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December 27, 1999

Health Canada Warns Miralex Cream Contains Undeclared Steroid

miralxOttawa, Canada (SafetyAlerts) - Health Canada is warning consumers who use Miralex Cream to contact their health care provider as soon as possible because it has been found to contain clobetasol, a prescription drug which could cause severe adverse reactions if used without medical supervision. It is important that individuals using Miralex Cream get their health care provider's help in finding an alternative treatment.

Miralex Cream is distributed in Canada by Miralex Health Care Inc., a wholly-owned subsidiary of Hueson Pharmaceutical Corporation. It is promoted as a naturally-derived product. It is packaged in a white cylindrical jar containing four ounces of clear cream. The name "Miralex Cream" is printed in black and red on a white label.

Health Canada has received written assurance from Miralex Health Care Inc. that they have voluntarily stopped the sale of Miralex Cream. Health Canada is discussing with the company the necessity to recall the product from all customers. Sales of the product were made directly from the company to customers via direct mail or through the Internet.

Individuals may have used Miralex Cream for psoriasis. Psoriasis is a chronic skin disorder that can be painful and disabling. It should be treated under the supervision of a health care practitioner. However, to suddenly stop using a steroid-containing product such as Miralex, may cause the more common form of plaque psoriasis to convert to pustular psoriasis. This may be a serious conversion that requires hospitalization and that may be life-threatening.

More commonly, patients may see their psoriasis worsen. This risk makes it critical that individuals using Miralex Cream contact their doctor before they stop using the product.

Consumers may also have used Miralex for itchy, scaley, or dry skin, not realising that the cream is a steroid-containing product. Steroid-containing products applied to the skin can cause thinning of the skin and dilation of tiny blood vessels, resulting in permanent scarring, stretch marks, and secondary infections.

Using clobetasol in large amounts or over a long period of time can cause the more serious side effects that are associated with use of steroid hormones. These include high blood pressure, diabetes, hairiness, acne, osteoporosis, weakening of bones, impaired wound healing, decreased resistance to infection, muscular wasting and behavioural changes such as mania and psychosis.

More important, misuse of clobetasol or other steroid-containing products can suppress the body's ability to produce its own corticosteroids which are needed to fight infection or deal with traumatic injury. These products should also be used with caution on lesions close to the eye because they may cause increased intra-ocular pressure, glaucoma or cataracts. Children are at a greater risk than adults when treated with steroid-containing creams.

The public is advised to discuss with their health care provider the disposal or the return of the product to the company in Canada.

Health Canada is issuing this warning to advise consumers, the Canadian Medical Association, the Canadian Dermatological Association, the Canadian Psoriasis Foundation, and the provincial ministries of health. Health Canada has also issued a nationwide import alert for detention of Miralex Cream at all border entry points.

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