Press Office
Food and Drug Administration
U.S. Department of Health and Human Services

Ivy F. Kupec: (301) 443-3285
Broadcast Media: (301) 827-3434
Consumer Hotline: (301) 532-4440

August 8, 1997

STATEMENT

Abruptly ceasing use of these steroid-containing products may potentially cause a person with the more common form of plaque psoriasis to convert to pustular psoriasis, which can necessitate hospitalization and even be life-threatening. More commonly, patients may see their psoriasis worsen. This risk makes it critical for people using Skin-Cap to immediately contact their health care providers.

FDA analysis has shown these products contain prescription levels of a potent topical steroid, clobetasol propionate. Potentially harmful side effects of clobetasol propionate, can include stretch marks, thinning skin and dilution of tiny blood vessels. Use of large amounts or long-term use of this drug also can cause more serious side effects, including hypertension, central obesity, diabetes, hairiness, acne, osteoporosis, weakening of bones, impaired wound healing, decreased resistance to infection, muscular wasting and behavioral changes such as mania and psychosis.

More importantly, it can suppress the body's ability to produce its own corticosteroids in helping it fight infection or deal with body trauma.

Skin-Cap is imported from Spain and marketed as a nonprescription spray, shampoo and cream for dandruff, seborrheic dermatitis, psoriasis and other skin disorders.

In addition to this warning, today, FDA 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 earlier this year. Further investigation of these products recently confirmed that these products also contained steroidal ingredients not identified on the product label.

Psoriasis is a chronic skin disorder that can be painful and disabling. It is characterized by inflamed, red, scaly lesions, caused when affected skin cells reproduce faster than normal skin cells.

Consumers can call the National Psoriasis Foundation toll-free at 1-800-723-9166 for more information on psoriasis and corticosteroids.

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