Geneva Briggs, Pharm.D., BCPS MedOutcomes, Inc.

Geneva Briggs, Pharm.D., BCPS MedOutcomes, Inc.

Objectives Discuss 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. 1

Poisons and medicines are oftentimes the same substances given with different intents Peter Mere Latham (1789-1875) 2

Complementary and Alternative Medicine Practices ~40% of the US population uses dietary supplements often ~ 50% of people have used herbals ~ 4% rely exclusively on alternatives In Germany over 700 herbs are available and prescribed by 70% of physicians NEJM 1993;328:246-52. JAMA 1998;279:1548-53. 3

Complementary and Alternative Medicine Practices <40% of patients inform someone they are taking alternative medications Most 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;103:1500-5 JAMA 1998;280:1569-75 Pharmacotherapy 2000;20:877-91 4

Pharmaceuticals vs Phytomedicines Must prove efficacy and safety Mandatory ADE monitoring Product formulation standards Consensus for use Marketing more restricted Safety & efficacy data may be lacking ADE monitoring not mandatory No product standards mandated Dosing uncertain No treatment or cure claims on label 5

Concerns with Phytomedicine Variability of active constituents Misidentification of the plant Selection of the wrong part of the plant Inadequate storage Contamination Adulteration Mislabeling of the final product 6

Asian or Chinese patent medicines Of 251 purchased in CA, 24 contained lead, 36 arsenic, 35 mercury 24% 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 7

Which herbals are most likely to cause significant adverse effects? 8

Top 10 Offenders Kava [Piper methysticum] Comfrey Chaparral [Larrea tridentata] Germander [Teucrium genus] Aristolochic acid Germanium dioxide or lactate citrate Lobelia [Indian tobacco] Stephania L-tryptophan Ephedra (ma-huang) 9

Beyond the Top 10 Pennyroyal oil Sassafras Borage Calamus Coltsfoot Life root 10

Significant Interactions with Alternative Supplements 11

St John s Wort [Hypericum perforatum] Digoxin Warfarin Theophylline Nefazodone Oral contraceptives Antiretrovirals Cyclosporine Imatinib (Gleevec) Irinotecan [Camptosar] Simvastatin Amitriptyline SSRI (fluoxetine, sertraline, etc.) 12 Lancet 2000;355:1343-8 Pharmacotherapy 2004;24:1508-14

Herbal and Supplement Products That Interact with Warfarin Increased INR Ginkgo Biloba Dong Quai (Angelica sinesis) Danshen (Salvia miltiorrhiza) Vitamin E Decreased INR St. John s Wort Coenzyme Q10 American ginseng Altered Platelets Garlic [Allium sativum] Feverfew Ginseng Turmeric Meadowsweet Willow bark Contain Coumarins* Horse chestnut Red clover 13 Lancet 2000;355:13438 J Clin Pharm Ther 2002;27:391-401

Significant Interactions with Alternative Meds and Supplements Siberian Ginseng (Eleutherococcus senticocous) - Digoxin Valerian [Valeriana officinalis] alcohol, benzodiazepines, anticonvulsants, TCA Licorice - ACE-I, ARB, diuretics, digoxin 14 Lancet 2000;355:13438

Significant Interactions with Alternative Meds and Supplements Kava and valerian alcohol, barbiturates, antispychotic drugs, sedatives, benzodiazepines, Garlic saquinavir Red rice yeast [Chinese red rice]- statins, gemfibrozil, fenofibrate 15

Patient Groups Most Likely to have Problems Multiple medications HIV/AIDS Cancer Transplant Treated with warfarin, digoxin, or other agents prone to drug interactions Undergoing surgery 16 Am J Health-Syst Pharm 2004;61:1707-11

Avoid Recommending Herbals Pregnant and lactating women Children 17

Problem Products in Surgery Ginkgo biloba Saw Palmetto American Ginseng [Panex quinquefolias] Kava St John s wort Feverfew 18

Problem Products in Cancer Treatment Garlic Ginkgo Echinacea Panax ginseng St John s wort Kava 19 J Clin Oncol 2004;22:2489-503

Reasonably Effective Herbals Aloe Vera (topical) Arnica (topical) Black Cohosh Chamomile tea Echinacea Evening primrose oil Feverfew Garlic Ginger Ginkgo Biloba Hawthorn Peppermint tea Saw Palmetto Siberian Ginseng St John s wort Valerian 20

Reliable Printed Resources Herbal medicine: Expanded Commission E monographs Review of Natural Products Tyler s Herbs of Choice. The Therapeutic Use of Phytomedicinals Tyler s Honest Herbal: A Sensible Guide to the Use of Herbs and Related Products. Facts and Comparisons: The Review of Natural Products 21

Reliable Online Resources consumerlab.com herbalgram.com American Botanical Council nccam.nih.gov NIH s National Center for Complementary and Alternative Medicine vm.cfsan.fda.gov Center for Food Safety and Applied Nutrition 22

Reliable Online Resources www.uic.edu/pharmacy/research/diet/content/scont_about _evaluations.htm University of Illinois www.pharmacist.com/pdf/dietary_supplements.pdf Healthcare Professional s Guide to Evaluating Dietary Supplements www.herbalwatch.com 23

To Buy Anything and Everything www.herbalremedies.com Blood Circulator Made 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. 24

Patient Counseling Encourage disclosure of ALL medicinal substances Discuss available information about alternative medicines Discuss health risk and self-monitoring Set objective goals to follow progress Steer patients seeking to self-treat serious disorders such as depression to a physician 25

How to Report an Adverse Effect Complete the Medwatch form online www.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. 26

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 manufacturer Consumerlab.com evaluations 27

Conclusion Current regulation of dietary supplements fails to address substantial risk to public health Educate patients to give Full Disclosure Know the problem herbs and most common interacting herbs Report adverse events 28