Dear Listmembers,
I just received this post from a university listserv. Although I haven't
heard anything about this supplement till now, I thought members might
like to be informed of its existence.
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[contains benzodiazepine Estazolam (ProSom - T1/2 10-15 hrs)]
E-DRUG: FDA WARNS CONSUMERS AGAINST TAKING DIETARY SUPPLEMENT
"SLEEPING BUDDHA"
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Press Office
Food and Drug Administration
.S. Department of Health and Human Services
STATEMENT Ivy Kupec: 301-827-6242
March 10, 1998 Broadcast Media: 301-827-3434
Consumer Inquiries: 800-532-4440
FDA WARNS CONSUMERS AGAINST TAKING DIETARY
SUPPLEMENT "SLEEPING BUDDHA"
The Food and Drug Administration is warning consumers not to purchase or
consume a product known as Sleeping Buddha. The product, which is being
marketed as a dietary supplement, contains an unlabeled prescription
drug
ingredient that poses possible health risks. The product also has not
been
submitted to FDA for review or approval for any of the uses for which it
is being sold.
Sleeping Buddha is marketed in capsule form as a product of China and
labeled as imported and distributed by Treasure Box Products Inc. of
Burnaby, B.C., Canada. The product is being promoted for insomnia and
restlessness and is sold as an herbal alternative to prescription
sedatives.
FDA has determined that the product actually contains the
prescription-strength drug ingredient, estazolam, which is a
sedative of the benzodiazepine family. Estazolam is known to have
serious
side effects, including the potential to cause fetal damage if a
pregnant
woman consumes the drug.
Also, because this product is a sedative, it poses a special risk to
consumers who take the drug while driving, while operating heavy
machinery,
or while taking other sedative drugs or alcohol.
FDA has not received any reports of injury or adverse reactions from
this
product. However, all consumers, and especially pregnant women, should
be
aware of the risks associated with this product.
Treasure Box Products Inc., in response to U.S. and Canadian government
testing, has initiated a voluntary recall of all their products sold in
the United States. FDA, in conjunction with Canada's Therapeutic
Products
Directorate, will be monitoring this recall.
Consumers who have used this product and have medical concerns should
consult with their health care providers.
--
Kathrynne Holden, MS, RD
"Nutrition you can live with!"
Medical nutrition therapy
http://www.nutritionucanlivewith.com/
Tel: 970-493-6532 // Fax: 970-493-6538
