Elidel (pimecrolimus) is used to treat skin conditions such as eczema (atopic dermatitis). The ointment, which is manufactured by Astellas Pharmaceuticals, was originally approved by the FDA in 2000 for use by adults and children 2 years and older. However, the FDA recently requested a label change for Elidel following a public health advisory to healthcare professionals warning of the potential risk of cancer.
On January 19th, 2006, the FDA announced that it will require a "black box" warning for the label of Elidel, in an effort to alert patients of the risk of cancer. The new label will also clarify that Elidel should only be prescribed after other medications have been tried (unsuccessfully) by patients. A black box warning is the most severe warning that the FDA can issue to the public.
Elidel ointment is applied to the skin to control eczema and other skin disorders. The drug was originally prescribed as an alternative to steroid creams, which have also been linked to major side effects.
Elidel works by suppressing the immune system, an action that is being directly linked to the development of cancer. Data collected by the FDA showed that the risk of cancer increases as the amount of Elidel being taken is increased. As of December 2004, the FDA received nearly 80 reports of Elidel therapy causing cancer-related side effects (skin and lymphoma).
If you are suffering from one of the following Elidel side effects, contact us immediately:
As the long-term effects of Elidel are still unknown, health care officials are urging patients to use the drug for short periods of time, not continuously. Data has shown the risk of cancer increases as the amount of the drug being given increases.
If you or a loved one have experienced side effects from Elidel including Lymphoma (skin cancer), please call us at 1.800.966.4999 or fill out the form to the right of the page for immediate attention to your case.
