Transcript What happens when things don`t work out like they were supposed to?

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.
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.


Sometimes, despite all the research
that is done during drug
development, there’s still a
problem.
How does that happen?




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
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?
Drugs to Research (continued)





Fenfluramine
Pemoline
Permax
Propulsid
Levomethadyl





Lipitor
Rezulin
Baycol
Vioxx (Rofecoxib)
Zelnorm
Drugs to research



What happened with this drug?
Is it still on the market?
What was it/is it used for?
Fenfluramine
Andrew
Vioxx (and Rofecoxib)
Angela
Permax
Andy
Propulsid
Candace
Pemoline
Susan
Levomethadyl
Cindy
Zelnorm
Brooke
Rezulin
Tekila
Baycol

Vicky
Lipitor

Extra
Questions?