URGENT – Cancer warning to be issued by Food and Drug Administration (FDA)

URGENT – Cancer warning to be issued by Food and Drug Administration (FDA)

A report in the Washington Post on Saturday stated that scientists of the FDA are planning to call for new warnings for Protopic and Elidel. Both Protopic and Elidel are topical prescription creams used to treat mild to moderate eczema.

“Reports of a variety of cancers are increasing…”

An FDA official said a study involving monkeys suggested that the creams may cause a cancer of the immune system known as lymphoma. He also said that reports of a variety of cancers in people using the creams are increasing.

“The evidence raises serious safety concerns in children…”

A recommendation posted Friday on the agency’s Web site reported Jean Temeck of the FDA’s division of pediatric drug development as writing “The evidence raises serious safety concerns in children regarding the potential for carcinogenicity in humans treated with these agents.”

Temeck went on to write “We believe regulatory action is needed at this time since a definitive answer to the carcinogenic risk of these products will not be known for years.”

An agency spokesman said that a “black box” warning on the labels was one of several recommendations being considered.

Did you know: That “Black Box” warnings are considered the strongest possible labeling? The only level higher than a “black box” is an outright ban of the product.

Protopic was approved in 2000 and Elidel in 2001. Both drugs work by suppressing the immune system and were seen as effective and much safer than the steroid creams and ointments that were, until that time the main form of treatment for eczema. They were approved for short or intermittent use by adults and children over the age of 2 years.

Always A Risk Involved

One of the reasons we focus on the more natural based products here at Epismooth.com is because of the decreased risk of such side effects.

Any new drug coming on to the market undergoes stringent testing before hitting our shelves however there is always a risk involved. Long term effects are never known initially. This is one of the reasons that I prefer the natural products where risk factors are considerably decreased.

As such, my preferred cream when treating eczema and psoriasis is the all-natural Calendulis Plus Cream. It’s gentle enough to use on any age group (including babies) and is very effective in controlling the itching, redness, dryness and inflammation experienced in both conditions.


  1. http://washingtontimes.com/upi-breaking/20050212-092725-7129r.htm
  2. http://www.chron.com/cs/CDA/ssistory.mpl/health/3036415

Mel Sinclair

[Note: March 24, 2005 – Followup article added. ]