PROTOPIC WARNING – PROTOPIC CANCER RISK
Protopic
Cancer Warning Suggested for Protopic Eczema Cream
"Black
Box" Warning for Protopic Recommended Due to Increased Risks of Cancer
& Lymphoma
Feb.
16, 2005 -- In an FDA meeting, a distinguished nationwide panel of experts
reviewed medical data that linked Elidel and Protopic with an increased risk of
skin cancer and lymphoma. These two new and very popular prescription creams
used to treat eczema in children and adults may soon carry a "black
box" warning -- indicating the drugs represent a cancer risk for some.
PROTOPIC
- BLACK BOX WARNING IS NEEDED
The
panel has recommended that both Elidel and Protopic carry a Black box warning
that the drugs maybe an increase the risk of cancer with repeated usage. The
panel agreed with the FDA to limit the usage of Elidel cream to those over two
(2) years of age. "We made our recommendation based on animal data and
biologic plausibility combined with the fact that the use of these products is
increasing tremendously," says Dianne Murphy, MD, committee member and FDA
director of the Office of Pediatric Therapeutics. While the FDA committee
recommends a stern warning for all those who use the drug, Murphy stresses that
there were no human clinical trials that indicated cancer was a risk. In
numerous animal studies, it was shown that the cancer risk is real, including
one monkey study that showed an increasing risk of developing tumors as doses
increased. "The greater the dose the greater the number of tumors -- and
with the highest dose we saw seven out of eight monkeys develop tumors,"
says Murphy.
Both
drugs are currently approved for the treatment of eczema, an inflammatory
condition of the skin which affects some 15 million Americans, 20% of whom are
children. The condition causes dry, red, itchy skin that can blister or develop
scaly patches. The problem is that the majority of patients develop their first
bout of eczema before they are 12 months old and Elidel and Protopic have been
effective in treating eczema, but with a potential cancer risk. The bottom line
is, Infants under 2 years of age should not use these products. The risk of
cancer is too great.
Equally
important was the "biologic plausibility of the drugs" -- meaning, the
way in which the medications work. These medications suppress the immune system,
which may be a precipitating factor in the development of cancer."It
depends greatly on what other precipitating factors may be present in an
individual patient's profile, but this could certainly be a contributing factor
under certain circumstances," says Murphy.
FDA
REPORTS OF PROTOPIC CANCER
Since
Protopic was approved in 2000, the FDA has received 10 reports of serious
adverse events in children under age 2, and 17 cancers in all age groups. These
included non-Hodgkin's lymphoma and skin cancer. Published reports say three of
these cancer patients have died.
Elidel,
which was approved in 2001, appears to have a similar profile. According to FDA
records, from approval in December 2001 through September 2004, there were 54
serious adverse events reported in children under the age of 2, and eight
cancers in all age groups, including four in children over the age of 2. The
majority of the non cancer events were skin related, and resulted in
hospitalization for 15 children.
PROPTOPIC
LAWSUIT EVALUATION
If
you or a loved one has been diagnosed with cancer, lymphoma, skin cancer,
Hodgkins Lymphoma or Non-Hodgkin’s Lymphoma and have used Protopic or
Elidel cream, then Call Us for a Free Confidential Consultation at
1-800-883-9858 or E-Mail us at
Protopic Cancer Lawsuit Evaluation
|
Nationwide
Assistance for Victims of Elidel & Protopic Related Injuries 
