'Black box' impacts TIM use

March 1, 2007

Scarsdale, N.Y. - "Black box" warnings added to labels of the eczema drugs Elidel Cream (pimecrolimus, Novartis) and Protopic Ointment (tacrolimus, Astellas Pharma, Inc.) have curtailed off-label use and slashed prescriptions some dermatologists write for these drugs by 75 percent, dermatologists say.

They add that while the flurry of patient concerns over the warning has largely subsided, existing alternatives to these drugs aren't perfect.

The Food and Drug Administration (FDA) added warnings about possible cancer risks to pimecrolimus and tacrolimus labels in January 2006.

At the time, he says, "We were starting to use them as alternatives for cortisone creams in other situations" outside their approved indication.

Now he says, use of these topical immunomodulators (TIMs) is "limited much more specifically to atopic dermatitis (AD) or eczema," a change that has cut the number of prescriptions he writes for these drugs at least 70 percent to 75 percent.

Amy E. Newburger, M.D., says she's seen a similar drop in prescriptions she writes for tacrolimus and pimecrolimus in her practice, which is half medical, half cosmetic.

"I had been using Elidel and Protopic for treating rosacea, psoriasis and seborrheic dermatitis," says Dr. Newburger, director, Dermatology Consultants of Westchester, Scarsdale.

However, she says her Elidel and Protopic prescriptions have decreased, because "Once there's a black box, I don't want people to feel concerned that I am in any way jeopardizing their health."

Indeed, the FDA's decision and its attendant publicity sparked reactions among patients and their families, Dr. Bishop tells Dermatology Times.

"Since a lot of patients who were on Elidel or Protopic are children," Dr. Bishop explains, "many of their parents called" to find out whether the drugs posed any risk to their children.

In fact, Dr. Bishop says his practice took two to three patient calls daily during the weeks when the studies had made headlines but the actual warnings had yet to be revealed.

As physicians, Dr. Bishop says, "We had to be up front with this from the beginning and explain the nature of the black box, then go over the studies" with patients or their parents, which became something of a burden.

However, he says, "It's important that doctors spend the time" to educate patients and urge them to use TIMs when appropriate.

Now that the initial furor has subsided, "There's far less concern on the part of patients," Dr. Newburger adds.

Generally, she says, "Patients trust what we say."

Accordingly, Dr. Newburger says she still uses tacrolimus and pimecrolimus for persistent dermatitis in the periocular region, for facial seborrheic dermatitis, and off-label for resistant psoriasis in areas where steroids aren't appropriate.

Regarding the studies, Dr. Newburger says, "I looked at the data very closely. And there was no evidence the drugs caused an increase in systemic lymphomas or other malignancies, in light of how many millions of prescriptions had been written over five or six years."