Florida Ephedra Side Effect Attorneys

FDA Bans Ephedra

Apr 12, 2004

After years of review and more than 150 deaths, the Food and Drug Administration has finally acted on a serious problem. As of April 12, 2004, the agency banned ephedra from sale in the United States.

The decision, announced in December 2003, came eight years after the FDA began receiving reports that the herb used for weight loss and bodybuilding could pose a danger to consumers. A variety of studies have linked ephedra to cardiovascular problems including high blood pressure, palpitations and heart attacks. Strokes, seizures, psychosis, insomnia and heatstroke have also been linked to the supplement.

Ephedra was brought to the public’s attention in February 2003 with the death of Steve Belcher, a 23-year-old pitcher for the Baltimore Orioles. Belcher suffered a heatstroke and died during practice after taking the stimulant for weight loss.

Ephedra, which is also known by its Chinese name, ma huang, has been used for centuries as a medicinal herb in India and China for the treatment of asthma, bronchitis and coughs.

The two primary chemicals in ephedra, ephedrine and pseudoephedrine, are stimulants that lead to the constriction of blood vessels. In low doses they act as decongestants, but in higher doses, they can bring about an increase in blood pressure.

While people with high blood pressure, heart disease, anxiety, glaucoma, enlarged prostate or hyperthyroidism are particularly at risk, even seemingly healthy people who use the recommended doses have reported serious problems after taking ephedra.

Burden of Proof Required

Why did it take the FDA so long to act? Simply stated, where supplements are concerned, the FDA has a tremendous burden of proof when deciding to take a product off the market. While manufacturers of prescription drugs must prove that a medicine is safe and brings about the advertised effects, supplement manufacturers do not have to prove that their product is safe and effective. Since 1994, the FDA has had to prove that a supplement is harmful. Thus, the agency has little power to regulate herbal products.

As part of its efforts, the FDA commissioned an independent research organization, the RAND Corporation, to study ephedra and report any adverse effects. The organization concluded that ephedra caused a 2- to 3-fold increase in health problems such as depression, anxiety, insomnia, vomiting, heartburn and heartbeat irregularities; prompting the agency to act.

In announcing its intentions, the FDA immediately contacted sixty-two companies that make or sell ephedra, telling them, “we intend to shut you down,” according to a statement released by FDA Commissioner Mark McClellan, who said his agency had meticulously worded the law to ensure that it would withstand any court challenge.

The Miami Ephdera side effect lawyers at our firm is actively investigating and engaged in current lawsuits against the manufacturers of products currently or previously containing ephedra, including:

• Metabolite 356
• Xenedrine RFA-1
• Ripped Fuel
• Stacker 2
• Yellow Jackets
• Metab-0-Lite
• Nets bo lift
• Diet Fuel
• AndroXtreme
• Thermo Thunder
• The rma lean
• Powers ha pe
• Ultimate Orange Speedball

If you or someone you know has suffered as the result of ephedra or any other defective and harmful pharmaceutical product, or to learn more about pending cases, contact us today.

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