/24-7PressRelease/ - ORLANDO, FL, September 04, 2005 - In March, the US Food and Drug Administration (FDA) asked the makers of Protopic and Elidel to include a black box warning on their labels and marketing materials. To date, Novartis and Astellas Pharma Inc. have yet to fulfill this request. In the meantime, family physicians are warning patients and the parents of children with eczema about the risks of these topical creams.
Protopic (Tacrolimus) and Elidel (Pimecrolimus) are two popular steroid-free creams marketed to adults, teens, and children as young as two years old for the treatment of eczema and Atopic Dermatitis. Eczema and Atopic Dermatitis are both persistent skin conditions recognized as red, scaly, itchy skin.
After research and reports linking the skin absorbent ointments to skin cancer and lymphoma, the FDA issued a Public Health Advisory. In one clinical trial, infants and children younger than 2 years of age treated with Elidel had a higher rate of upper respiratory infections than those treated with a placebo cream.
Since the long term side effects of using Protopic or Elidel have not yet been identified, the FDA recommends only using the prescription creams as a last resort and then only for a limited time. The FDA also warns that patients under two years of age or those with weakened immune systems should not use either product.
Elidel is manufactured and marketed by Novartis; in June, Elidel's mid-year sales were down 14% from 2004, totaling $118 million in the US. Protopic, manufactured and marketed by Astellas Pharma Inc. (formerly Fujisawa Pharmaceutical Co.) ended its Chinese year this month with gross sales of $200 million (USD) worldwide.
To support adults and children affected by the use of Protopic or Elidel, LawyersandSettlements.com provides access to free legal evaluations. For more information about the warnings against Protopic and Elidel, visit: https://www.lawyersandsettlements.com/case/protopic or https://www.lawyersandsettlements.com/case/elidel
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