Update on Eczema Skin Care

On March 10, 2005, the Food and Drug Administration (FDA) Pediatric Advisory committee recommended "black box" warnings for two atopic dermatitis treatments because of the potential risk of cancer: pimecrolimus (Elidel) and tacrolimus (Protopic)

A "black box" warning is the most serious type of warning in prescription drug labeling, according to the FDA.  As of now this warning has yet to be issued and is under considerable debate by physicians and researchers.  The American Academy of Allergy Asthma & Immunology formed a joint task force to review the data and present their findings on the medications.  In summarizing the current data, the joint task force examined animal data, which showed that the medication can have a cancer-causing effect at very high doses.  For instance, mice developed cancerous cells after exposure to tacrolimus and pimecrolimus at 26 to 47 times the maximum recommended human dose.  They also noted that there is no evidence of increased incidence of cancer in humans with use of topical tacrolimus or pimecrolimus at this time.

The task force recommended that the current FDA guidelines for prescribing topical tacrolimus and pimecrolimus should be followed for the short-term or intermittent long-term treatment of atopic dermatitis in patients 2 years of age or older who are unresponsive to or intolerant of other conventional therapies, or for whom other conventional therapies are inadvisable due to the potential risks.  It concluded that the doses in which cancers occur in the animal data were substantially higher than the levels that have been seen in humans.

They also noted that the long-term effect of tacrolimus and pimecrolimus on the developing immune system in infants and children is not known at present.  Based on the task force recommendations, it is important for parents to use Elidel or Protopic on their children according to the FDA guidelines for treatment.  Several million doses of these medications have been administered, and if used appropriately the medications do not appear to cause any increase in the risk of cancer.

Additionally, the joint task force recommends the following for atopic dermatitis patients

  • Liberal moisturization
  • Evaluation for food and inhalant allergy
  • Treatment of infections and complications
  • Referral to an allergist or dermatologist for identification of trigger factors and optimal skin care

While the FDA public health advisory is concerning, certainly the task force of a number of leading experts has reassured us that these medications have a good safety profile and a similar risk to benefit ratio as other available medications.  If you have any concerns please email or call us.

Date: 6/29/2005

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