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What did the Dietary Supplement Health and Education Act of 1994 do?
- provided a definition of dietary supplement: a product intended to supplement the diet through ingestion of a pill, capsule, tablet, or liquid that is not considered a food or a drug.
- required "....not evaluated by the FDA. lllnot intended to diagnose, treat, cure, or prevent...." to be on the label
- only requires removal of a product when it's hazardous
- created the office of dietary supplements
- limited claims to structure/function, no claims of efficacy
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What OTC claims are allowed as structure/function claims?
- antacid
- antigas
- laxative
- stool softener
- stimulant
- nighttime sleep-aid
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What are the advantages of dietary supplements?
- patient autonomy
- patient use
- cheaper than prescription meds
- faster to market
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What are the disadvantages of dietary supplements?
- may be ineffective
- may not be safe
- amount of active ingredient not regulated
- fear of legal liability
- lack of reputable manufacturers
- absence of FDA approval
- difficulty identifying product content
- too many to work with
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Which dietary supplements have been deemed unsafe?
- Borage
- Calamus
- Coltsfoot
- Comfrey
- Life root
- Sassafras
- Butterbur
- Chaparral
- Germander
- Pennyroyal oil
- Heliotrope
- Comfrey
- Kava
- Licorice
- Ma Huang
- Pokeroot
- Willow bark
- Jin Bu Huan
- Stephania
- Magnolia
- Lobelia
- L-tryptophan
- Phenylalanine
- Yohimbe
- Aconite
- Bitter Orange
- Colloidal Silver
- Coltsfoot
- Country Mallow
- Greater Celadine
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What did the June 2007 Good Manufacturing Practices ruling do?
- required identity, purity, strength, and composition
- plants must be designed and contructed in a way that facilitates maintenance
- plants must be clean
- plants must use proper manufacturing operations
- quality control procedures must be in place
- final product, incoming, and in-process materials must be tested
- consumer complaints must be handled
- records must be maintained
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What are the limitation trends in dietary supplement studies?
- several ingredients studied
- lack of standardization
- adulterated or misbranded
- foreign language only
- small sample size
- poorly defined inclusion/exclusion
- short study durations (usually 1-2 wks)
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What is black cohosh used for?
- premenstrual symptoms
- painful menstruation
- hot flashes
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What are the CI/precautions for black cohosh?
- pregnancy
- no more than 6 mo use
- liver disease
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What are the drug interactions for black cohosh?
- cisplatin (decreased)
- 2D6 drugs
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What is cranberry used for?
recurrent urinary tract infections
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What are the CI/precautions for cranberry?
- BPH
- urinary obstruction
- nephrolithiasis
- allergies/asthma (high salicylic acid content)
- GERD/ulcers
- d/c 2wks prior to surgery
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What are the drug interactions of cranberry?
- B12 absorption (increased - but not really an issue)
- warfarin (increased INR through 2C9 interactions AND salicylic acid aspirin effects)
- 2C9 drugs (warfarin and phenytoin)
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What are the SE associated with cranberry?
- NVD
- nephrolithiasis (salycilic acid content)
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What are the SE associated with black cohosh?
- intestinal problems
- wt gain
- nausea
- liver toxicity (monitor LFTs)
- autoimmune hepatitis
- dizziness, HA, stiffness, and trembling limbs at high doses
- no increase in endometrial hyperplasia
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What is echinacea used for?
strengthens resistance to upper respiratory tract infections
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What are the CI/precautions for echinacea?
- TB
- leukosis
- collagenosis
- MS
- AIDS
- HIV
- autoimmune diseases (theoretical)
- allergies to ragweed
- 8 wk maximum use
- asthma (exacerbated one attack)
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What are the DIs associated with echinacea?
- immunosuppressants
- 1A2 drugs
- 3A4 drugs
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What are the SE associated with echinacea?
- N,V
- allergic rxns (anaphylaxis, angioedema, urticaria)
- acute asthma
- leukopenia
- decreased male fertility
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What is feverfew used for?
prophylaxis of migraines
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What are the CI/precautions of feverfew?
- pregnancy, lactation
- children
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What are the DI of feverfew?
- anticoagulants
- 1A2, 2C9, 2C19, 3A4 drugs
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What are the SE of feverfew?
- mucosal and gastric irritation
- "post-feverfew syndrome" (anxiety, HA, insomnia, muscle and joint stiffness)
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What is fish oil supposedly useful for?
- HTN
- hyperlipidemia
- bipolar
- psychosis
- depression
- anticoagulant
- coronary heart disease
- stroke
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What are the CI/precautions for fish oil?
- seafood allergy
- bipolar
- bleeding
- cardiac disease
- depression
- DM
- HTN
- immunodeficiency
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What are the DI of fish oil?
- anticoagulants/antiplatelets/thrombolytics
- antihypertensives
- xenical, Alli, Orlistat
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What are the SE of fish oil?
- bleeding
- bruising
- nosebleeds
- hypervitaminosis A and D
- rash
- dyspepsia
- burping
- NVD
- halitosis
- taste perversion
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What is flaxseed supposedly good for?
- constipation
- diarrhea
- diabetes
- menopause
- HTN
- hyperlipidemia
- CAD
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What are the DI of flaxseed?
- anticoagulants
- antidiabetic agents
- estrogens
- decreased absorption of oral drugs
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What are the SE of flaxseed?
- bloating
- flatulence
- abdominal pain
- diarrhea
- constipation
- dyspepsia
- nausea
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What is garlic used for?
- hyperlipoproteinemia
- arteriosclerosis
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What are the CI/precautions for garlic?
- diabetes (increases insulin)
- pregnancy/lactation
- children
- peptic ulcers
- GERD
- d/c 2 wks prior to surgery
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What are the DI of garlic?
- anticoagulants
- protease inhibitors (decreased)
- NNRTI (decreased)
- 2D6, 2C9, 2C19, 2E1, 3A4 drugs
- increases Amp B activity against cryptococcus neoformans
- diabetic agents
- doxorubicin, APAP, methotrexate, fluorouracil toxicity protected against
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What are the SE of garlic?
- GI discomfort
- sweating
- dizziness/lightheadedness
- allergic rxns (anaphylaxis and urticaria)
- bleeding
- menorragia
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What is horse chestnut seed used for?
- venous conditions
- eczema
- leg pains
- hemorrhoids
- phlebitis
- menstruation
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What are the CI of horse chestnut seed?
- nephropathy
- liver injury
- children
- pregnancy/lactation
- diabetes
- GI irritation
- latex allergy
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What are the DI of horse chestnut seed?
- anticoagulants/antiplatelets (theoretical)
- antidiabetic drugs
- Li (theoretical)
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What are the SE of horse chestnut seed?
- GI irritation
- pruritis
- giddiness
- HA
- toxic nephropathy
- bleeding/bruising
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What is ginkgo used for?
- cerebral circulatory disturbances
- peripheral arterial circulatory disturbances
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What are the CI of gingko?
- epilepsy
- bleeding disorders
- diabetes
- infertility
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What are the DI of ginkgo?
- antiplatelets
- NSAIDS
- warfarin
- aminoglycosides
- thiazide (increases BP)
- trazadone
- seizure threshold lowering drugs
- anticonvulsants
- antidiabetic drugs
- 1A2, 2C19, 2C9, 2D6, 3A4
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What are the SE of ginkgo?
- GI disturbances
- HA
- dizziness
- allergic skin rxns
- bleeding
- seizures and unconsciousness
- death
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What is the best ginseng available?
asian ginseng (also chinese, korean, oriental by name)
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What is ginseng used for?
- adaptogen - for increasing resistance to environmental stress
- lassitude and debility
- lack of energy
- inability to concentrate
- convalescence
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What are the CI for ginseng?
- HTN
- emotional and psychological imbalances
- HA
- palpitations
- insomnia
- inflammation
- infection
- pregnancy/lactation
- children
- Hx of bleeding
- d/c 2 wks prior to surgery
- diabetes
- schizophrenia
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What are the DI of ginseng?
- hormonal tx
- antihypertensives
- cardiac meds
- asthma meds
- 2D6
- immunosuppressants
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What are the SE of ginseng?
- diffuse mammary nodularity
- vaginal bleeding
- gynecomastia
- HTN
- hypglycemia
- nervousness/excitation
- insomnia
- inability to concentrate
- palpitations
- diarrhea
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What is milk thistle used for ?
- chronic inflammatory liver conditions
- cirrhosis
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What are the CI of milk thistle?
- pregnancy
- allergy to ragweed, chryanthemums
- hormone sensitive cancers
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What are the DI of milk thistle?
2C9 and 3A4
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What are the SE of milk thistle?
- nausea
- diarrhea
- dyspepsia
- flatulence
- allergic rxns
- rash
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What is saw palmetto used for?
BPH
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What are the CI of saw palmetto?
- pregnancy
- children
- d/c 2 wks before surgery
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What are the DI of saw palmetto?
- anticoagulants
- contraceptive drugs
- HRT
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What are the SE of saw palmetto?
- intraoperative hemorrhage
- HA
- stomach upset
- acute hepatitis and pancreatitis
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What is St. John's wort used for?
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What are the CI of St. John's wort?
- fair-skinned
- pregnancy/lactation
- psychiatric conditions
- alzheimer's
- hypothyroidism
- anesthesia
- d/c 2 wks before surgery
- infertility
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What are the DI of St. John's wort?
- antidepressants
- anti-retrovirals
- clopidogrel (increased efficacy)
- 1A2, 2C9, 2C19, 3A4
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What are the SE of St. John's wort?
- photodermatitis/phototoxicity
- nausea
- constipation
- GI distress
- allergic rxns
- tiredness
- restlessness
- sleep disturbances
- mania or hypomania
- elevated TSH
- elevated BP
- male/female infertility
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What is coenzyme Q supposedly used for?
- CHF
- HTN
- stable angina
- ventricular arrhythmias
- cancer
- heart surgery
- periodontal disease
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What are the CI for coenzyme Q?
- biliary obstruction
- DM
- hepatic insufficiency
- renal insufficiency
- HTN
- hypotension
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What are the DI of coenzyme Q?
- statins may lower Coenzyme Q levels
- oral hypoglycemic agents
- doxorubicin toxicity increased
- antihypertensive agents
- warfarin (coenzyme Q is related to vitK K)
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What are the SE of coenzyme Q?
- rash
- GI disturbances
- elevations in LFT
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