Drug Warning: Elidel
Generic name: Pimecrolimus
Manufactured and marketed by: Novartis
Purpose: An "immunomodulating agent" used in the treatment of dermatitis.
Side Effects Reported
- The most common side effects of Elidel are a feeling of warmth or burning where the cream was applied, headache, cold-like symptoms such as stuffy nose, sore throat, and cough, and, infrequently, viral skin infection.
- It has also been cited by the FDA as a possible cancer risk.
Industry Report
The FDA has issued a public health advisory to inform patients and healthcare providers about the possible risk of lymph node or skin cancer from use of Elidel. Animal studies, along with small numbers of case reports, indicate that Elidel may have a cancer risk. They have indicated that it may take human studies of 10 years or longer to confirm these reports.
The FDA advisory follows recommendations made by the FDA's Pediatric Advisory Committee during its mid-February meeting. At that meeting, the committee reviewed research that showed that the risk of cancer in three different species of animals increased along with increases in the doses of Elidel. The research material also included reports of cancers in children and adults treated with Elidel.
Seeger Weiss is not currently pursuing lawsuits on this drug, but its drug warnings will remain on our radar.
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