An Internet post has come to our
attention stating that a child had a reaction to the Belladonna in
Hyland’s Teething Tablets. While we do not have the details of the
incident, we want to provide you the following information.
Hyland’s is a reputable manufacturer
of homeopathic drugs since 1903. In the more than 60 years that
Hyland’s Teething Tablets have been on the market, we have received
no significant adverse events reports related to the product. In
addition, the American Association of Poison Control Centers has
told Hyland’s that it has received no report of a serious adverse
reaction to Teething Tablets.
Our #1 priority as a company has
always been providing safe, effective healthcare to our consumers,
especially the children that we serve. Our pharmacist is
available 24/7 at 1-800-624-9659 to provide emergency information to
consumers and the medical community. As an FDA-regulated drug
manufacturer, we adhere to all mandated standards and practices to
ensure the highest quality product. Please feel free to contact us
at the same number with any concerns. More information on Hyland’s
Teething Tablets is available in the document below.
FACT SHEET
Contact:
Mary C. Borneman:
Hyland’s Inc., 800/624-9659
Hyland's Teething Tablets
Safety Information
December 19, 2007
As a manufacturer of homeopathic medicines, and as parents
ourselves, we want to share with you how Hyland’s Teething Tablets
are made and what they contain to effectively and safely alleviate
your child’s teething aches and pains.
First and foremost, homeopathic
medicines are regulated as drugs by the Food and Drug Administration
(FDA), as required in the Food, Drug and Cosmetic Act. The
production of Hyland’s homeopathic medicines occurs within a
validated process, as with any FDA-regulated drug, to ensure an
accepted level of consistency in product output.
Hyland’s Teething Tablets contain
homeopathically prepared forms of Calcarea Phosphorica, Chamomilla,
Coffea Cruda, and Belladonna. These ingredients are all prepared in
accordance with the Homeopathic Pharmacopœia of the United States (HPUS).
HPUS has been recognized by the FDA since 1938 as the official
compendium (or formula book) for homeopathic medicine in the U.S.
When homeopathically prepared, active ingredients are diluted to the
point that the risk of toxicity is extremely low (see specific
details below).
Calcarea Phosphorica is included in
Hyland’s Teething Tablets for its ability to support teeth
formation. Chamomilla is included in the Tablets for its actions on
irritability commonly associated with teething pain. Coffea Cruda is
included in the Tablets for its actions on wakefulness and increased
urination.
Belladonna is included in the Tablets to
ease the redness, inflammation and discomfort of the child’s gum
that often occurs during the teething process. Belladonna 3X HPUS is
manufactured from the whole plant, of which a small portion is
Belladonna alkaloids (the component sometimes associated with side
effects). Each Teething Tablet (which weighs about 65 mg) is
composed of 0.0003% Belladonna alkaloids as stated on the label.
This means that each complete teething tablet contains only
approximately 0.0002 mg of Belladonna alkaloids.
The amount of Belladonna alkaloids in
teething tablets is minuscule, especially when compared to
conventional medicine. Conventional medicines typically use 0.2 to 5
mg of Belladonna alkaloids per tablet as an anti-spasmodic – roughly
1,000 to 25,000 times larger than the quantities used in Hyland’s
Teething Tablets. The side effects sometimes caused by conventional
medicines delivering more than 0.2 mg of Belladonna alkaloids – such
as dry mouth, blurred vision and urinary retention – are not
associated with homeopathic medicines because of their minute
dosage.
To put homeopathic dosages in
perspective, typically a 10-pound child would need to ingest 1,000
Hyland’s Teething Tablets (at least 6 bottles of 125 tablets) to
exhibit even the first possible side effect of Belladonna.
Hyland’s Teething Tablets have been
safely used by millions of children since being introduced to the
U.S. market in 1945!
Click here to see what actual parents have to
say about Hyland’s Teething Tablets.
We care about your child and our
consumers’ safety is our #1 priority. For that reason, we have
pharmacists available around the clock (24 hours per day, 7 days per
week) to provide emergency information related to any of our
products. You can contact us at 1-800-624-9659 (number also
available on all packaging). We are confident that our pharmacist
can help parents and their doctors reach informed conclusions
regarding our products.
Please keep in mind that even if a child
ate an entire bottle of homeopathic medicine, the minute amount of
active ingredients renders an overdose unlikely. Nonetheless, we
understand that parents are rightfully cautious about their own
child so feel free to call us anytime if you are concerned.
While adverse symptoms that may be
attributed to an overdose of Belladonna alkaloids are well
documented in the literature, the concentration necessary would
require the ingestion of multiple bottles of Teething Tablets. As
this is very unlikely, such symptoms could be due to any of a number
of other causes (click here for more causes that could be explored).
We at Hyland’s, Inc. greatly value our
relationship with the consumers who make up our Hyland’s family.
Please do not hesitate to call 1-800-624-9659 and ask for our
on-staff pharmacist to receive any additional information.
Iris R. Bell, MD PhD
Director of Scientific Affairs
