European panel allows careful use of eczema creams

LONDON (Reuters) – The European Medicines Agency said on
Monday two prescription creams used to treat eczema could still
be used but “with greater caution” to reduce skin cancer and
lymphoma risks.

The creams are Novartis AG’s Elidel and Astellas Pharma
Inc’s Protopic, the London-based agency said in a statement,
adding “the benefit associated with the use of these
dermatological medicinal products outweigh the risks.”

Its Committee for Medicinal Products for Human Use (CHMP)
has been reviewing the safety of the two creams since last
April following reports of skin cancer and lymphoma in
patients.

“On the basis of the available data, the committee was
unable to conclude whether Protopic/Protopy or Elidel caused
the reported cases of skin cancer or lymphoma,” the European
Medicines Agency said.

The creams’ makers have been asked to gather more data on
long-term safety. In the meantime, “patients who are using
Protopic/Protopy or Elidel should not stop or modify their
treatment without consulting their prescribing healthcare
professional,” the agency said.

On January 19, the U.S. Food and Drug Administration said
Elidel and Protopic would carry strong warnings about the
possible risk of skin cancer, lymphoma and other cancers.

The creams now come with a “black-box” warning — the
strongest type used in the United States. FDA officials said
while a clear link between the drugs and cancer risk had not
been found, there were enough reports to warrant the change.

Eczema, a rash-like inflammation that causes itchy, red
skin, can also be treated with antihistamines, oral and topical
steroids and over-the-counter products.