The Food and Drug Administration (FDA) has announced new labeling for the eczema drugs Elidel Cream and Protopical Ointment that warn patients and healthcare providers of the potential risk of cancer.  The FDA has previously released a public health advisory warning of the potential link between the use of these eczema drugs and cancer.

The Food and Drug Administration (FDA) has announced that the labeling on Elidel Cream and Protopical Ointment is being updated to include a boxed warning about the potential risk of cancer.

Elidel (generically known as pimecrolimus) and Protopical are used to treat the common skin disorder eczema. 

In March 2005, the FDA had released a public health advisory warning patients and healthcare providers of the potential link between cancer and the use of these eczema drugs. 

A definitive casual link between these eczema drugs and cancer has not been established.  However, rare reports of skin cancer and lymphoma in patients and animal studies are a cause for concern.

The FDA has issued the following recommendations regarding the use of Elidel:

• Elidel should not be the first drug you use to eczema.  It should be used only when all other medications have failed or you had too many side effects from other drugs.
• Elidel is not approved for use in children under the age of 2.  Elidel may negatively affect the developing immune system in infants and children.
• Use Elidel only for short periods of time.  The continuous, long-term effects of the drug are still unknown.
• Use the minimum amount of Elidel necessary for treatment.

Eczema is a common skin disorder that affects about 15 percent of the childhood population.

Note - Do not change medications without first consulting your doctor.