Strong Topical Steroids Often Sold Over the Counter Illegally in the U.S., Study Finds

Corticosteroid medications, commonly known as steroids, are synthetic versions of hormones that are normally produced by the adrenal glands (two small glands located above the kidneys). These medications are available in various strengths and forms — systemic (injections and oral [such as tablets and solutions]), inhaled and topical (such as creams, gels and lotions that are applied externally to the skin or scalp) — to treat many types of inflammatory and autoimmune diseases, including allergic reactions, asthma, chronic obstructive pulmonary disease, lupus, rheumatoid arthritis, musculoskeletal pain and skin conditions.

The benefits of corticosteroids must be balanced against their multiple, potentially serious adverse effects, especially when they are taken at high doses for extended periods. Therefore, except for a single low-strength topical medication available over the counter that is taken for up to a week only, all corticosteroids should be taken only by prescription with monitoring by a health care professional.

However, a study published in the February issue of the Journal of the American Academy of Dermatology showed that potent (prescription-strength) topical steroids can be purchased over the counter readily in many U.S. cities.[1]

Learn about topical corticosteroids and the findings of this study to protect yourself and your loved ones from these illegal and potentially harmful products.

About topical corticosteroids and their risks

Prescription topical corticosteroids that are approved by the Food and Drug Administration are divided into seven groups according their anti-inflammatory potency.[2] Examples of these drugs include betamethasone (BETA-VAL, DERMABET, DIPROLENE, LUXIQ, SERNIVO, VALNAC), clobetasol (CLOBEX, CORMAX, EMBELINE, IMPOYZ, OLUX), fluocinonide (LIDEX, VANOS), fluocinolone (DERMA-SMOOTHE/FS, SYNALAR) and hydrocortisone (ALA-CORT, ALA-SCALP, ANUSOL HC, LOCOID, PANDEL, STIE-CORT, TEXACORT).

Of all topical corticosteroids, the Food and Drug Administration allows only hydrocortisone to be sold over the counter in very low-potency formulations with concentrations that do not exceed 1%;[3] examples of brands with these formulations include CORTAID and CORTIZONE. The approved uses of these formulations are limited to the temporary relief of skin itching and rashes caused by allergic skin conditions, such as eczema, insect bites or contact dermatitis from poison ivy.[4]

Topical corticosteroids are generally safer than systemic corticosteroids.[5] Nevertheless, topical corticosteroids can cause local (skin) and systemic (caused by absorption into the blood stream) adverse effects, particularly with potent versions or with prolonged use of lower-potency formulations of these products.

The local adverse effects of topical corticosteroids include changes in skin pigmentation, acneiform eruption (small, raised, acne-like skin bumps), purple-colored spots and patches on the skin, skin atrophy, striae (stretch marks), telangiectasia (dilated small blood vessels on the skin that cause threadlike red lines or patterns) and hypertrichosis (abnormal amount of hair growth over the body). Bacterial and fungal infections of the skin also can occur as adverse effects of even short-term topical corticosteroid use.[6] Additionally, withdrawal of these drugs without medical supervision after prolonged use, especially on the face or genitals, can cause burning or stinging sensation, pain, pruritus, redness and facial hot flashes.[7]

One important potential systemic adverse effect for corticosteroids, including topical formulations, is suppression of the production of natural glucocorticoid hormones, such as cortisol, by the adrenal glands. As a result, patients may experience signs and symptoms of adrenal insufficiency during or shortly after stopping corticosteroid treatment. Symptoms of adrenal insufficiency include fatigue, muscle weakness, loss of appetite, nausea, vomiting, dizziness (particularly upon standing) and fainting.

Excessive exposure to corticosteroids also can lead to Cushing’s syndrome, a disorder characterized by muscle weakness, severe fatigue, thin arms and legs, and upper-body obesity, and diabetes, as well as growth retardation in children.[8]

Factors that predispose patients to these serious conditions when using topical corticosteroids include use of high-potency corticosteroids, long-term use, application to highly permeable skin areas (such as the armpit and genitals), treatment of large areas of skin, use of occlusive techniques (such as gloves or plastic films that trap the topical drug on the skin), liver disease and young age.[9] Notably, routine use of even low-potency topical corticosteroids in young children can cause suppression of natural adrenal gland hormones.

The new study[10]

The study researchers selected a sample of stores selling imported drugs in 13 cities including Chicago, Ill.; Durham, N.C.; Los Angeles, Calif.; and New York City, N.Y. They identified this sample by searching for “ethnic” or “international” stores within each region. To find over-the-counter topical corticosteroid medications, the researchers posed as consumers and asked the staff of each store to show them all their topical products available on store shelves for “itchy rash.” The researchers then collected and analyzed information on the labeling of these products to determine their active ingredients and strengths.

The researchers found that out of 80 stores that sold over-the-counter topical corticosteroids, 36 (45%) had medications with prescription-strength concentrations of corticosteroids, which makes these products illegal for sale in the U.S. These drugs included commonly used steroids such as clobetasol, fluocinonide and fluocinolone, often in combination with antibiotics or antifungal drugs. The products were made in Europe, Latin America, the Middle East, Africa and Asia.

Notably, these imported topical corticosteroids were much less expensive than their U.S. counterparts. For example, the average price for the imported high-potency clobetasol was approximately $7, whereas its U.S. equivalent was approximately $195, according to the researchers.

The researchers also noted that in many other nations, high-potency topical steroids available only by prescription in the U.S. are sold legally over the counter. Therefore, immigrants used to buying these products over the counter in their home countries may be at a higher risk of the potential harms associated with unsupervised use of these medications.

What You Can Do

Do not buy your medications from pharmacies or stores that sell unregulated foreign-made products. If you have purchased a topical corticosteroid or any other medication from one of these places or have a medication that you brought from overseas, show it to your doctor to ensure that you are using the right medication.

Never use, without medical supervision, any medication that contains corticosteroids, except for short-term use of over-the-counter hydrocortisone. If you are prescribed a topical corticosteroid, ask your doctor about how long you should take it and do not exceed that timeframe. Do not discontinue your corticosteroid treatment suddenly, and ask your doctor whether you should “taper down” your medication to minimize adverse withdrawal effects.
 

References

[1] Kimyon RS, Schlarbaum JP, Liou YL, et al. Prescription-strength topical corticosteroids available over the counter: Cross-sectional study of 80 stores in 13 United States cities. J Am Acad Dermatol. 2020;82(2):524-525.

[2] Goldstein BG, Goldstein AO. Topical corticosteroids: Use and adverse effects. UpToDate. February 10, 2020.

[3] Kimyon RS, Schlarbaum JP, Liou YL, et al. Prescription-strength topical corticosteroids available over the counter: Cross-sectional study of 80 stores in 13 United States cities. J Am Acad Dermatol. 2020;82(2):524-525.

[4] Bausch Health US, LLC. Label: hydrocortisone (CORTAID 12-hour advanced anti-itch cream). December 2016. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=94c6a460-01b9-4c18-ac16-887e10823271&type=display. Accessed April 30, 2020.

[5] Goldstein BG, Goldstein AO. Topical corticosteroids: Use and adverse effects. UpToDate. February 10, 2020.

[6] Verma SB. Topical corticosteroid misuse in India is harmful and out of control. BMJ. 2015;351(November 25):h6079.

[7] Goldstein BG, Goldstein AO. Topical corticosteroids: Use and adverse effects. UpToDate. February 10, 2020.

[8] Gilbertson EO, Spellman MC, Piacquadio DJ, Mulford MI. Super potent topical corticosteroid use associated with adrenal suppression: Clinical considerations. Rev J Am Acad Dermatol. 1998;38(2 Pt 2):318-321.

[9] Goldstein BG, Goldstein AO. Topical corticosteroids: Use and adverse effects. UpToDate. February 10, 2020.

[10] Kimyon RS, Schlarbaum JP, Liou YL, et al. Prescription-strength topical corticosteroids available over the counter: Cross-sectional study of 80 stores in 13 United States cities. J Am Acad Dermatol. 2020;82(2):524-525.