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Should Elidel and Protopic have been given a black box warning? How should physicians consider use of TCIs?
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Concerns were based on limited data
Edwin Rhim, MD
My interpretation of the FDA statement is that there is a concern about potential risk of cancer based on limited studies, reports and extrapolating the data from the systemic administration of such immunosuppressive medications on a long-term basis, but there are no conclusive data that use of such medications in a topical form will cause cancer.
Judging from the fact that long-term systemic administration of steroids causes a long list of severe side effects, but intermittent use of topical steroids used appropriately does not cause any of those serious systemic side effects, I wouldn’t conclude that topical application of immunosuppressive medicine will necessarily cause similar side effects as systemic administration. The reports of skin cancers and lymphomas in patients using these topical medications are anecdotal reports and have not proved increased incidence of such cancers in patients using the medication compared to the general population. The dosages of topical medications used in animal studies were artificially high dosages that are typically not used in clinical practice.
My understanding is that FDA came out with the boxed warning partially to fend off the aggressive marketing of these topical medications by the manufacturers to doctors and patients that lead to indiscriminate prescription and usage of these medications. Just as any other medications available OTC or by prescriptions, these medications have potential side effects that patients need to be informed about before making decisions to use them.
In many dermatologists’ practices, including mine, these medicines are used as a secondary line of treatments when topical steroids are not effective or not tolerated, as there are no effective alternatives. I go over the FDA warning and what it means with each patient before I prescribe it. There are many medications that have significant toxicity and potential serious side effects — that doesn’t mean they should be banned.
Edwin Rhim, MD, is a Dermatologist at Virginia Mason Medical Center, Seattle, Wash.
Gap in eczema treatment now exists
Joyce N. Fox, MD
I agree that there have been no convincing cases of internal malignancies of the type that would be found in someone using these topical immune-modulating medications. They are both still FDA-approved, and are helpful as per the indications: short-term or intermittent usage in patients with atopic dermatitis (eczema) who are not responding to, or who cannot tolerate, other conventional treatments such as topical steroids.
Ongoing studies have still not shown the problems the FDA warned about. Pediatric and adult dermatologists continue to use these products appropriately, though certainly not with the same frequency or duration as before the black box warning, often out of the need for prolonged explanations. Dermatologists strive to use less potent forms of topical medication in order to minimize potential side effects, but occasionally these medications are needed.
These topical products have decided benefits for those patients with severe eczema where conventional steroid therapy is not appropriate, such as around the eyes or in skin folds, or where topical steroids are not tolerated or effective. The alternative may be internal immune suppressing medications that have much graver risks.
Oncologists should tell the patient that their dermatologist will use his/her best judgment on the patient’s behalf and advise them of the safe methods for using these medications. This would be for short-term, intermittent use, applied sparingly, and with precautions to avoid sunlight or artificial light (tanning beds, sunlamps) to treated areas and to have follow-up examinations.
The black box warning has definitely inhibited patients from using these products for themselves or their children, leaving a gap in how we can help many sufferers of eczema. Spending the extra time with patients, explaining the safety and efficacy of these products, and why the black box warning should be taken with more than a grain of salt, takes time that busy dermatologists often do not have, but worth the time.
Joyce N. Fox, MD, is Head of the Department of Dermatology, Cedars-Sinai Medical Group and Clinical Chief in the Division of Dermatology, Cedars-Sinai Medical Center, Los Angeles.