Potential Adverse and Allergic Reactions from Complementary and Alternative Medicine and Dietary Supplements

A 59-year-old Vietnamese woman with chronic urticaria reported the use of two CAM preparations: Kwan Loong Oil (containing methyl salicylate) and Zhui Feng So Hop Wan (pills with unknown content).

A 68-year-old Chinese woman with allergic rhinitis was taking a Chinese patent medicine, Dan Shen Pill (containing radix Salvia miltiorrhiza), for her coronary artery disease.

A 34-year-old Caucasian man with allergic rhinitis and asthma had been taking ClearLungs Chinese Formula For The Lungs (capsules containing licorice root and other herbal and food components) and YOUR CHOICE - SPORTS 52 EPHEDRINE-HCL (30 mg capsules).

A 30-year-old Caucasian man with a food anaphylaxis to mustard (confirmed by positivity on skin-prick testing) recently started taking two DS products: (1) LifePak Dietary Supplement, a vitamin/phytonutrient capsule with extracts of grape, tomato, broccoli, and alfalfa, and (2) Natural Factors Acidophilus & Bifidus capsules, containing a base of whey and powdered goat milk.

The two Asian patients obtained the three CAM products from local Chinese herbal shops whereas the two Caucasian patients used CAM and DS products purchased from health food stores.

None of the patients manifested specific adverse or allergic reactions to these CAM preparations and DS products. However, the potential for reactions was discussed with the patients and was reported to the referring family physicians.

YOUR CHOICE - SPORTS 52 EPHEDRINE - HCL was manufactured for YOUR CHOICE, Scottsdale, AZ. Each capsule contained ephedrine HCl 30 mg, without wheat, corn, dairy, soy, yeast, or any other filler. The direction was to "take one capsule 30 minutes before exercise, or as directed by health care professional."

Warnings included the following: "Ephedrine is a CNS (Central Nervous System) stimulator, do not use if receiving MAO inhibitors, prone to hypertension, hyperthyroidism or presence of coronary thrombosis"; "The amino acid L-tyrosine can be use in conjunction with ephedrine"; "Tyrosine has shown to increase the effects of ephedrine by up to 50% and by combining these two products, sensitive person could cut in half their ephedrine dosage"; and "There was no animal testing done on this product."

The first patient used two CAM products for her chronic urticaria. Kwan Loong Oil contained 28% methyl salicylate, and its instructions warned of interaction with the anticoagulant effect of warfarin. Methyl salicylate can be absorbed through the skin, being more lipid soluble than is aspirin or salicylic acid. Ten millilitres of the 28% methyl salicylate medicated oil contain the salicylate equivalent of thirteen 300 mg aspirin tablets. Hence, it may cause bleeding when used with warfarin [3, 4].

It is not uncommon to have preparations whose herbal content is unknown, as with Zhui Feng So Hop Wan (Pill) [5]. There is a potential for herb-drug interaction. In addition, some Chinese patent medicines may contain pharmaceutical products [6], and prescription drugs [7, 8].

Dan Shen Pill, containing radix Salvia miltiorrhiza, was used by the second patient. In traditional Chinese medicine, Dan Shen, the dried root of Salvia miltiorrhiza Bge. (Labiatac), is used for coronary artery disease [9]. As with the case of the methyl salicylate medicated oil, a warfarin-Dan Shen interaction has been well documented [3, 10, 11]. A recent randomized controlled trial showed that American ginseng reduces warfarin's effect in healthy patients [12]. However, Dan Shen Pill claimed to have no side effects. Its insert described the results of a clinical study but was not entirely clear. This preparation was used by the patient for coronary artery disease and not for the allergic rhinitis for which she had been referred.

ClearLungs Chinese Formula for the Lungs and YOUR CHOICE - SPORTS 52 EPHEDRINE - HCL (30 mg) capsules were used by the third patient for allergic rhinitis and asthma. The composition of the first preparation included Chinese licorice root containing glycyrrhizin and glycyrrhetinic acid with mineralocorticoid activity [13]. Hypertensive crisis and hypokalemia from Chinese patent medicine containing licorice has been documented [14].

The adverse cardiovascular and central nervous system side effects from ephedra/ephedrine are well known [15]. The 30 mg dosage of the EPHEDRINE-HCL capsule exceeded that outlined by the US Food and Drug Administration's 1997 proposal [16]. Health Canada issued a voluntary recall of certain products containing ephedra/ephedrine [17]. The following resolution was proposed by the author through the Alternative Therapies and Allied Health Committee: "ephedra/ephedrine-be it resolved that the board of British Columbia Medical Association (BCMA) make representation to the provincial and federal health authorities to make the recent voluntary recall by Health Canada on certain natural health products containing ephedra/ephedrine compulsory." [18] It was passed during the annual meeting of BCMA on June 15, 2002.

At present, avoidance remains the number-one approach in the management of food anaphylaxis, along with epinephrine auto-injectors (EpiPen, Twinject) and antihistamines for emergency use. Careful reading of food labels is very important. The two DS products (the LifePak Dietary Supplement vitamin/phytonutrient capsules and the Natural Factors Acidophilus & Bifidus capsules) used by the fourth patient, who had food anaphylaxis, contain food products. Mustard anaphylaxis, as seen in this patient, is uncommon [19]. Mustard is not among the food products listed as included in these two DS preparations. On the other hand, patients with the more common dairy product allergy, for example, may be in trouble with the second preparation, which contains whey.

The CAM product ClearLungs Chinese Formula For The Lungs capsules used by the third patient contains food products in addition to herbal components.

Besides the reading of food labels, diligent examination of the contents of both CAM and DS products is important for patients with food anaphylaxis or who experience adverse food reactions.

In the United States, natural/herbal health products are classified as dietary supplements under the Dietary Supplement Health and Education Act of 1994 [20]. They are not subject to the stringent regulation of the US Food and Drug Administration. There is relatively better regulation of these products under the Natural Health Products Directorate in Canada.

All seven preparations discussed in this article were purchased in local Chinese herbal shops and health food stores. The Natural Health Products Directorate should provide and enforce higher standards of regulation. The BCMA resolution in 2002 noted above was to raise such standards in one specific area.

In summary, seven CAM and DS products were used by four patients, Asian and Caucasian. The products were purchased locally and were used for allergic and other disorders. They included one preparation of unknown content and two preparations with a known herb-drug interaction causing bleeding complications (also of concern to surgical colleagues). Other preparations contained ephedrine and Chinese herbs with potential cardiovascular and other side effects and food substances with the potential to cause allergic food reactions.

Physicians should inquire about their patients' use of CAM and DS products and should document the contents of such products diligently. Patients are to be advised to read labels and inserts carefully, especially if they have a food or drug allergy or an underlying illness, and to report the use of these products to their doctors. Potential adverse and allergic reactions and herb-drug interactions from CAM and DS products can be identified and avoided. There should be higher regulation of natural health products in British Columbia and in the rest of Canada.

Some of the information contained in this article was presented at the Canadian Society of Allergy and Clinical Immunology 2001 Annual Scientific Meeting, October 26 to 28, 2001, Banff, AB.