Astellas Pharma U.S., Inc, manufacturer of Protopic (tacrolimus), is
now facing several lawsuits that the drug may cause cancer. Protopic has
been on the market for the last five years as a topical medication for
eczema. Since its launch, both Protopic and similar drug Elidel
(pimecrolimus) have been prescribed to 7.5 million people, including
children. Elidel is manufactered by Novartis Pharmaceuticals
Corporation. Both Protopic and Elidel were marketed as effective and
safe drugs for people with moderate eczema. After all, both these drugs
are steroid free and have been considered as suitable alternatives to
corticosteroids (traditionally the method of treatment for eczema).
and similarly Elidel, can control the symptoms of eczema that includes
redness, itching and inflammation. They can be used in almost all parts
of the body including the neck and facial area. The recommended use of
these creams were about twice a day for six weeks or as directed by your
However, since early January 2006, these drugs are
made known by the U.S. Food and Drug Administration, of possible cancer
risks. It directed that manufacturers of Protopic and Elidel to add a
warning black box in their product label of possible risks.
are now reported cases of skin cancer arising from the use of Protopic
as an eczema treatment. More people now realize that Protopic and Elidel
are classified as immunosuppressant. This simply means that anyone who
uses this medication is exposed to a number of diseases, including
cancer, because the imune system is relatively weakened.
Reilly of Naperville in the U.S. thinks that the two widely prescribed
medications may be responsible for her breast cancer. She first
developed a lump in her right breast which was the exact area where she
was using the drug.
Reilly had used both Protopic and Elidel. She
was prescribed these medications as she was suffering from a condition
called vitiligo that caused small patches of discolored skin on her
Vitiligo, a type of skin disease, may as well be the first
signs of skin cancer. It is characterized with loss of skin pigmentation
and may leave a milky white patch on the skin. (If you are using Elidel
or Protopic for eczema pain treatment and observe this kind of symptom,
stopped the medication and consult your physician immediately. )
are also reported cases of lymphoma that are allegedly caused by
Elidel. Lymphoma is a cancer of the tissues or lymph modes. Elaine
Eklund had been using Elidel to treat a rash on her facial area and two
weeks later she notice a lump on her neck. She is sure that Elidel is
the cause of her lymphoma.
Tom Moore, an author of several
books involving the pharmaceutical industry, claims that there should
have been warnings from the start. In all these cases, the warning by
FDA came too late.
He studied about 1,200 cases of suspected
drug injuries pertaining to Protopic and Elidel reported to the FDA
through 2005. Moore discovered more than 100 potential cancer cases in
children and adults, although he believed that the numbers should be
higher as many cases go unreported. Most of the 100 potential cases
involve lymphoma or skin cancer, although it cannot be concluded that
they are all directly linked to the drugs.
Moore also cited an
animal study involving monkeys who were given high doses of Protopic.
The monkeys developed cancer after receiving the oral form of the
Protopic. Together with other studies, the conclusion was that the
higher the dose of Protopic used, the higher the rates of cancer became.
These studies, together with more reported cases of drug injuries,
prompted the FDA to issue to the need for the black box warning.
laboratories are now studying more cases involving the use of Protopic
and Elidel. Still, such human studies, as the FDA pointed out, can take
ten years or more. At the present moment, it is best that you refrain
from using these medications for eczema. Hence, if you wish to
continue to use Protopic or Elidel, then be aware of the cancer risks
and discuss your options thoroughly with your physician. In any case,
you are strongly advised not to use these drugs if you have a weak
immune system or for babies or children less than 2 years old.