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UPJOHN's HYDROCORTISONE .5% ADR REPORTS ARE MOSTLY FOR LACK OF EFFICACY

Executive Summary

UPJOHN's HYDROCORTISONE .5% ADR REPORTS ARE MOSTLY FOR LACK OF EFFICACY, Upjohn reported in a May 26 petition requesting an Rx-to-OTC switch, via an OTC monograph amendment, for hydrocortisone 1%. From the market introduction of the Cortaid (hydrocortisone .5%) OTC line in 1979 through Dec. 31, 1986, the company said, "only 945 medical event reports for these products have been received by the Upjohn Company. Of the 945 reports, 647 were for lack of efficacy." Upjohn commented that "this information not only confirms the safety of topical hydrocortisone products but also emphasizes the need for an over-the-counter 1% stength." The firm noted that the next most frequently reported events for the Cortaid products were: exacerbation of a condition (9.6%); skin inflammation (6.1%); rash (4.4%); allergic reaction (3.5%); erythema (2.6%); progression of underlying disease (2.2%); and contact dermatitis (2.1%) Upjohn has had supplements to its Cortef Acetate cream and ointment NDAs for OTC status of the 1% formulations pending since December 1984. The company said it has now withdrawn the supplements because "we feel that amending the monograph better serves the interests of all consumers of OTC hydrocortisone products and is more compatible with the current regulatory climate." Following Upjohn's supplemental NDA submissions, Combe petitioned FDA to switch hydrocortisone 1% through the monograph process. FDA brought the proposed switch before its Dermatologic Drugs Advisory Committee in November 1985. The committee voted four in favor and four opposed to a 1% OTC, primarily because of concerns that the product would be inappropriately advertised. Addressing advertising issues that came up at the meeting, Upjohn proposed labeling that would exclude directions for use in "chronic conditions, such as eczema." The firm said it agrees that "OTC topical 1% hydrocortisone preparations should be reserved for short-term use in acute dermatologic conditions." In addition, Upjohn said, "the concern that the . . . advisory committee expressed regarding the potential use of 1% hydrocortisone products in the treatment of diaper rash is a valid one. Consequently, it is felt that the warning 'do not use for the treatment of diaper rash . . . except under the advice and supervision of a physician' is necessary to help restrict use of the 1% hydrocortisone preparations to children 2 years of age and older adults."
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