Geneva Briggs, Pharm.D., BCPSMedOutcomes, Inc.

ObjectivesDiscuss the alternative medications that are most dangerous.Identify the most common drug interactions with alternative medications.List five sources for unbiased information on alternative medications and supplements.

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“Poisons and medicines are oftentimes the same

substances given with different intents”

Peter Mere Latham (1789-1875)

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Complementary and Alternative Medicine Practices

~40% of the US population uses dietary supplements often~ 50% of people have used herbals~ 4% rely exclusively on alternativesIn Germany over 700 herbs are available and prescribed by 70% of physicians

NEJM 1993;328:246-52.JAMA 1998;279:1548-53.

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Complementary and Alternative Medicine Practices

<40% of patients inform someone they are taking alternative medicationsMost commonly purchased – echinacea, feverfew, garlic, ginseng, ginkgo, goldenseal, kava, St. John’s wort, saw palmetto, and valerian“Typical” user – female, 35-64, white, college graduate, relatively affluent

J Am Diet Assoc 2003;103:1500-5JAMA 1998;280:1569-75

Pharmacotherapy 2000;20:877-91 4

Pharmaceuticals vs PhytomedicinesMust prove efficacy and safetyMandatory ADE monitoringProduct formulation standardsConsensus for useMarketing more restricted

Safety & efficacy data may be lackingADE monitoring not mandatoryNo product standards mandatedDosing uncertainNo treatment or cure claims on label

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Concerns withPhytomedicine

Variability of active constituentsMisidentification of the plantSelection of the wrong part of the plantInadequate storageContaminationAdulterationMislabeling of the final product

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Asian or Chinese patent medicines

Of 251 purchased in CA , 24 contained lead, 36 arsenic, 35 mercury24% of 2,609 samples of Chinese patent medicines contained pharmaceutical adulterants

J Clin Pharmacol 1997; 37: 344-50.BMJ 1994; 308: 1162.

N Engl J Med 1998; 339: 847

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Which herbals are most likely to cause significant adverse

effects?

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Top 10 OffendersKava [Piper methysticum] ComfreyChaparral [Larrea tridentata] Germander [Teucrium genus]Aristolochic acid Germanium dioxide or lactate citrate

Lobelia [Indian tobacco]Stephania L-tryptophan Ephedra (ma-huang)

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Beyond the Top 10Pennyroyal oilSassafrasBorageCalamusColtsfootLife root

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Significant Interactions with Alternative Supplements

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St John’s Wort [Hypericum perforatum]

DigoxinWarfarinTheophyllineNefazodoneOral contraceptivesAntiretroviralsCyclosporineImatinib (Gleevec)

Irinotecan [Camptosar]SimvastatinAmitriptylineSSRI (fluoxetine, sertraline, etc.)

Lancet 2000;355:1343-8Pharmacotherapy 2004;24:1508-1412

Herbal and Supplement Products That Interact with Warfarin

Increased INRGinkgo BilobaDong Quai (Angelica sinesis)Danshen (Salvia miltiorrhiza)Vitamin E

Decreased INRSt. John’s WortCoenzyme Q10American ginseng

Altered PlateletsGarlic [Allium sativum]FeverfewGinsengTurmericMeadowsweetWillow bark

Contain Coumarins*Horse chestnutRed clover

Lancet 2000;355:13438J Clin Pharm Ther 2002;27:391-40113

Significant Interactions with Alternative Meds and Supplements

Siberian Ginseng (Eleutherococcus senticocous) -DigoxinValerian [Valeriana officinalis] – alcohol, benzodiazepines, anticonvulsants, TCALicorice - ACE-I, ARB, diuretics, digoxin

Lancet 2000;355:1343814

Significant Interactions with Alternative Meds and Supplements

Kava and valerian– alcohol, barbiturates, antispychotic drugs, sedatives, benzodiazepines, Garlic – saquinavirRed rice yeast [Chinese red rice]- statins, gemfibrozil, fenofibrate

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Patient Groups Most Likely to have Problems

Multiple medicationsHIV/AIDSCancerTransplantTreated with warfarin, digoxin, or other agents prone to drug interactionsUndergoing surgery

Am J Health-Syst Pharm 2004;61:1707-1116

Avoid Recommending Herbals

Pregnant and lactating womenChildren

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Problem Products in SurgeryGinkgo biloba Saw PalmettoAmerican Ginseng [Panex quinquefolias]KavaSt John’s wortFeverfew

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Problem Products in Cancer Treatment

GarlicGinkgoEchinaceaPanax ginsengSt John’s wortKava

J Clin Oncol 2004;22:2489-50319

Reasonably Effective Herbals

Aloe Vera (topical)Arnica (topical)Black CohoshChamomile teaEchinaceaEvening primrose oilFeverfew Garlic

GingerGinkgo BilobaHawthornPeppermint teaSaw PalmettoSiberian GinsengSt John’s wortValerian

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Reliable Printed ResourcesHerbal medicine: Expanded Commission E monographsReview of Natural ProductsTyler’s Herbs of Choice. The Therapeutic Use of PhytomedicinalsTyler’s Honest Herbal: A Sensible Guide to the Use of Herbs and Related Products.Facts and Comparisons: The Review of Natural Products

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Reliable Online Resources consumerlab.comherbalgram.com

American Botanical Councilnccam.nih.gov

NIH’s National Center for Complementary and Alternative Medicine

vm.cfsan.fda.govCenter for Food Safety and Applied Nutrition

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Reliable Online Resourceswww.uic.edu/pharmacy/research/diet/content/scont_about_evaluations.htm

University of Illinoiswww.pharmacist.com/pdf/dietary_supplements.pdf

Healthcare Professional’s Guide to Evaluating Dietary Supplements

www.herbalwatch.com

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To Buy Anything and Everything

www.herbalremedies.com

Blood CirculatorMade of medicinal rhubarb, prepared rehmannia root, common peony root, peach seed, bitter apricot seed, licorice root, scute, dun fly, gadfly, leech, June beetle grub, dried lacquer and ground beetle.

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Patient CounselingEncourage disclosure of ALL medicinal substancesDiscuss available information about alternative medicinesDiscuss health risk and self-monitoringSet objective goals to follow progressSteer patients seeking to self-treat serious disorders such as depression to a physician

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How to Report an Adverse Effect

Complete the Medwatch form onlinewww.fda.gov/medwatch/report/hcp.htm

Report by telephone (1-800-FDA-1088)Download a copy of the form and either fax it to 1-800-FDA-0178 or mail it back using the postage-paid addressed form.

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Evaluating Products for Quality

Look for USP standardization

feverfew, ginger, chamomile, cranberry, ginkgo biloba, St John’s wort, saw palmetto, milk thistle, valerian, siberian ginseng, and echinacea

Reputable manufacturerConsumerlab.com evaluations

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ConclusionCurrent regulation of dietary supplements fails to address substantial risk to public healthEducate patients to give “Full Disclosure”Know the problem herbs and most common interacting herbsReport adverse events

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