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Black-box warning added to Protopic and Elidel label to alert consumers of severe health risks

With risks of skin cancer and lymphoma, promotes free case evaluations for people using these eczema creams.

Orlando, Florida The makers of Protopic and Elidel have finally revised the labels on their skin cream ointments to include the FDA-mandated black-box warning, the highest health alert used by the FDA.

The FDA requested this label change 10 months ago when realizing there were approximately 78 Protopic and Elidel patient cases with cancer. With severe risks of skin cancer and lymphoma, physicians, patients, and parents who administer Protopic and Elidel on their children need to be aware.

The new black-box label warns patients not to use Protopic or Elidel continuously over a long period of time, not to use on children under 2 years old, and only use on skins areas that have eczema. Upon FDA recommendation, the label continues to warn against using these creams on those with weakened immune systems.

Protopic (Tacrolimus) and Elidel (Pimecrolimus) are two popular steroid-free creams classified as immunosuppressants. These creams are marketed worldwide 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.

Elidel is manufactured and marketed by Novartis. Protopic is manufactured and marketed by Astellas Pharma Inc. (formerly Fujisawa Pharmaceutical Co.). Both skin creams have hundred-million dollar annual sales.

To support adults and children negatively affected by Protopic or Elidel before the Black-box label warning, provides access to free legal evaluations. Visit: or

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