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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Colitis: Clindamycin can cause severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of clindamycin. VELTIN Gel should be discontinued if significant diarrhea occurs. (5.1) • Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight, sunlamps, and weather extremes. Wear sunscreen daily. (5.2) 5.1 Colitis Systemic absorption of clindamycin has been demonstrated following topical use. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. If significant diarrhea occurs, VELTIN Gel should be discontinued. Severe colitis has occurred following oral or parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death. Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. 5.2 Ultraviolet Light and Environmental Exposure Exposure to sunlight, including sunlamps, should be avoided during the use of VELTIN Gel. Patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Daily use of sunscreen products and protective apparel (e.g., a hat) are recommended. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with VELTIN Gel.
6 ADVERSE REACTIONS Observed local treatment-related adverse reactions (≥ 1%) in clinical trials with VELTIN Gel were application site reactions, including dryness, irritation, exfoliation, erythema, pruritus, and dermatitis. Sunburn was also reported. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Stiefel Laboratories, Inc. at 1-888-784-3335 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Adverse Reactions in Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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 clinical practice. The safety data reflect exposure to VELTIN Gel in 1,104 subjects with acne vulgaris. Subjects were 12 years and older and were treated once daily in the evening for 12 weeks. Adverse reactions that were reported in ≥1% of subjects treated with VELTIN Gel are presented in Table 1. Table 1. Treatment-Related Adverse Reactions Reported by ≥1% of Subjects VELTIN Gel N = 1,104 n (%) Clindamycin Gel N = 1,091 n (%) Tretinoin Gel N = 1,084 n (%) Vehicle Gel N = 552 n (%) Patients with at least one adverse reaction 140 (13) 38 (3) 141 (13) 17 (3) Application site dryness 64 (6) 12 (1) 62 (6) 3 (1) Application site irritation 50 (5) 4 (<1) 57 (5) 5 (1) Application site exfoliation 50 (5) 2 (<1) 56 (5) 2 (<1) Application site erythema 40 (4) 6 (1) 39 (4) 3 (1) Application site pruritus 26 (2) 7 (1) 23 (2) 6 (1) Sunburn 11 (1) 6 (1) 7 (1) 3 (1) Application site dermatitis 6 (1) 0 (0) 8 (1) 1 (<1) Local skin reactions actively assessed at baseline and end of treatment with a score >0 are presented in Table 2. Table 2. Local Skin Reactions in Subjects Treated With VELTIN Gel VELTIN Gel Vehicle Gel Local Reaction Baseline N = 476 (%) End of Treatment N = 409 (%) Baseline N = 219 (%) End of Treatment N = 209 (%) Erythema 24% 21% 31% 35% Scaling 8% 19% 14% 12% Dryness 11% 22% 18% 13% Burning 8% 13% 8% 4% Itching 17% 15% 22% 14% During the 12 weeks of treatment, each local skin reaction peaked at Week 2 and gradually reduced thereafter.