We used a sample back when DS's eczema first appeared at 6 months. He got a stuffy nose/cold symptoms from it. He got increasingly fussy and rubbed his head so I suspected a headache as well.
When I researched these side effects, I found out that the FDA published a warning in October 2003 that children under 2 shouldn't use Elidel. Infants tend to have blood levels much higher than older children/adults...since their skin surface relative to their body mass is much higher. And "the effects of topical immunosuppressants on the developing immune system are unknown."
"Not recommended for use in pediatric patients less than 2 years of age. Infants on Elidel Cream had an increased incidence of some adverse events compared to vehicle which included pyrexia, URI, nasopharyngitis, gastroenteritis, otitis media, and diarrhea."
"In the 6-month infant safety study, adverse events occurring more frequently in the Elidel cream group compared to vehicle included pyrexia, upper respiratory tract infection, cough, vomiting, hypersensitivity, rhinitis, viral rash, rhinorrhea, and wheezing."
The point is that this drug is not as safe as some people might think and that there are not long term studies on it. Suppressing the immune system may have far reaching consequences especially for young patients. Animal studies did show some tumor concerns at high blood levels:
http://www.fda.gov/ohrms/dockets/ac/...ver%20Memo.pdf
http://www.fda.gov/ohrms/dockets/ac/...pts/3999T2.htm
Sadly as much as 50% of the prescriptions are being written now for under 2. One of the peds in our practice first gave it to us for diaper rash for which it is clearly not indicated!
