News and Press
Important - September 15, 2005
To our patients:
Many of you have heard reports on the news or seen articles in the media regarding new issues surround Protopic and Elidel. Recently, a Food and Drug Administration Panel of the Division of Pediatric Drug Development convened. They discussed issues regarding a collective review of data which show several new animal studies documenting an increase in the likelihood of skin cancer and lymphoma with prolonged use of Elidel or Protopic. As a result, both Protopic and Elidel have received a black box warning from the Food and Drug Administration.
It should be noted that there is a marked discrepancy between animal studies and human studies. Pharmaceutical manufacturers Astellas (formerly Fujisawa) and Novartis document no increase in the risk of skin cancer and lymphoma in the patient population using Protopic and Elidel compared to the general population. There have been several long-term studies regarding the safety and efficacy of these products. To date, none of htem have shown an increased risk of skin cancer or lymphomas in humans compared to the general population.
Given these findings, I am recommending that any patient utilizing therapies of Elidel or Protopic for more than 6 months should contact our office for adjustment of your treatment regimen. We currently use a rotational therapy system for patients currently using Protopic or Elidel. Regimens are rotated to other therapies at 6 month intervals.
Patients using Protopic or Elidel in combination with Phototherapy should discontinue the use of Protopic and/or Elidel immediately. You may continue to use phototherapy alone. Again, all patients who are currently on a regimen of Protopic or Elidel and have not been evaluated in the past 6 months should schedule a follow-up appointment so that we can ensure that you feel safe and comfortable with your mode of treatment.
Sincerely,
Pearl E. Grimes, MD
