09-08-2005

documento de American Pharmaceutical Association

Cancer risk: Warnings, MedGuides added for topical tacrolimus, pimecrolimus
http://www.pharmacist.com/news.cfm

Agents for eczema should be used only after other therapies fail, FDA says in public health advisory.

Pharmacists will soon be issuing Medication Guides to patients receiving topical tacrolimus (Protopic Ointment—Fujisawa) and pimecrolimus (Elidel Cream—Novartis) as a result of FDA actions announced today. Following the advice of a pediatric advisory committee that met last month, FDA is adding black-box warnings to the labeling of the two products, cautioning that they are agents of last resort for treatment of atopic dermatitis (eczema) because of their carcinogenicity, and the agency is mandating Medication Guides for patients.

Citing studies in three animal species and reports of cancers in a small number of children and adults using these drugs topically, FDA advised prescribers to consider the following:

• Elidel and Protopic are approved for short-term and intermittent treatment of atopic dermatitis in patients unresponsive to or intolerant of other treatments.

• Elidel and Protopic are not approved for use in children younger than 2 years old. The long-term effect of Elidel and Protopic on the developing immune system in infants and children is not known. In clinical trials, infants and children younger than 2 years of age treated with Elidel had a higher rate of upper respiratory infections than those treated with placebo cream.

• Elidel and Protopic should be used only for short periods of time, not continuously. The long-term safety of these products is unknown.

• Children and adults with a weakened or compromised immune system should not use Elidel or Protopic.

• Use the minimum amount of Elidel and Protopic needed to control the patient’s symptoms. Animal data suggest that the risk of cancer increases with increased exposure to Elidel or Protopic.
Web links

FDA talk paper
FDA public health advisory
FDA alert about tacrolimus
FDA alert about pimecrolimus
Related resources on www.pharmacist.com

APhA DrugInfoLine (available to APhA members): May 2001 issue: Lactobacillus GG cuts eczema risk
New Drug At-a-Glance: Elidel
Contact the writer: L. Michael Posey (mposey@aphanet.org), Pharmacy Today

Jairo Mesa Cock