FDA Adds new Cancer Warning to Eczema Cream and Ointment Labels - Elidel and Protopic

January 19th 2006

Eczema

The Food and Drug Administration (FDA) is requiring new labeling for two creams used to treat eczema. The new cautions are “black box” warnings for possible cancer risks. Both Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus) are prescription drugs and will carry the label warnings.

The Black Box warning is the most serious type of warning and will be located lower on the labels. According to the FDA the label helps clarify that these drugs are recommended for use as a second-line treatment. This means that other topical medicines should be tried first. Also children under 2 years of age should not use the drug.

Eczema (also known as atopic dermatitis) is one of the most common skin disorders seen in infants and children. It affects 10 to 15 percent of the childhood population. The causes are not clear, but the chronic itching and dry skin could be caused by an allergic or immune condition. The redness is caused by scratching.

It is not known how the products work, but they appear to effect the body’s immune system. Dr. Steven Galson, Director of the FDA’s Center for Drug Evaluation and Research (CDER) said "We are taking steps to ensure that healthcare providers and patients are aware of the possible long-term risks of these products so that they will be used appropriately."

According to the FDA the Medication Guide will “provide consumer friendly information to patients about how to use the drugs safely. Pharmacists are required to provide the Medication Guide to patients when dispensing the drug. Patients are advised to read the entire Medication Guide and talk to their healthcare provider if they have further questions.”

Novartis manufactures Elidel cream and Astellas Pharma, Inc (formerly Fujisawa Healthcare) is the manufacturer of Protopic ointment. It is suspected these creams may cause skin cancer. According to the Lawyers and Settlements (L&S) website “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.”

According to the L&S website you may want to watch for disorders including Vitiligo and skin cancer. Vitiligo is caused by an attack on the immune system often brought on by immunosuppressant drugs. Sufferers may lose skin pigmentation leaving white milky patches.

According to L&S, users should watch for T-Cell Lymphom, Basal Cell Carcinoma (BCC) and Squamous Cell Carcinoma (SCC), Hodgkin's Lymphoma (HL), Non-Hodgkin's Lymphoma. BCC is the most common type of skin cancer and often resembles eczema or psoriasis.

Even Consumer Reports warns their readers that Protopic and Elidel are in the 12 most popular prescriptions thought to be dangerous. Consumer Reports says the side effects may be “undetected or underestimated”.

If you or a loved one has suffered from any adverse side effects from using Protopic, the L&S website has offered a form for logging your name. In the event that a class action lawsuit is brought you will be included. Both way, the company will have a lawyer review your case and he or she may contact you. There is no obligation and you are free to choose any lawyer you want to work with.