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Considerations Background Government Regulations

Currently, there is an inconsistency in


ASA’s Role in Patient Safety Suggested Reading
The American Society of Ang-Lee MK, Moss J, Yuan CS. Herbal medicines
safety guidelines for manufacturing, and perioperative care. JAMA. 2001; 286:208-216.
for In 1997, adults in the United States spent an estimated $3.5 bil- labeling, promotion of health claims, Anesthesiologists (ASA)
lion on herbal medicines, plus billions more on commercial diet and potency and purity of com- Blumenthal M, Goldberg A, Gruenwald J, et al. The
takes no formal position on
pounding. Herbal medications and German Commission E Monographs: Therapeutic
Anesthesiologists: products, vitamins and mineral supplements. One in five indi- dietary supplements cannot gain the therapeutic properties of
viduals who takes prescription medications also takes herbal patent rights and, as such, they are Monographs on Medicinal Plants for Human Use,
herbal medications and has Austin, TX, American Botanical Council. 1998.
preparations, high-dose megavitamins, or both. Eisenberg et al. not termed “drugs.” The Food and
Drug Administration (FDA) can no formal statement
estimate that 15 million people who take herbal medicine may “suggest” but cannot require the Eisenberg DM, Davis RB, Ettner SL, et al. Trends in
of policy or standard of alternative medicine use in the United States,
be at risk for potential adverse interactions between their pre- herbal industry to provide scientific
data to its consumers. care that is specific to 1990-1997. JAMA. 1998; 280:1569-1575.
scription medications and these products.
phytopharmaceuticals. It is Gillis CN. Medicinal plants rediscovered. Seminars in
The Dietary Supplement Health and
Especially troubling for physicians is that as many as 70 percent Education Act of 1994 places the important, however, for the Anesthesia, Perioperative Medicine and Pain. 1998;
burden of product safety assurance 17(4):319-330.
of patients taking alternative medications do not disclose this to their public and the medical
on the manufacturer. The FDA still
doctors. It is imperative that health care providers as well as assumes the responsibility for proving community to be aware that Gruenwald J, Brendler T, Jaenicke C, scientific eds.
that a product is unsafe, not the PDR for Herbal Medicines. 1st ed. Montvale, NJ:
patients become aware of the interactions of these products and manufacturer, and only if the FDA
these products could pose a
Medical Economics Co; 1998.
that herbal-use habits become a part of the patient’s document- has reason to suspect that an herb is serious health risk if they
ed history and treatment plan. For example, the anesthesiologist unsafe can it require that a product Johnston BA. Prevention magazine assesses use of
are taken prior to surgery.
be removed from the market. By law, dietary supplements. Herbalgram. 2000; 48:65-72.
might consider whether or not to proceed with a regional anes- however, the FDA cannot require the People often believe that a
thetic in the face of increased bleeding potential due to a testing of all herbal products and Leak JA. Herbal medicine: Is it an alternative or an
product that is labeled “all
dietary supplements before they are unknown? A brief review of popular herbals used
patient’s use of a specific herbal medicine. Some herbal effects available to consumers. natural” must therefore be
may be subtle and less critical, but expecting a reaction is by patients in a pain and symptom management
safe. This is an inaccurate practice setting. Current Review of Pain. 1999;
always preferred to reacting to an unexpected condition. Because of continued concerns regard-
ing safety and health claims practices, and dangerous assumption 3:226-236.
on April 29, 1998, the FDA put forth
that can put patients at McLeskey CH, Meyer TA, Baisden CE, et al. The
Johnston noted that by the year 2000, 91 million users, or the “Regulations on Statements Made
for Dietary Supplements Concerning unnecessary risk. The incidence of herbal and selected nutraceutical
What You approximately one-half of U.S. adults, had used an herbal prod- the Effect of the Product on the use in surgical patients. Anesthesiology. 1999;
uct in the last year and that about one-quarter of U.S. adults Structure or Function of the Body.” 91(3A):All68.
used herbs on a regular basis. Government sources estimate Specifically, these regulations state that Use of herbs and other
“under the proposal, dietary supple- Miller LG. Herbal medicinals: Selected clinical
that more than one-half of the adult population uses dietary dietary supplements is not
Should Know ments that expressly or implicitly claim considerations focusing on known or potential
supplements. New extrapolations may indicate that as many as to diagnose, treat, prevent, or cure a necessarily a contraindica-
disease continue to be regarded as drug-herb interactions. Arch Intern Med. 1998;
22 million users of these products may be at risk for adverse drugs and have to meet the safety and
tion for anesthesia. 158(20):2200-2211.
interactions from herb/supplement, prescription medication and effectiveness standards for drugs Pending more definitive
About Your under the Food, Drug, and Cosmetic O’Hara MA, Kiefer D, Farrell K, et al. A review of
over-the-counter product usage. studies and in the best inter- 12 commonly used medicinal herbs. Arch Fam Med.
Act.” Disease is defined as “any devia-
tion from, impairment of, or interrup- est of patient safety, ASA is 1998; 7:523-536.
This brochure does not include information regarding herbal tion of the normal structure or func-
taking a leading role in edu-
Patients’ dosages or specific practice guidelines. Nor does this brochure
tion of any part, organ, or system…of
the body that is manifested by a char- cating the physician as well This brochure has been developed by ASA for its members,
discuss herbs used in other healing traditions, such as Chinese acteristic set of one or more signs or but has not been reviewed or approved as a practice para-
as the patient about the meter or policy statement of the ASA House of Delegates.
or Mexican-American herbs. Few, if any, double-blinded, place- symptoms…”
Variance from suggestions contained in this document may
Use of Herbal bo-controlled series of studies support any specific recommen-
importance of a thorough
be acceptable based on the judgment of the responsible
Implicit in this new definition would
history of a patient’s med- anesthesiologist. The suggestions here are designed to
dations with regard to anesthetic management. This brochure be acceptance of the claim, “promotes
vascular health” but rejection of the ication use. Patients should encourage quality patient care and safety in the workplace,
does, however, offer information about the current trends in assertion, “decreases blood pressure.” but cannot guarantee a specific outcome. They are subject to
Medicines and herbal use, governmental oversight of the industry and some of Many herbal and dietary product
tell their physicians—and revision from time to time as warranted by evolution of
manufacturers, therefore, add infor- physicians should ask— technology and practice.
the more common herbal medicines and dietary supplements
mation to their product advertise-
and their common uses, potential side effects and drug interac- about all herbal, dietary or Please see the chart on the reverse side for information on some of the
ments or labeling that indicates that
Other Dietary tions. their product “is not intended to diag- other over-the-counter hundreds of currently available herbal products. This chart outlines
nose, treat, cure or prevent any dis- these phytopharmaceuticals by product name, scientific name, common
preparations as well as pre- name(s), common uses and potential side effects and drug interactions.
ease,” and thus is not subject to FDA
drug regulations. At this point in time, scription medicine that the
Supplements herbal and dietary supplements will
patient is taking.
continue to be examined by the FDA
under similar guidelines as the food
industry.

Copyright © 2003. The American Society of Anesthesiologists. All rights reserved.

10M303OO
Brand Name Scientific Name Common Names Common Uses Possible Side Effects and Drug Interactions
Echinacea Echinacea purpurea Purple Cone Flower Common colds
Wounds and burns
1 May cause hepatotoxicity, especially when used with other hepatotoxic drugs,
i.e., anabolic steroids or methotrexate.
Urinary tract infections 2 May also see decreased effectiveness of corticosteroids.
Coughs and bronchitis

Ephedra sinica Ma-Huang Over-the-counter diet aids Potential Drug Interactions


Ephedra Ephedrine Bacteriostatic 1 Heart glycosides or halothane: arrhythmias.
Chinese Joint Fir Antitussive 2 Guanethedine: enhanced sympathomimetic effects.
3 Monoamine oxidase inhibitor (MAOI): enhanced sympathomimetic effects.
4 Oxytocin: hypertension.

Tanacetum parthenium Feverfew Migraine prophylactic 1 Can inhibit platelet activity and increase bleeding. Avoid use in patients on warfarin
Feverfew Featherfew Antipyretic or other anticoagulants; may enhance bleeding.
Midsummer Daisy 2 Rebound headache with sudden cessation.
3 5-15% of users develop aphthous ulcers or gastrointestinal tract irritation.

Gamma-butyrolactone; GBL, BD, GHB Bodybuilding 1 Death.


GBL, BD and GHB Butyrolactone gamma; (abbreviations for illegally dis- Weight loss aid 2 Seizures.
1,4 butanediol; tributed, unapproved drugs Sleep aid 3 Unconsciousness.
Gamma hydroxybutyrate [not approved by FDA]) 4 Bradycardia.
5 Slowed respirations that may require intubation.

Allium sativum Clove Garlic Lipid lowering 1 May potentiate warfarin; will see increased INR(PT).
Garlic Ajo Blood pressure lowering 2 May decrease effectiveness of certain HIV protease inhibitor drugs, e.g., saquinavir.
Has antiplatelet, antioxidant and
antithrombolytic qualities

Ginger Zingiber officinale Black Ginger


African Ginger
Antinauseant
Antispasmodic
1 Potent inhibitor of thromboxane synthetase; may increase bleeding time.
2 Use caution when taking warfarin; may cause excessive bleeding.

Ginkgo biloba Maidenhair Tree Circulatory stimulant May enhance bleeding in patients on anticoagulant or antithrombotic therapy,
Ginkgo Fossil Tree i.e., aspirin, NSAIDs, warfarin or heparin.

Ginseng Panax ginseng American Ginseng


Chinese Ginseng
Adaptogenic
Energy level enhancer in athletes
1
2
Ginseng Abuse Syndrome (>15g per day): sleepiness, hypertonia, edema.
Avoid use with other stimulants; may see tachycardia or hypertension.
Korean Ginseng Antioxidant 3 Mastalgia.
4 Post-menopausal bleeding.
5 May cause mania in patients on phenelzine.
6 May have antiplatelet properties; may increase bleeding, particularly in patients on
anticoagulant and antithrombotic agents.

Hydrastis canadensis Orange Root Diuretic 1 Functions as an oxytocic.


Goldenseal Yellow Root Anti-inflammatory 2 Overdose may cause paralysis (amount not known).
Ground Raspberry Laxative 3 Functions as an aquaretic, not a diuretic (no sodium excreted, just free water).
Turmeric Root Hemostatic 4 May worsen edema and/or hypertension.
Eye Root

Piper methysticum Ava Anxiolytic 1 May cause serious hepatotoxicity.


Kava-kava Kawa 2 Potentiates barbiturates and benzodiazepines.
Ava Pepper 3 Can potentiate ethanol effects.
4 Increased suicide risk in patients with endogenous depression.

Licorice Glycyrrhiza glabra Licorice Root


Sweet Root
Gastric and duodenal ulcers
Gastritis
1 Glycyrrhizic acid in licorice may cause high blood pressure, hypokalemia and edema.
2 Contraindicated in many chronic liver conditions, renal insufficiency, hypertonia,
Cough/bronchitis hypokalemia.

Serenoa repens Sabal Benign prostatic hypertrophy May also see additive effects with other hormone therapies,
Saw palmetto Cabbage Palm Antiandrogenic i.e., birth control pills or estrogen replacement therapy.
Antiexudative

Hypericum perforatum Hardhay Treatment for depression 1 May decrease effectiveness of all currently marketed HIV protease inhibitors and
St. John’s wort Amber and anxiety non-nucleoside reverse transcriptase inhibitors.
Goatweed 2 May decrease blood levels of digoxin via the induction of hepatic cytochromes P450 3A4.
3 May prolong effects of anesthesia (anecdotal reports only).

Valeriana officinalis All-heal Mild sedative 1 Will likely potentiate barbiturate effect.
Valerian Setwall Mild anxiolytic 2 May decrease symptoms of benzodiazepine withdrawal
Vandal Root (benzodiazepine-like effects but different receptors).

Vitamin E Vitamin E Vitamin E To slow aging process


Prevention of stroke and
1 May increase bleeding, particularly in conjunction with other anticoagulant and antithrombotic drugs.
2 May affect thyroid function in otherwise healthy patients.
pulmonary emboli 3 May enhance hypertension in hypertensive patients in doses ≥400 IU per day.
Prevention against atherosclerosis
Promotion of wound healing
Effective against fibrocystic
breast syndrome

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