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.

SOLAGE (NDA-020922)

(MEQUINOL; TRETINOIN)

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

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12/02/2019 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Risk of Embryofetal Toxicity

(newly added subsection)

Based on findings in animal studies, Solagé may cause fetal harm. Avoid use in pregnant women.

5.2 Phototoxicity and Risk of Sunburn

(subsection title revised, additions underlined)

…Patients must be advised to use protective clothing and comply with a comprehensive sun avoidance program (including using sunscreen) when using Solagé.

…

5.3 Local Adverse Reactions

(additions underlined)

…

Tretinoin has been reported to cause severe irritation of eczematous skin, including the development of skin fissures. Solagé should be used with caution in patients with this condition.

…

Avoid concomitant use of other potentially irritating topical products (such as products with high concentration of alcohol, astringents, spices or lime, medicated soaps or shampoos, permanent wave solutions, electrolysis, hair depilatories or waxes, or products with a strong skin drying effect). Weather extremes, such as wind or cold may be more irritating to patients using Solagé.

5.4 Hypopigmentation

(newly added subsection)

Hypopigmentation has occurred with Solagé use. Solagé should be used with caution by patients with a history, or family history, of vitiligo, as they might be more susceptible to hypopigmentation, which can also be more severe in these patients.

6 Adverse Reactions

6.1 Clinical Trials Experience

(extensive additions and revisions, please refer to label)

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion, please refer to label)

8.2 Lactation

(PLLR conversion)

Risk Summary

There are no data on the presence of topical tretinoin, mequinol or their metabolites in human milk, the effects on the breastfed infant or the effects on milk production. It is possible that topical administration of large amounts of Solagé could result in sufficient systemic absorption to produce detectable quantities in human milk (see Clinical Considerations). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Solagé and any potential adverse effects on the breastfed infant from Solagé or from the underlying maternal condition.

Clinical Considerations

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

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

PATIENT COUNSELING INFORMATION

(additions underlined)

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

Risk of Embryofetal Toxicity

Based on findings in animal studies, Solagé may cause fetal harm. Avoid use in pregnant women.

Photosensitivity and Risk of Sunburn

Advise patients to avoid excessive sun exposure and to use of sunscreens and protective measures (hat, visor). Advise patients to avoid using Solagé if also taking other medicines may increase sensitivity to sunlight.

Lactation

Advise a woman to use Solagé on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Solagé directly to the nipple and areola to avoid direct infant exposure.

Important Administration Instructions

Advise patients of the following:

Use Solagé twice daily, morning and evening at least 8 hours apart.
Apply Solagé to the solar lentigines using the applicator tip while avoiding application to the surrounding skin.
Do not apply to non-intact skin.
Avoid concomitant use of topical products with a strong drying or irritating effect.
Advise patients not to use more than the recommended amount and not to apply more than twice daily as this will not produce faster or better results but may increase irritation and hypopigmentation.

PATIENT INFORMATION

(extensive changes, please refer to label)