The FDA issued a health warning in March 2005 for the topical Eczema creams Protopic and Elidel, after recommendations from the FDA's Pediatric Advisory Committee during its February 15, 2005 meeting due to the risk of cancer (including skin cancer and lymphoma) associated with these drugs, especially in young children. In January 2006, after additional cancer reportings were filed with the FDA, Novartis and Astellas were required to put a "Black Box Label Warning" regarding the use of Protopic and Elidel and the risk of developing skin cancer or lymphoma.

From topical use, a common side effect of Protopic and Elidel ointments is to cause a burning or itching sensation on the first one or two applications, but in the seven years since the FDA approved Protopic in 2000 and Elidel in 2001, at least seven cases of lymphoma and six skin cancer cases have been reported in patients. Animal tests have also suggested the creams could cause cancer.

Usage:

Protopic (Tacrolimus, also FK-506 or Fujimycin) is an immunosuppressive drug whose main use to reduce the activity of the patient's immune system is after organ transplant and so the risk of organ rejection. It was first approved by the Food and Drug Administration (FDA) in 1994 for use in liver transplantation, this has been extended to include kidney, heart, small bowel, pancreas, lung, trachea, skin, cornea, bone marrow, and limb transplants. Protopic is also used in a topical preparation in the treatment of severe atopic dermatitis ("eczema"), severe refractory uveitis after bone marrow transplants, and the skin condition vitiligo.

Litigation:

Astellas' January 23, 2006 response to the "Black Box Warning" label revision requirement was to send a fax to pharmacists across the United States contradicting previous company statements about the safety and absence of cancer risks. Tacrolimus was previously touted as an advantageous alternative to steroids for patients suffering from Eczema because it is equally effective in suppressing inflammation, but it does not cause skin thinning (atrophy) or any other steroid related side-effects. It was therefore suggested to be used continuously on the body and applied to the thinner skin over the face and eyelids

Continued marketing of a drug without warning of the risk of developing cancer is a serious violation of your rights as a consumer. If you or a loved one have taken Protopic or Elidel and have experienced severe side effects, cancer or death, you may be eligible for compensation. Please fill out the short form to the right of the page and an experienced DrugSettlement.com attorney or representative will contact you to discuss your claim.