 |
 |
|||
 |
 |
 |
 |
|
|
 |
Elidel WarningThe U.S. Food and Drug Administration (FDA) recently issued a Public Health Advisory for users of Protopic and Elidel while urging the medication manufacturers to add a black box warning to their eczema creams. The FDA's warning states, "It may take human studies of ten years or longer to determine if use of Elidel or Protopic is linked to cancer."Protopic (tacrolimus) and Elidel (pimecrolimus) are classified as Topical Immunosuppressant Calcineurin Inhibitors and are popular steroid-free treatments for eczema and Atopic Dermatitis. Eczema and Atopic Dermatitis are both persistent skin conditions recognized as red, scaly, itchy skin. Since the FDA approved Elidel, several cases of lymphoma and skin cancer have been reported in patients. Elidel is classified as an immunosuppressant which can lower a patient’s normal immune response, making the user susceptible to a variety of diseases and cancers. With research and reports linking the skin absorbent Elidel ointment to skin cancer, the FDA recommends patients only use the cream prescription as a last resort and then only for a limited time. Elidel should not be used by those with a weakened immune system and never be used on babies under two years old. The makers of Elidel state that the cream is effective for mild and moderate eczema and can be used on children. Elidel is manufactured and marketed by Novartis. Types of skin cancer and warning signs It is alleged that Protopic and Elidel have been linked to various types of skin cancer. These cancers include:Skin Cancer, T-Cell Lymphoma, Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC), Hodgkin's Lymphoma (HL), Non-Hodgkin's Lymphoma Basal cell carcinoma is the most common form of skin cancer (90%), affecting 800,000 people in the U.S. each year. Typically this cancer occurs in parts of the body that are not exposed to sunlight. Basal cell carcinoma often resembles eczema or psoriasis. Common warning signs of Basal Cell Carcinoma include: Open Sore – non-healing sore, remaining open for 3 or more weeks Reddish skin patch – a reddish patch that may or may not be irritated and uncomfortable Shiny mole-like Bump – nodule that can be translucent, tan, black or brown. Pink Growth – circular growth with raised outer edge Scar-like patch- similar to scar tissue, this skin cancer appears shiny and taut, white or yellow There are over 30 types of Lymphoma, including 5 types of Hodgkin’s lymphoma and 25 types of non-Hodgkin’s lymphoma. These lymphomas start in the lymph nodes and symptoms include swelling of the lymph nodes, fever, night sweats, unexplained weight loss, lack of energy. Similar to basal cell carcinoma, there are many causes of lymphoma, including weakened immune functions. If you currently use Elidel or if you show signs of skin cancer, talk to your doctor or dermatologist immediately. It is noted that the long-term side effects of using Elidel ointment have not been identified. If you currently use Protopic, a prescription skin medication similar to Elidel, learn more [ABOUT PROTOPIC]. Elidel In the News Health Canada is advising people who use Elidel(R) cream ointment about safety information that indicates a potential cancer risk. (Apr-27-05) [NEWS WIRE]FDA’s Pediatric Advisory Committee reviewed tests that linked Elidel and Protopic to an increased risk of skin cancer and non-Hodgkin’s lymphoma. (Mar-10-05) [FOX NEWS] Food and Drug Administration issues a Public Health Advisory. (Mar-10-05) [FDA] The National Institute of Allergy and Infectious Diseases reports that as immuno-modulators, Protopic and Elidel "could increase the risk of cancer by suppressing the immune system's ability to control the Epstein-Barr virus". (Feb-20-05) [MED PAGE TODAY] LEGAL NOTICE AND
DISCLAIMER: The materials
within this web site are for informational purposes only. They
are not legal advice and should not be used as such. Transmission
of the information in this web site is not intended to create,
and receipt does not constitute, an attorney-client relationship.
Internet users and readers should not act upon this information
without first seeking professional legal counsel. The information
in this web site is provided only as general information which
may or may not reflect the most current legal developments. Past
results do not guarantee the outcome of future cases. PLEASE
CLICK HERE FOR FULL WEBSITE TERMS OF USE, IMPORTANT ADVERTISING
DISCLAIMERS AND PRIVACY INFORMATION. |
|
|
|||
|
|||||||
