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.

LOCOID LIPOCREAM (NDA-020769)

(HYDROCORTISONE BUTYRATE)

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

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10/03/2024 (SUPPL-15)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Endocrine System Adverse Reactions

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

Use of topical corticosteroids, including Locoid Lipocream, can cause systemic adverse reactions including HPA-axis suppression with the potential for clinical glucocorticosteroid insufficiency. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Consider patients for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH1-24) stimulation testing (CST). If HPA-axis suppression is noted, reduce the frequency of application or withdraw Locoid Lipocream, or substitute a less potent corticosteroid. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.

Studies conducted in pediatric subjects demonstrated reversible HPA-axis suppression after use of Locoid Lipocream. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Locoid Lipocream due to their larger skin-surface-to-body-mass ratios [see Use in Specific Populations (8.4), Clinical Pharmacology (12.2)].

Cushing’s Syndrome, Hyperglycemia, and Glucosuria

Systemic adverse reactions of topical corticosteroids, including Locoid Lipocream, may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria.

Additional Considerations for Endocrine Adverse Reactions

Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure.

Minimize systemic corticosteroid effects by mitigating the risk factors for increased systemic absorption and using Locoid Lipocream as recommended [see Dosage and Administration (2)].

5.2 Ophthalmic Adverse Reactions

Newly added subsection:

Use of topical corticosteroids, including Locoid Lipocream, 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 [see Adverse Reactions (6.2)].

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

5.3 Skin Infections

Additions and revisions underlined:

Use of topical corticosteroids, including Locoid Lipocream, may delay healing or worsen concomitant skin infections. If skin infections are present or develop, use an appropriate antifungal, antibacterial or antiviral agent. If a favorable response does not occur promptly, discontinue use of Locoid Lipocream until the infection has been adequately controlled.

5.4 Allergic Contact Dermatitis

Additions and revisions underlined:

Use of topical corticosteroids, including Locoid Lipocream, can cause allergic contact dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation. Such an observation should be corroborated with appropriate patch testing. Discontinue Locoid Lipocream if the diagnosis is established.

6 Adverse Reactions

Additions and revisions underlined:

The following adverse reactions are discussed in greater 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)]
Skin infections [see Warnings and Precautions (5.3)]
Allergic contact dermatitis [see Warnings and Precautions (5.4)]

6.1Clinical Trials Experience

Extensive changes; please refer to label

6.2 Postmarketing Experience

Additions and revisions underlined:

The following adverse reactions have been reported during post approval use of topical corticosteroids, including Locoid Lipocream. 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.

Local Adverse Reactions: burning, itching, drying, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

Ophthalmic Adverse Reactions: blurred vision, cataracts, glaucoma, and increased intraocular pressure.

8 Use in Specific Populations

8.1 Pregnancy

Extensive changes; please refer to label

8.2 Lactation

Additions and revisions underlined:

Risk Summary

There are no data on the presence of hydrocortisone in human or animal milk, the effects on the breastfed infant, or the effects on milk production after treatment with Locoid Lipocream.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of Locoid Lipocream could result in sufficient systemic absorption to produce detectable quantities in human milk.

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

8.4 Pediatric Use

Additions and revisions underlined:

Corticosteroid-Responsive Dermatoses

The safety and efficacy of Locoid Lipocream for relief of the inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses have not been established in pediatric patients.

Atopic Dermatitis

The safety and effectiveness of Locoid Lipocream for the topical treatment of mild to moderate atopic dermatitis have been established in pediatric patients 3 months of age and older. Use of Locoid Lipocream for this indication is supported by evidence from a multicenter, randomized, vehicle-controlled trial of 264 pediatric subjects 3 months of age and older [see Clinical Studies (14)].

The safety and efficacy of Locoid Lipocream for the topical treatment of mild to moderate atopic dermatitis have not been established in pediatric patients younger than 3 months of age.

Endocrine Adverse Reactions

Eighty-six (86) subjects (between 5 months and 18 years of age) with moderate to severe atopic dermatitis affecting at least 25% of body surface area (BSA) treated with Locoid Lipocream 3 times daily for up to 4 weeks were assessed for HPA-axis suppression in two separate studies. . Five of the 82 evaluable subjects (6.1%) demonstrated evidence of suppression, where the criterion for defining HPA-axis suppression was a serum cortisol level of ?18 mcg/dL after cosyntropin stimulation. At the first follow-up visit, approximately 1 month after the conclusion of treatment, cosyntropin stimulation results of all subjects had returned to normal, with the exception of one subject. This last subject recovered adrenal function by 65 days post-treatment [see Clinical Pharmacology (12.2)].

Because of higher skin-surface-to-body-mass ratios, pediatric patients are at a greater risk than adults of HPA-axis suppression when they are treated with topical corticosteroids [see Warnings and Precautions (5.1)]. They are therefore also at a greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing’s syndrome while on treatment. Manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels in response to ACTH stimulation.

Linear growth retardation, delayed weight gain, and intracranial hypertension have also been reported in pediatric patients receiving topical corticosteroids. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

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

PATIENT COUNSELING INFORMATION

Extensive changes; please refer to label