October 12, 2001 – On September 6, the Public Citizen Health Research Group, an American lobby group, filed a petition with the Food and Drug Administration (FDA) to have ephedra supplements taken off the market because of numerous reports of unwanted side effects related to this plant. Complaints and petitions are increasing for the authorities to act before other people are affected.
Ephedra (my huang in Chinese medicine) is usually used as a decongestant to treat respiratory ailments (flu, colds, bronchitis, asthma, etc.), but also to lose weight and, in the case of athletes and bodybuilders, to increase their performance. Ephedra contains substances similar to adrenaline, ephedrine and pseudoephedrine, which stimulate the nervous system and the heart.
Based on data from the FDA and the American Association of Poison Control Centers (AAPCC), the Public Citizen Health Research Group says consuming ephedra is dangerous. From 1993 to 2000 in the United States, 800 reports of suspected adverse reactions to ephedra indicate, among other things, 81 deaths and 69 strokes and 62 cases of cardiac arrhythmia. In Canada, as of October 2000, there were 60 such reports, including two suicides.
However, the Ephedra Education Council (EEC) vigorously refutes this information.1. According to this organization linked to the American dietary supplement industry, there is currently no scientific evidence that ephedra is toxic when the recommended dosage is taken, a maximum of 100 mg per day. And, adds the EEC, not only are some of the reported adverse reactions not even related to ephedra, but 85% of the 800 reports in question are poorly documented. Note, however, that a study analyzing 140 cases of unwanted side effects concluded that ephedra could be dangerous for some people.2. The organization defends itself by pointing out that a product like aspirin generates more than 13,000 reports of undesirable side effects each year. However, another American lobby group, the Center for Science in the Public Interest (CSPI), claimed in 1999 that since the system for reporting adverse side effects of dietary supplements is voluntary in the United States, it was likely that the number actual cases is greater than the number of cases actually reported. The EEC replied that many studies show that taking ephedra is safe and that, although the consumption of supplements containing ephedra has tripled in recent years, the number of reported side effects remained weak.
This is not the first time that ephedra has attracted attention. In 1997, for example, the FDA, worried about the many cases of reported adverse effects, had proposed to regulate the manufacture and marketing of products containing ephedra. The ministry recommended in particular that the supplements display warnings, that the suggested daily dosage be limited to 24 mg and that the duration of use not exceed 7 days. In addition, the FDA proposed to ban claims related to weight loss and increased muscle mass. Faced with an industry outcry and an independent review of the data, the FDA had to withdraw its proposal in 1999, much to the satisfaction of supplement manufacturers.
In the United States, a recent survey of more than 14,000 Americans found that 1% of them used ephedra for the purpose of losing weight.3. In Canada, claims regarding the slimming and stimulating effects of ephedra are prohibited4.5 and Health Canada strongly advises consumers against using these supplements for these purposes.6. Only products displaying a DIN (drug identification number) are permitted and the only indication permitted is the relief of nasal congestion.
In addition, a toxicological study published in 2000 revealed that certain conditions in the preparation of ephedra promote the production of toxins7. The dosage, the combination of ephedra with other substances (especially caffeine) and the duration of treatment are also risk factors. The EEC has developed strict manufacturing and distribution standards and is urging the FDA to adopt them rather than taking ephedra supplements off the market. However, according to Dr Woosley, a cardiologist who supports the Public Citizen Health Research Group’s request, labels clearly displaying the maximum dosage and warnings are not enough. According to him, ephedra must be withdrawn from the market, because patients having taken into account the indications and contraindications of the product have nevertheless been victims of strokes and heart attacks.
Monique Lalancette – PasseportSanté.net
According to Richters HerbLetter, September 30, 2001, nos. 3, 4 and Reuters Health, September 6, 2001
1. Ephedra Education Council, Questions and answers.
2. Haller CA, Benowitz NL. Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids. N Engl J Med 2000 Dec 21; 343 (25): 1833-8.
3. Health Canada, Labeling Standard, Ephedrine / Pseudoephedrine, October 10, 2001.
4. Health Canada, Labeling Standard, Ephedra, October 10, 2001.
5. Health Canada, Warning regarding products containing ephedra or ephedrine, June 14, 2001.
6. Blanck HM, Khan LK, Serdula MK. Use of nonprescription weight loss products: results from a multistate survey. JAMA 2001 Aug 22-29; 286 (8): 930-5.
7. Lee MK, Cheng BW, Che CT, Hsieh DP.Cytotoxicity assessment of Ma-huang (Ephedra) under different conditions of preparation. Toxicol Sci 2000 Aug; 56 (2): 424-30.
