Topical Corticosteroid Adrenal Suppression Risk Precludes Over-The-Counter Use
Mar 26, 2005 - 9:37:00 AM
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HPA axis suppression may lead to decreased ability of the adrenals to then respond and produce cortisol, Luke said. If there is a failure to mount such a response it can lead to hypertension and cardiovascular collapse.
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By FDA advisory committe,
[RxPG] Potentially fatal adverse events related to adrenal suppression of cortisol from maximal use of topical corticosteroids should preclude an Rx-to-OTC switch of those drugs, an FDA advisory committe said March 24.
The reason we care about hypothalamic, pituitary and adrenal axis suppression in unsupervised consumers is that the condition could lead to sudden death, committee consultant Constantine Stratakis (National Institutes of Health) said.
FDA's Nonprescription Drugs and Dermatologic & Ophthalmic Drugs Advisory Committee members voted 21-5 that any topical corticosteroid that causes HPA axis suppression under maximal use conditions is not an appropriate over-the-counter switch candidate.
Division of OTC Drug Products Director Charles Ganley defined maximal use as two weeks of topical corticosteroid therapy on over 30% of the body.
The HPA axis helps regulate stress response, Dermatologic & Dental Drug Products Division Lead Medical Officer Markham Luke explained.
HPA axis suppression may lead to decreased ability of the adrenals to then respond and produce cortisol, Luke said. If there is a failure to mount such a response it can lead to hypertension and cardiovascular collapse.
The committee was also concerned with the accepted method of testing for HPA axis suppression, the cosyntropin stimulation test.
The test has a sensitivity of about 70% and specificity of about 95%-100%, Stratakis observed.
The test is only 70% sensitive so therefore we miss 30% of people, committee member Mary Tinetti (Yale University) said.
Dermatologic committee member Elizabeth Whitmore (Wheaton, Ill.) noted she was not in favor of an OTC switch, but pointed out that 20% or 30% of our patients [who] are using the higher potency steroids are having this HPA suppression, which we are not doing anything about.
This is happening all the time, and theres nothing thats being done about it, so I dont know that it makes any difference whether its over-the-counter or by prescription still nothing is being done about it.
Most committee members agreed that zero events out of a sample size of 1,000 would provide confidence in ruling out HPA axis suppression at a desired upper limit.
However, dermatologic committee chair Michael Bigby (Beth Israel Deaconess Medical Center) qualified his response: I would say greater than 1,000, and then the other thing I would say is that we already have a signal in the lowest class of drugs that we can consider
so I dont know why were giving a number.
Dermatologic & Dental Drug Products Division Medical Officer Denise Cook presented HPA axis suppression results from pediatric trials in mid-potent topical corticosteroids that exhibited suppression signals in small patient populations.
In a 15-patient trial with Schering-Ploughs Dirposone (betamethasone diproprionate) lotion .05%, 73% of patients showed evidence of HPA axis suppression, Cook said. However, corticosteroid absorption may vary by drug vehicle used cream, lotion or ointment.
Publication:
FDA's Nonprescription Drugs and Dermatologic & Ophthalmic Drugs Advisory Committee
On the web:
FDA advisory committe 
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