Update on Drugs and Drug News

UPDATE ON DRUGS
Class	Name/Company	Approval Dates and Comments
Antipsoriatic Agent	Alefacept AMEVIVE™ Biogen Idec	TPP Canada approved this biologic therapy in October 2004, for the treatment of patients with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Anti-arthritic Agent	Infliximab Remicade® Schering-Plough	The European Medicines Agency (EMEA) granted approval in October 2004, for this product to be used in combination with methotrexate for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to diseasemodifying antirheumatic drugs.
Dermal Fillers	Hylan-B Gel Hylaform® Plus Inamed	The US FDA granted marketing approval in October 2004, for this dermal filler for the correction of moderate-to-severe facial wrinkles and folds.
Anti-acne Agent	Clindamycin 1% + Tretinoin .025% Gel Velac® Connetics	The US FDA accepted a New Drug Application in October 2004, for this investigational new drug as a potential new topical treatment for acne.
Drug News
Drug Warning	Important new information on side-effects associated with the use of Bextra, a COX-2 selective nonsteroidal anti-inflammatory drug that is indicated for the treatment of osteoarthritis, rheumatoid arthritis, and dysmenorrhea was reported in December 2004 by the US FDA. A “boxed” warning will be added to the label, stating that patients taking Bextra have reported serious, potentially fatal skin reactions, including Stevens-Johnson Syndrome and toxic epiderma necrolysis. These skin reactions are most likely to occur in the first 2 weeks of treatment, but can occur at any time during therapy. In a few cases, these reactions have resulted in death. The labeling advises doctors that Bextra should be discontinued at the first appearance of a skin rash, mucosal lesions, or any other sign of allergic reactions. The warning also states that Bextra contains sulfa, and patients with a history of allergic reactions to sulfa may be at a greater risk of skin reactions.
Risk Minimization Actions Plan for Anti-acne Agent	The US FDA announced in November 2004, that the risk minimization actions plan (RiskMAP) for Accutane® (isotretinoin) and its generic equivalents is being enhanced in order to reduce the risk of birth defects associated with fetal exposure to isotretinoin. Under the new program, sponsors will obtain registration of not only prescribers, but also pharmacies that dispense and patients who use isotretinoin. The program also includes documentation of a negative preganancy test before giving isotretinoin to women who are capable of becoming pregnant. The registration system will be built to incorporate physician and patient identification codes that will also protect the privacy of the patients. The innovator and generic sponsors of isotretinoin have jointly contracted with Covance, Inc. to design, build, implement and operate a single strengthened isotretinoin RiskMAP incorporating these elements.

1. Table of Contents
2. Imiquimod 5% Cream for the Treatment of Actinic Keratoses
3. The Surgical Correction of Protuberant Ears
4. Update on Drugs and Drug Warnings