Protopic Warning
The 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 Protopic in 2000, several cases of lymphoma and skin cancer have been reported in patients. Protopic 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 Protopic ointment to skin cancer, the FDA recommends patients only use the cream prescription as a last resort and then only for a limited time. Protopic should not be used by those with a weakened immune system and never be used on babies under two years old.
The makers of Protopic state that the cream can be used any where on the body and can be used on children. The original makers of Protopic, Fujisawa Pharmaceutical Co. Ltd merged with Yamanouchi Pharmaceutical Co. Ltd. in April 2005 to form Astellas Pharma Inc. Currently Protopic is being marketed and distributed throughout the world and generating millions of dollars.
Types of skin cancer and warning signs
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 Protopic 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 Protopic ointment have not been identified.
If you currently use Elidel, a prescription skin medication similar to Protopic, learn more [ABOUT ELIDEL].
Protopic In the News
Health Canada is advising people who use Protopic 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]