Usage:

Pimecrolimus is an immunomodulating (immune suppressing) agent used in the treatment of atopic dermatitis (eczema). It is currently available as a topical cream, once marketed by Novartis, (however Galderma will be promoting the molecule in Canada in early 2007) under the trade name Elidel.

Side Effects:

Topical immunomodulators like pimecrolimus (Elidel® and Douglan®) and tacrolimus (Protopic®) were developed after corticosteroid treatments, effectively suppressing the immune system in the affected area, and appear to yield better results in some populations. However, such suppression is believed by alternative health practitioners to have possible adverse health effects. The US Food and Drug Administration has issued a public health advisory about the possible risk of lymph node or skin cancer from use of these products.

The theory is that the immune system may help remove some pre-cancerous abnormal cells which is prevented by these drugs. However, any chronic inflammatory condition such as eczema, by the very nature of increased metabolism and cell replication, has a tiny associated risk of cancer.

In addition to cancer risk, there are other potential side effects with this class of drugs. Adverse reactions including severe flushing, photosensitive reactivity and possible drug interaction in patients who consume even small amounts of alcohol.

Litigation:

On January 19, 2006 the FDA required black box labeling for two topical eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus). The labeling will be updated with a boxed warning about a possible risk of cancer. The FDA action in January 2006 follows an agency advisory committee recommendation in February 2005 that Elidel cream and Protopic ointment carry the cancer risk label warnings.

The response by the drug companies involved (Astellas/Fujisawa & Novartis) has been to try and block a series of FDA actions on elidel and protopic over the past few years. Moreover, the drug companies now appear to be backtracking and contradicting earlier claims about the safety of using elidel or protopic.

If you or a loved one have experienced adverse effects as a result of Elidel, please submit the contact form at right and an experienced Elidel attorney will call you to discuss your rights.