What is it?

Ephedra is banned by the United States Food and Drug Administration (FDA). It is an herbal medicine that has been used for asthma, the common cold, hay fever, and weight loss. You should not take ephedra as it is not safe. You can have very serious heart problems or even die if you use ephedra.

Other names for ephedra include: Ma huang, Chinese jointfir, and Indian jointfir.

Ask your doctor, nurse, or pharmacist if you need more information about this medicine or if any information in this leaflet concerns you.

Before Using:

Tell your doctor if you

• are taking medicine or are allergic to any medicine (prescription or over-the-counter (OTC) or dietary supplement).
• are pregnant or plan to become pregnant while using this medicine.
• are breastfeeding.
• have any other health problems, such as high blood pressure or heart or blood vessel disease.

Drug and Food Interactions:

Do not take ephedra without talking to your doctor first if you are taking:

• Alcohol, or any medicine that contains alcohol (such as cough medicine) (13)
• Caffeine, cola nut (kola nut) (13,14,27,30,32,36)
• Corticosteroids (examples: dexamethasone (Decadron(R)), prednisone (Deltasone(R))) (15)
• Creatine, guarana (14,27,34,35)
• Medicines used for depression or Parkinson's disease (monoamine oxidase inhibitors (MAOIs), examples: phenelzine (Nardil(R)), selegiline (Eldepryl(R))) (1,18,28,29)
• Medicine to decrease swelling or to lower blood pressure (30-33)
• Nonsteroidal anti-inflammatory medication (examples: ibuprofen (Advil(R), Motrin(R)), naproxen (Aleve(R)), Naprosyn(R), Anaprox(R)), celecoxib (Celebrex(R)), diclofenac (Arthrotec(R), Voltaren(R)), etodolac (Lodine(R)), flurbiprofen (Ansaid(R)), indomethacin (Indocin(R)), ketoprofen (Orudis(R)), ketorolac (Toradol(R)), oxaprozin (Daypro(R)), piroxicam (Feldene(R)), rofecoxib (Vioxx(R)), sulindac (Clinoril(R)), tolmetin (Tolectin(R))) (25)
• Reserpine (Resa(R), Serpalan(R), Serpasil(R)) (30-33)
• Clonidine (Catapres(R), Duraclon(R)) (10,31,32)
• Minoxidil (Loniten(R), Minodyl(R), Rogaine(R)) (30-33)
• Stimulants, decongestants, or diet aid medicines (including herbs, pseudoephedrine, phenylephrine (Sudafed(R), Drixoral(R)), theophylline, midodrine (Orvaten(R)) (6,35)

Warnings:

• Ephedra is known to cause seizures, a heart attack, stroke, and death. This is most common when taking more than 8 milligrams at a time or a total of 24 milligrams in a day. Do not take very much ephedra or take it for long periods. You could become addicted to it or possibly die (1).
• Ephedra should not be used by children under 18 years old (3).
• Do not take ephedra if you are pregnant or breast feeding, or if you have a seizure disorder or emotional problems, such as depression, anxiety, or an eating disorder (3,35).
• Do not take ephedra if you have high blood pressure, heart problems, trouble sleeping, thyroid problems, diabetes, glaucoma, or stomach ulcers (3,35).
• Do not take ephedra if you have an enlarged prostate gland (benigh prostatic hypertrophy or BPH) (3,35).
• Do not take ephedra before or during hard exercise (35).

Side Effects:

Call your doctor right away if you have any of these side effects:

• Allergic reaction: itching or hives, swelling in your face or hand, swelling or tingling in your mouth or throat, chest tightness, trouble breathing, or rash.
• Chest pain, shortness of breath, rapid and/or irregular heartbeat, increase in blood pressure
• Dizziness, fainting, bad headache
• Emotional or behavioral changes (depression, hallucinations (seeing or hearing things), bad mood swings, or hysteria (wild behavior), irritability)
• Heart attack, stroke, seizures
• Nausea

Other Side Effects:

You may have the following side effects, but this medicine may also cause other side effects. Tell your doctor if you have side effects that you think are caused by this medicine.

• Hard time passing urine, especially if you are a male with prostate gland problems
• Insomnia (sleeping problems)
• Weight loss

References:

1. Blumenthal M, Busse WR, Goldberg A et al: The Complete Commission E Monographs: Therapeutic Guide to Herbal Medicines. American Botanical Council, Austin, TX; 1998.

2. McGuffin M, Hobbs C, Upton R et al (eds): American Herbal Products Association's Botanical Safety Handbook. CRC Press, Boca Raton, FL; 1997.

3. Brinker F: Herb Contraindications and Drug Interactions. Eclectic Medical Publications, Sandy, OR; 1998.

4. Ault A: FDA proposes limits on ephedrine stimulants. Lancet 1997; 349: 1753.

5. Werbach MR & Murray MT: Botanical influences on illness: a sourcebook of clinical research. Third Line Press, Tarzana, CA; 1994.

6. Gurley BJ, Gardener SF, White LM et al: Ephedrine pharmacokinetics after the ingestion of nutritional supplements containing Ephedra sinica (Ma Huang). Ther Drug Monit 1998; 20: 439-445.

7. Schuckit MA: Ma-huang (Ephedrine) abuse and dependence. Drug Abuse Alcohol Newsletter 1996; 25:1-4.

8. Wilkinson GR & Beckett AH: Absorption, metabolism, and excretion of the ephedrines in man, I. The influence of urinary pH and urine volume output. J Pharmacol Exp Ther 1968; 162: 139-147.

9. Anon: Therapeutic conferences. Drug Interactions. Br Med J 1971; 1: 389.

10. Nishikawa T, Kimura T, Taguchi N et al: Oral clonidine preanesthetic medication augments the pressor responses to intravenous ephedrine in awake or anesthetized patients. Anesthesiology 1991; 74: 705-710.

11. Product Information: Ephedrine sulfate injection USP. Abbott Hospital Products, North Chicago, IL; 1997.

12. Hansten PD & Horn JR: Drug Interactions. Lea & Febigu, Philadelphia, PA; 1990.

13. Tormey WP & Bruzzi A: Acute psychosis due to the interaction of legal compounds - ephedra alkaloids in 'Vigueur Fit' tablets, caffeine in 'Red Bull' and alcohol. Med Sci Law 2001; 41(4):331-336.

14. Vahedi K, Domigo V, Amerenco P et al: Ischaemic stroke in a sportsman who consumed ma huang extract and creatine monohydrate for body building. J Neurol Neurosurg Psychiatry 2000; 68(1):112-113.

15. Brooks SM, Sholiton LJ, Werk EE et al: The effects of ephedrine and theophylline on dexamethasone metabolism in bronchial asthma. J Clin Pharmacol 1977; 17(5-6):308-318.

16. Anon: Facts and Comparisons. Facts and Comparisons, Inc, St. Louis, MO, USA, 1999.

17. Pettinger WA, Soyangco FG & Oates JA: Inhibition of monoamine oxidase in man by furazolidone. Clin Pharmacol Ther 1968; 9:442-447.

18. Dawson JK, Earnshaw SM & Graham CS: Dangerous monoamine oxidase interactions are still occurring in the 1990s. J Accid Emerg Med 1995; 12(1):49-51.

19. Anon: Bundesverband der Pharmazeutischen Industrie e.V. Rote Liste. Editio Cantor, Aulendorf, Germany, 1994.

20. DeVita VT, Hahn MA & Oliverio VT: Monoamine oxidase inhibition by a new carcinostatic agent, n-isopropyl-alpha(2-methylhydrazine)-p-toluamide (MIH). Proc Soc Exp Biol Med 1965; 120:561-565.

21. Weinberger M, Bronsky E, Bensch GW et al: Interaction of ephedrine and theophylline. Clin Pharmacol Ther 1975; 17:585-592.

22. Product Information: Tasmar(R), tolcapone. Roche Laboratories Inc, Nutley, NJ, USA, 1998.

23. Misage JR & McDonald RH Jr: Antagonism of hypotensive action of bethanidine by "common cold" remedy. Br Med J 1970; 4:347.

24. Jablonski J: Guanethidine (Ismelin) as an adjuvant in pharmacological mydriasis. Ophthalmologica 1974; 168:27.

25. Cho S, Hong T, Jin GB et al: The combination therapy of ephedra herb and loxoprofen caused gastric lesions in mice. Am J Chin Med. 2002;30(4):571-7.

26. FDA: Final rule declaring dietary supplements containing ephedrine alkaloids adulterated because they present an unreasonable risk. Federal Register February 11, 2004, Docket NO. 1995N-0304. Available at http://www.fda.gov/OHRMS/DOCKETS/98fr/1995n-0304-nfr0001.pdf (cited 02/13/2004).

27. Haller CA & Benowitz NL: Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids. N Engl J Med 2000; 343(25); 1833-1838.

28. Dawson JK, Earnshaw SM & Graham CS: Dangerous monoamine oxidase interactions are still occurring in the 1990s. J Accid Emerg Med 1995; 12(1):49-51.

29. Terry R, Kaye AH & McDonald M: Sinutab (letter). Med J Aust 1975; 1(24):763.

30. Zahn KA, Li RL & Purssel RA: Cardiovascular toxicity after ingestion of "herbal ecstacy." J Emerg Med 1999; 17:289-291.

31. White LM, Gardner SF, Gurley BJ et al: Pharmacokinetics and cardiovascular effects of ma-huang (Ephedra sinica) in normotensive adults. J Clin Pharmacol 1997; 37:116-122.

32. Blumenthal M & King P: Ma huang: ancient herb, modern medicine, regulatory dilemma. Herbalgram 1995; 34:22-26, 43, 56-57.

33. Chua SS & Benrimoj SI: Non-prescription sympathomimetic agents and hypertension. Med Toxicol Adverse Drug Exp 1988; 3:387-417.

34. Haller CA, Jacob P 3rd & Benowitz NL: Pharmacology of ephedra alkaloids and caffeine after single-dose dietary supplement use. Clin Pharmacol Ther 2002; 71:421-432.

35. FDA: Proposed labeling changes. Federal Register February 28, 2003. Docket No 95N-0304. Available at http://www.fda.gov/ohrms/dockets/ (cited 01/05/2003).

36. Boozer CN, Daly PA, Homel P et al: Herbal ephedra/caffeine for weight loss: a 6-month randomized safety and efficacy trial. Int J Obesity 2002; 26:593-604.