Elidel^® (Pimecrolimus)

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SIDE EFFECTS, SAFETY AND RISKS

• 19,000 patients used Elidel cream in clinical trials (as of January 2005)
• Over 5 million patients have used Elidel cream worldwide (as of January 2005)
• The main side effect of cream application is a feeling of warmth/burning at site of application (Elidel: 10%. Placebo: 12%).
• The cream must not be used at sites of active bacterial or viral infection. There is a possibility of an increased risk of eczema herpeticum.

Cancer risk

• The current available data does not support an increased risk of cancer in humans treated with Topical Calcineurin inhibitors.
• The FDA expressed uncertainty about the possible risk of cancer based primarily on animal studies conducted with an oral form of the drug taken at high doses over a long period of time.
• Since the approval of Elidel in December 2001, more than 5 million patients have been treated worldwide. As of June 9th, 2005, twenty-two (22) cases of cancers have been reported worldwide (clinical trials and spontaneous reports):13 lymphomas, 5 skin carcinomas, 1 malignant melanomas, 1 colon carcinoma, 1 breast cancer, 1 myelodysplastic syndrome.
• External medical experts reviewed those cases and concluded that the use of Elidel did not cause these malignancies. In fact the rate of cancers reported with Elidel is much lower than that found in the general population.

REFERENCES - Professional Groups:

FDA warning:
www.fda.gov/cder/drug/advisory/elidel_protopic.htm

Canadian Dermatology Association position statement:
www.dermatology.ca/english/public-patients/positions_e.html#calcineurin

American Academy of Dermatology position statement:
www.aad.org/public/News/NewsReleases/fda_decision.htm

Maddin S: Pimecrolimus and Tacrolimus:
The US FDA Public Health Advisory. Skin Therapy Letter. May 2005;10 (4) :1-3

American College of Allergy, Asthma and Immunology (ACAAI) & American Academy of Allergy Asthma and Immunology (AAAAI):
www.acaai.org (select Member Information, then Guidelines on Pimecrolimus and Tacrolimus)

Dermatology Foundation:
www.dermatologyfoundation.org/symposia

REFERENCES - Patient Groups:

Eczema Society of Canada:
www.eczemahelp.ca

National Eczema Association for Science and Education (NEASE):
www.nationaleczema.org/NEASEStatementToPatients.Mar2005%20FINAL.doc

Inflammatory Skin Disease Institute:
www.isdionline.org/current.htm

Asthma and Allergy Foundation of America:
www.aafa.org/display.cfm?id=7&sub=92&cont=450

vaccination

• Elidel does not interfere with the development of protective antibodies after vaccination

[Papp KA.J Am Acad Dermatol. 2005 Feb;52(2):247-53]
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15692469&query_hl=1

systemic absorption

• Potential systemic absorption of Elidel has been studied. There was no systemic absorption in the majority of patients.Negligible transient systemic absorption may rarely occur. No drug accumulation occurs.
• Elidel permeates less through skin than corticosteroids and tacrolimus. Elidel is more lipophylic.

Van Leent EJ et al.Dermatology. 2002;204:63-68:
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11834853&query_hl=10

Allen BR et al. Ach Dis Child 2003;88:969-973:
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14612358&query_hl=13

Billich A et al. Int J Pharm. 2004;269:29-35:
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14698574&query_hl=16

Stuetz A et al. J Cut Med Surg. 2001;20:233-241:
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11770910&query_hl=24

Harper J et al. Br J dermatol. 2001;144:781-787:
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11298537&query_hl=26

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