ClassName/CompanyApproval Dates and Comments
ImmunomodulatosPimecrolimus and

Elidel® Cream and
Protopic® Ointment

Elidel®: Novartis
Protopic®: Astellas
(formerly Fujisawa)
TPP Canada issued a Health Advisory in April 2005 informing healthcare providers and patients about safety information indicating a potential cancer risk for these calcineurin inhibitors which are approved for the treatment of eczema in adults and children >2 years of age. They further asked healthcare providers and patients to consider the following:

  • Use these drugs only when other treatments have been shown to be ineffective or unsuitable.
  • Use a thin layer to control symptoms and only for short periods of time, as long-term safety is unknown.
  • Avoid use in children under 2 years, as the effect on the developing immune system is unknown.
  • Avoid use in children and adults with weakened immune systems.
  • Patients should consult their physician if they have any concerns.

TPP Canada will require labeling changes for these products including updates to safety information about the potential cancer risk.

AEterna Zantaris
The Columbian Food and Drug Agency approved this oral alkylphospholipid in March 2005 for the treatment of the cutaneous form of leishmaniasis as well as the visceral form of this condition.

Drug News

RubellaAccording to a Reuters report published on page A13 of the New York Times on 22 March 2005, rubella, a virus that once caused tens of thousands of birth defects and deaths in a single outbreak, has been eliminated from the US. However, US health officials from the Center for Disease Control and Prevention maintain that children must still be vaccinated and pregnant women must still ensure they are immune because the disease exists elsewhere. In 2004, nine rubella cases were reported in the US, all originating in other countries. Rubella, also known as German measles, is a usually mild viral infection that causes fever and rash, but early in pregnancy it can cause birth defects.
A New
A team of researchers led by Steven A. Rosenberg, MD at the US National Cancer Institute* have found that patients with advanced melanoma who had not responded to previous therapies experienced a significant reduction in the size of their cancers as a result of receiving a new immunotherapy which consisted of a combination of chemotherapy and reintroduction of their own (autologous) lymphocytes that were activated to attack the tumor. With this treatment, 18/35 patients (51%) experienced an improvement in the amount of tumor present at diverse sites in the body including the skin. Fifteen of the 18 patients had a partial response lasting from 2 months to more than 2 years. The 3 remaining patients had complete clearance of the tumor.

*J Clin Oncol 23(10):2346-57 (2005 Apr 1).