Today, the manufacturer of Protopic (tacrolimus) is faced with hundreds of lawsuits. Protopic has been on the market for the last five years as an eczema treatment. Since their launch about 5 years ago, both Protopic and similar drug Elidel (pimecrolimus) have been prescribed to 7.5 million people, including children. These drugs are now the a matter of concern that they can possibly cause skin cancer.
It was not until early January 2006, that the U.S. Food and Drug Administration, warned of a cancer risk. It directed that manufacturer of Protopic and Elidel to add a warning black box in its product label of possible risks.
Until this time, Protopic and Elidel were touted as the wonder drugs for people with severe eczema. The advantage of these drugs was that they were steroid-free and were hailed as a welcome relief for those who did not wish to contend with side effects from steroids.
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.
There are now reported cases of skin cancer and breast cancer arising from using Protopic as an eczema treatment. The same goes for Elidel. More people now realize that both these drugs are classified as immunosuppressant. This simply means that anyone who uses this medication is exposed to a number of diseases, including cancer, because a person’s immune 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. “I noticed a lump in my right breast which is the exact area where I was using the drug.”
Reilly, 41, developed breast cancer after using Protopic and Elidel. She was prescribed these medications due to 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 positive that Elidel is the cause of her lymphoma.
Tom Moore, an author of several books involving the pharmaceutical industry, speaks up for these unfortunate cases. “There should have been warnings from the start,” he says.
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 cited a 2005 FDA report involving animals given high doses of Protopic. In one study, monkeys developed cancer after receiving the oral form of the Protopic. The animal study also showed that the higher the dose of Protopic used, the higher the rates of cancer became. With more cases of drug injuries reported, the FDA issued the requirement of the black box warning.
More long-term cancer studies involving the topical form of both drugs are now underway. However, human studies, as the FDA pointed out, may take ten years or more. Hence, if you wish to continue to use Protopic or Elidel as an eczema treatment, then be aware of the cancer risks. 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 of age.