The FDA is warning consumers about treatments for dandruff or psoriasis called "Skin-Cap." These products contain prescription-strength corticosteroids, which might pose a health hazard to many people. Individuals currently using these products are advised to immediately contact their health careproviders.
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 that these products contain prescription levels of a potent topical steroid, clobetasol propionate. Side effects 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, the FDA issued a nationwide import alert for detention of these products at all border entries, and the state of Florida has 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 earlier this year. Further investigation of these products recently confirmed that they also contained steroidal ingredients not identified on the
product label.
Psoriasis, a chronic skin disorder that can be painful and disabling, is characterized by inflamed, red, scaly lesions, caused when affected skin cells reproduce faster than normal. If you have been injured by this or some other product, it may be important to
contact an attorney who can help you protect your legal rights. Please keep in mind that there may be
time limits within which you must commence suit.