New warnings about Elidel and Protopic eczema drugs and cancer

The FDA has issued a new warning about Elidel (pimecrolimus) and Protopic (tacrolimus) and the risk of cancer, and the proper use of these drugs in children and adults. Some of these warnings, like not using these medicines in children less than 2 years of age, are not new; however, these drugs have been increasing in popularity and have been increasingly used in younger children and in children who have not failed other therapies.

Elidel (pimecrolimus) and Protopic (tacrolimus) are two relatively new creams used to treat eczema or atopic dermatitis. They are not steroid creams, which are one of the main treatments for eczema; they work instead by directly suppressing the immune system, presumably in the skin. These drugs have become very popular in recent years because of the side effects of steroid creams, and because of heavy marketing by the companies to physicians. However, like all new drugs, the side effects and effects of long term use are unknown. There has always been a concern about the fact that these drugs may increase the risk of cancer because they suppress the immune system. There are new animal studies which suggest that these drugs increase the risk of cancer. In addition, since the drugs went on the market, there are increasing case reports of cancer in children who are using these drugs. The FDA notes that the risk is not yet proven, and will likely take 10 years or longer to tell whether the drugs are linked to cancer. In the meanwhile, they are issuing new warnings and guidelines for use of these drugs:

• Use Elidel and Protopic only as second-line agents for short-term and intermittent treatment of atopic dermatitis (eczema) in patients unresponsive to, or intolerant of other treatments.
• Avoid use of Elidel and Protopic in children younger than 2 years of age. The effect of Elidel and Protopic on the developing immune system in infants and children is not known. In clinical studies, infants and children younger than 2 years old treated with Elidel had a higher rate of upper respiratory infections than did those treated with placebo cream.
• Use Elidel and Protopic only for short periods of time, not continuously. The long term safety of Elidel and Protopic are unknown.
• Children and adults with a weakened or compromised immune system should not use Elidel or Protopic.
• Use the minimum amount of Elidel or Protopic needed to control the patient’s symptoms. In animals, increasing the dose resulted in higher rates of cancer.

Eczema is a common disease in children and can often be effectively managed by proper skin care and occasional use of steroid creams. In addition, eczema is sometimes linked to allergies and once the allergies are properly diagnosed and treated, the eczema improves. There are some children who may benefit from these drugs, but only in severe cases in which other therapies have failed. Like any medication, they should be used only when the benefits outweigh the risks. Unfortunately, I have seen many physicians (and myself have been tempted to) use new drugs and treatments right away, even when a well-established treatment, with better known risks and side effects, may be effective. For now, I would advise that children should not use these drugs unless the eczema is significant and other therapies have failed.

FDA public health advisory: Elidel and Protopic

Patrick N. Pulliam, MD, FAAP
March 11, 2005
Last modified: 3/11/05
Last reviewed: 3/11/05

Home | About us | Patient Service Center | Parent Resource Center | Contact us | HIPAA Privacy Notice

Covenant Care Pediatrics, P.C.
130 Medical Way Suite B • Stockbridge, GA 30281
tel: (770) 389-4543 • fax: (770) 474-0566