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.
Revision date: June 11, 2011
Last revised: by Sebastian Scheller, MD, ScD