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Update on Drugs & Drug News

UPDATE ON DRUGS

Class

Name/Company

Approval Dates and Comments

Antipsoriatic Agent

Infliximab
Remicade®
Centocor/Schering-
Plough

The US FDA approved this monoclonal antibody in May 2005 for the treatment of psoriatic arthritis. This is the ninth new indication for this product.

Health Advisory

Cyproterone
Ethinyl

Diane-35
Berlex

TPP Canada issued a Health Advisory in May 2005 informing consumers of a new version of the product monograph agreed upon by Berlex and TPP Canada that includes the following information:

  • This product must not be used in women with
    thrombohebitis, thromboembolic disorders, or a history of these conditions.
     
  • Some published studies show that Diane-35® users appear to have an elevated risk of blood clots compared with users of combination oral contraceptives.
     
  • Diane-35® should not be prescribed for birth control alone.
     
  • Oral contraceptives should not be taken during treatment with Diane-35®.
     
  • Diane-35® should be discontinued 3-4 months after signs of acne have completely resolved.
     
  • Consumers should be aware that cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from Diane-35® use.

Any occurrences of thromboembolic disorders (blood clots) or other serious and/or unexpected adverse reactions in patients taking Diane-35® should be reported to TPP Canada.

Drug News

Antipsoriatic Agent

Biogen Idec and Fumapharm AG in April 2005, announced results from a multicenter, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy and safety of BG-12, an oral fumerate, in the treatment of moderate-to-severe psoriasis. The trial met the primary endpoint and
patients receiving BG-12 demonstrated a statistically significant clinical improvement as measured by a lower median psoirasis severity score after 16 weeks of treatment compared with patients receiving placebo. The median PASI was 5.8 for the BG-12 group and 14.2 for the placebo group.
Median percentage reduction from baseline PASI was 68% for patients receiving BG-12 and 10% for patients receiving placebo.

Hair Dye

In an article recently published in of the scientific evidence looking
strong evidence of increased risk. hematopoietic cancers (e.g., leukemia of a causal effect is too weak to represent a major public health concern.

*JAMA 293:2516-25 (2005).