Prescription-Strength Topical Steroids Often Sold OTC in US

November 13, 2019

By Reuters Staff

NEW YORK (Reuters Health) - Prescription-strength topical corticosteroids (TCs) can be purchased over the counter (OTC) in stores selling foreign products in many U.S. cities, new research shows.

"These findings underscore the importance of asking about and physically examining patients' products," Rebecca S. Kimyon of Park Nicollet Contact Dermatitis Clinic in Minneapolis and colleagues note in the Journal of the American Academy of Dermatology, online October 28.

Preparations containing 1% hydrocortisone or less are approved for OTC sale by the U.S. Food and Drug Administration (FDA). Following up on a 2017 report on a patient who purchased prescription-strength topical corticosteroids without a prescription at a U.S. store selling African products, Kimyon and her team looked at the OTC availability of extra-potent steroids in 13 cities in nine U.S. states.

The researchers asked staff at 80 stores selling foreign imports about products for "itchy rash," and inspected all topical products available on store shelves.

They found 30 different prescription-strength products containing clobetasol propionate 0.025-0.05%, betamethasone dipropionate 0.05-0.12%, betamethasone valerate 0.02-0.1%, dexamethasone 0.075%, fluocinonide 0.025% and fluocinolone acetonide 0.05%, often in combination with antibiotics or antifungals.

The products had been made in Europe, Latin America, the Middle East, Africa and Asia.

Average cost was $6.90 per 30 g for clobetasol propionate 0.05% and $10.02 for 30 g of betamethasone dipropionate 0.05%. The authors note that the prices are in "stark contrast" to the U.S. price of $195.27 and $91.37 per 30 grams, respectively.

"In many countries, prescription-strength TCs are available legally OTC; therefore, immigrants from these countries may expect to purchase (them) without visiting a doctor. It is imperative to educate vulnerable patients on the potential harms associated with unmonitored prescription-strength TC use," the authors state.

They say research is needed to assess OTC availability of prescription-strength TCs in other geographic areas as well as availability of other types of medications illegally sold over-the-counter such as skin lightening creams and oral antibiotics. "The illegal sale of these items may be reported (to the FDA) at: Reporting Unlawful Sales of Medical Products on the Internet (https://bit.ly/2Q1ZaV8)," they add.

SOURCE: https://bit.ly/32qu63T

J Am Acad Dermatol 2019.

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