Ephedrine Safety Information

Ephedrine Safety Information

The following articles & information come from the Food and Drug Administration (FDA) or Journal of American Medicine (JAMA):

“Ephedrine” is a chemical contained in the ephedra herb. Ephedrine has medical uses, mostly in operating rooms and intensive care units. Its chemical properties raise blood pressure and heart rate and open up the large air passages in the lungs. Ephedrine is safe when used under the supervision of a doctor and with proper monitoring of the patient. Ephedrine has also been used as a weight loss product and by athletes who believe it makes them stronger or have more energy and endurance.” (JAMA)
(JAMA)

FDA Enforcement Actions

FDA Enforcement Actions

At the core of FDA’s enforcement efforts is our commitment to enhance the legitimate manufacture, sale, and use of dietary supplements while enforcing the law aggressively against fraudulent product claims and other illegal practices. Achieving these goals relies on a number of strategies, including cooperation and coordination with other Federal, state, and international law enforcement agencies in protecting consumers against unapproved and potentially harmful products offered by Internet outlets.”

“With a mutual goal of consumer protection, FDA and FTC formed a Dietary Supplement Enforcement Group to closely coordinate their enforcement efforts against health care fraud. Requiring medical supervision in the dispensing and use of specific dietary supplements [such as ephedrine], we can ensure improved public safety. (FDA)

Special Fit America Notation

Over-the-counter versions of ephedra/ephedrine weight loss products have been removed from the marketplace and decongestant products containing ephedrine (such as Sudafed, etc.) have been governmentally controlled by requiring their dispensing through pharmacies requiring photo identification and personal signature because the ephedrine contained in these products have been used in the production of illicit street drugs such as methamphetamine (meth-labs). The continued availability of ephedrine products provided illicit street drug manufactures an inexpensive source of ingredients used for purposes detrimental to the public. Therefore, ephedrine is now only available by prescription.

FDA – Why Ephedra & Ephedrine was removed from the over-the-counter supplement market: Ephedrine Alkaloid-Containing Dietary Supplements
Statement of: Mark B. McClellan, M.D., Ph. D, Commissioner Food and Drug Administration

Before the Subcommittees on Commerce, Trade, and Consumer Protection and Oversight and Investigations House Committee on Energy and Commerce

Background on Regulation of Dietary Supplements
July 24, 2003

More than half of the population of the United States uses “dietary supplements.” The Dietary Supplement Health and Education Act of 1994 (DSHEA) (P.L. 103-417) set up a unique regulatory framework in an attempt to strike the right balance between providing consumers access to dietary supplements that they may choose to use to help maintain and improve their health, and giving FDA the necessary regulatory authority to take action against supplements or supplement ingredients that present safety problems, have false or misleading claims, or are otherwise adulterated or misbranded. Although dietary supplements are generally regulated as foods, there are special statutory provisions and implementing regulations for dietary supplements that differ in some respects from those covering “conventional” foods. Moreover, the regulatory requirements for dietary supplements also differ from those that apply to drug products (prescription and over-the-counter).

Ephedrine and pseudoephedrine are used in some over-the-counter and prescription drugs, where they have been demonstrated to be safe and effective for the labeled use. While ephedra has been used in herbal medicine preparations for thousands of years, in recent years ephedra has been sold primarily in dietary supplement products for weight control, as well as in products promoted to boost energy levels or to enhance athletic performance. Some ephedra-containing products have been marketed as alternatives to illicit street drugs.** Ephedra-containing products often contain other stimulants, such as caffeine, that may have synergistic effects and increase the potential for adverse effects.

Fit America Note:

Fit America RX Caps do NOT contain caffeine and have been specifically formulated
to be effective without it.

** Special Fit America Notation

It is also important to note that over-the-counter versions of ephedra/ephedrine weight loss products have been removed from the marketplace in 2003 and decongestant products containing ephedrine (such as Sudafed, etc.) have been governmentally controlled by requiring their dispensing through pharmacies requiring photo identification and personal signature because the ephedrine contained in these products have been used in the production of illicit street drugs such as methamphetamine (meth-labs). The continued availability of ephedrine products without medical supervision or control provided illicit drug manufactures an inexpensive source of ingredients used for purposes detrimental to the public. Therefore, ephedrine is now only available by prescription.

JAMA – Efficacy and Safety of Ephedra and Ephedrine for Weight Loss and Athletic
Performance

A Meta-Analysis

Paul G. Shekelle, MD, PhD; Mary L. Hardy, MD; Sally C. Morton, PhD; Margaret Maglione, MPP; Walter A. Mojica, MD, MPH; Marika J. Suttorp, MS; Shannon L. Rhodes, MFA; Lara Jungvig, BA; James Gagné, MD JAMA. 2003;289:1537-1545.

Objective

To assess the efficacy and safety of ephedra and ephedrine used for weight loss and enhanced athletic performance.

Data Sources

We searched 9 databases using the terms ephedra,ephedrine,
adverse effect, side effect, efficacy, effective,and
toxic. We included unpublished trials and non–English-languagedocuments.
Adverse events reported to the US Food and Drug AdministrationMedWatch program were assessed.

Study Selection

Eligible studies were controlled trials of ephedra or ephedrine used for weight loss or athletic performance and case reports of adverse events associated with such use.Eligible studies for weight loss were human studies with at least 8 weeks of follow-up; and for athletic performance, those having no minimum follow-up.

Data Extraction

Two reviewers independently identified trials of efficacy and safety of ephedra and ephedrine on weight loss or athletic performance; disagreements were resolved by consensus. Case reports were reviewed with explicit and implicit methods.

Data Synthesis

No weight loss trials assessed duration of treatment greater than 6 months. Pooled results for trials comparing placebo with ephedrine (n = 5), ephedrine and caffeine(n = 12), ephedra (n = 1), and ephedra and herbs containing caffeine (n = 4) yielded estimates of weight loss (more than placebo) of 0.6 (95% confidence interval, 0.2-1.0), 1.0 (0.7-1.3),0.8 (0.4-1.2), and 1.0 (0.6-1.3) kg/mo, respectively. Sensitivity analyses did not substantially alter the latter 3 results.. Safety data from 50 trials yielded estimates of 2.2- to 3.6-fold increasesin odds of psychiatric, autonomic, or gastrointestinal symptoms,and heart palpitations. Data is insufficient to draw conclusions about adverse events occurring at a rate less than 1.0 per thousand.

Conclusions

Ephedrine and ephedra promote short-term weight loss ( 0.9 kg/mo more than placebo)in clinical trials.There are no data regarding long-term weight loss, and evidence to support use of ephedra for athletic performance is insufficient.

Author Affiliations

Southern California Evidence-based Practice Center–RAND, Santa Monica, Calif(Drs Shekelle, Morton, Mojica, and Mss Maglione, Suttorp, Rhodes, and Jungvig); Cedars-Sinai Medical Center, Los Angeles, Calif (Dr Hardy); Greater Los Angeles Veterans Affairs Healthcare System (Dr Shekelle); and Department of Family Medicine, University of Southern California, Los Angeles (Dr Gagné).