# Presentation: 494487

## FDA, CDER, Div. Of OTC Drug Products 

**Matthew R. Holman, Ph.D.**
**Interdisciplinary Scientist**
**FDA, CDER, Div. Of OTC Drug Products**** **

**April 22, 2002**

**1**

## 2

**2**

##  • U.S. regulations regarding OTC anti-histamines

-   • Foreign marketing of loratadine

-   • Summary of label comprehension study

**3**

##  • Advance Notice of Proposed Rulemaking (ANPR)

**	****	***Advisory Review Panel Report*

-   • Tentative Final Monograph (TFM)

-   • Final Monograph (FM)

**4**

## ANPR (1976)
	 • Advisory Review Panel Report
		 – Does not mention CIU or hives

**	** • Advisory Review Panel Report
- 		 **– **Does not mention CIU or hives

**TFM for OTC Antihistamine Drug Products **(1985)
**	** • One comment requested hives indication
- 		 **–** No data submitted
- 		 **–** Panel did not review hives

**5**

## • One comment recommended “symptomatic

-    treatment of allergic itching”

**–** Hives are component of anaphylactic reaction

**–** Average person cannot distinguish mild and
-    life-threatening condition with similar symptoms

**–** Cited reference states ideal urticaria treatment is removal of cause

- • One comment referenced data supporting relief of
-    itching skin caused by . . . hives

**6**

##  • U.S. regulations regarding OTC anti-histamines

-   • Foreign marketing of loratadine

-   • Summary of label comprehension study

**7**

## • 22 countries sell “behind-the-counter”

-         Belgium, Canada, Germany, Ireland,
-         the Netherlands, Russia, and United Kingdom

**•** 22 countries sell “behind-the-counter”

- 	 – 29 countries allow hives indication

- • Prescription required in 80 countries

- • Prescription-free in 33 countries

**8**

## • Marketed OTC since 1990 

- • Marketed OTC since 1990

- • OTC indications: allergic rhinitis and hives

**9**

## 10

**10**

## • Marketed General Sales List (GSL) since December 2001;

-    previously Pharmacy (P) class

- • OTC indications: allergic rhinitis and hives

- • Cetirizine only other GSL oral antihistamine with hives
-    indication

*– **GSL sales limited to 7 tablets*

**11**

## Clarityn Allergy may also be 

- Clarityn Allergy may also be
- taken for allergic skin
- conditions including rash,
- itching and urticaria (hives).

**12**

## • chronic urticaria and/or hives: 12 countries

- • chronic urticaria of unknown source: 1 country

- • urticaria or hives: 3 countries

- • “after being told by doctor”: 0 countries

- • allergic skin condition and urticaria: 3 countries

**50% of cartons do not list indication**

**13**

## Uses

***Uses***
***• ***relieves and reduces itching and rash
-   due to recurring or chronic hives of
-   an unknown source.
- • **use only after being told by a doctor**
**   ****that you have recurring or chronic **
**   ****hives (chronic idiopathic urticaria).**

**14**

## Uses

***Uses***
- • relieves and reduces itching and rash
-   due to recurring or chronic hives of an
-   unknown source; **however, only use **
**  ****this product for itching and rash**
**  ****after being told by a doctor that you**
**  ****have recurring or chronic hives **
**  ****(chronic idiopathic urticaria).**

**15**

##  • U.S. regulations regarding OTC anti-histamines

-   • Foreign marketing of loratadine

-   • Summary of label comprehension study

**16**

## 565 subjects

- 	 • Cohort 2: general population (N=116)
- 	 • Cohort 3: low literacy (N=96)
- 	 • Cohort 4: pregnant/nursing, liver/kidney disease (N=114)
- 	 • Cohort 5: acute hives sufferers (N=102)

- _565 subjects_

**17**

## Based on the label, what is this product used for?

- • 62% correct or acceptable response

- – 79% incorrect responses mentioned hives

- – Other incorrect responses: trouble
-    speaking/swallowing, drooling, food or
-    medication allergy, fever, breathing problems

**18**

## Is this product intended to be used for the 

- Is this product intended to be used for the
- following conditions?

- Recurring or chronic hives of
- an unknown cause

**92%**

**12%**

- Food allergies

**21%**

- One time breakout of hives

**32%**

**42%**

**37%**

**38%**

**42%**

**19**

## Considering everything on the package label, is this product 

- Considering everything on the package label, is this product
-   intended for **you**, _**personally**_, to take home and start using?

**20**

##  • OTC oral antihistamines cannot be marketed

-    currently for hives or CIU under monograph system

-   • Foreign Market
- 		– Chronic hives is the commonly labeled
-  		   indication
- 		– Loratadine is typically marketed Rx or
- 		   “behind-the-counter”

-   • Consumers will use for all types of hives

**21**