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.

ELOCON (NDA-019625)

(MOMETASONE FUROATE)

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

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07/06/2026 (SUPPL-27)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Endocrine Systems Adverse Reactions

Subsection title revised

Additions and/or revisions underlined:

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

. . .

Cushing’s Syndrome, Hyperglycemia, and Glucosuria

Systemic effects of topical corticosteroids, including ELOCON cream, may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria.

Additional Considerations

Concomitant use of ELOCON cream with other corticosteroid-containing products may increase total systemic corticosteroid exposure, and result in increased risk for adverse reactions.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)].

Minimize the risk of adverse reactions by using ELOCON cream as recommended [see Dosage and Administration (2)].

5.3 Allergic Contact Dermatitis

Additions and/or revisions underlined:

Use of topical corticosteroids, including ELOCON cream, can cause allergic contact dermatitis. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation. Corroborate such an observation with appropriate diagnostic patch testing. If allergic contact dermatitis develops, discontinue ELOCON cream and institute appropriate therapy.

5.4 Concomitant Skin Infections

Additions and/or revisions underlined:

Use of topical corticosteroids, including ELOCON cream, may delay healing or worsen concomitant skin infections. If concomitant skin infections are present or develop, treat with an appropriate antimicrobial agent. If a favorable response does not occur promptly, gradually withdraw ELOCON cream and discontinue use until the infection has been adequately controlled.

6 Adverse Reactions

Newly added information

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

Endocrine System Adverse Reactions [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)]
Ophthalmic Adverse Reactions [see Warnings and Precautions (5.2)]
Allergic Contact Dermatitis [see Warnings and Precautions (5.3)]
Concomitant Skin infections [see Warnings and Precautions (5.4)]

6.2 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identified during postapproval use of topical corticosteroids.

. . .

Endocrine Disorders: Cushing’s syndrome, linear growth retardation, and delayed weight gain.
Local Adverse Reactions: irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, striae, and miliaria.
Nervous System Disorders: intracranial hypertension.
Ophthalmic Adverse Reactions: blurred vision, cataracts, glaucoma, and increased intraocular pressure

8 Use in Specific Populations

8.1 Pregnancy

PLLR Conversion

Additions and/or revisions underlined:

Risk Summary

There are no adequate and well-controlled studies in pregnant women. Available data from postmarketing reports and published observational studies over decades of use with mometasone furoate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal outcomes. Maternal use of potent or very potent topical

corticosteroids may be associated with an increased risk of low birth weight infants (see Data). Advise pregnant women to use ELOCON cream on the smallest area of skin and for the shortest duration possible.

When administered subcutaneously, orally, or topically to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy (see Data). The available data do not allow the calculation of relevant comparisons between the systemic exposure of mometasone furoate observed in animal studies to the systemic exposure that would be expected in humans after topical use of ELOCON cream.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data

Human Data

Published data from one observational study that included 60,497 pregnancies exposed to topical corticosteroids, including 10,056 pregnancies exposed to topical mometasone, did not identify an increased risk of low birth weight infants. However, data from other observational studies demonstrate that maternal use of potent to very potent topical corticosteroids was associated with an increased risk of low birth weight infants, especially when the cumulative dosage throughout pregnancy was greater than 300 grams. Available studies have limitations including confounding by disease severity, imprecision in birth weight outcomes, and data reliance on filled prescriptions rather than actual use.

Animal Data

In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above.

Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg.

In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above.

Mometasone furoate produced delays in ossification, but no malformations at 300 mcg/kg.

In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above. In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg.

When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival were observed at 15 mcg/kg. Similar effects were not observed at 7.5 mcg/kg.

8.2 Lactation

PLLR Conversion

Additions and/or revisions underlined:

Risk Summary

There are no data on the presence of mometasone furoate following topical administration in animal or human milk, the effects on the breastfed infant, or the effects on milk production. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. To minimize potential exposure to the breastfed infant via breast milk, use ELOCON cream on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply ELOCON cream directly to the nipple and areola to avoid direct infant exposure [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ELOCON cream and any potential adverse effects on the breastfed infant from ELOCON cream or from the underlying maternal condition.

8.3 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of ELOCON cream for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses have been established in pediatric patients 2 years of age and older. Use of ELOCON cream for this indication is supported by evidence from a clinical trial in 24 subjects (19 subjects 2 to 12 years of age) with atopic dermatitis treated with ELOCON cream once daily [see Adverse Reactions (6.1) and Clinical Studies (14)].

The safety and efficacy of ELOCON cream have not been established in pediatric patients younger than 2 years of age. The safety and efficacy of ELOCON cream use for longer than three weeks have not been established in pediatric patients 2 years of age and older.

The following adverse reactions were reported to be possibly or probably related to treatment with ELOCON cream during clinical trials in 4% of 182 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 2; paresthesia, 2; folliculitis, 1; moniliasis, 1; bacterial infection, 1; skin depigmentation, 1. The following signs of skin atrophy were also observed among 97 subjects treated with ELOCON cream in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; thinness, 1; and bruising, 1.

Endocrine Adverse Reactions

Ninety-seven pediatric subjects ages 6 to 23 months with atopic dermatitis were enrolled in an open-label HPA axis safety study. ELOCON cream caused HPA axis suppression in approximately 16% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and applied ELOCON over a mean body surface area of 41% (range 15%-94%). The criteria for suppression were: basal cortisol level of less than or equal to 5 mcg/dL, 30-minute post-stimulation level of less than or equal to 18 mcg/dL, or an increase of less than 7 mcg/dL. Follow-up testing 2 to 4 weeks after trial completion, available for 5 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria.

ELOCON cream is not indicated for use in pediatric patients younger than 2 years of age [see Clinical Pharmacology (12.2)].

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids [see Warnings and Precautions (5.1)]. They are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids.

. . .

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Important Administration Instructions

Inform patients of the following [see Dosage and Administration (2)]:

Use ELOCON cream as directed by the healthcare provider. It is for external use only. Wash hands after use.
Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, contact the healthcare provider.
Avoid contact with the eyes.
Avoid using ELOCON cream on the face, underarms, or groin areas.
Do not bandage or otherwise cover or wrap the treated skin area so as to be occlusive. Do not use ELOCON cream in the treatment of diaper dermatitis.
Endocrine System Adverse Reactions
Advise patients that ELOCON cream may cause HPA axis suppression. Inform patients that use of topical corticosteroids, including ELOCON cream, may require periodic evaluation for HPA axis suppression. Topical corticosteroids may have other endocrine effects Instruct patients not to use other corticosteroid-containing products while using ELOCON cream without first consulting their healthcare provider [see Warnings and Precautions (5.1)].
Ophthalmic Adverse Reactions
Advise patients to report any visual symptoms to their healthcare provider [see Warnings and Precautions (5.2)].
Allergic Contact Dermatitis
Advise patients to report any signs of allergic contact dermatitis to their healthcare provider [see Warnings and Precautions (5.3)].
Pregnancy and Lactation
Advise patients that may become pregnant to use ELOCON cream on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding patients not to apply ELOCON cream directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.1, 8.2)].

PATIENT INFORMATION

Additions and/or revisions underlined:

. . .

Before using ELOCON cream, tell your healthcare provider about all your medical conditions, including if you:

have had irritation or other skin reaction to a steroid medicine in the past.
have a skin infection at the site to be treated. You may need medicine to treat the skin infection before using ELOCON cream.
have thinning of the skin (atrophy) at the treatment site.
have diabetes.
have adrenal gland problems.
have liver problems.
are pregnant or plan to become pregnant. It is not known if ELOCON cream will harm your unborn baby. If you use ELOCON cream during pregnancy, use ELOCON cream on the smallest area of the skin and for the shortest time needed.
are breastfeeding or plan to breastfeed. It is not known if ELOCON cream passes into your breast milk. If you use ELOCON cream and breastfeed, use ELOCON cream t on the smallest area of the skin and for the shortest time needed. Do not apply ELOCON cream directly to the nipple and areola to avoid contact with your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids. Do not use other products containing a corticosteroid medicine while
using ELOCON cream without talking to your healthcare provider first.
. . .

What are the possible side effects of ELOCON

. . .

Cushing’s syndrome, a condition that happens when your body is exposed to too much of the hormone cortisol.
High blood sugar (hyperglycemia).

05/21/2018 (SUPPL-26)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions are underlined)

ELOCON Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

5 Warnings and Precautions

5.2 Ophthalmic Adverse Reactions

(Newly Added Subsection)

Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products, including the topical mometasone products.

Avoid contact of ELOCON Ointment with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions and/or revisions are underlined)

Because adverse 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.

Postmarketing reports for local adverse reactions to topical corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. These adverse reactions may occur more frequently with the use of occlusive dressings.

Postmarketing reports for ophthalmic adverse reactions to topical corticosteroids include blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of the following:

Advise patients to report any visual symptoms to their healthcare providers.
Do not bandage or otherwise cover or wrap the treated skin area so as to be occlusive, unless directed by the physician.