FDA Takes Aim at Ephedra

FDA Takes Aim at Ephedra
Posted by FoM on March 19, 2000 at 16:49:54 PT
By Guy Gugliotta, Washington Post Staff Writer 
Source: Washington Post
The Food and Drug Administration has gathered information on 134 cases of serious illness or death linked to the dietary supplement ephedra, renewing its efforts to show that the popular energy-boosting and fat-burning herbal extract can pose serious health risks.
The agency intends to publish the new data March 31, then hold a public meeting to discuss the reports before taking further action. The Washington Post examined a copy of the case documents.FDA officials have not made clear whether they intend to resume their unsuccessful three-year quest to impose dosage restrictions on ephedra products. Previous efforts have foundered on the FDA's inability to satisfy Congress and the supplements industry on the reliability of its case reports.But it is clear from the new data that the agency tried to document the cases thoroughly, with an eye on past objections: that it failed to establish a causal link between ephedra and the illness; that consumers deliberately overdosed themselves; and that consumers ignored warnings about drug interactions and pre-existing medical conditions.In one case, a woman described in a letter how she had begun taking Herbalife ephedra supplements and drinking Herbalife tea on May 27, 1998, then went into cardiac arrest running the bases after hitting a grand slam in a softball game:"I had to be resuscitated four times," said the woman, whose name and address were redacted from the report. "In the emergency room doctors kept asking . . . if I was using an inhaler," because "I was a perfectly healthy 28-year-old female."The report said the woman consumed only the number of pills recommended on the label--which was photocopied and filed with the report. Eventually, doctors surgically implanted a defibrillator to regulate her heartbeat.Herbalife Senior Vice President Richard Marcotullio said he had "absolutely no knowledge" of the case, that Herbalife has "never been contacted by the FDA" and that "we've got a very exemplary safety record."Another report, several hundred pages long, documented a massive brain hemorrhage suffered on a treadmill by a 29-year-old soldier who had just graduated from college and was on his way to officer training.His Army career is over, his mother said, and "he may never walk again." The man drank an ephedra-containing beverage made with Ultimate Orange, a product that advertises "one serving and you'll feel the difference." Next Nutrition, the maker of Ultimate Orange, did not return telephone calls seeking comment.Ephedra, also known as ma huang, is an herb used in Asia as a treatment for asthma. In the United States, synthetic ephedra is an active ingredient in over-the-counter bronchial drugs.Ephedra also is almost identical chemically to methamphetamine. In one of the new FDA case studies, a 44-year-old woman was kicked out of the hospital between grand mal seizures because doctors found amphetamines in her urine and "accused her of being on drugs," the report said.Since the FDA in 1993 established its Special Nutritionals Adverse Event Monitoring System to receive voluntary reports of illness and death from dietary supplements, ephedra products have been the biggest source of complaints--685 between 1993 and October 1998, including 39 deaths.Those complaints sketch out a range of symptoms explored in detail in the 134 new reports: tightness in the chest, jitteriness and insomnia, as well as addiction, hypertension, seizure, stroke and death.In June 1997, the FDA proposed a new federal regulation restricting dosages of ephedra to 8 milligrams per serving and 24 milligrams per day, limiting the treatment regime to one week, and prohibiting blends of ephedra with natural caffeine products such as guarana and cola nut.The supplements industry widely attacked the agency proposal, and Congress discounted the FDA's monitoring reports as sloppy, incomplete and poorly documented.In February 1999, the FDA conceded defeat on the rule, withdrawing the dosage and duration recommendations, but it also announced it would publish more information. The new data include every ephedra complaint received by the agency between June 1, 1997, when the original rule was proposed, and March 31, 1999.R. William Soller of the Consumer Healthcare Products Association, which represents supplement manufacturers and distributors, was reluctant to comment on the reports before seeing them. He noted that the FDA's 1997 proposal was closely screened by the industry, and "there will be even more heightened scrutiny" this time. "Let's look at the documents first." By Guy GugliottaWashington Post Staff WriterSunday, March 19, 2000; Page A22  Copyright 2000 The Washington Post CompanyCannabisNews Articles on Methamphetamine & Ephedrine:
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Comment #3 posted by Nancy Williams on April 08, 2001 at 23:06:42 PT:
Has anyone ever linked Pancreatitis to this? Will appreciate any comments. Step-daughter is suffering terribly for no reason the doctors can find. But has a history of using Ephedra. Very curious. Please comment.Thank you.
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Comment #2 posted by FoM on March 19, 2000 at 22:02:27 PT
Ma Huang
Ah Mormon Tea! Thanks observer. I wonder if Senator Hatch likes it! Do you believe to get an ounce of Ma Huang I had to go out of state a few years ago? It was banned in Ohio but they lifted it. It's cheap too! If I remember right about $3.00 an ounce. Of course they don't want something that is a great herb and cheap to be legal. It is a mild tasting tea with a little uplift an decongestant abilities that are needed for many people when hay fever season starts.
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Comment #1 posted by observer on March 19, 2000 at 21:38:00 PT
Ephedra is Sagebrush and Grows all over the West
> .. Ephedra, also known as ma huang, is an herb used in Asia as a treatment for asthma. ...Aye! It's them wiley foreigners again! It, it ... it "is found over much of the southwestern deserts and intermountain west, ranging northward to the southern-most portions of southeastern Oregon." boy! Talk about tilting at windmills. Try to make a sagebrush (tea) illegal. 
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