FDA launches effort to ban ephedra products: linked to serious adverse events

FDA launches effort to ban ephedra products: linked to serious adverse events – News

Deeanna Franklin

The Food and Drug Administration has announced plans to ban the sale of all dietary supplements containing ephedra, marking the first time the agency has moved to ban a dietary supplement. The agency has issued a consumer alert advising the public to immediately stop buying and using products containing ephedra.

FDA Commissioner Dr. Mark B. McClellan and Health and Human Services Secretary Tommy G. Thompson announced the agency’s plan to publish a final rule prohibiting the use and sale of dietary supplements containing ephedrine alkaloids. The FDA rule will state that the use of ephedra poses an unreasonable risk of serious illness or injury. The ban becomes effective 60 days following publication of this rule; however, the FDA could not give an exact date when the rule would be published as it is still under review.

The FDA “worked hard to obtain and review all available evidence about the risks and benefits of ephedra, including its pharmacology, studies of ephedra safety and effectiveness, adverse event reports, and reviews by independent experts,” Dr. McClellan said in a statement.

Ephedra is contained in a variety of products that claim it can aid weight loss, enhance athletic performance, and increase energy. Aside from some evidence showing limited effectiveness for short-term weight loss, the FDA could not substantiate any other benefits.

Adverse events linked to ephedra include increased blood pressure, heart ailments, strokes, dizziness, psychosis, headache, exfoliative dermatitis, and insomnia, as well as uterine contractions.

As many as 155 deaths have been tied to the dietary supplement, including the high-profile death last year of 23-year-old Baltimore Orioles pitcher Steve Bechler. The National Football League banned the use of the herb by its players, and last year legislatures in California, Illinois, and New York had banned its use.

Several large retailers, including GNC and 7-Eleven stores, had also stopped selling ephedra before the announcement from the FDA.

In April 2003, the American Heart Association issued a statement claiming that the herb’s dangers outweighed any potential benefits and urging the FDA to prohibit sales. The AHA supported the agency’s early proposal to limit manufacturing and marketing of the stimulant, and recommended that consumers consult with their physicians before using any ephedra products. The American Academy of Family Physicians and the American Medical Association issued similar statements.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), in order to ban a supplement, the onus is on the FDA to prove that a product presents a significant and unreasonable risk to consumers. The FDA based its ephedra decision on data it received from a commissioned report by the Rand Corporation, an independent, nonprofit scientific institute, and over 16,000 reports of adverse reactions.

The agency also received information from the House Energy and Commerce Committee, which had been holding hearings on the safety of ephedra. The congressional committee’s information suggested that the safety claims made by various manufacturers of ephedra products were false

Ephedra is a naturally occurring botanical (Ephedra sinensis) that goes by several names (see box) and has been used in Chinese medicine for over 4,000 years to treat asthma, nasal congestion, edema, colds, flu, and fever, and as an appetite suppressant. It contains two alkaloids: ephedrine and pseudoephedrine. Ephedrine can produce amphetamine-like actions and acts as a central nervous system stimulant. It can cause bronchodilation, mydriasis, increased heart rate, and constipation. Pseudoephedrine is a stronger diuretic with similar adrenergic activity, but is less potent than ephedrine.

When chemically synthesized, ephedrine is regulated as a drug. According to the FDA, the ban does not pertain to over-the-counter and prescription drugs containing synthesized ephedrine. Nor does the ban apply to traditional Chinese herbal remedies or herbal teas, which are regulated the same as foods.

Many critics of the new rule regarded the ban as too little too late. The Washington-based consumer advocacy group Public Citizen filed a petition with the FDA in September 2001 seeking to ban ephedra. “When we filed our petition, there were reports of 81 ephedra-related deaths. Now, after that number has nearly doubled and very little ephedra is being manufactured, the FDA finally announces a ban. This is an inexcusable dereliction of responsibility,” said Dr. Sidney Wolfe, the group’s health research director, in a statement.

While the FDA has sent letters to numerous manufacturers warning them of the impending ban, many of these manufacturers, including the largest, Twin Laboratories, EAS, and Metabolife, had already discontinued making and selling ephedra products.

Numerous lawsuits with multimillion-dollar awards to plaintiffs had made it difficult for many companies to secure liability insurance.

BY DEEANNA FRANKLIN

Senior Writer

COPYRIGHT 2004 International Medical News Group

COPYRIGHT 2004 Gale Group