US Pharm. 2009;34(4):12-15.
The introduction of hydrocortisone to the nonprescription market in 1979 was a revolutionary move by the FDA.1,2 It marked the first time that a corticosteroid had been judged sufficiently safe for use without a physician’s supervision. How was hydrocortisone judged safe enough for consumer self-use?
The Path to Nonprescription Status
Hydrocortisone was first marketed as a prescription medication in 1952.1 In 1956, the FDA was petitioned to switch hydrocortisone to nonprescription status. According to the agency, two factors were critical in denying the petition. First, there was insufficient evidence that consumers could safely self-medicate with hydrocortisone. Second, the agency was concerned about percutaneous absorption.
In 1979, the FDA OTC review process was ongoing. The Advisory Panel on Topical Analgesic, Antirheumatic, Otic, Burn, and Sunburn Prevention and Treatment Drug Products (the Topical/External Analgesics Panel) began meeting in 1973, and through 70 subsequent meeting days considered hydrocortisone (acetate) and other ingredients.2 The panel was composed of six physicians and a pharmacist/PhD who was serving as dean of a school of pharmacy.
In 1979, the FDA published the results of its deliberations in the Federal Register as “External Analgesic Drug Products for Over-the-Counter Human Use; Establishment of a Monograph and Notice of Proposed Rulemaking.”2 This groundbreaking document was the first to extensively explore potential self-care uses of hydrocortisone. The experts concluded that hydro cortisone 0.25% to 0.5% and its acetate salt would be safe and effective for use as nonprescription antipruritics. Addressing a matter of paramount concern to the FDA in its negative 1956 decision, the panel concluded on the basis of current research that hydrocortisone did not cause hypothalamus-pituitary-adrenal (HPA) axis suppression in patients with chronic skin disease. Based on this report, the FDA allowed OTC sales to proceed.3 In just 2 years, this move saved patients as much as $600 million in medical costs.4
In the late 1980s, the FDA received a citizen’s petition to allow hydrocortisone 1% to gain nonprescription status. A 1990 Notice of Proposed Rulemaking alerted the nation’s health care professionals that the agency would allow the stronger concentration to be marketed if correctly labeled.5 This amendment was finalized, and patients were able to benefit from the enhanced efficacy of the 1% products.
Whether or not hydrocortisone should be available on a nonprescription basis was debated by the American Academy of Dermatology in 1965 and 1975.4 At both times, the dermatologist society concluded that the risks to unsupervised use were too compelling, outweighing any potential benefit. Among their concerns have been masking the development of skin cancers or other serious conditions, thereby delaying their diagnosis, as well as such adverse reactions as atrophy, striae, and steroid-induced rosacea. A 2007 paper in the Archives of Dermatology concluded that the earlier opposition had been unwarranted and that the switch was justified.4
Current Hydrocortisone Labeling
Hydrocortisone carries numerous instructions and warnings that must be read carefully, thoroughly understood, and scrupulously followed to ensure safe use.6-8 When patients purchase powerful pharmacologic agents such as hydrocortisone in nonpharmacy outlets, they must rely on their own skills to ensure safe use. However, when a pharmacist is involved in the interaction, the patient can take advantage of a trained professional’s ability to explain any section of the label that is unclear.
The age of the patient is important for the pharmacist to ascertain. Hydrocortisone is not safe for any patient under the age of 2 years.6-8 Thus, whether or not the infant has a hydrocortisone-responsive condition, he or she must be referred to a physician for proper care. Patients aged 2 years or older are directed to apply the product to the affected area three to four times daily.
Hydrocortisone is approved to self-treat a variety of dermatologic conditions. These include insect bites; allergic reactions (e.g., to soap, detergents, cosmetics, or jewelry); rashes; poison ivy, oak, or sumac; eczema; psoriasis; seborrheic dermatitis; and external genital or anal itching.6-8
The FDA does not allow hemorrhoid products to be labeled for those under the age of 12 years and advises that a physician should be consulted when treating external anal itching in this age-group.6-8 Furthermore, patients over age 12 years are cautioned on hydrocortisone labels to stop use and seek a physician if rectal bleeding occurs and are advised not to insert hydrocortisone into the rectum using the fingers or any type of applicator.
Patients are instructed to halt use of nonprescription hydrocortisone and see a physician if the symptoms worsen, if they persist for more than 7 days, or if they clear up and recur again within a few days.6-8
Nonprescription hydrocortisone products should not be applied to the eyes or eyelids.8 Patients should not cover the hydrocortisone after application in an attempt to create an occlusive dressing, unless advised to do so by a physician. Patients who are pregnant or nursing should only use hydrocortisone on the advice of a physician.8
Conditions That Should Not Be Treated
The labels of hydrocortisone products warn patients against use in diaper rash.7 The logic is obvious, in that hydrocortisone could be absorbed percutaneously through damaged skin, especially when it is moistened by urine and feces and covered by a diaper, which functions as an occlusive dressing.
Hydrocortisone is contraindicated if a female patient with genital itching also has a vaginal discharge.6,7 In this case, discharge indicates the presence of a vaginal infection (e.g., candidiasis, trichomoniasis). Hydrocortisone might provide symptomatic relief, giving the patient the idea that she is better, and delaying her visit to a physician for an antibiotic or antibacterial.
Burns should not be treated with hydrocortisone, as it is not known to be effective in burned skin.7 In addition, burned skin is damaged to some degree, and depending on the depth of the burn, hydrocortisone could be absorbed, leading to systemic problems.
Hydrocortisone is inappropriate as sole therapy for fungal conditions, such as tinea pedis, tinea corporis, or tinea cruris.7 Corticosteroids used alone in these dermatophytic infections allow the tinea to spread and assume atypical forms, known medically as tinea incognito. Hydrocortisone is not known to be effective or safe for treating such minor conditions as acne, dandruff, hair loss, warts, corns, calluses, or sunburn.7
Survey Reinforces Added Value of Pharmacist Intervention
The United States is one of the only countries without a widespread third class of medications that would require pharmacist counseling (with the limited exceptions of pseudoephedrine, ephedrine, and Plan B).7 As a result of this situation, the vast majority of nonprescription products can be purchased at any location without pharmacist intervention. Since professional intervention is not required in sales of nonprescription products, the label must contain every bit of information needed to ensure proper use by the self-medicating patient.
The FDA assumes that patients using nonprescription products will read and heed all sections of the label, thoroughly understanding all of the information and acting exactly as the label directs. This assumption underlies virtually every decision made by the FDA regarding nonprescription products, but it is especially critical in Rx-to-OTC switched products such as hydrocortisone. To verify or disprove this assumption, researchers must survey actual users of the products in question.
A British study explored that issue for hydrocortisone products and the corticosteroid clobetasone (clobetasone has been available as a nonprescription product in Britain since 2002).9 A group of researchers surveyed patients who purchased a topical steroid in 2003. The 315 respondents purchased the products intending to treat a variety of conditions, including eczema (61%), dermatitis (21%), insect bites (4%), sweat rash (4%), vaginal thrush (3%), psoriasis (3%), tinea pedis (1%), diaper rash (1%), acne (1%), and other conditions (10%) (e.g., tinea, rosacea, otitis externa, shaving rash, pruritus vulvae or ani, dry skin, unspecified rashes). Several patients were treating multiple conditions.
This tabulation illustrates the value of pharmacist intervention in advising against use where nonprescription corticosteroids are inappropriate (e.g., vaginal thrush, tinea pedis, diaper rash, acne, otitis externa).9 On further questioning, 39% of respondents were judged to be using the product for unlabeled uses, and 13% were judged to be using the products on the “borderline” of labeled use, such as exceeding the 7-day use limit. Nine percent used them for more than 7 days, and 6% had used them in excess of 14 days. Ten percent applied the products to the face, in direct opposition to clear label directions not to do so. The diagnosis had been made by a physician in 53% of cases and by a pharmacist in only 6% of cases. In 35% of cases, the patient had engaged in self-diagnosis. An interested pharmacist trained in recognition of minor dermatologic conditions might have been able to render a more reliable judgment of what type of condition was present in that large segment of shoppers.
Hydrocortisone is a nonprescription product that carries numerous critical instructions and warnings to help ensure that it is used safely and effectively. However, research in Britain confirmed that there are numerous instances when patients engage in incorrect use. Pharmacists can be vitally important in ensuring that patients use powerful OTC pharmacologic agents only when appropriate and that they heed all warnings and precautions.
Nonprescription hydrocortisone has been on the market for 30 years. It is available as several popular trade names, including Cortaid, Cortizone, Aveeno Hydrocortisone Anti-Itch Cream, and Itch-X Anti-Itch Moisturizing Lotion.
What Can I Use It For?
Hydrocortisone is useful for different types of dermatitis or skin inflammations caused by such allergens or irritants as soap, detergents, cosmetics, jewelry, and poison ivy, oak, or sumac. The skin affected with these problems may appear to have a rash, be broken out with blisters, be affected with raw areas, or have a dry, scaly appearance. Hydrocortisone can help stop itching of the skin and genital or anal areas, and it also helps relieve the discomfort from insect bites. In addition, it is of some use in psoriasis or seborrheic dermatitis. The product should be applied three to four times daily.
It is important to avoid incorrect usage of this product. Hydrocortisone should not be used for the following conditions without a physician’s advice: diaper rash, female itching when there is a vaginal discharge, vaginal thrush, any form of fungal skin infection (i.e., athlete’s foot, ringworm of the body, jock itch), burns, acne, dandruff, hair loss, warts, corns, calluses, sunburn, or any other condition not specifically mentioned on the label. Patients under the age of 12 years should not use it for rectal conditions such as hemorrhoids without a physician’s advice. If you are using it for hemorrhoids, do not attempt to place it into the rectum, whether using the fingers or any other type of applicator device.
Who Shouldn’t Use Hydrocortisone?
Using hydrocortisone without a physician’s advice can be dangerous unless you read and follow all of the directions. For instance, you should never allow it to be used on anyone under the age of 2 years. It should not be used in or near the eyes. If the condition worsens or lasts longer than 7 days, you should stop use and consult a physician. If the condition clears up but returns a few days later, hydrocortisone is not appropriate and a physician appointment is the best move. Pregnant patients and those who are breast-feeding should not use it unless advised to do so by their physician.
Which Type of Product Is Best?
You will notice that hydrocortisone is available in several forms, such as creams, ointments, sprays, and lotions. The choice is personal, as all products are effective. Creams have a smooth feel that some patients prefer, whereas ointments cover the skin with a greasy or oily layer of active ingredient. Ointments are more resistant to water removal, such as when one later washes the hands. Lotions spread over the skin more smoothly than creams or ointments but are also subject to water removal. Sprays allow the user to cover the area without rubbing a product on. This is an advantage when rubbing or touching the affected area causes itching or pain.
If after reading the OTC hydrocortisone labels you are still confused about which product to select, please do not hesitate to ask the pharmacist for a recommendation.
Remember, if you have questions, Consult Your Pharmacist.
2. Recommendations regarding the safety and effectiveness of hydrocortisone. Advisory panel review of OTC topical analgesic, antirheumatic, otic, burn, and sunburn protection and treatment drug products. December 4, 1979. FDA. www.fda.gov/ohrms/dockets/ac/
3. Concurrence with the recommendation of the topical analgesics panel. February 8, 1983. FDA. www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4099B1_03_FDA-Tab3.pdf. Accessed February 26, 2009.
4. Ravis SM, Eaglstein WH. Topical hydrocortisone from prescription to over-the-counter sale. Arch Dermatol. 2007;143:413-415.
5. FDA recognition that hydrocortisone is safe and effective as an OTC antipruritic active ingredient at concentrations up to 1.0 percent. February 27, 1990. FDA. www.fda.gov/ohrms/dockets/ac/
6. Cortaid Maximum Strength Cream. Jonson & Johnson Consumer Companies, Inc. www.cortaid.com/prod_cream.
7. Pray WS. Nonprescription Product Therapeutics. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2006.
8. Frequently asked questions. Cortaid. Johnson & Johnson Consumer Companies, Inc. www.cortaid.com/faq.jsp. Accessed February 26, 2009.
9. Rogers PJ, Wood SM, Garrett EL, et al. Use of nonprescription topical steroids: patients’ experiences. Br J Dermatol. 2005;152:1193-1198.
10. Watsky KL, Warshaw EM. Allergic contact dermatitis: another adverse effect of over-the-counter topical hydrocortisone. Arch Dermatol. 2007;143:1217.
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