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. Tacrolimus was 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 may therefore be used continuously on the body and applied to the thinner skin over the face and eyelids.
From oral and intravenous administration, side effects can be severe and include blurred vision, liver and kidney problems, seizures, tremors, hypertension, hypomagnesemia, diabetes mellitus, hyperkalemia, itching, insomnia, confusion, loss of appetite, hyperglycemia, weakness, depression, cramps, and neuropathy, as well as potentially increasing the severity of existing fungal or infectious conditions such as herpes zoster or polyoma viral infections. From topical use, a common side effect of tacrolimus ointment, if used over a wide area, is to cause a burning or itching sensation on the first one or two applications.
The FDA issued a health warning in March 2005 for the drug, 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 on the products. Astellas' January 23, 2006 response to the label revision requirement was sent via fax to pharmacists across the United States contradicting previous company statements about the safety and absence of cancer risks.
Continued marketing of a drug without warning of the risk of cancer is a serious violation of consumer rights. If you or a loved one have taken Protopic and 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 products liability attorney will contact you to discuss your rights.
