The US FDA ‘Black Box’ Warning for Topical Calcineurin Inhibitors

Ring, Johannes; Möhrenschlager, Matthias; Henkel, Verena

doi:10.2165/00002018-200831030-00001

Cited by 93 publications

(68 citation statements)

References 73 publications

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“…Therefore, these data support the use of topical calcineurin inhibitors for CLE, considering the guidelines, as outlined in the manufacturer's prescribing information. 34 In conclusion, off-label treatment with 0.1% tacrolimus ointment reduced edema and erythema in CLE skin lesions most effectively. These observations suggest that patients with LET and ACLE as well as early inflammatory skin lesions without prominent hyperkeratosis show the highest response to the treatment.…”

Section: Discussionmentioning

confidence: 81%

“…Nevertheless, in 2005, the Pediatric Advisory Committee of the US Food and Drug Administration implemented a 'black box' warning for tacrolimus ointment because of the lack of longterm safety data and the potential risk of the development of malignancies, which is still an ongoing controversy. 34 Therefore, tacrolimus ointment should be applied along with high sun protection factor sunscreens if used on sun-exposed areas, such as the face.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Efficacy of tacrolimus 0.1% ointment in cutaneous lupus erythematosus: A multicenter, randomized, double-blind, vehicle-controlled trial

Kuhn

Gensch

Haust

et al. 2011

Journal of the American Academy of Dermatology

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Section: Discussionmentioning

confidence: 81%

Section: Discussionmentioning

confidence: 99%

Efficacy of tacrolimus 0.1% ointment in cutaneous lupus erythematosus: A multicenter, randomized, double-blind, vehicle-controlled trial

Kuhn

Gensch

Haust

et al. 2011

Journal of the American Academy of Dermatology

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“…In addition, the Food and Drug Administration has issued a so-called "black box" or boxed warning for TCIs, citing a potential cancer risk with the medication, on the basis of the observation that laboratory animals exposed to high doses of systemic calcineurin inhibitors developed malignancies more frequently and on rare case reports of adult patients using TCIs who developed lymphoma and skin cancers. 46 However, the cause-and-effect relationship between TCI use and malignancy in these case reports is unclear. Reassuringly, TCIs have been used in children for more than 15 years, there have been no reports of malignancy in children, and there is little to no concern for systemic absorption or systemic immunosuppression.…”

Section: Topical Antiinflammatory Medicationsmentioning

confidence: 90%

Atopic Dermatitis: Skin-Directed Management

Tollefson¹,

Bruckner²,

Dermatology³

2014

Pediatrics

111

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Atopic dermatitis is a common inflammatory skin condition characterized by relapsing eczematous lesions in a typical distribution. It can be frustrating for pediatric patients, parents, and health care providers alike. The pediatrician will treat the majority of children with atopic dermatitis as many patients will not have access to a pediatric medical subspecialist, such as a pediatric dermatologist or pediatric allergist. This report provides up-to-date information regarding the disease and its impact, pathogenesis, treatment options, and potential complications. The goal of this report is to assist pediatricians with accurate and useful information that will improve the care of patients with atopic dermatitis. Pediatrics 2014;134:e1735-e1744Atopic dermatitis (AD), commonly referred to as eczema, is a chronic, relapsing, and often intensely pruritic inflammatory disorder of the skin. A recent epidemiologic study using national data suggested that the pediatric prevalence is at least 10% in most of the United States. 1 AD primarily affects children, and disease onset occurs before the ages of 1 and 5 years in 65% and 85% of affected children, respectively. 1 The number of office visits for children with AD is increasing. 2 Up to 80% of children with AD are diagnosed and managed by primary care providers, often pediatricians. 3 Although medical subspecialists, such as pediatric dermatologists and/or pediatric allergists, may be suited to provide more advanced care for children with AD, lack of a sufficient number of such physicians, particularly pediatric dermatologists, 4 likely means the burden of AD care will continue to fall to primary care providers. Although consensus guidelines and practice parameters regarding the management of AD in children have been published, 5-10 considerable variability persists in clinical practice, particularly regarding the roles that bathing, moisturizing, topical medications, and allergies play in management. Inconsistencies in opinion and treatment approach as well as the chronic and relapsing nature of AD can lead to frustration for the patient, family, and primary care providers when managing AD. STATEMENT OF THE PROBLEMNew data support the theory that AD results from primary abnormalities of the skin barrier, 11 suggesting that skin-directed management of AD is of paramount importance. This clinical report reviews AD and provides an up-to-date approach to skin-directed management that is based on pathogenesis. Effectively using this information to create treatment plans

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“…Steroid related atrophy has not been observed with topical calcineurin inhibitors, such as tacrolimus [29]. Since calcineurin inhibitors also have side-effects, such as sensation of burning at the side of application and rare cases of malignancy have been reported [30,31], a pressure to develop and test new topical therapeutics exists.…”

Section: Discussionmentioning

confidence: 99%