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).
Protopic, 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 physician.
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.
There 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.
Traci 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 body.
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. )
There 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.
Research 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.