Protopic Cancer Risks

Protopic (tacrolimus), manufactured and marketed by Astellas Pharma, is a topical ointment used to treat of atopic dermatitis (eczema), the symptoms of which is dry, red, itchy skin that often develops scaly patches or blisters. After receiving numerous allegations of dangers posed by Protopic, the FDA in 2006 required its strongest “black box” safety label on Protopic packaging.

How Protopic works

Protopic, also sold as Advagraf and Prograf, comes as an atopic cream. The active ingredient in Protopic is tacrolimus. Tacrolimus suppresses the immune system by blocking calcineurin, a protein that activates T cells, white blood cells in the immune system. This activity suppresses the growth of atopic dermatitis.
Protopic reduces inflammation, but unlike steroids that are also used to combat inflammation, it does not cause the skin to thin with continuous use.


A Japanese research team discovered tacrolimus, the active ingredient in Protopic in a soil fungus in 1984. In 1994, the FDA approved its use in liver transplants. The approval for this use was later extended to other organ transplants. The FDA approved its use to treat eczema in 2000.

Cancer concerns

Soon after approving the drug to treat eczema, the FDA began receiving reports of lymphomas and skin cancers in patients using it. Research presented at the FDA’s Pediatric Advisory Committee in 2005 linked 25 cases of cancer to the use of Protopic and Elidel. The active ingredient, pimecrolimus, acts similarly to tacrolimus in blocking calcineurin.
The manufacturer is conducting tests to test a possible link of Protopic to cancer, but the FDA says a definitive answer may be years away. Until the results are known, the FDA says that patients should avoid continuous, long-term use of Protopic.

Cancer alerts

In March 2005, the FDA issued an alert warning patients and doctors about a possible increase in skin cancer from using the drug. In April, 2006 Health Canada, the department of the Canadian government charged with helping its citizens maintain their health, warned of the danger of cancer from using tacrolimus creams. The FDA’s MedWatch has encouraged physicians to report suspected adverse reactions to the use of tacrolimus ointment.

Approved use

Tacrolimus ointment should only be used when the initial therapy doesn’t work or has stopped working.
Its use should be limited to the short-term treatment of moderate to severe atopic dermatitis that is chronic. It should only be prescribed for adults whose immune systems have not been compromised. It should only be prescribed for children who have failed to respond to other topical prescriptions.
The ointment is available in .03 percent and .1 percent solutions for adults. The strongest form of the ointment that should be used on children from 2 to 15 years old is a .03 percent solution.

Protopic (tacrolimus)