OTC & Herbal Supplements (Exam V) Flashcards
1
Q
What governing body regulates herbal supplements?
A
- FTC - supplements have to be safe, effectiveness isn’t considered.
2
Q
What was thalidomide used to treat in the 1950’s?
What occurred because of this?
A
- Morning sickness
- Some of the children developed Phocomelia (lack of limb development).
3
Q
What is GRASE?
A
- Generally recognized as safe & effective
4
Q
What two examples of Behind-the-Counter products were given in lecture?
A
- Insulin (some states)
- Pseudoephedrine
5
Q
What are the three phases of drug development before an NDA is filed?
A
- In Vitro Studies
- Animal Testing
- Clinical Testing
6
Q
What are the three phases of Clinical Testing?
What is evaluated in each?
A
- Phase 1 - 20-100 subjects, safety & pharmacokinetics
- Phase 2 - 100-200 patients, double blind, does it work?
- Phase 3 - 1000-6000 patients, double blind, dosing, does it work?
7
Q
What is an IND and when is it filed?
A
- Investigational New Drug (IND) is filed after In Vitro & animal testing.
8
Q
When does a drug patent expire?
A
- 20 years
9
Q
When is an NDA filed?
Who reviews it?
A
- After/During Phase III clinical testing
- FDA
10
Q
What organization has to the burden of proving a supplement is unsafe?
A
- FDA
11
Q
What is echinacea used for?
A
- ↑ WBCs & cytokines & anti-inflammatory through COX inhibition
12
Q
What is Gingko Biloba used for?
A
- ↑ blood flow
- free radical scavenging
- dementia/memory
13
Q
What is St. John’s Wort used for?
How does it do this?
A
- Antidepressant for very mild depression
- Slight inhibition of MAOs, SERT, & NET.
14
Q
Can St. John’s Wort be taken with MAOIs or SSRI’s? Why or why not?
A
- No, increased chance of serotonin syndrome development
15
Q
What is Ginseng used for?
A
- Memory
