FDA Issues Public Warning Re Elidel and Protopic

On February 15, 2005 the US Food and Drug Administration (FDA) Pediatric Advisory Committee recommended a "black box" warning be placed on topical calcineurin inhibitor (Elidel® - pimecrolimus and Protopic® - tacrolimus), followed by the FDA issuing a Public Health Advisory on March 10, 2005 regarding the safety concerns.

Click on one of the titles below to read statements regarding the FDA's black box warning:

American Academy of Dermatology (AAD)
www.aad.org/public/News/NewsReleases/fda_decision.htm

Canadian Dermatology Association (CDA)
www.dermatology.ca/english/public-patients/positions_e.html

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

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

Cutivate^® (Fluticasone propionate)

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INTRODUCTION
A synthetic fluorinated corticosteroid recently introduced to Canada but has been available in the U.S market for a number of years. Fluticasone propionate is classified as a medium potency topical corticosteroid... | Read more ...

CLININCAL EXPERIENCE
Topical corticosteroids are extensively used. Atopic eczema will be used as a model for discussing this new topical corticosteroid. A concern with the use of any long term medication is the potential for... | Read more ...

INDICATIONS
Used for all inflammatory and pruritic conditions that are corticosteroid responsive e.g. eczema, psoriasis and dermatitis. It should not be used in rosacea, acne, or perioral dermatitis... Read more ...

PATIENT PROFILE
4 double blind randomized controlled studies in 772 adults and children showed the once the acute episode of moderate to severe eczema had been treated effectively that twice weekly... | Read more ...

DOSING
For the acute stage of eczema daily application of Cutivate is recommended. New evidence guides us to apply Cutivate twice a week to maintain control of eczema... | Read more ...

EFFICACY
Although not indicated for use on children in Canada, studies have shown that once daily application is safe and effective in children with atopic eczema... | Read more ...

COMPLIANCE
Daily application in the acute phase and thereafter twice weekly maintaince should help with compliance ... | Read more ...

SIDE EFFECTS, SAFETY AND RISKS
Approx 270 million packs sold since 1990 in US ... | Read more ...

COST OF TREATMENT
Cost of this drug is in line with other potent topical corticosteroids. Cost effectiveness is seen if effective clinical response is realized. The utilization of a twice a week regimen significantly reduces costs... | Read more ...

View the entire Cutivate® (Fluticasone propionate) presentation.