Why did the FDA require a label change?
The FDA changed the label in January 2006 due to concerns over a specific class of drugs that treat eczema, called topical calcineurin inhibitors, including ELIDEL. The FDA’s concern for these types of drugs was based on a theoretical risk which stemmed from events that have been seen with high doses in animal studies and transplant patients. The adverse events were associated with prolonged systemic immunosuppression. This effect cannot be achieved with ELIDEL Cream because it is applied to the skin and very low amounts enter the blood stream. In fact, in clinical studies most blood levels of ELIDEL were too low to measure.
