1. 1 Prilosec 1 Label Comprehension Studies 02255 and12179 Karen Lechter, J.D., Ph.D. FDA Division of Surveillance, Research, and Communication Support Office of Drug Safety

2. 2 Overview Purpose of label comprehension studies 2 Prilosec 1 label comprehension studies –Study 02255--general pop./self-selection –Study 12179--appropriate use by special populations Issues about which we have concerns Implications for label

3. 3 21 CFR 330.10 (a) (4) (v) OTC labels must be …likely to be read and understood by the ordinary individual, including individuals of low comprehension, under customary conditions of purchase and use.

4. 4 Study 02255: Participants N=684: 43% male; 57% female 1. General population (N=297) Frequent HB sufferers 2. low literate (<8th gr. reading level; N=162) 3. high literate (N=155) 4. HB sufferers taking drugs listed on label as requiring MD advice (N=96) 5. Pregnant or nursing HB sufferers (N=42)

5. 5 Study 02255--Product Purpose Product Purpose (open-ended question) High Response Gen.pop. Lit. Low Lit. Prevent frequent HB 39% 39% 36%

6. 6 Study 02255--Episodic Use 3 questions about acute episodic relief –range 48%-55% correct (general cohort) 2 questions about acute episodic prevention –range 54%-61% correct (general cohort)

7. 7 Study 02255 --Self-Selection Subgroup Correct/Acceptable Had labeled symptoms (85) 41% Used labeled meds (96) 50% After brand names 82%

8. 8 Study 02255--Self-Selection: Those who should not use or should consult MD Subgroup Correct/Acceptable Total:should not use (659) 67% Non HB (137) 80% Infreq. HB (92) 76% Allergic to product (7) 86% HB preg./nursing (42) 91% continued...

9. 9 Study 02255 -- Applying the Label to Self and Others Self-selection questions suggest problem applying label to self Scenario responses about use with listed medications or medical conditions suggest good understanding but may be artifact

10. 10 Conclusion--Study 02255 The tested label failed to convey adequately that Prilosec i s not for episodic use – It is not for acute HB symptoms – It is not for prevention of meal- induced HB

11. 11 Conclusion--Study 02255 It is not clear if consumers can apply the label well to their own situation if they require physician consultation because – They are using medicines listed on the label, or – They have health conditions listed on the label

12. 12 More Data Needed Further testing would help determine if the proposed label works better.

13. 13 Study 12179: Purpose Do consumers with medical conditions requiring physician consultation –Understand they must see a physician before use? –Understand the indication? –Apply label information correctly about consulting a doctor before use with certain medical conditions?

14. 14 Study 12179: Participants N=145: 41% male; 59% female Had frequent heartburn Had at least 1 condition mentioned on label as requiring physician consultation Were not taking medications listed on label as needing physician consultation

15. 15 Study 12179: Label Label similar to final proposed label, but listed 6 medications requiring physician consultation, rather than 3

16. 16 Study 12179: Agency Analysis of Self-Selection Question Include only those who should see a physician before use Eliminate those 40 –Taking Prilosec –With infrequent chest pain or infrequent wheezing Analyze results for the 105 remaining –All should have said they should not use or would consult a physician

17. 17 Study 12179: Scoring Differences with Sponsor Sponsor scored anyone who had ever discussed their condition listed on label with health care professional as OK to use the product. Agency did not score these participants as OK to use

18. 18 Study 12179: Agency Analysis of Self-Selection Results Responses N% Incorrect--would use56 53% Correct/Acceptable 47 45% Ask a doctor27 26% Would not use 20 19%

19. 19 Study 12179: Product Purpose Response % (N=145) Prevent frequent HB 32%

20. 20 Study 12179: Applying the Label to Other People Hypothetical question scores in 90%’s –3 conditions needing physician consultation –Correct response was to consult doctor or not use 1/3 said person with headache should consult doctor or not use

21. 21 Label Changes after Label Comprehension Studies The label was not changed to improve communication of non-episodic use and prevention only messages. List of medications shortened in proposed label from 6 to 3. List of medical conditions in proposed label is shorter and more bulleted than in 02255 study, same as in 12179

22. 22 Conclusions: Studies 02255 and 12179 Participants understand –Prilosec 1 is for frequent heartburn –Do not use Prilosec 1 if you Do not have heartburn Have infrequent heartburn Are allergic Are pregnant or nursing

23. 23 Conclusions: Studies 02255 and 12179 Participants understand do not use if –Trouble swallowing –Chest pain with other symptoms –Chronic cough –Black tarry stools –Unexplained weight loss –Under age 18 –Heartburn worse with nausea and vomiting

24. 24 Conclusions Consumers believe Prilosec 1 can be used episodically to relieve acute HB symptoms or to prevent meal-induced HB Not clear if consumers with medical conditions listed on label or taking medications listed on label would seek medical advice before use or decline to use