December 27, 1999
Health Canada Warns Miralex Cream Contains
Ottawa, 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
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
Safety Alerts compiles comprehensive safety recall information for
the United States. SafeMail is a free email service to warn consumers of faulty products
and contaminated foods. For complete information regarding current recalls, past recalls
and timely product warning notification visit: www.safetyalerts.com.
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