FDA weighs black box warning for two eczema creams

Share this article:
The FDA convened an outside panel of experts this week to consider adding black box labeling to two prescription eczema creams to warn they might increase the risk of certain cancers, especially in children. The panel discussed Novartis' Elidel and Fujisawa Pharmaceuticals' Protopic after 13 reports of skin cancer and lymphoma in children and adults. Novartis said there was no evidence
Elidel causes lymphoma, noting the number of lymphomas in question "is below the number typically observed in the general population." Fujisawa said it did not believe Protopic raised the risk of skin cancer or lymphoma and that the cream "has a favorable benefit-risk ratio."
Share this article:

Email Newsletters

More in News

Astellas, DOJ settle for $7.3M

Astellas, DOJ settle for $7.3M

Astellas has settled a False Claims case with the Department of Justice over the 2010-2013 marketing of an antifungal medication. Astellas denies the allegations.

Boehringer drug lands US, EU orphan tag

Boehringer drug lands US, EU orphan tag

The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.

Omnio app moves to smartphones

Omnio app moves to smartphones

Physicians Interactive is introducing the third wave of its Omnio app, making the tablet-only tool available for iPhones and Android phones.