What actions have the FDA and the manufacturers taken to make the public aware of this safety information?
The FDA has worked with the manufacturers of Sporanox® and Lamisil® to revise the professional labeling to inform health care providers about these possible serious side effects, describe the types of patients that should not receive Sporanox® or Lamisil®, and explain when Sporanox® or Lamisil® therapy should be stopped and distribute a “Dear Health Care Professional” letter which the manufacturers will send to health care providers to convey new information on safety.
The FDA has worked with the manufacturers of Sporanox® and Lamisil® to revise the professional labeling to inform health care providers about these possible serious side effects, describe the types of patients who should not receive Sporanox® or Lamisil®, and explain when Sporanox® or Lamisil® therapy should be stopped and distribute a “Dear Health Care Professional” letter which the manufacturers will send to health care providers to convey new information on safety.
