Warning issued about ephedra, an herbal product

Copyright © 1996 Nando.net
Copyright © 1996 The Boston Globe

BOSTON (Aug 2, 1996 9:11 p.m. EDT) -- A 23-year-old Boston College student died in April after taking a Chinese herbal stimulant, state officials revealed Friday as they issued a warning about the dangers of herbal products containing the substance ephedra, or ma huang.

The death of George Korizis, a Greek national who lived in Boston, was the 16th US fatality from ephedra-containing products in the past 2 1/2 years, said a spokesman for the US Food and Drug Administration.

Officials of the state Department of Public Health said the death is the first in Massachusetts attributed to the drug. Nancy Ridley, assistant commissioner of the DPH, said Korizis was found dead in his apartment after he had drunk a "thermogenic protein drink containing ma huang."

"He was a very health-conscious student, involved in weight-lifting and body-building," and had no history of heart trouble, said Ridley in an interview. An autopsy revealed patches of dead tissue in his heart muscle, or myocardial necrosis, which was listed as the cause of death.

Ma huang, or ephedra, is a plant form of the drug ephedrine, a stimulant that can cause dizziness, rapid heartbeat, heart attack and psychosis, said a statement from the Massachusetts Department of Public Health. Medically, ephedrine is used in drugs that dilate the bronchial passages to ease breathing.

Ephedra is found in a variety of herbal food supplements that claim to be energy boosters or muscle builders or to generate a "natural high."

The FDA spokesman, who said that over 600 adverse events from ephedra have been reported nationally, said the products are sold on the street, at rock concerts, on college campuses and in health food stores. Florida has banned herbal products containing ephedra following a student's death there, and the FDA plans to hold a hearing on "how to best regulate these products to reduce risk to consumers," said the spokesman.

Because the herbal products are considered food supplements, not drugs, the burden is on the FDA to prove that they are dangerous, the spokesman said.

The state health department said in its statement Friday that consumers should not use any of the products known as "herbal ecstasy," promoted as giving a natural high, nor should they take herbal dietary supplements containing ephedra for enhancing athletic performance without consulting a doctor.

Ridley asked that people who have experienced adverse effects after taking ephedra-containing products contact the DPH's Division of Food and Drugs at .

WASHINGTON (Reuter) - U.S. health officials warned against using diet supplements containing ephedrine sold as alternatives to street drugs such as ``Ecstasy'', saying they posed serious health risks.

The Food and Drug Administration said the products, often targeted at adolescents and young adults, are marketed under brand names with implications that they produce euphoria, heightened sexual sensation and awareness or increased energy.

 It said they contain botanical or ``natural'' sources of ephedrine, an amphetamine-like stimulant that can have dangerous effects on the nervous system and heart.

 The FDA said the possible adverse effects ranged from heart attack, stroke, seizures, psychosis and death to less serious ones such as dizziness and irregular heartbeat.

It said the risks were serious and it was investigating the production and marketing of ephedrine-containing products sold as alternatives to illegal street drugs.

The FDA said that many of the products bear labels implying they can produce a ``high'' and it said it considered this type of promotion and these claims to violate the food and drug law, even as amended in 1994.

 It said it was committed to take any action needed to remove such products from the market.

 But the agency added that under the amended law it has to act product-by-product to show that something is unsafe rather than be able to require a manufacturer to prove its product is safe before it can be marketed.

 The agency said that ingredients listed on the panels of the products may include ma huang, Chinese ephedra extract, ephedra herb powder, epitonin or ephedrine, any of which indicate the present of ephedrine.

The FDA asked that consumers who have had an adverse reaction after taking a dietary supplement or any product containing an ephedrine alkaloid to call the agency at 1-800-FDA 4010. It said health professionals who have treated patients with adverse side effects should call the FDA's Medwatch hot line at 1-800-FDA-1088.