SKIN-CAP PULLED FROM CANADIAN MARKET FOR SECOND TIME
Portland, OR/March 29, 2000--Skin-Cap Spray, an over-the-counter (OTC) product available in Canada and promoted for psoriasis and other skin conditions, has been found to contain a prescription steroid, which can cause severe adverse reactions if used without medical supervision. The National Psoriasis Foundation (NPF) is urging anyone using this product to consult their healthcare provider.
Health Canada, the health policy and regulatory agency for Canada, warns that Skin-Cap Spray contains a formulation of the topical steroid betamethasone. Health Canada conducted follow-up analyses of Skin-Cap Spray, after the previous ban of the product was lifted in mid-January 2000. This infraction marks the second time a Skin-Cap product has contained a prescription steroid, according to Health Canada.
Betamethasone is a prescription potent topical steroid that when prescribed and monitored by a physician can be an effective treatment for psoriasis. However, side effects from long-term use of potent topical steroids can include stretch marks, thinning skin, and tiny dilated blood vessels. High doses, overuse or long-term use of potent steroids can also cause serious internal side effects such as hypertension, diabetes, hyperglycemia, osteoporosis, and behavioral changes such as mania and psychosis.
A person with psoriasis should not abruptly stop using Skin-Cap Spray or any product containing topical steroids without guidance from their physician. Sudden withdrawal from topical steroids can significantly worsen psoriasis and cause the disease to flare or change to a more severe form. A steroid induced conversion of plaque psoriasis to pustular psoriasis may require hospitalization and may, in rare instances, be life-threatening.
Skin-Cap Spray was allowed to return to the Canadian market in January as an anti-dandruff preparation, but people may have been using it to treat skin conditions for which it is not authorized, such as psoriasis.
Skin-Cap Spray is manufactured in Europe and is being distributed across Canada by Dermalabs Inc., in Don Mills, Ontario. Skin-Cap Spray cannot be legally sold or obtained in the United States due to the federal Food and Drug Administration's (FDA) ban of the product in 1997 for containing the undisclosed prescription superpotent steroid clobetasol propionate.
Health Canada issued a nationwide health warning, and a recall has been voluntarily initiated by Dermalabs Inc.
Psoriasis is a noncontagious immune disorder that affects any part of the body, including the nails and scalp. In psoriasis, the skin cells mature in three to four days rather than the normal 28 days. This excessive reproduction causes skin cells to build up and form red, raised, scaly lesions. About 10 to 30 percent of people with psoriasis also have an associated form of arthritis called psoriatic arthritis.
The NPF is a lay, nonprofit health organization with a mission to inform and support the seven million people in the U.S. with psoriasis, educate the general public, and fund psoriasis research for a cure. Information about treatments, access to psoriasis support groups and educational materials are available through the NPF.
For free up-to-date information about psoriasis or topical steroids, please contact the NPF at (800) 723--9166 or visit the Web site http://www.psoriasis.org.
More information about Health Canada's warning can be found on its Web site http://www.hc-sc.gc.ca or by calling (613) 957--2991.
Media Contact: Jessica Wise, NPF Public Relations Manager, 503-244-7404 x22 or e-mail: [email protected]
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