Ephedra / Metabolife

On December 30, 2003, the Food and Drug Administration announced a ban of the herbal dietary supplement Ephedra. The FDA cited more than 16,000 reports of complications – ranging from dizziness to strokes – that may have been triggered by the supplement, along with its link to 155 deaths.

These products contain botanical, or so-called "natural," sources of ephedrine. Ephedrine is an amphetamine-like stimulant that can have potentially dangerous effects on the nervous system and heart. Possible adverse effects of ephedrine range from clinically significant effects such as heart attack, stroke, seizures, psychosis and death, to clinically less significant effects that may indicate the potential for more serious effects (for example, dizziness, headache, gastrointestinal distress, irregular heartbeat, and heart palpitations).

Ingredient panels on these products may list ma huang, Chinese ephedra, ma huang extract, ephedra, Ephedra sinica, ephedra extract, ephedra herb powder, epitonin or ephedrine.

FDA: December 30, 2003

FDA Plans Regulation Prohibiting Sale of Ephedra-Containing Dietary Supplements and Advises Consumers to Stop Using These Products

The Food and Drug Administration (FDA) is alerting the public to its forthcoming determination that dietary supplements containing ephedra present an unreasonable risk of illness or injury, and should not be consumed. The agency has notified firms manufacturing and marketing these products that it intends to issue a final rule prohibiting their sale, which will become effective 60 days after its publication.

The FDA has taken this step after conducting an exhaustive and highly resource-intensive process required under the Dietary Supplement Health and Education Act (DSHEA) of 1994 for banning a dietary supplement that presents a significant and unreasonable risk to human health.

To meet this challenging standard, the FDA gathered and thoroughly reviewed a prodigious amount of evidence about ephedra's pharmacology; clinical studies of ephedra's safety and effectiveness; newly available adverse events reports; the published literature; and a seminal report by the RAND Corporation, an independent scientific institute. The FDA also reviewed tens of thousands of public comments on the agency's request in February, 2003 for information about ephedra-associated health risks.

The totality of the available data showed little evidence of ephedra's effectiveness except for short-term weight loss, while confirming that the substance raises blood pressure and otherwise stresses the circulatory system. These reactions have been conclusively linked to significant adverse health outcomes, including heart ailments and strokes.

By informing more than 60 dietary supplement firms about the upcoming final rule, FDA is sending a strong and unambiguous signal that dietary supplements containing ephedrine alkaloids present an unreasonable risk. Consumers are urged to stop buying and using these products immediately.

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 under the Federal Food, Drug and Cosmetic Act of 1938 as a drug. In contrast to the DSHEA-regulated dietary supplements that contain natural ephedra, the safety and effectiveness of the synthesized ephedrine has to be proven by the manufacturer, not the FDA. In recent years ephedra products have been extensively promoted for aiding weight control and boosting sports performance and energy.

Today's announcement is a continuation of a process that started in June, 1997 when FDA first proposed to require a statement on dietary supplements with ephedra warning that they are hazardous and should not be used for more than 7 days. FDA modified this proposed rule in 2000, and in February 2003 it announced a series of measures that included strong enforcement actions against firms making unsubstantiated claims for their ephedra-containing products.

These measures have prompted voluntary compliance with FDA rules, voluntary product recalls, FDA warning letters, seizures and injunctions, criminal actions, and joint enforcement actions with the Federal Trade Commission and the Department of Justice.

Metabolife News:

TEXAS - Woman awarded $7.4 million in suit against Metabolife.
Diet supplement caused stroke.

06/24/04 - A jury awarded a Texas woman $7.4 million after deciding that the popular Metabolife diet supplement caused a stroke that left her with permanent brain damage.

The three women and nine men on the jury deliberated six hours before unanimously deciding that Metabolife International Inc. acted maliciously by including the now-banned drug Ephedra in the supplement.

The jury awarded Rhea McAllister, 35, $2.4 million for damage caused by the drug and $5 million in punitive damages. She is numb on her right side, making the use of her right hand difficult and causing her to drag her right foot, according to her attorneys. She also has short-term memory loss and unpredictable dizziness that makes her reluctant to drive, her attorneys say.

The lawsuit is one of the first to be tried since the U.S. Food and Drug Administration banned Ephedra in April 2004 and is one of a mounting number of cases pending nationwide. An estimated 12 million people used Metabolife in 1999, and the company's revenues at one time exceeded $1 billion.

During the seven-day trial, McAllister's lawyers said Metabolife tried to conceal thousands of complaints about the adverse reactions to its product. Metabolife sent letters to state and federal regulatory agencies stating that the product had no adverse effects and that the company had comprehensive safety monitoring procedures, according to testimony.

The company later admitted it had received reports of 15,000 adverse events and that it lacked safety monitoring procedures.

Metabolife attorney Darrell Barger said several top company officials could not testify because they had been under investigation for two years and were asserting their Fifth Amendment right against self-incrimination.

The FDA announced in 2002 that it had asked the U.S. Justice Department to investigate allegations that Metabolife had made false statements about the existence of adverse event reports.

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Irwin & Boesen represents persons who have been injured by dangerous drugs. Please contact us for an honest and fair evaluation of your case.