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.

TACLONEX (NDA-022185)

(BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE)

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

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07/25/2019 (SUPPL-27)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Effects on Endocrine System

Extensively changed; please refer to label for complete information.

5.5 Ophthalmic Adverse Reactions replaces Eye Irritation

Newly added information:

Use of topical corticosteroids, including Taclonex Topical Suspension, may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported with the postmarketing use of topical corticosteroid products. Avoid contact of Taclonex Topical Suspension with eyes. Taclonex Topical Suspension may cause eye irritation. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

6 Adverse Reactions

6.1 Clinical Trials Experience

Newly added information:

Clinical Trial Conducted in Subjects 12 to 17 years with Psoriasis of the Scalp and Body

In an uncontrolled clinical trial, 107 subjects aged 12 to 17 years with plaque psoriasis of the scalp and body applied Taclonex Topical Suspension once daily for up to 8 weeks. The median weekly dose was 26.6 grams. Adverse reactions were folliculitis, acne, and erythema (0.9% each).

6.2 Postmarketing Experience

Newly added information:

Ophthalmic adverse reactions of cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported during use of topical corticosteroids, including topical betamethasone products.

8 Use in Specific Populations

PLLR conversion for 2 subsections below:

8.1 Pregnancy

8.2 Lactation

Additions and/or revisions underlined:

8.4 Pediatric Use

The safety and effectiveness of Taclonex Topical Suspension for the treatment of plaque psoriasis of the scalp and body have been established in pediatric patients age 12 to 17 years. The use of Taclonex Topical Suspension for this indication is supported by evidence from adequate and well-controlled trials in adults and from three uncontrolled trials in pediatric subjects that enrolled 109 adolescents with moderate psoriasis of the scalp and 107 adolescents with psoriasis of the scalp and body. After 4 weeks of once daily treatment with Taclonex Topical Suspension, HPA axis suppression was observed in 3% of adolescents with psoriasis of the scalp and 16% of adolescents with psoriasis of the scalp and body. Calcium metabolism was evaluated in 107 adolescents with psoriasis of the scalp and body treated with Taclonex Topical Suspension and no cases of hypercalcemia or clinically relevant changes in urinary calcium were reported. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical corticosteroids. Pediatric patients are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency with the use of topical corticosteroids including Taclonex Topical Suspension.

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

PATIENT COUNSELING INFORMATION

Extensively changed; please refer to label for complete information.

PATIENT INFORMATION

What are the possible side effects of Taclonex Topical Suspension? Taclonex Topical Suspension may cause serious side effects, including:

Newly added information:

Eye problems. Using Taclonex Topical Suspension may increase your chance of getting cataracts and glaucoma. Do not get Taclonex Topical Suspension in your eyes because it may cause eye irritation. Tell your healthcare provider if you have blurred vision or other vision problems during treatment with Taclonex Topical Suspension.