Bitter Orange Has Been Associated With Adverse Events. On July 27, 2004, the FDA announced that it is going to start looking into the safety of alternatives to Ephedra. One product that has filled the market niche of Ephedra is Bitter Orange (generic name: Citrus Aurantium). It contains Synerphrine, which brings about stimulation similar to Ephedra and many believe that it is as dangerous as Ephedra.
Supplement manufacturers are already gearing up to replace Ephedra with supplements like bitter orange. An FDA spokesman said Bitter Orange has been associated with seven deaths and 25 adverse reactions.
Bitter Orange Is Now Used In Diet Pills
Bitter orange is now used in a new generation of herbal diet pills that are being marketed as safe alternatives to the banned Ephedra. Popular products include Xenadrine EFX and Metabolife’s Metabolife Ultra.
Metabolife declined to answer questions about Metabolife products that contain bitter orange or whether the company has conducted any product safety tests.
Bill Gurley, a professor of pharmaceutical sciences at the University of Arkansas, said it is too early to declare ‘bitter orange’ safe. The substance is chemically similar to Ephedra and could pose similar health risks, he said. “Based on the pharmacology of some of these compounds and the few case reports starting to come out, it doesn’t look good,” Gurley said.
A government ban on Ephedra went into effect after years of reports and studies on its potential dangers. About 16,000 adverse events and numerous deaths had been linked to the substance, and the agency was criticized widely for not taking action sooner.
Several lawmakers have already asked the FDA to investigate the safety of Ephedra substitutes and to remove dangerous products. And Sen. Richard Durbin (D-Ill.), who has expressed concern over bitter orange, is working with Sen. Orrin G. Hatch (R-Utah), a longtime supporter of the dietary supplement industry, to introduce a bill mandating that manufacturers promptly report serious adverse events related to dietary supplements.
Researchers say the supplement may cause cancer, severe liver or kidney damage, heart problems, or even death. Supplements do not have to undergo the strict trials and regulations that ethical/prescription drugs do.
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