"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data reflect exposure to FABIOR Foam in 744 subjects with acne vulgaris. Subjects were aged 12 to 45 years and were treated once daily in the evening for 12 weeks. Adverse reactions reported in ≥ 1% of subjects treated with FABIOR Foam are presented in Table 1. Most adverse reactions were mild to moderate in severity. Severe adverse reactions represented 3.0% of the subjects treated. Overall, 2.6% (20/744) of subjects discontinued FABIOR Foam because of local skin reactions.
Table 1: Incidence of Adverse Reactions in ≥ 1%
of Subjects Treated With FABIOR Foam
N = 744
N = 741
|Patients with any adverse reaction, n (%)||163 (22)||19 (3)|
|Application site irritation||107 (14)||9 (1)|
|Application site dryness||50 (7)||8 (1)|
|Application site erythema||48 (6)||3 ( < 1)|
|Application site exfoliation||44 (6)||3 ( < 1)|
|Application site pain||9 (1)||0|
|Application site photosensitivity (including sunburn)||8 (1)||3 ( < 1)|
|Application site pruritus||7 (1)||3 ( < 1)|
|Application site dermatitis||6 (1)||1 ( < 1)|
Additional adverse reactions that were reported in < 1% of subjects treated with FABIOR Foam included application site reactions (including discoloration, discomfort, edema, rash, and swelling), dermatitis, impetigo, and pruritus.
Local skin reactions, dryness, erythema, and peeling actively assessed by the investigator and burning/stinging and itching reported by the subject were evaluated at baseline, during treatment, and end of treatment. During the 12 weeks of treatment, each local skin reaction peaked at Week 2 and gradually reduced thereafter with the continued use of FABIOR Foam.
Read the Fabior (tazarotene) Side Effects Center for a complete guide to possible side effects
No formal drug-drug interaction studies were conducted with FABIOR Foam.
Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided. It is recommended to postpone treatment until the effects of these products subside before use of FABIOR Foam is started.
Concomitant use with oxidizing agents, such as benzoyl peroxide, may cause degradation of tazarotene and may reduce the clinical efficacy of tazarotene. If combination therapy is required, they should be applied at different times of the day (e.g., one in the morning and the other in the evening).
The impact of tazarotene on the pharmacokinetics of progestin-only oral contraceptives (i.e., minipills) has not been evaluated.
In a trial of 27 healthy female subjects between the ages of 20 to 55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, concomitant use of tazarotene did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/12/2016
Additional Fabior Information
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