The European Medicines Agency's Committee for Products for Human Use (CHMP) has recently conducted a safety review of atopic dermatitis (excema) treatments Protopic/Protopy (tacrolimus) and Elidel (pimecrolimus), and has concluded that the drugs should be used with greater caution in order to reduce the potential risk of skin cancer and lymphoma. The CHMP launched its review in April 2005, following reports of serious adverse events in patients who had used the products.
According to the CHMP, patients who are using Protopic/Protopy or Elidel should not stop or modify their treatment without consulting their healthcare professional.
On the basis of the available data, the committee was unable to conclude whether Protopic/Protopy or Elidel directly caused the reported cancer cases.
Even with this new recommendation, "patients who are using Protopic/Protopy or Elidel should not stop or modify their treatment without consulting their prescribing healthcare professional," the CHMP said. The drugs' manufacturers have been asked to gather additional data on the safety of the medications, which will be presented to the CHMP later in the year.