There has been a great deal of discussion in the healthcare community about the safety of using Elidel (pimecrolimus) cream to treat those who suffer from eczema. The FDA (Food and Drug Administration) felt it was important to issue a public health advisory to make both healthcare professionals as well as their patients aware of the risk involved in using Elidel, especially on a long term basis.
Elidel carries with it a potential risk for cancer when the cream is applied topically to the skin of eczema patients. This information has been gleaned from three sources- first studies done on animals, second, case reports done on a specific amount of eczema patients and thirdly, due to findings on how the drug works in general.
While the risk has not been proven for a certainty, research is ongoing. Patients are advised to consider the pros and cons of Elidel treatment carefully. The FDA recommends that Elidel only be considered as a last resort when other treatments fail to bring about the desired result.
For those who do decide to undergo this method of treatment, it is highly recommended that they follow their doctors orders and the labels on the Elidel cream very closely and dont ever overdo it. FDA Advises
The FDA asks that physicians and patients alike to consider a number of different items of concern in regards to using Elidel as a treatment for eczema. First of all, Elidel is recommended to only be used on a short-term basis for intermittent treatments of atopic eczema and only for patients whose eczema is stubborn and refuse to respond to other treatment and/or cannot tolerate other treatment methods.
Elidel should be a second-line agent, and not the first line of defense against the skin condition. The long-term ramifications of his drug are not yet known. It cannot be emphasized enough, this drug should be used for short spurts of time but not as a continuous treatment.
Infants and Toddlers
Elidel should never be used on children who are two years old or younger. Research has not yet proven what effect this drug could have on the immune system of babies or children and the FDA believes that it is not a risk worth taking until more information is known.
Clinical studies that have been conducted so far into the effect on young children had shown less than promising results. In controlled studies babies and children under two years of age who were treated with small amounts of Elidel applied topically to their skin experienced much higher rates of colds, flu, and other upper respiratory infections than those in the placebo group.
Weakened Immune Systems
Those with a weakened immune system, regardless of the cause should never use Elidel as its complete effects on the immune system are not known. It may in fact contribute to an even greater weakening of the immune system. This goes for both children over the age of two and adults alike.
Elidel cream is a topical immunosuppressant calcineurin inhibitor and is approved (as is the ointment Protopic) but still it must be administered with the greatest of caution. Use the minimum quantity that is required to improve the symptoms of the eczema sufferer, never more. In studies done on animals in laboratory settings, giving high quantities of Elidel to them brought about a tremendous rise in the incidence of cancer.