CONTACT: Donna Stein
(847) 330-0101, ext. 341
E-mail: [email protected]
AMERICAN ACADEMY OF DERMATOLOGY
WARNS PATIENTS ABOUT PSORIASIS DRUG
SCHAUMBURG, IL (August 12, 1997) -- The American Academy of
Dermatology joins the FDA and the National Psoriasis Foundation (NPF)
in cautioning the public about using the psoriasis treatment,
Skin-Cap. This product can be potentially harmful because it contains
prescription-strength corticosteroids (clobetasol propionate), but had
been marketed without disclosing this ingredient on the product label.
Numerous potentially harmful side-effects of clobetasol propionate
include stretch marks, thinning skin and dilation of tiny blood
vessels.
The FDA alert cautions, however, that users should not stop treatment
with this product without a dermatologist's help because an abrupt
halt could cause serious, even life-threatening, flare-ups.
Laboratory studies about Skin-Cap were conducted at Mayo Clinic, Glaxo
Dermatology, and confirmed by independent labs.
Skin-Cap is manufactured by Cheminova International in Madrid, Spain
and has been marketed in the U.S. as a nonprescription shampoo, spray,
or cream for dandruff, seborrheic dermatitis, psoriasis and other skin
disorders. These products can be purchased through the mail. They are
also available at a few pharmacies.
The FDA also issued a nationwide import alert for detention of these
products at all border entries, and the state of Florida stopped
distribution of Skin-Cap from the primary distributor.
The agency has previously expressed concern about the marketing of
these unapproved products in two warning letters sent to two U.S.
distributors of these products. Further investigation of these
products recently confirmed these products also contained steroidal
ingredients not identified on the product label.
"The potential health hazards are significant and should not be
tolerated," said Roger Ceilley, MD, President of the American Academy
of Dermatology. "We're fortunate in this country that organizations
like the FDA and the NPF are watching."
Anyone using this product should consult their dermatologist to
discuss other treatment options.
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