NAPLEX Natural Products & Vitamins**

Dietary supplements SAFETY and EFFICACY regulated by…

TRICK: FDA only regulates SAFETY (aka production), efficacy is NOT regulated

What are two major concerns regarding the manufacturing of dietary supplements?

- may not follow "good manufacturing practices" (GMP) resulting in POOR QUALITY products

- manufacturer does not have to PROVE product SAFETY and EFFECTIVENESS before it is marketed

What is the "Dietary Supplement Health and Education Act" (DSHEA)?

By law, the MANUFACTURER IS RESPONSIBLE for ensuring their supplement product is SAFE before marketing**

- but they do not have to PROVE it - (unlike drugs)

Under DSHEA, once the product is marketed, the FDA is responsible for showing a product is UNSAFE prior to removal from marketplace

- the product's company is REQUIRED to record, investigate and forward to the FDA reports they receive of serious adverse events**

Dietary supplements can make claims that ____.

describe the ROLE of an ingredient that affectes normal body structure or function

- e.g. "calcium builds strong bones"

Dietary supplements CANNOT makes claims that ___.

the product TREATS OR CURES a condition

Which natural products increase bleeding risk and should be used in caution with warfarin, NSAIDs, antiplatelets, and other anticoagulants?

- ginkgo biloba

- garlic

- ginseng

- fish oils (high-dose)

- dong quai

- vitamin E

Which natural product increases bleeding risk and may increase INR in warfarin patients?

dong quai

What are the major concerns with St. John's Wort?

- drug interactions (induces 3A4 >> 2C9 > 1A2)

- photosensitivity

- serotonergic

- seizure risk

List several drugs that should be avoided with St. John's Wort due to enzyme induction.

- oral contraceptives

- transplant drugs

- warfarin

- 5HT (serotonin) drugs

Which natural products may be hepatotoxic?

- chaparral

- comfrey

- KAVA

Describe the concept of homeopathy or homeopathic medicine.

Homeopathy is based on "the law of similars" or the concept that "like is cured by like"

- belief that giving very small amounts of illness (diluting the original substance to unmeasurable amounts) will protect or cure them of illness

Which non-FDA approved products are permitted to make health claims?

- "homeopathic" products

- medical foods

What is the concern with homeopathic products?

Products labeled as "homeopathic" are permitted to make health claims, however they may actually contain MEASURABLE concentrations of drugs

- these drugs are not FDA-approved or monitored

- result could be toxicities (e.g. recalled Hyland's Teething Tablets in 2010 due to belladonna toxicity)

What is a complication of vitamin B1 (thiamine) deficiency?

Wernicke's encephalopathy

All prescription meds for low bone density (e.g. osteoporosis meds) require adequate ___ and ___ supplementation taken concurrently (when dietary intake is inadequate).

calcium

vitamin D

Women planning to conceive (and all women of child-bearing age) should be taking what dose of folic acid supplement for prevention of birth defects?

400-800 mcg/daily

(or 0.4-0.8 mg/daily)

What is the duration of time that folic acid should be taken during pregnancy?

Take folic acid AT LEAST 1 MONTH before pregnancy and continue for the FIRST 2-3 MONTHS

What is the typical dose of folic acid in prescription prenatal vitamins?

1,000 mcg

(or 1 mg)

What is the name for vitamin A?

retinol

Excessive intake of vitamin E is considered a ____ risk and should not exceed a dose of ___ daily.

CVD risk

max 150 IU daily

What is the vitamin D supplementation recommendation for infants or babies per the American Academy of Pediatrics (AAP)?

400 IU vitamin D daily (e.g. Poly-Vi-Sol)

- only if exclusively breastfed and drinking < 1 liter of baby formula

What are the iron requirements for BREAST-FED 4-6 month old babies per the AAP?

1 mg/kg/day

- start around 4-6 months old until they start consuming iron-rich foods

List 3 drugs that require supplementation in order for the drug to work.

- ALL OP drugs - calcium, vitamin D

- epoetin alfa/darbepoetin alfa - IRON

- calcium - vitamin D supp.

Most antiepileptic drugs may require supplementation of which vitamins due to depletion?

calcium, vitamin D

What is the name for vitamin B1?

thiamine

What is the name for vitamin B12?

cobalamin

What is the name for vitamin B3?

NIACIN

What is the name for vitamin B6?

PYRIDOXINE

What is the name for vitamin B9?

FOLIC ACID

What is the name for vitamin C?

ascorbic acid

Name some commonly used natural products for anxiety. (4)

- valerian

- passion flower

- chamomile tea

- kava (do not recommend due to liver damage)

Name some commonly used natural products for sleep. (4)

- melatonin

- valerian

- chamomile tea

- kava (do not recommend due to liver damage

Name some commonly used natural products for ADHD. (2)

- fish oil supplements

... with or without primrose oil

Name some commonly used natural products for canker sores. (1)

lysine

Name some commonly used natural products for cholesterol. (2)

- fish oils (for triglycerides)

- red yeast rice

Name some commonly used natural products for depression. (7)

- St. John's Wort

- SAMe (do not use with MAOI)

- fish oil

- 5-HTP

- tryptophan

- glutamine

- inositol (for OCD and PD)

Name some commonly used natural products for colds and flu. (5)

- echinacea

- elderberry

- garlic

- zinc

- vitamin C

Name some commonly used natural products for dementia/memory. (2)

- ginkgo

- vitamin E

Name some commonly used natural products for diabetes. (4)

- bitter melon

- chromium

- cinnamon

- green tea (may lower risk)

Name some commonly used natural products for energy/weight loss.

- bitter orange (caution: CVD risk similar to ephedra)

- guarana (caffeine)

- raspberry ketone

Name some commonly used natural products for UTI. (1)

cranberry

Name some commonly used natural products for GI distress. (2)

- peppermint oil

- chamomile tea

Name some commonly used natural products for IBD.

- cascara (constipation)

- senna (stimulant laxative for constipation)

- psyllium (diarrhea - found in Metamucil, etc.)

- "bulk-forming" fiber products (diarrhea)

- peppermint oil/tea (antispasmodic)

- chamomile tea (antispasmodic)

Name some commonly used probiotics. What conditions can they be used for?

- Lactobacillus

- Bifidobacterium infantis

May be used for many conditions, including diarrhea prevention with antibiotics, irritable bowel, cholesterol-lowering, etc.

What is important to check when a probiotic is being considered for us?

The type of probiotic needs to match the indication, based on efficacy.

Name some commonly used natural products for heart health/heart failure. (6)

- coenzyme Q10

- fish oil

- grape seed extract

- garlic

- hawthorne (caution - additive hypotensive effects)

- arginine (avoid w/ antihypertensives due to additive effect)

Name some commonly used natural products for inflammation. (2)

- fish oils

- willow bark (a salicylate)

Name some commonly used natural products for liver. (1)

milk thistle

Name some commonly used natural products for menopausal symptoms. (4)

- black cohosh

- dong quai

- red clover

- evening primrose

Name some commonly used natural products for migraine/headache? (8)

- feverfew

- willow bark

- butterbur

- guarana (caffeine)

- fish oils

- magnesium

- coenzyme Q10

- riboflavin

Name some commonly used natural products for motion sickness/nausea? (2)

- ginger

- peppermint

Name some commonly used natural products for osteoporosis? (6)

- calcium

- vitamin D

- soy

- black cohosh

- flax seed

- evening primrose

Name some commonly used natural products for osteoarthritis. (3)

- glucosamine (may raise INR)

- chondroitin

- SAMe (avoid use with MAOI)

Name some commonly used natural products for prostate enlargement? (1)

saw palmetto

Name some commonly used natural products for skin conditions? (2)

- aloe vera

- tea tree oil

What skin conditions is tea tree oil possibly used for?

- acne

- onychomycosis symptoms (NOT treatment)

- athlete's foot (do not use the cream)

What is an important counseling point regarding the concurrent use of probiotics and antibiotics?

Do not take together - otherwise the probiotic will be destroyed by the antibiotic. Separate the dosing by at least 2 hours.

What is an important counseling point for saw palmetto being used for BPH?

First see a doctor to rule out the possibility of prostate cancer and receive treatment, if needed.

note: saw palmetto is rate as "possibly ineffective"