FDA Recalls Herbal Weight Loss Remedies

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The FDA has recalled several herbal weight loss remedies because they were found to contain ephedrine alkaloids which the FDA contends are dangerous and may cause heart attack.

Ephedrine alkaloids come from a grass called Herba Ephedra and have been used for centuries to treat asthma and bronchitis because the plant dilates the bronchial passages. It is also used to combat sea sickness and drowsiness and is used by medical professionals to treat post-operative low blood pressure.

By the beginning of the 21st century, manufacturers began making ephedrine synthetically since it was so time consuming to obtain from the grass.
It bears a chemical similarity to amphetamines but contains hydroxyl, whereas amphetamine and methamphetamines don’t.

Side effects include nausea, dizziness, headache, dry mouth, tremor, difficulty urinating, agitation, panic, hostility, confusion, paranoia, and heart complications such as tachycardia (fast heart beat), arrhythmias (irregular heart beat), angina, vasocontriction and high blood pressure. Ephedrine is also dangerous for people taking anti-depressants.

There is contention, however, over just how neuro-toxic ephedrine is. A US court ruling in 2005 stated that the FDA did not have enough evidence it was unsafe:

"The conclusion that 9mg per day of ephedrine alkaloids produces negative health effects is based upon chronic uptake, which is not the condition of use suggested on the labeling of the plaintiff’s product. The evidence, cannot, on its own, support a conclusion that a recommended dose of 10mg a day of EDS presents a significant or unreasonable risk."

However, the decision was appealed the following year and overturned, with the FDA saying it could cause heart attack, stroke and death. It is still available for medical use and as a tea, but is not allowed as a slimming remedy.

The recalled products are:
Shi Shen Tang - Mahuang & Cimicifuga Combination (Mfg no. CP10217).
Ding Chuan Tang - Mahuang & Ginkgo Combination (Mfg no. 2008-12).
Shen Mi Tang - Mahuang & Magnolia Combination (Mfg no. CP11022).
Xu Ming Tang - Mahuang & Ginseng Combination (Mfg no. P122101).

Any customers with the product should return it to the company. Call Quality Control at 1-800-533-5907 Monday thru Friday 8:30 to 5pm Pacific Standard time for instructions on the return and refund process. If you have had an adverse reaction you can report it to the FDA online at:
www.fda.gov/medwatch/report.htm

Sources:
FDA Press Release, 28th July 2011 - http://www.fda.gov/Safety/Recalls/ucm265881.htm
United States District Court for the District of Utah - http://www.ephedrinehydrochloride.com/204cv409-28.pdf
Chemically Synthesized Ephedrine Put Into Mass Production in China, People’s Daily, page accessed 29th July 2011 - http://english.peopledaily.com.cn/english/200111/05/eng20011105_83931.html
The British National Formulary, number 61 - http://bnf.org/bnf/bnf/current/
Comparison of the effects of D-(-)-ephedrine and L-(+)-pseudoephedrine on the cardiovascular and respiratory systems in man, Br J Clin Pharmacol. 1978 September; 6(3): 221–225 - http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1429447/
http://www.healthadel.com/ephedra-what-it-is-and-how-it-can-be-used/

Reviewed July 29, 2011
by Michele Blacksberg R.N.
Edited by Shannon Koehle

Joanna is a freelance health writer for The Mother magazine and Suite 101 with a column on infertility, http://infertility.suite101.com/. She is author of the book, 'Breast Milk: A Natural Immunisation,' and co-author of an educational resource on disabled parenting, in addition to running a charity for people damaged by vaccines or medical mistakes.

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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.