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warnings and cautions
5 WARNINGS AND PRECAUTIONS Allergic/ Hypersensitivity Reactions: Allergy/hypersensitivity reactions include anaphylaxis, angioedema, urticaria, and pruritis. Discontinue DIFFERIN Lotion in the event of an allergic/hypersensitivity reaction. ( 5.1 ) Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided. ( 5.2 ) Local Cutaneous reactions: Erythema, scaling, dryness, and stinging/burning may occur with use of DIFFERIN Lotion. Avoid application of DIFFERIN Lotion to cuts, abrasions, eczematous or sunburned skin. Avoid concomitant use of other potentially irritating topical products (abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes). ( 5.3 ) 5.1 Allergic/ Hypersensitivity Reactions Anaphylaxis, angioedema, urticaria, face edema, eyelid edema, lip swelling, and pruritus that sometimes required medical treatment have been reported during postmarketing use of adapalene. Advise a patient to stop using DIFFERIN Lotion and seek medical attention if experiencing allergic or anaphylactoid/anaphylactic reactions during treatment. 5.2 Ultraviolet Light and Environmental Exposure Avoid exposure to sunlight, including sunlamps, during the use of DIFFERIN Lotion. Patients with high levels of sun exposure and those with inherent sensitivity to sun should be warned to exercise caution. Use of sunscreen products and protective apparel (e.g., hat) are recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, may be irritating to patients under treatment with DIFFERIN Lotion.. 5.3 Local Cutaneous Reactions Signs and symptoms of local skin irritation (such as erythema, scaling, dryness, stinging/burning) may be experienced with use of DIFFERIN Lotion. These are most likely to occur during the first 2 weeks of treatment, are mostly mild to moderate in severity, and usually lessen with continued use of DIFFERIN Lotion. Depending upon the severity of these side effects, patients should be instructed to use a moisturizer, reduce the frequency of the application of DIFFERIN Lotion or discontinue use. Avoid application of DIFFERIN Lotion to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with DIFFERIN Lotion. Avoid concomitant use of other potentially irritating topical products (abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes).
6 ADVERSE REACTIONS The most common adverse reactions reported (≥ 1%) are dry skin and skin irritation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 2141 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks. Of these, 1068 were exposed to DIFFERIN Lotion during the clinical trials. A total of 1057 subjects completed at least one post treatment evaluation. Related adverse reactions that were reported in at least 1% of subjects treated with DIFFERIN Lotion or with the Vehicle Lotion are presented in Table 1. The majority of cases were transient, mild to moderate in severity and were managed with moisturizers. Table 1: Adverse Reactions Reported in Clinical Trials by At Least 1% of Subjects System Organ Class/Preferred Term Adapalene Lotion 0.1% N = 1068 Vehicle Lotion N = 1073 Subjects with Related AR(s) 10.2% 4.6% Dry Skin 7.7% 3.0% Skin irritation 1.5% 0.7% Skin burning/skin discomfort 0.9% 0.0% Sunburn 0.6% 0.6% Local tolerability evaluations, presented in Table 2, were conducted at each study visit in clinical trials. Erythema, scaling, dryness, burning/stinging were assessed: Table 2: Incidence of Local Cutaneous Irritation, for Subjects Whose Irritation Score was Higher than at Baseline, in Controlled Clinical Trials Adverse Reactions (DIFFERIN Lotion Group N = 1057*) Combined Trial 1 and Trial 2 Maximum Severity During Treatment (N = 1057) Week 12 Treatment Severity (N = 950) Local Cutaneous Irritation (skin irritation) Mild Moderate Severe Mild Moderate Severe Erythema 21.8% 8.0% 0.2% 7.9% 2.6% 0.2% Scaling 25.3% 6.5% 0.1% 5.3% 1.1% 0% Dryness 36.1% 7.3% 0.3% 7.6% 2.0% 0% Stinging/burning 22.1% 7.0% 0.9% 4.6% 1.0% 0.4% * Data from 11 subjects with missing data are not included Local tolerability scores for erythema, scaling, dryness, burning/stinging rose during the first two weeks of treatment and generally decreased thereafter. In an open label postmarketing pharmacokinetic trial of 13 adolescent subjects, the adverse reaction of pruritus was reported in 8 out of 13 subjects. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of adapalene: Immune system disorders: angioedema, face edema, lip swelling Skin disorders: application site pain Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.