Summary of Issues on Urticaria as an OTC Indication

Charles Ganley, M.D.

Division of OTC Drug ProductsApril 22, 2002 Non-Prescription Drug Advisory Committee

April 22, 2002 2

Safety Criteria for OTC Drugs

• Low incidence of adverse reactions or significant side effects under adequate directions for use

• Warnings against unsafe use

• Low potential for harm which may result from abuse under conditions of widespread availability

April 22, 2002 3

Observations

• FDA position on urticaria as an OTC indication• Urticaria or hives is an OTC indication in other

countries– recognize that pharmaceutical marketing, consumer

behavior, pharmacy practices vary

• Consumers may be already using OTC anti-histamines for urticaria– influenced by information resources, marketing (Brand

names that include “Allergy”)

April 22, 2002 4

Urticaria (hives) as an OTC Use

• For acute or chronic hives– Frequency and significance of

• Associated conditions (e.g. angioedema, anaphylaxis)

• Consequences leading to serious adverse outcomes

• Conditions misdiagnosed by the consumer as urticaria (e.g. vasculitis, manifestation of another disease)

April 22, 2002 5

Urticaria (hives) as an OTC Use

• Physician intervention– When is it necessary– Delay in seeking physician advice

• Consumer behavior – Does OTC availability encourage self-treatment

without diagnosis for chronic urticaria – Can consumers self-diagnose– What will influence behavior

April 22, 2002 6

Sponsor Proposal for an OTC Urticaria Indication

• The use should be limited to consumers who have a diagnosis of chronic idiopathic urticaria (CIU) by a physician

• Accuracy of self-selection and use of the product by a CIU population– Surveys

– Label Comprehension

April 22, 2002 7

Other “Studies”: Consumer and Physician Surveys

• Source: Internet database– Unable to validate the background of responders

• Physician survey provides anecdotal experience• Consumer survey of CIU sufferers

– Multiple choice questions were used instead of open ended questions

– Oral anti-histamines used by 62% prior to physician diagnosis

– Chronic idiopathic urticaria not commonly used term

April 22, 2002 8

Sponsor Proposal: Limit to CIU Population

• Limitation of use to CIU population accomplished through labeling– “use only after being told by a doctor that you

have recurring or chronic hives of an unknown source (chronic idiopathic urticaria)”

April 22, 2002 9

Prior Experience with Restriction to Physician Diagnosed Population

• Vaginal Anti-fungal products• Do not use if you have never had a vaginal yeast

infection diagnosed by a doctor

• Restriction is not adhered to by many consumers– Internal NDA data from an actual use study

• 40% did not have a prior diagnosis by a physician

– 20% - 34% in published reports did not have previous diagnosis

April 22, 2002 10

Problems with this Approach

• Product likely to be used for any type of urticaria– 20 - 25 % of subjects who experience hives have chronic

hives

• No data provided to demonstrate accurate self-selection and de-selection in a general population

• No consensus for consumers on the name CIU• “Hives” likely to translated broadly by consumer

• The labeling restriction proposed by the sponsor will not likely limit use to CIU subjects

April 22, 2002 11

Issues for the Committee

• Urticaria as an OTC claim– If no, what is the basis for denying?

• (If no, there is no need to continue the meeting)

• Sponsor data to support chronic urticaria as a claim– Chronic vs. general claim for hives

– Type of information to support efficacy and safety OTC

– Labeling issues