Elidel Followup – Manufacturers dispute their eczema creams cause for cancer

The recent revelation by the US Food & Drug Administration (FDA) that the use of Elidel & Protopic when treating eczema may carry a risk of cancer is still causing considerable concern. Indeed there has been little else in the news of eczema since this find hit the headlines a few weeks ago.

The FDA said that long term human studies will need to be carried out before it is known for sure if Elidel or Protopic are responsible for the concerns that have been reported in the few adults and children using these medications.

Long term studies are needed before we know for sure…

The FDA said, Novartis and Fujisawa healthcare, the manufacturers of Elidel and Protopic respectively, have agreed to conduct research to determine whether there is an actual risk of concern in humans, and if so its extent.

“Both products are applied to the skin to control eczema by suppressing the immune system. FDA’s Public Health Advisory specifically advises physicians to weigh the risks and benefits of these drugs in adults and children” the FDA said.

“Elidel and Protopic are not approved for the use in children younger than 2 years old,” the FDA added.

Not appropriate for children under 2 years old…

“The long term effect of Elidel and Protopic on the developing immune system in infants and children is not known. In clinical trials, infants and children younger than 2 years of age treated with Elidel had higher rate of upper respiratory infections than those treated with placebo cream.”

Despite this it is believed that of 5 million patients using Elidel worldwide 500 000 are infants younger than 2 years of age.

A black box: The strongest warning that the FDA can issue short of a complete recall.

At a meeting last month the FDA reviewed the products and as a result both Elidel and Protopic will soon carry a “black box” warning – the FDA’s strongest warning.

Novartis the manufacturers of Elidel dismissed claims that Elidel could increase the risk of cancer.

In a statement it said: “Novartis agree that patients suffering from mild to moderate eczema need to be informed about the safe and effective use of Elidel, but we believe a recommendation to add a black box warning to the label is unsubstantiated by clinical evidence and experience in more than five million patients worldwide.”

Fujisawa Pharmaceutical and manufacturers of Protopic claim they had not found any data to clearly link Protopic to cancer and they believe they have provided sufficient information to ensure the drug is used safely.

“The companies were aggressively advertising the products to treat infants…”

In February this year members of the FDA advisory panel expressed concerns that the companies were aggressively advertising the products to treat infants and others with skin conditions for which the creams are not approved to treat.

And so US authorities have ruled that Elidel and Protopic should carry warnings that they may increase the risk of cancer.

This is of grave concern to all eczema sufferers and it’s a situation I’ll continue to closely monitor. For now my strongest advice is to cease the use of Elidel and Protopic until more information is available.

Mel Sinclair, RN


  1. http://www.cancer.org/docroot/NWS/content
  2. http://www.reuters.com/financeNewsArticle.jhtml?type=businessNews&storyID=7868896
  3. http://news.bbc.co.uk/1/hi/health/4339317.stm