Protopic, a topical treatment for eczema, is manufactured by Astellas Pharma, Inc., formerly known as Fujisawa Healthcare. Protopic, generic tacrolimus, was approved by the FDA (Federal Food and Drug Administration) in 2000. Astellas Pharma aggressively markets this drug worldwide, and it is used by millions of people, including children. The Protopic claim is that, unlike steroid treatments for eczema that cause thinning of the skin, Protopic can be used directly on the face. The manufacturer claims that Protopic is safe for use on small children.
The FDA has required a black box warning saying that that Protopic and a similar drug, Elidel, may be linked to cancer and should be used very sparingly. A black box warning is the strongest level of warning required by the FDA for products that are allowed to stay on the market. See Drug Warning: Protopic Side Effects and Risks for information about the FDA’s warnings and recommendations for the use of Protopic.
Check out the following articles for more information about Protopic, filing an Protopic lawsuit and finding an Protopic attorney: