The Food and Drug Administration has decided to add 'black box' warnings to two medications used to treat the skin condition eczema. The black box warning is considered the most serious warning the FDA can issue about an approved medication.
The medications in question, Elidel cream and Protopic ointment, are now only recommended for use by patients after they have tried other medications and those have proven ineffective.
As of October, the FDA has reported 78 cases of skin cancer from patients using Elidel cream and Protopic ointment.
'This is something that is a possible risk, is a long-term possibility and is something that still needs to be researched,' FDA spokeswoman Susan Cruzan said.
Not surprisingly, the makers of the medications said the warning were unnecessary but agreed to abide by them.
The makers of Elidel, Novartis Pharmaceuticals, released a statement saying, 'While Novartis believes this action is not substantiated by scientific or clinical evidence, Novartis has agreed to make the requested changes.'
Astellas Pharma Inc., the makers of Protopic were also questioning the link between their medication and cancer.
'It [the study] addresses a theoretical risk — a potential risk, not a demonstrated link,' Dr. Joyce Rico, vice president for medical sciences research and development at Astellas, said.
It is estimated that approximately 10 million people have used the two drugs in question. The long term safety of the medications has yet to be determined.
