The FDA has decided to require black box warnings for Elidel cream and Protopic ointment. These are two prescription medications used to treat eczema. The FDA had been notified of almost 80 cases of cancer in patients treated with Elidel and Protopic. Also, animal tests have shown an increased risk in cancer associated with these two drugs. The new warnings will advise patients about the cancer risk. The new drug labels will also clarify that these medications are to be used after patients have tried other treatments. A black box warning is the most serious type of warning in prescription drug labels. Novartis Pharmaceuticals makes Elidel and Astellas Pharma. Inc. makes Protopic. The two companies dispute the need for the new warnings.
Comments are closed.