Protopic ointment linked to Lymphoma Cancer

Woburn, Mass.I just woke up one morning and found a large lymph node under my right arm," said Daniel Sabbatelli. "I didn't think much of it at the time and neither did my doctor." Back in 2003, not even the characters in "House" would think of linking Protopic Ointment to a lymphoma.

Lymphoma is a broad term encompassing a variety of cancers of the lymphatic system.

The two main groups of lymphoma are Hodgkin's Disease (characterized by the growth of Reed-Sternberg cells in the cancer) and the Non-Hodgkin's Lymphomas. In 2005, about 56,390 Americans were expected to be diagnosed with non-Hodgkin's lymphoma while more than 7,000 new cases of Hodgkin's disease will be diagnosed in the US this year. Both forms of lymphoma are a serious condition.

"In 2000 I had dermatitis on my face so my dermatologist prescribed Protopic ointment (tacrolimus). It certainly helped the symptoms - mainly itching and inflammation - but it wasn't intended to cure an allergic reaction that caused the dermatitis in the first place," says Daniel. He used it sporadically for the next few years, applying the cream daily for a few days until the rash cleared up. Then it would reappear a few days later. This went on for a few years.

"Then I discovered this enlarged lymph node. I showed it to a physician friend and he wasn't too concerned but suggested that I get a CAT Scan. Well, one year later I still hadn't done anything about it. It hadn't got any larger and it didn't bother me; I was going to work, taking care of my kids (I'm a single Dad with three girls) and besides, there really wasn't enough time in the day.

By 2004 I visited my primary care physician and showed him this lump. He didn't think it was cancerous but what he couldn't understand was how it had just appeared one day.

He ordered a CAT scan. This time I paid attention - I lit up like a Christmas tree! I had nodules everywhere, hundreds of them, mostly surrounding my critical organs. I don't have x-ray vision and had no idea -I had none of the classic cancer signs. The only symptom I noticed was fatigue and I would get out of breath when I exercised. I am 41 years old and consider myself in excellent health; the only medication I have ever taken besides Protopic is aspirin. So this came right out of the blue.

The reality was this: the lymphoma had been there the whole time, maybe for a few years, but was held back by muscle tissue. And now, - like the proverbial finger in the dyke - it couldn't hold back anymore.

But I am a problem solver so I said, 'What do we do now, what is the next step?' My doctor interpreted the scan to be serious and sent me right away to the oncologist and had it removed. Next up, I started chemotherapy treatments.

Of course I lost my hair. I had six treatments, 21 days apart. I consider myself lucky because this lymphoma was only a stage four. My oncologist told me that, if I had waited another six months, I probably wouldn't have survived. I can't even imagine what would happen to my family - I'm a single Dad with three girls, from ages 9 to 12.

My treatments were over and about three weeks later I was watching Fox news; there was a trailer at the bottom the screen and it said that the FDA recently black-boxed two popular dermatological type medications - Elidel and Protopic. I was in shock - I finally realized that Protopic had caused my lymphoma!

Then I filled out some form on the FDA website about Protopic but I didn't hear back from the agency or Fujisawa Pharmaceuticals, the makers of Protopic. I know the company didn't develop this product to hurt people but it has been a very unpleasant thing to go through and has definitely compromised my health. And I was out of work for one year. I would never have Protopic if I knew that it was an immunosuppressive drug."

Fujisawa Pharmaceuticals, the maker of Protopic, said its research indicated no increase in the rates of lymphoma or skin cancer in users of the drug, but the FDA has received reports of lymphoma and skin cancer in children and adults treated with Protopic since it approved the drug in December 2000. Since its approval, an estimated 2.1 million patients in the United States and 5.4 million patients worldwide have been treated with Protopic.

In January 2006, the FDA updated the labeling of Elidel® cream and Protopic® ointment. The new labeling includes a boxed warning about a possible risk of cancer and a Medication Guide (FDA-approved patient labeling). Now, Health Canada is advising people who use Elidel® cream and Protopic® ointment about safety information that indicates a potential cancer risk.

The Fujisawa Pharmaceuticals website has now issued a warning: "Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Protopic. Therefore, continuous long-term use of topical calcineurin inhibitors, including Protopic, in any age group should be avoided."