Eczema is a chronic inflammatory skin condition affecting millions of children and is often very difficult to treat. Steroids have always been the doctors preferred option of treatment until several years ago when two new wonder drugs appeared on the market.
Two wonder drugs that have proven to be quite controversial and possibly very dangerous for our children.
Elidel and Protopic
Elidel (Pimecrolimus) and Protopic (Tacrolimus) were released in 2000 and 2001 as the new prescription wonder drugs to treat eczema. Their short history on the markets has been flanked by controversy with fears that they may be linked to skin cancer and lymphoma. A “Black Box” warning which is the strongest of all safety warnings has been a requirement to be displayed on these two products since 2005.
Documents released in March 2010 suggest that the drug companies manufacturing Elidel and Protopic may need their warning labels expanded as a result of dozens of new reported cases of cancer and infections associated with the use of these drugs in children.
Immunosuppressants to treat Eczema
Elidel and Protopic are topical calcineurin inhibitors or TCI’s and are the first non-steroid medications developed to treat eczema. The drugs suppress the immune system however this immunosuppressant action could be a factor in the cancer and infection cases reported.
The Food And Drug Administration (FDA) make the rulings on the safety of drugs used and any warnings required to be displayed on packaging. Their 2005 ruling for a Black Box to be displayed was met with strong criticism by the manufacturers of both Elidel and Protopic.
The latest report which was released ahead of an FDA advisory meeting to assess potential safety concerns with a variety of drugs used in children shows further concerns regarding cancer and infection in children under 16.
“Agency scientists said 46 cancer cases and 71 infection cases have been reported in patients aged 16 and younger from 2004 to 2008 with Novartis’ Elidel and Astellas’ Protopic.” (http://www.reuters.com/article- Thu Mar 18, 2010 10:07am EDT)
Along with the Black Box display the FDA requires that Elidel and Protopic only be used for moderate and severe eczema after other lines of treatment have been attempted. The FDA also stipulates that they are only to be used on children over the age of 2 years and only for short periods of time.
The warning on the Protopic drug label currently reads: “The safety of using Protopic, and drugs like it, for a long period of time is not known. A very small number of people who have used Protopic have had cancer (for example, skin or lymphoma). However a link with Protopic has not been shown.” Similar language is displayed on the Elidel label.
In Summary
In summary Elidel and Protopic are for short term treatment of moderate to severe eczema in children over 2 years where other forms of treatment have been ineffective. There is an associated risk of developing cancer when using these drugs.
Elidel and Protopic may not be the miracle treatment they were originally heralded as. Perhaps steroids are the safer option after all. Or perhaps the safest option is the natural treatments for eczema that many parents are now opting for.
Read my original article on Elidel and Protopic from 2008.