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FDA Health Advisory Issued for Two Eczema Medications

On March 10, 2005, the FDA issued a public health advisory to inform the public about a potential cancer risk from the use of Elidel® (pimecrolimus) and Protopicâ (tacrolimus). A black box warning will be added to the prescription label of both products. The FDA is also developing Medication Guides for patients about the two drugs. This action occurred following the results of animal studies in three different species that showed the development of lymphoma following application of either of these agents. The occurrence of cancer was found to increase with increasing exposure to either Elidelâ or Protopicâ. Clinical trials to determine whether the risk of cancer applies to humans will be conducted by the manufacturers of the products. However, these trials could take years to produce results. Until that time, the FDA is recommending strict adherence to approved prescribing information for these two agents. During post-marketing surveillance, ten reports of cancer-related adverse events have been linked to Elidelâ, while 19 reports have been linked to Protopicâ. Seven of these cases involved children, and 3 of those children were less than 6-years old. These cases included reports of lymphomas, cutaneous tumors, squamous cell carcinomas, and basal cell carcinomas with or without associated lymphadenopathy.

Both Elidelâ and Protopicâ are indicated for the short-term and intermittent treatment of atopic dermatitis (eczema). They should be used only as second-line agents in patients unresponsive or intolerant to other therapies. The use of these agents should be avoided in children younger than 2 years old due to the lack of information regarding their effect on the developing immune system. These agents should not be used on a continuous basis; rather, the minimal amount of the agent needed to control symptoms should be used for only a short time. Adults and children with weakened and/or compromised immune systems should not use these medications, due to the fact that both Elidelâ and Protopicâ control eczema by suppressing the immune system.

References:

FDA website. www.fda.gov/cder/

Michelle Kovach, Pharm.D. candidate