Update on Drugs and Drug News: September, 1997

Anti-acne &
antipsoriatic

Tazarotene Gel 0.05%, 0.1%


Tazorac® topical gel

Allergan

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.)

Antifungal

Ketoconazole Shampoo 2%


Nizoral®

Janssen

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.

Glucocorticoid

Fluticasone proprionate


Cutivate® Cream 0.05%

Glaxo Wellcome

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

Antibiotic

Amoxicillin/clavulanic acid


Augmentin®

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.

Anti-HIV

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.

Indinavir


Crixivan®

Merck

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

Acitretin


Soriatane®, Neotigason®

Roche

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)