unborn baby.
are breastfeeding or plan to breastfeed. IMITREX passes into your breast milk. It is not known if this can harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take IMITREX.

…

How should I use IMITREX?

…

It is not known how using IMITREX nasal spray for a long time affects the nose and throat.

…

What are the possible side effects of IMITREX?

IMITREX may cause serious side effects. See “What is the most important information I should know about IMITREX?”

These serious side effects include:

…

local irritation. Some people who use IMITREX nasal spray may have irritation of their throat and nose. Symptoms of local irritation of the throat and nose include: burning, numbness, tingling sensation, nasal discharge, pain or soreness.