Risks of Using Elidel and Protopic for Eczema

Black Box Warning on Elidel and Protopic

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Elidel (pimecrolimus) and Protopic (tacrolimus) are topical medications used for the treatment of atopic dermatitis (eczema). These medications, called topical calcineurin inhibitors (TCIs) were the first non-steroid topical medications developed to treat eczema.

Unlike topical steroids, TCIs do not cause skin thinning, pigment changes, blood vessel formation, striae formation, or loss of response with prolonged use. TCIs are also not absorbed into the body to any significant degree, unlike topical steroids. In addition, TCIs can be used on any skin, including the face and eyelids.

Elidel and Protopic are topical versions of calcineurin inhibitors, which are medications used to suppress the immune system in people receiving organ transplants as well as for people with autoimmune diseases. These medications, such as cyclosporine, can have severe side effects, including causing various forms of cancer.

While Elidel and Protopic were only approved for use in people two years and older, many doctors used these medications for infants and younger toddlers. These medications became very popular due to the lack of side effects compared to topical steroids.

What Risks Are Associated With Elidel and Protopic?

Elidel and Protopic both currently have a “black box” warning, which is a precautionary statement given to the medication by the Food and Drug Administration. This warning came about as a result of reports of children and adults who developed cancer (such as skin cancers and lymphomas) while using these medications.

The decision of the FDA to give these medications a “black box” warning was quite controversial and went against recommendations from the professional societies of allergists and dermatologists. The reason for this was because the available data did not support that TCIs caused an increase in the risk of any form of cancer. The rate of cancer development occurring in people using Elidel and Protopic was actually below the rate expected in the general population, and the types of cancers seen were not the types seen in people using cyclosporine.

In addition, even when TCIs are used over large areas of the body, the medication cannot be detected in the bloodstream. There is also no evidence that TCIs suppress the body’s immune system whatsoever, which is probably the main reason why oral forms of these medications cause cancer.

Despite any real scientific basis for the FDA’s “black box” warning, however, Elidel and Protopic were being used by doctors for purposes for which they were never intended. These medications were probably over-prescribed for just about any itchy rash in children and adults, which is inappropriate. TCIs are still very useful medications, and I frequently prescribe these medications in my practice.

When Should Elidel and Protopic Be Used?

Elidel and Protopic are indicated as second choice treatments (topical steroids are the first choice) for atopic dermatitis in adults and children two years and older. These medications should only be used for short-term flares of eczema, and should not replace the liberal use of moisturizers to maintain good skin hydration.

I tend to use Elidel and Protopic more often for skin that is prone to side effects from topical steroids, especially the thin skin on the face and eyelids and in body folds such as the armpits and groin. Because TCIs are more expensive (and there is no generic form), I tend to use cheaper topical steroids for other areas on the body with thicker skin, such as the arms, legs, hands, feet, neck, and trunk.

I also discuss the above risks with any patients and parents of children for whom I prescribe Elidel and Protopic. While in general, I do not have serious concerns regarding the safety of these medications (see above for my reasoning), it is the right of my patients to know what I know. I also want my patients to hear the risks of these medications from me, rather than from the internet, where they might find false information.

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Article Sources

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  • Aaronson DW. The “Black Box” Warning and Allergy Drugs. J Allergy Clin Immunol. 2006;117:40-4.
  • Report of the Topical Calcineurin Inhibitor Task Force of the ACAAI and AAAAI. JACI. 2005;115:1249-53.