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.

CLOBEX (NDA-021835)

(CLOBETASOL PROPIONATE)

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

Download Data

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12/21/2018 (SUPPL-15)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Ophthalmic Adverse Reactions

(Newly Added Subsection)

Use of topical corticosteroids, including CLOBEX Spray, may increase the risks of glaucoma and posterior subcapsular cataract. Glaucoma and cataracts have been reported in postmarketing experience with the use of topical corticosteroid products, including topical clobetasol products.

Avoid contact of CLOBEX Spray 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)

Ophthalmic adverse reactions of blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids.

8 Use in Specific Populations

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)

Risk Summary

There are no available data on CLOBEX® Spray use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Observational studies suggest an increased risk of low birthweight in infants with the maternal use of potent or very potent topical corticosteroids (see Data). Advise pregnant women that CLOBEX® Spray may increase the risk of having a low birth weight infant and to use CLOBEX® Spray on the smallest area of skin and for the shortest duration possible.

Animal reproduction studies have not been conducted with CLOBEX® Spray. In an animal reproduction study, subcutaneous administration of clobetasol propionate to pregnant rats at doses greater than 12.5 microgram/kg/day during the period of organogenesis caused an increase in malformations (increased incidence of umbilical hernia). The available data do not allow calculation of relevant comparisons between the systemic exposure of clobetasol propionate in animal studies to the systemic exposure that would be expected in humans after topical use of CLOBEX® Spray.

The estimated 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

Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. However, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants.

Animal Data

Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it caused alformations in both the rabbit and the mouse.

Clobetasol propionate has greater potential for adverse developmental effects than steroids that are less potent.

The effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat. Clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 microgram/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter. The maternal no- observed-adverse-effect-level (NOAEL) for clobetasol propionate was less than 12.5 microgram/kg/day due to reduced body weight gain and feed consumption during the gestation period.

8.2 Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)

Risk Summary

There is no information regarding the presence of clobetasol propionate in human milk or its effects on the breastfed infant or on milk production. It is not known whether topical administration of clobetasol propionate 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 CLOBEX® Spray and any potential adverse effects on the breastfed infant from CLOBEX® Spray or from the underlying maternal condition.

Clinical Considerations

To minimize potential exposure to the breastfed infant via breast milk, use CLOBEX® Spray on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply CLOBEX® Spray directly to the nipple and areola to avoid direct infant exposure

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

17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients

(Additions and/or revisions are underlined)

Advise patients to report any visual symptoms to their healthcare providers.
Advise a woman to use CLOBEX® Spray on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding women not to apply CLOBEX® Spray directly to the nipple and areola to avoid direct infant exposure.