ClassName/CompanyApproval Dates and Comments

Anti-acne &

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.

ClassName/CompanyDrug 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.



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)