Saturday, April 12, 2008

Teething, take 2

I never should have publicly trumpeted the ease of Junior's teething. He's been a mess. Drool everywhere. Crying while eating. Poor guy.

Our all-natural, homeopathic-loving friends recommended Hyland's Teething Tablets. We used them as directed but didn't notice much of an improvement in his level of discomfort. Then I found the following thread on a website forum:

My DH and I just returned from the ER with our 5 month old. Prior to purchasing Hyland's, I did research and spoke to a physician about the safety. Everything I read online, including personal experiences on BC, indicated that it was safe. I was highly concerned about the Belladonna Hyland's contains. All the websites that exist reviewing the product RAVE about it. I decided to use it. We gave our LO the recommended dosage on the days that he was having a hard time teething. We NEVER gave him more than the suggested amount. He never had a problem until last night.

We purchased a new bottle to keep upstairs. We used this bottle for the first time yesterday. We gave him a dose during the early afternoon and then one at around midnight. At 1 am he began to toss and turn in his bed. He was very restless but never cried. I picked him up and offered him the breast. He refused to nurse. He didn't fuss or make a sound but was WIDE AWAKE. My DH took him downstairs to rock him and he continued to move constantly. It was like he was moving involuntarily. My DH brought him up to me again and I noticed that his pupils were dilated. He could not focus on either of us. He kept looking around. He wanted to touch every thing and was fascinated with his hands and our clothing.

He appeared to be having a petite mall seizure and exhibited other anticholinergic effects that you typically see when someone is "tripping" on LSD or other street drugs. Because he would not cry, coo, babble, smile, or anything we decided to take him to the ER. He had not slept, had a wet diaper, nor nursed in 14 hours.

My son experienced Belladonna poisoning from the recommended dose of Hyland's Teething tablets. The preliminary tests they did on random samples of tablets in the bottle we were using showed a variance of 50 to 1000% of belladonna. The national poison control center stated that they are seeing more and more of this and they are trying to get stores to stop carrying this product.

This product is not regulated by the FDA or any other organization so there is no way to know how much belladonna is in each tablet regardless of what the bottle says.
My son could have died if ingested any more of this product. Please take the necessary precautions. No amount of sleep for you or your child is worth the potential of going through what we just experienced.

Mary Anne


Hyland's Communications Manager, in turn, provided a lengthy reply (excerpted below):

We have not heard of the forwarded incident directly so cannot respond to the actual incident in question.

As with any medication, there can be unique experiences; however, 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. We do actively monitor any and all reports concerning our products.

1) Homeopathic medicines are regulated by the Food and Drug Administration (FDA) as drugs, and have been so since 1938 (http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg400-400.html). Our products are not regulated as herbs or dietary supplements. As a drug manufacturer, Hyland's adheres to the Good Manufacturing Practices (GMP) Regulations promulgated by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act. "These regulations, which have the force of law, require that manufacters [sic]...of drugs...take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors." (http://www.gmp1st.com/gmp.htm) Hyland's is proud of its history of safety and attention to the quality of our products.

2) The American Association of Poison Control Center (AAPCC) has made no attempt to remove Hyland's Teething Tablets from store shelves. Neither the AAPCC nor its staff has made any statement to that effect according to our conversations with them late last week. The AAPCC also verified that it has not had any severe adverse events reports related to Hyland's Teething Tablets, in 2007 or before.

3) In researching Belladonna, it is important to note the difference between the Belladonna in conventional drugs and homeopathically-prepared Belladonna, as included in our Teething Tablets. Extensive notes can be found on our website from our Director of Scientific Affairs, Iris Bell, MD, PhD (http://www.hylands.com/news/teethinginfo.php). However, as a brief synopsis - homeopathic Belladonna is manufactured from the whole plant, of which a small portion is Belladonna alkaloids, the component sometimes associated with side effects. Each of our Teething Tablets contains only approximately 0.0002 mg of Belladonna alkaloids (or 0.0003%). This is a very tiny amount. To put this homeopathic dosage in perspective, typically a 10-pound child would need to ingest 1,000 Hyland's Teething Tablets to exhibit even the first possible side effect of Belladonna, dry mouth. A single flawed Tablet containing the amount of Belladonna alkaloids necessary to cause any adverse side effects would in all likelihood be brown in appearance rather than the standard chalky white.

Mary C. Borneman

It sounds unlikely that Hyland's would cause Belladonna but why chance it?

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