FDA to Ban Sale of Ephedra Supplements
The U.S. Food and Drug Administration (FDA) is issuing a final rule on dietary supplements containing ephedrine alkaloids (ephedra) that will ban the sale of the supplements after 60 days. The rule will state that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury. Consumers were advised to stop using ephedra products immediately. After the announcement, however, retail stores that sell the product reported that the demand was so high they could not keep it stocked.
Ephedra, also called ma huang, is a naturally occurring substance derived from botanicals. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. Ephedra products have been promoted extensively to aid weight loss, enhance sports performance, and increase energy.
FDA’s concerns about dietary supplements containing ephedra arise somewhat from ephedra’s mechanism of action in the body. Ephedra is an adrenaline-like stimulant that can have potentially dangerous effects on the heart. The RAND Corp. evaluated many studies of the supplement and found little evidence for effectiveness other than for short-term weight loss, as well as evidence suggesting safety risks. Other recent studies also have confirmed that ephedra use raises blood pressure and otherwise stresses the circulatory system—effects that have been linked conclusively to significant and substantial adverse health effects such as heart problems and strokes.
FDA has sent 62 letters to firms marketing dietary supplements containing ephedra and ephedrine alkaloids alerting them of this future rule.
Massage Therapy Popular Among Hospital CAM Services
Massage therapy (78%) and pastoral counseling (62%) are the most popular complementary and alternative medicine (CAM) services offered at America’s hospitals, according to a survey conducted by the American Hospital Association’s (AHA’s) Health Forum. Programs involving stress management and yoga follow closely behind. Sita Ananth, the project manager for the CAM survey, told AHA News that 61% of the hospitals surveyed that offered CAM said they provided stress management services, while 58% had yoga. About 16.6% of U.S. hospitals offered CAM services in 2002, according to the AHA’s Annual Survey of Hospitals. That’s up from 7.9% in 1998. Just more than 1,000 hospitals responded to the separate CAM survey, conducted last year, and 269 said they had CAM programs.
St. John’s Wort Might Block Certain Medications
St. John’s wort, the popular herbal product used widely to self-treat depression, may significantly reduce the effectiveness of 50% of all marketed medications.
A study, published in the Sept. 17 issue of the Journal of the American Medical Association, looked at the effect of St. John’s wort on cytochrome P450 (CYP) enzymes. Twelve healthy volunteers (six men and six women) were given St. John’s wort for 14 days. Participants were given dextromethorphan and alprazolam before and after administration of St. John’s wort to assess plasma pharmacokinetics. After 14 days use of St. John’s wort, a two-fold decreased area under the curve for alprazolam plasma concentration and a two-fold increase in alprazolam clearance was found as well as an elimination half-life that decreased from 12.4 hours to 6.0 hours, suggesting significantly induced activity of CYP 3A4. (All findings were considered significant.) Dextromethorphan metabolism, a measure of CYP 2D6, was unchanged.
The effect of St. John’s wort on CYP 3A4 is quite significant, however, since at least 50% of all medications currently on the market are metabolized at least partially by this enzyme. This, coupled with two recent multicenter, double-blind, placebo-controlled studies questioning the effectiveness of St. John’s wort for the treatment of depression, should alert consumers to potential problems in using the herbal product.
Hardy ML. FDA to Ban Sale of Ephedra Supplements; Massage Therapy Popular Among Hospital CAM Services; St. Johns Wort Might Block Certain Medications. Altern Ther Women's Health 2004;6(2):16.
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