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Update on Drugs and Drug News - March 2006




Approval Dates and Comments

Antipsoriatic Agent

Calcipotriene/ Betamethasone Dipropionate Ointment
Warner Chilcott/LEO Pharma

The US FDA approved this product in January 2006 as a once daily treatment for psoriasis vulgaris in adults. This ointment is marketed as Dovobet® and Daivobet® outside of the US.

Antipsoriatic Agent

Amgen/Wyeth Pharmaceuticals

TPP Canada approved this biologic therapy in December 2005 for the treatment of moderate-to-severe psoriasis in adults. It has been previously approved in Canada for the treatment of rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Drug News

Updated Labeling

The US FDA, in January 2006, approved updated labeling for two eczema drugs, pimecrolimus (Elidel®, Novartis), and tacrolimus (Protopic®, Astellas Pharma). The new labeling will include a boxed warning about a possible risk of cancer, informing healthcare professionals that the longterm safety of these drugs has not been established, though studies are underway and there is a recognized benefit associated with these drugs when used appropriately. The new labeling also clarifies that these drugs are recommended for use as second-line treatments. Use of these drugs in children < 2years of age is not recommended. A Medication Guide has been published that provides consumer friendly information to patients about how to use the drugs safely. Pharmacists are required to provide the Medication Guide to patients when dispensing the drug.

Dear Doctor Letter

In January 2006, HPB Canada sent out a Dear Healthcare Professional letter concerning hepatitis B virus relapse in all TNF blocking agents, including etanercept (Enbrel®, Amgen Canada/Wyeth Pharmaceuticals), adalimumab (Humira®, Abbott) and infliximab (Remicade®, Centocor). These effects are very rare (< 1 adverse event/10,000 treated patients) and are not unique to the anti-TNF-á products, having been reported for other immunosuppressive agents as well. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before beginning therapy with any anti-TNF-á product. Those patients identified as carriers of HBV should be monitored for signs and symptoms of HBV relapse throughout their therapy and for several months following termination of therapy.

Dear Doctor Letter

In October 2005, Biogen Idec sent out a Dear Doctor letter to inform healthcare providers of new safety information for AMEVIVE® (alefacept), which is now contraindicated for patients with HIV disease. This decision is based on the pathophysiology of HIV and the fact that AMEVIVE® reduces CD4+ T lymphocyte counts. Such a reduction could accelerate disease progression or increase complications of disease in these patients.

Cleansing Agents

In a study by Retroscreen Virology, a subsidiary of University of London’s Queen Mary School of Medicine, Skinvisible’s patent-pending Chlorhexidine Hand Sanitizer demonstrated a >99% kill on the “bird flu virus” (H5N1) within seconds of contact. In vitro studies demonstrate a sustained release of the active ingredient over a 6 hour period. The results were presented at the Retroscreen Virology Conference, “Bird Flu: The First Pandemic of the 21st Century” in January 2006.

  1. An Update on the Role of Topical Metronidazole in Rosacea
  2. The Forehead Flap for Nasal Reconstruction: How We Do It
  3. Update on Drugs and Drug News - March 2006