1. What happens when things don’t work out like they were supposed to? Drug Recalls This workforce solution was funded by a grant awarded under the President’s Community-Based Job Training Grants as implemented by the U.S. Department of Labor’s Employment and Training Administration. The solution was created by the grantee and does not necessarily reflect the official position of the U.S. Department of Labor. The Department of Labor makes no guarantees, warranties, or assurances of any kind, express or implied, with respect to such information, including any information on linked sites and including, but not limited to, accuracy of the information or its completeness, timeliness, usefulness, adequacy, continued availability, or ownership. This solution is copyrighted by the institution that created it. Internal use by an organization and/or personal use by an individual for non-commercial purposes is permissible. All other uses require the prior authorization of the copyright owner.

2. FDA  Very early beginning: 1902  Approval for food, medicine, supplements, vaccines, cosmetics, and medical devices  Typically use labeling as initial warning. If warranted, can request the compound be pulled from the market.

3.  Sometimes, despite all the research that is done during drug development, there’s still a problem.  How does that happen?

4.  Side effect wasn’t seen in animal testing  Side effect wasn’t seen during human testing  Small “issue”  FDA missed during paperwork review and approval

5. Drugs to research  What happened with this drug?  Is it still on the market?  What was it/is it used for?  Which company manufactured the drug?  Was the drug recalled?  Was the recall voluntary?  What were the side effects?  Any other interesting information?

6. Drugs to Research (continued)  Fenfluramine  Pemoline  Permax  Propulsid  Levomethadyl  Lipitor  Rezulin  Baycol  Vioxx (Rofecoxib)  Zelnorm

7. Drugs to research  What happened with this drug?  Is it still on the market?  What was it/is it used for?

8. Fenfluramine Andrew

9. Vioxx (and Rofecoxib) Angela

10. Permax Andy

11. Propulsid Candace

12. Pemoline Susan

13. Levomethadyl Cindy

14. Zelnorm Brooke

15. Rezulin Tekila

16. Baycol  Vicky

17. Lipitor  Extra

18. Questions?