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Update on Drugs and Drug News - Number 6 1997

Class Name/Company Approval Dates and Comments

Anti-acne & antipsoriatic

Tazarotene Gel 0.05%, 0.1%
Tazorac® topical gel

Approved by the FDA June 13, 1997 for the topical treatment of patients with stable plaque psoriasis of up to 20% body involvement, or facial acne vulgaris of mild to moderate severity. Previously approved in Germany and Canada. (Reviewed in Volume 2, Number 4, Pages 1-2.)


Ketoconazole Shampoo 2%

Approved by the FDA 30 May, 1997 for the supplemental indication of treatment of tinea (pityriasis) versicolor. Previously granted OTC status as an anti-seborrheic in most countries except the USA.


Fluticasone proprionate
Cutivate® Cream 0.05%
Glaxo Wellcome

Approved by the FDA May, 1997 for once daily dosing for eczema patients.

Class Name/Company Drug Warning


Amoxicillin/clavulanic acid
SmithKline Beecham

The UK Committee on Safety of Medicines recommends that, because of the risk of cholestatic jaundice, amoxicillin should be used instead of Augmentin, unless beta-lactamase producing bacteria are suspected of causing the infection. Use of Augmentin® longer than two weeks increases the risk of jaundice and should usually be avoided.


Indinavir, Crixivan®, Merck;
Nelfinavir, Viracept®, Agouron;
Ritonavir, Norvir®, Abbott;
Saquinavir, Invirase®, Roche;

The FDA has issued a letter warning of diabetes mellitus and hyperglycemia developing in patients receiving protease inhibitors. Causality has not been clearly established. These adverse effects occur relatively infrequently, and protease inhibitors should not be discontinued without medical advice.


Prescribing information is to be updated, US and worldwide, to include warnings about the possibility of patients developing hemolytic anemia. According to Merck, 20 cases have been reported in 140,000 patients and no causal link has been established, but this warning is appropriate as the condition needs to be recognized and treated quickly.

Anti-psoriasis Antiproliferative

Soriatane®, Neotigason®

An FDA advisory panel agreed with the position taken by the FDA, in recommending that women taking acitretin avoid pregnancy for at least three years after treatment stops. Although the FDA approved acitretin last year, Roche objected to the labelling proposed and have not yet commenced marketing in the US. In Europe and other markets, the restriction is for two years. (Scrip April 25th, 1997: 19)

In this issue:

  1. Penciclovir Cream A New Treatment for Herpes Labialis
  2. Human Skin Equivalent (HSE) , Apligraf® Part II Clinical Use
  3. Medicated Shampoos are Effective in Many Scalp Conditions
  4. Update on Drugs and Drug News - Number 6 1997