FDA Adds new Cancer
Warning to Eczema Cream and Ointment Labels - Elidel and Protopic
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
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
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
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.
Best Syndication Staff Writer
Keywords and misspellings: law legal legle exema exsema