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Dietary Supplements: Enough Already!
Rhonda M. Cooper‐DeHoff, Pharm D, MS, FACC, FAHAUniversity of Florida
Associate Professor of Pharmacy and Medicine
Top Ten Things to Know
After this lecture you will be able to:Understand current usage and expenditure patterns for dietary supplements
Recall US regulations surrounding dietary supplements
Recognize how dietary supplements may affect efficacy of and interact with prescription drugs
Promote patient safety by counseling patients on issues pertaining to dietary supplement use
Learning Objectives
Categories of CAM (NIH)
Biologically Based
Vitamins &
Minerals
Natural Products•Plants (gingko)
Diets
Manipulative and Body‐Based
Approaches
Massage therapy
Chiropractmedicine
Mind‐body Techniques
Spiritual
Meditative
Relaxation
Energy Medicine
Biofield
Magnetic field
Reiki
Alternative Medical Systems
Acupunct.
Chinese Medicine
Ayurveda
• Group of diverse medical and healthcare systems, practices and products that are not generally considered part of conventional medicine.
Definition
1998
Expenditure on CAM
Biologically Based
Manipulative and Body‐Based Approaches
Mind‐body Techniques Energy Medicine Alternative
Medical Systems
$34 Billion OOP
1.5% of total HCE but 11% of
OOP
NCAM 2007 survey, published in 2009
Expenditure on CAM
Biologically Based
Vitamins & Minerals
Natural Products
•Plants (gingko)
Manipulative and Body‐Based Approaches
Mind‐body Techniques Energy Medicine Alternative
Medical Systems
$32 Billion OOP
($10 B Herbals)
> 33% of total OOP Rx Expense
NCAM has awarded more than $250 Million over the last decade
NCAM 2007 survey, published in 2009
(38%) used a DS in last 2 years4 in 10 US adults
Female, Richer, more educatedAmerican Indian / CaucasianAges 18‐70
Users tend to be
take both Rx and dietary supplements
1 in 3 US Adults (72 M)
Who’s Taking Supplements?
41%To feel better
41%To
improve overall energy levels
36%To boost immune system
28%To reduce risk of heart disease
Why People Take Dietary Supplements
2011 Harvard School of Public Health Survey
Telling their Health Care Provider
CAM – Complimentary and Alternative Medicines
2006 AARP Survey
35% in 2011 Harvard Survey
The 20 Top‐Selling Herbal Supplements in the US for 2012 (Food, Drug, Mass Market Channel)
St. John’s wort (Hypericum perforatum)
Interactions
PharmacodynamicAugments or antagonizes the activity
of the drug
Herb‐Drug Interactions
PharmacokineticAbsorption, Distribution, Metabolism, or Elimination
Time
Con
cent
ratio
nInduction of metabolismInhibition of metabolism
Gardiner P, Am Fam Physician. 2008 Jan 1;77(1):73-8
Warfarin + Ginkgo Bleeding
St. John’s Wort‐CYP3A4 and P‐gp
CV DRUGSDrug Effect Pathway
Cyclosporin A 46% ↓ AUC CYP3A, P‐gpDigoxin 25% ↓ AUC P‐gpSimvastatin 48% ↓ AUC CYP3ATacrolimus 35% ↓ AUC CYP3AWarfarin 28% ↓ AUC CYP2C9Verapamil 78%↓ AUC CYP3A
(Hyperforin) (Hypericin)
Drug Effect Pathway
Irinotecan 24% ↓ ACU CYP3A
Indinavir 57% ↓ AUC CYP3A
Amitriptyline 22% ↓ AUC CYP3A
Midazolam 20% ↓ AUC CYP3A
Fexofendadine 10% ↓ AUC P‐gp
Alprazolam 53% ↓ AUC CYP3A
Norethindrone 14% ↑oral CL CYP3A
70 yo african american man seen on house call by NP and consultant pharmacist
PMH: hypertension, CHF, osteoarthritis hip, neuropathy, depression, anxiety, BPH, gastritis
CC: light headedness and worsening hip pain, feeling depressed
Exam: orthostatic hypotension, elevated pulseMeds: EC ASA, methadone, enalapril, furosemide, pantoprazole, doxazosin, travoprost eye drops, sertraline
Poly Herbs
Prevention MagazineHerbal Medications can help conditions, improve overall QOLSt John Wart, Bilberry, Zing (gingko biloba, ginseng etc), Hawthorne extract, CoQ10, Cata‐clear (bilberry, vitamins), Colon‐Helper (aloe, gentian, goldenseal, etc), Valerian, Saw Palmetto
Cappuzzo K. Consultant Pharmacist 2006;11:911-915
Which of the following are potential drug‐herb interactions in this patient?A) St John Wart – Methadone (decreased activity)B) St John Wart – SSRI (serotonin syndrome)C) Ginkgo Biloba – ASA (platelet inhibition)D) All of the above
Audience Response
At end of visit patient asked about whether he could take Viagra to reduce stress on his heart……..
He had heard about it on the news………
Herb Containing StimulantsINGREDIENT USE Adverse CV EffectBitter Orange Weight Loss, Nasal Cong. Hypertension
Cola Nut (1-3.5% caff) Mental or physical fatigue Arrhythmia, ↑ HR, palpit.
Country Mallow (0.8-1.2% ephedrine)
Weight loss, ↑ energy, impotence, asthma
Arrhythmia, ↑ BP, tachy
Ephedra Appetite sup ↑ HR, ↑BPGreen Tea (2-4% caff) Cognition, diuretic,
cholesterolArrhythmia, ↑ HR, palpit.
Guarana (2.5% caff) Weight loss, athletic perf, fatigue
↑ HR, CNS stimulant
Khat (bath salts) Depression, fatigue, obesity SOB, circ stimulant
Yerba mate (0.2-2% caff) Appetite sup, mental stim. Arrhythmia, ↑ HR, palpit.
Ann Pharmacotherapy 2004;38:812-6
61 yo man w/ hx of hypercholesterolemia x 11 yrs, tx with multiple different statins (all at 10mg dose) which was unsuccessful due to muscle intolerance (w/in 1 week). Normal CK, moderate LFT bumps. Patient drank 3 cups of green tea everyday “to reinforce his health”.
Statins
The likely underlying mechanism for the green tea – simvastatin interaction isA) CYP3A4 inductionB) CYP3A4 inhibitionC) Unknown mechanism
Audience Response
DSB is a 42 yo police officer. He weighs 260 lbs, BP 143/92, TC 200, LDL 130mg/dl, glucose 105 mg/dl
He takes a weight loss supplement (imported from Brazil) and loses 10 lbs
Label: vitamin E, centella, senna, cascara, other “natural ingredients”
He undergoes routine, random drug screenHe loses his job
Case Presentation
NEJM 2009;361:1523-1525
“Natural Ingredient”: AMPHETAMINE
How comfortable do you feel with your knowledge of CAM?A) Very comfortableB) Somewhat comfortableC) Not at all comfortable
Audience Response
How much do we know?#
of su
bjec
ts
Suchard JR et. al., Eur J Emerg Med. 2004 Aug;11(4):193-7.
Self-assessed knowledge of herbal toxicities and herb–drug interactions among physicians• 16 question MC quiz regarding toxic effects and drug interactions of herbals• Mean score was only slightly higher than would have occurred from random guessing
Pharmacists scored < 50% in a yes or no quiz on herbal medicines
Chang et. al. Ann Pharmacother. 2000 Jun;34(6):710-5
Red Yeast Rice ‐ Content
Becker D J et al. Ann Intern Med 2009;150:830-839 Halbert SC et al. Am J Cardiol 2010;105:198-204
Citrinin (byproduct of fermenting process) is a mycotoxin (nephrotoxic)
• DS are regulated on the food side of FDA (not drug side)• Serving Size, not Dose• Supplement vs Food
FDA
• Nongovernmental, NFP organization • USP sets standards for Rx and OTC drugs (required)• 2001 USP launched verification program for DS (voluntary)
USP (United States Pharmacopeia)
Dietary Supplement Oversight
• Dietary Supplement Health and Education Act• Statute of US federal legislation (Orin Hatch R‐Utah April 1993)
• Went through senate and house in less than a year and signed by Clinton in Oct 1994
DSHEA
Companies Participating in the USP Programs
Verifies what’s on the label is in the bottle
No harmful contaminants DS will break down and
release ingredients in the body
DS has been made under GMP
Products
Reumofan Plus & WOW
August 2012Pulled due to discovery of dexamethasone, diclofenac and methocarbamol
Black AntViaXtreme
Sexual Enhancement ProductsFDA puts out warnings on many products – all contain Sildenafil
Advanced Slim 5
FDA puts out warnings on many products – all contain Sibutramine (withdrawn from market in 2010)
6.6 mg Lorcaserin (Belviq) (10mg in standard tablet)
FDA Allowed Claims
“Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect”
Health
“fortified, high, rich in, excellent source of, good source of, and high potency”Nutrient
“calcium builds strong bones”Structure Function
DISCLAIMER"This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."
• 75% said “minimally influenced by government statements contradicting efficacy claims of DS manufacturers”
• 25% said “would cease use of a DS if public health authorities stated it was ineffective”
Impact of government‐sponsored studies on efficacy of
DS:
Impact of Study Results
The widespread, indiscriminate use of dietary supplements presents substantial risks to public health and pharmacists have an opportunity and a professional responsibility to reduce those risks
State of complementary and alternative medicine in CV, lung and blood research fosters and encourages collaboration among scientists
Professional Societies
Integrating complementary medicine into CV medicine – puts emerging area of CAM into focus and enables physicians to provide better patient care
US consumption: 2.3B drinks in 2005, 6B drinks in 2010, 31% of young teens, 51% of 18‐24yo, 45% of US troops$10B spent on energy drinks in 2012
Increasing use in elderly → medica on interac ons
Most energy drinks do not list correct caffeine content or other herbs
Caffeine poisoning on the rise
Energy Drinks
Alcohol can prolong the 5 hr half‐life of caffeine and contribute to it’s toxic effects
AMED: alcohol mixed with energy drinks (cocktails at bars: red bull + vodka)
Energy Drinks and Alcohol
offsets the sedating effects of alcohol
reduces the sensation of intoxication
induces more alcohol consumption
•Add dietary supplements to intake formTalk to your patients about what they are
taking
•Avoid products that do not specify the exact amount of extract per serving
Content – DS may contain more than what is listed,
“USP verified” provides some reassurance
Take Home Messages
•High potential for important drug‐drug‐herb‐herb interactions
Polypharmacy Meets
Polyherbacy
• THINNER, MORE ENERGETIC, MORE SEXUAL, MORE………
•Without the work of dieting, exercise, sleeping…..• These products will continue to be available
As long as people want
to be
Take Home Messages