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Chief Medical Editor Message

FDA Warnings
Have No Meaning

February 2006

In February 2005, The Washington Post ran an article, “FDA Panel Urges Warnings on 2 Eczema Drugs” (Rob Stein, Wednesday, Feb. 16, 2005; Page A08).  


The article stated: “A prescription cream and an ointment that millions of Americans use to control eczema should carry strong warnings to alert consumers that the drugs may increase the risk of some forms of cancer, especially among children, a federal panel concluded yesterday. Although the risks posed by Elidel and Protopic remain far from clear, the Food and Drug Administration advisory panel said the agency should take steps to aggressively caution consumers and monitor the drugs’ safety, including adding a prominent ‘black box’ to the labels.”  

A year later, the long wait is over, and we now see what the FDA did regarding new warnings in the package inserts for pimecrolimus (Elidel) and tacrolimus (Protopic). But, did the FDA do the right thing? And how, in the long run, will it affect dermatology?

Boxed Warning

There is no “black box.” Instead, a boxed warning has been added. (See New Boxed Warning for Elidel and Protopic on page 16 for more on this topic.)


The wording of the indication for Elidel and Protopic has also been changed to state that the drugs are indicated as “second-line therapy for the short-term and non-continuous, chronic treatment” of atopic dermatitis.  

Big deal.

This will not change my prescribing habits.

Inducing an Unwarranted State of Fear

What has the FDA achieved in its efforts to re-label Elidel and Protopic?  


Based on my clinical experiences, the FDA was definitely able to induce a state of fear concerning these products. My general impression is that this state of fear was completely unwarranted.

There hasn’t been any detectable increase in lymphoma rates with use of the topical calcineurin inhibitors (TCIs) tacrolimus or pimecrolimus. There have been, however, lots of unnecessary phone calls and worried patients.

The FDA’s attempt to define the use of these products is especially annoying. An essential element that must be considered is that the decision is generally not whether to use one of these drugs or not, but whether to use one of these drugs versus some topical corticosteroid.

I know of no evidence that tacrolimus or pimecrolimus are less safe than topical corticosteroids. I do know that topical corticosteroids offer risks of atrophy, glaucoma, HPA axis suppression and even growth retardation that are not even issues for the TCIs.

The FDA warnings may encourage people to use a topical corticosteroid as a first-line treatment for eyelid dermatitis, and I’m not sure we can safely say they are doing more good than harm in doing so.

Will Our Patients Benefit?

We need to be cautious with all of our medication decisions. I’m sure I don’t know what the FDA was really thinking with their efforts to re-evaluate and re-label Elidel and Protopic. However, I am fairly sure the basis for those efforts wasn’t scientific evidence of actual risks.


The politics of drug regulation is complex, and patients’ best interests don’t always seem to be served.




Steven R. Feldman, M.D., Ph.D.
Chief Medical Editor

In February 2005, The Washington Post ran an article, “FDA Panel Urges Warnings on 2 Eczema Drugs” (Rob Stein, Wednesday, Feb. 16, 2005; Page A08).  


The article stated: “A prescription cream and an ointment that millions of Americans use to control eczema should carry strong warnings to alert consumers that the drugs may increase the risk of some forms of cancer, especially among children, a federal panel concluded yesterday. Although the risks posed by Elidel and Protopic remain far from clear, the Food and Drug Administration advisory panel said the agency should take steps to aggressively caution consumers and monitor the drugs’ safety, including adding a prominent ‘black box’ to the labels.”  

A year later, the long wait is over, and we now see what the FDA did regarding new warnings in the package inserts for pimecrolimus (Elidel) and tacrolimus (Protopic). But, did the FDA do the right thing? And how, in the long run, will it affect dermatology?

Boxed Warning

There is no “black box.” Instead, a boxed warning has been added. (See New Boxed Warning for Elidel and Protopic on page 16 for more on this topic.)


The wording of the indication for Elidel and Protopic has also been changed to state that the drugs are indicated as “second-line therapy for the short-term and non-continuous, chronic treatment” of atopic dermatitis.  

Big deal.

This will not change my prescribing habits.

Inducing an Unwarranted State of Fear

What has the FDA achieved in its efforts to re-label Elidel and Protopic?  


Based on my clinical experiences, the FDA was definitely able to induce a state of fear concerning these products. My general impression is that this state of fear was completely unwarranted.

There hasn’t been any detectable increase in lymphoma rates with use of the topical calcineurin inhibitors (TCIs) tacrolimus or pimecrolimus. There have been, however, lots of unnecessary phone calls and worried patients.

The FDA’s attempt to define the use of these products is especially annoying. An essential element that must be considered is that the decision is generally not whether to use one of these drugs or not, but whether to use one of these drugs versus some topical corticosteroid.

I know of no evidence that tacrolimus or pimecrolimus are less safe than topical corticosteroids. I do know that topical corticosteroids offer risks of atrophy, glaucoma, HPA axis suppression and even growth retardation that are not even issues for the TCIs.

The FDA warnings may encourage people to use a topical corticosteroid as a first-line treatment for eyelid dermatitis, and I’m not sure we can safely say they are doing more good than harm in doing so.

Will Our Patients Benefit?

We need to be cautious with all of our medication decisions. I’m sure I don’t know what the FDA was really thinking with their efforts to re-evaluate and re-label Elidel and Protopic. However, I am fairly sure the basis for those efforts wasn’t scientific evidence of actual risks.


The politics of drug regulation is complex, and patients’ best interests don’t always seem to be served.




Steven R. Feldman, M.D., Ph.D.
Chief Medical Editor

In February 2005, The Washington Post ran an article, “FDA Panel Urges Warnings on 2 Eczema Drugs” (Rob Stein, Wednesday, Feb. 16, 2005; Page A08).  


The article stated: “A prescription cream and an ointment that millions of Americans use to control eczema should carry strong warnings to alert consumers that the drugs may increase the risk of some forms of cancer, especially among children, a federal panel concluded yesterday. Although the risks posed by Elidel and Protopic remain far from clear, the Food and Drug Administration advisory panel said the agency should take steps to aggressively caution consumers and monitor the drugs’ safety, including adding a prominent ‘black box’ to the labels.”  

A year later, the long wait is over, and we now see what the FDA did regarding new warnings in the package inserts for pimecrolimus (Elidel) and tacrolimus (Protopic). But, did the FDA do the right thing? And how, in the long run, will it affect dermatology?

Boxed Warning

There is no “black box.” Instead, a boxed warning has been added. (See New Boxed Warning for Elidel and Protopic on page 16 for more on this topic.)


The wording of the indication for Elidel and Protopic has also been changed to state that the drugs are indicated as “second-line therapy for the short-term and non-continuous, chronic treatment” of atopic dermatitis.  

Big deal.

This will not change my prescribing habits.

Inducing an Unwarranted State of Fear

What has the FDA achieved in its efforts to re-label Elidel and Protopic?  


Based on my clinical experiences, the FDA was definitely able to induce a state of fear concerning these products. My general impression is that this state of fear was completely unwarranted.

There hasn’t been any detectable increase in lymphoma rates with use of the topical calcineurin inhibitors (TCIs) tacrolimus or pimecrolimus. There have been, however, lots of unnecessary phone calls and worried patients.

The FDA’s attempt to define the use of these products is especially annoying. An essential element that must be considered is that the decision is generally not whether to use one of these drugs or not, but whether to use one of these drugs versus some topical corticosteroid.

I know of no evidence that tacrolimus or pimecrolimus are less safe than topical corticosteroids. I do know that topical corticosteroids offer risks of atrophy, glaucoma, HPA axis suppression and even growth retardation that are not even issues for the TCIs.

The FDA warnings may encourage people to use a topical corticosteroid as a first-line treatment for eyelid dermatitis, and I’m not sure we can safely say they are doing more good than harm in doing so.

Will Our Patients Benefit?

We need to be cautious with all of our medication decisions. I’m sure I don’t know what the FDA was really thinking with their efforts to re-evaluate and re-label Elidel and Protopic. However, I am fairly sure the basis for those efforts wasn’t scientific evidence of actual risks.


The politics of drug regulation is complex, and patients’ best interests don’t always seem to be served.




Steven R. Feldman, M.D., Ph.D.
Chief Medical Editor