NEWS - Stroke in a 38 year-old with the use of ephedra-free dietary supplement for weight loss containing bitter orange

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DO NOT USE!

STROKE IN A 38 YEAR-OLD WITH THE USE OF A WIDELY-USED EPHEDRA-FREE DIETARY

SUPPLEMENT FOR WEIGHT LOSS CONTAINING BITTER ORANGE (SYNEPHRINE)

The passage of the Dietary Supplement Health and Education Act (DSHEA) in

1994 opened the door for the deregulation of alternative medicines, such as

dietary supplements. Under DSHEA, the number of possible alternatives that

can be marketed without testing for safety or effectiveness and promoted for

unsubstantiated uses is endless and the alternatives for dangerous

supplements may be as, or more harmful, than the products they replace.

This adverse effect of deregulation is underscored by a carefully documented

case report appearing in the April 2005 Mayo Clinic Proceedings, a medical

journal published by the Mayo Clinic. The case involved an otherwise

healthy 38 year old man who suffered a stroke after using a heavily -

promoted weight loss dietary supplement, Stacker 2 Ephedra-Free, for one

week. Stacker 2 Ephedra-Free contains the stimulant bitter orange or

synephrine, the predominant alternative being used to replace the dangerous,

now banned, dietary supplement ephedra. This product, as well as most of the

other ephedra-free products, also contains large doses of caffeine,

contributing to the adverse effects of these products such as increased

blood pressure and pulse rate.

A recent search on the internet for " ephedra-free " yielded more than 1.2

million sites, mainly selling products such as Stacker 2.

The authors of the Mayo Clinic Proceedings report identified two other cases

of people being harmed by synephrine that had been reported in the medical

literature. The first report described an association between a heart

attack and the use of a synephrine containing dietary supplement. The

second report was of an otherwise healthy young woman who experienced

electrical conduction problems with her heart after taking the synephrine

containing supplement Xenadrine EFX.

We found a single review of the safety and efficacy of Citrus aurantium

(synephrine) published in the November 15, 2004 is of the American Journal

of Cardiology. This review found only one randomized placebo controlled

trial of sufficient quality to be analyzed. This trial followed 20 patients

for six weeks and demonstrated no statistically significant benefit for

weight loss and limited information about the supplements safety.

Synephrine is derived from the plant Citrus aurantium and goes by a number

of common names including Seville orange, green orange, sour orange, or zhi

shi. Synephrine is not to be confused with the old nasal decongestant

Neo-Synephrine.

Synephrine belongs to a general class of compounds known as sympathomimetic

amines. As a class sympathomimetic amines are central nervous stimulants

that raise heart rate and blood pressure. More familiar members of this

class include methamphetamine, or speed; dextroamphetamine (ADDERALL,

DEXEDRINE); phenylpropanolamine also known as PPA; the dietary supplement

ephedra; and now synephrine.

Public Citizen has a long history of opposition to many members of this

unsafe class of drugs. We petitioned the FDA in October 2000 to ban

phenylpropanolamine in all over-the-counter (OTC) products because of the

link between the use of the drug and stroke (see Worst Pills, Best Pills

News December 2000). PPA was commonly found in OTC weight loss products and

was also used as a nasal decongestant. Subsequently, the FDA took steps to

have PPA banned on November 6, 2000.

With the removal of PPA from the market, the dietary supplement industry

rapidly geared up to replace PPA with ephedra in weight loss products,

claiming it was the " natural " and safe way to loss weight. Over the years

we have written a number of articles on the dangers of ephedra containing

products. In September 2001, Public Citizen filed a formal petition with

the FDA to ban the use of ephedra, arguing that the large number of deaths,

heart attacks, strokes, heart arrhythmia cases, and episodes of hypertension

reported to the FDA exceeded the sum for all other dietary supplements

combined.

The FDA ultimately took steps to remove ephedra from the market (see Worst

Pills, Best Pills News February 2004). However, by this time many producers

of ephedra had stopped selling their products because of media coverage

about the dangers of the supplement and the fact that producers could no

longer get liability insurance.

But even before the belated FDA ban, the dietary supplement industry was

already thinking about an alternative for ephedra: synephrine or bitter

orange.

The FDA action led several ephedra product producers to file suit against

the agency. A federal court in Utah ruled on April 13, 2005 that the FDA's

ban on ephedra was improper. The court prohibited the FDA from taking any

enforcement action against the plaintiffs in the case that would prevent

them from marketing supplements containing 10 milligrams or less of ephedra

per daily dose.

A drug law expert from the University of land College of Pharmacy was

quoted as saying " In effect, I do think that [the ruling] does open the door

for other manufacturers " of dietary supplements containing 10 mg of

ephedrine alkaloids or less " marketing these products without FDA taking

action against them. " As this goes to press, the FDA is seriously

considering appealing the Utah court's ruling.

DSHEA has left the American public at an unacceptable level of risk. This

law has allowed the dangerous dietary supplement synephrine to be marketed

as an alternative to ephedra. Both synephrine and ephedra are chemically

similar to the " speed " like drugs including the banned PPA. The legal

marketing of dangerous dietary supplements will remain until DSHEA is

repealed.

What You Can Do

You should not use dietary supplements containing synephrine, also known as

bitter orange or Seville orange.

You can report serious adverse reactions to the FDA MedWatch program by

phone (1-800-FDA-1088), by fax (1-800-FDA-0178), or online

(www.fda.gov/medwatch ).

Public Citizen fights for the rights of the individual citizen in the halls

of power and leads the battle to strengthen public health, safety, and

environmental protection. To retain our independence, Public Citizen does

not accept government or corporate funds. For more information about Public

Citizen, visit www.citizen.org.

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org