Update on Drugs and Drug News: January, 1998

Scalp Dermatoses

Norgestimate / Ethinyl
estradiol


Tri-Cyclen®

Janssen-Ortho

Approved by the Canadian HPB March, 1998 for the new
indication of treatment of moderate acne vulgaris in
females who have no known contraindications to oral
contraceptive therapy. Previously approved in the US in
1997.

Topical
anesthetic

Lidocaine/Prilocaine Cream


Emla®

Astra

Approved by the FDA February, 1998 as a pre-procedural
application to adult male genital skin prior to site-specific
subcutaneous infiltration with lidocaine for the removal of
genital warts.

Acne vulgaris

Tretinoin gel 0.025%


Avita®

Penederm

This new gel formulation was approved by the FDA
February, 1998 for the treatment of acne vulgaris.

Acne vulgaris
& oily skin

Adapalene solution 0.1%


Differin®

Galderma

Applied once a day in the evening for the treatment of acne.
The solution also provides a drying effect for patients with
oily skin.

Wound
closure

Topical tissue adhesive


Dermabond®

Closure Medical

An FDA advisory panel recommended approval of this
sterile, liquid, topical tissue adhesive to hold closed
trauma-induced lacerations or surgical incisions (including
punctures from minimally invasive surgery) which otherwise
would be closed with sutures of USP size 5-0 or
smaller in diameter, staples or adhesive strips.

Atorvastin
calcium


Lipitor®

Parke-Davis

This lipid reducing agent has been reported to cause angioneurotic edema in some patients
and labelling has been changed accordingly.

Isotretinoin


Accutane®

Hoffman La Roche

Upon advice from the FDA in early March, Roche sent out Dear Doctor letters to US physicians
advising them of labelling changes. The Warnings section will now begin with the following
paragraph in bold type: Psychiatric disorders: Accutane may cause depression,
psychosis and, rarely, suicidal ideation, suicide attempts and suicide. Discontinuation
of Accutane therapy may be necessary. No mechanism of action has been established
for these events. The adverse events section is also revised.