What happens when things don’t work out like they were supposed to?

Drug Recalls

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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?