A Safety Assessment of Topical Calcineurin Inhibitors in the Treatment of Atopic Dermatitis

Mark Lebwohl, MD; Tara Gower, PhD


October 10, 2006

Responses From the Medical Community

Since the March 2005 PAC meeting, physicians and professional societies, including the American Academy of Dermatology (AAD), the American College of Allergy, Asthma and Immunology (ACAAI), and the American Academy of Allergy, Asthma and Immunology (AAAAI), have issued statements supporting the safety of TCIs after careful evaluation of the data.[35,36,53,59,60] In particular, the published report of the AAD Task Force (conducted before the TCI label changes) discussed relevant TCI safety data and the clinical impact of the FDA warnings.[35] The following list summarizes key conclusions and recommendations:[35]

  • Negative effects of limiting TCI use

    • Increased topical corticosteroid use and potential for increased adverse events

    • Failure to treat/undertreatment may lead to recurrent infections and further diminish patient/caregiver quality of life

  • Numerous clinical studies of TCIs support their efficacy and safety in children and adults

    • Data from randomized clinical trials are at the top of the hierarchy of clinical evidence

  • Carcinogenicity data from animals, although high-quality, and case reports do not support a causal link between TCI use and malignancy

  • Follow the label guidelines as closely as possible while weighing the risks and benefits of TCI use for each patient (with these risks being effectively communicated to the patient)

  • Monitor patients who use TCIs for any adverse events (encourage enrollment in patient registries).

In response to the PAC meetings and Public Health Advisory for TCIs, the AAD Task Force met on July 21, 2005. This meeting was convened to review the data in regard to possible TCI side effects and provide a useful context for physicians and patients. Key points and recommendations of this report are summarized.[35]


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