FDA and Warnings for Popular Eczema Creams
The Division of Pediatric Drug Development (DPDD) recommended a boxed warning for both Protopic and Elidel.
Government scientists have proposed adding stronger warnings to the product labels of Protopic and Elidel which are common creams used to treat eczema. The concern is over the risk for certain cancers, especially among children.
Animal and laboratory studies show a correlation between Protopic and Elidel and a handful of cancer cases reported from adults and children using the creams. The FDA is concerned these two eczema creams may be to blame for side effects of cancer.
Jean Temeck of the FDA's division of pediatric drug development stated in his recommendation to the FDA "The evidence raises serious safety concerns in children regarding the potential for carcinogenicity in humans treated with these agents. These products are being widely used to treat atopic dermatitis, a non-life threatening disease, and heavily advertised for use in young children without appreciation by parents and physicians regarding the potential for carcinogenic risk.” You can read more at http://www.fda.gov/ohrms/dockets/ac/05/Briefing/2...
Protopic and Elidel were approved by the FDA in 2000 and 2001 for the treatment of atopic dermatitis/eczema. Millions of prescriptions have been written. Eczema is one of the most common skin conditions in the U.S. and affect up to 20% of the population including children. Eczema is a skin allergy and symptoms are a red, extremely itchy rash. Elidel and Protopic are popular because they do not contain steroids. Topical steroids are a common treatment for atopic dermatitis/eczema and have a variety of side effects.
These drugs are applied topically, but they may be systemically absorbed. Detectable drug levels in the blood are more commonly observed in children than adults. This higher systemic drug exposure in kids could be caused by their greater body surface area to mass ratio.
The warnings state, “a small number” of people who have used Protopic and Elidel “have had cancer (for example, skin or lymphoma),” evidence from the FDA’s own reporting system indicates that this may be a major understatement. Since less than 10% of all serious adverse drug reactions are reported to the FDA, parents should consider other forms of treatment other than Protopic and Elidel.
If you decide to use these eczema creams on your children make sure you know that the FDA approved the use of Protopic and Elidel for only short-term or intermittent use by adults and children age 2 and older. There is concern that Novartis Pharmaceuticals Corp. has promoted Elidel aggressively, and both Protopic and Elidel are thought to be used for longer periods and among babies.
Temeck also wrote "These products are being widely used to treat . . . a non-life-threatening disease, and heavily advertised for use in young children without appreciation . . . regarding the potential for carcinogenic risk.”
Novartis and Fujisawa Healthcare Inc., which makes Protopic, claim their product is safe.
Scientists are concerned that the drugs effectively treat eczema by suppressing the immune system and this could increase cancer. Due to this concern, the FDA required both companies to monitor cancer rates from users of these drugs.
Studies show monkeys using these drugs develop lymphoma, a cancer of the immune system and a variety of other cancers and cancer rates in humans using these eczema creams have continued to rise.
Temeck also wrote, “At least seven cases of lymphoma have been reported, as well as at least seven cases of skin cancer and a handful of others. Several children reported infections, including an 8-month-old boy whose infection was so severe he suffered a heart attack after Protopic was applied "over his entire body for six months”.
How can you treat your child’s eczema without Protopic, Elidel and topical steroids. There are many techniques you can try to manage eczema drug free.
First, find out the eczema triggers. To understand how to manage eczema triggers visit http://www.adrescuewear.com/blog/what-causes-eczema-knowing-your-triggers-can-help-you-manage-it/
Second, use the Soak and Seal technique daily. Soak you child in luke warm water for at least 10 minutes daily. After removing your child from the tub, pat dry and immediately apply an ointment before the skin dries. Apply cotton clothing or FDA designated wet and dry wrap clothing for eczema.
Thirdly, wet wrap therapy is a very effective treatment for eczema and has been advocated by doctors as a safe and effective treatment for childhood eczema for 20 years. Wet wrap therapy studies report a 70% reduction in symptoms in just one week. Research also shows it cuts the need for drugs in kids. Below is a demonstration of wet wrap therapy.