"About eight months after I was using Elidel on a regular basis, I was diagnosed with lymphoma," says Johnson (not his real name pending a lawsuit). "I first saw an ad on TV and that's how I found out about it." It is ironic that about one year later, he saw another ad about Elidel on TV, but this time warning users that it could cause lymphoma. If Ed hadn't been watching the TV, he would have continued to use Elidel and possibly would have needed even more chemotherapy treatments...
"I was no stranger to lymphoma, in fact I have a history of it," says Johnson. All the more reason why he would never have taken Elidel; being predisposed to lymphomas, he certainly wouldn't have taken this drug had he known the dangerous side effects - that would be the equivalent of putting a gun to his head. Johnson started to get excruciating back pains but had no idea it was another lymphoma. It wasn't like the others.
"I spent 10 days in hospital and went through six hard-core chemotherapy treatments. I still have to take chemo treatment, although a milder form, every eight weeks. If this doesn't work I will have to get a bone marrow transplant, so I'm not out of the woods yet.
Nobody knows exactly what caused this lymphoma to come back, but I believe that Elidel triggered it, especially because it is a different kind from the other lymphomas I had.
I want to tell Novartis, the makers of Elidel, that in my situation, their black box warning came too late if it had anything to do with my recurrent lymphoma. And I am concerned about the statute of limitations..."
The Food and Drug Administration (FDA) approved updated labeling on January 19, 2006 for Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus). The labeling now includes a boxed warning about a possible risk of cancer and a Medication Guide (FDA-approved patient labeling). The purpose of the Medication Guide, which is distributed with every prescription, is to help ensure that patients using these prescription medicines are aware of this concern. The new labeling also clarifies that these drugs are recommended for use as second-line treatments, meaning that other prescription topical medicines should be tried first.
According to the Elidel website, "The safety of using Elidel for a long time is not known" but it does admit that "a very small number of people who have used Elidel have had skin cancer of lymphoma." Novartis had better count again.