Sunday, October 24, 2010

Recall of Hyland's Teething Tablets

Okay, I know this is totally unrelated to my usual subjects of Age of Autism, vaccines or censorship, but this really raised my ire. You see, I signed up to receive e-mail notices from the FDA on warning letters, recalls and enforcement reports. These satisfy my interest in keeping an eye on what kinds of foods and medical products have issues. This has the added benefit of letting me know when to toss out something that poses a risk to me, in case I miss the announcement on the local news.

Today I received a brief notice that FDA is recalling Hyland's Homeopathic Teething Tablets.

Hyland's is a company that produces a wide range of homeopathic products. According to their web site, their teething tablets are indicated to relieve the "restlessness, peevish whining and irritability" associated with infant teething. The tablets are quite small and dissolve on the tongue. As one might expect, their site carries a plethora of testimonials about how great the tablets are, yet nary a link to any scientific evaluation of the safety and efficacy of the product can be found.

So, with such favorable parent stories, why on earth would FDA recall Hyland's Homeopathic Teething Tablets?

Apparently, the tablets do not contain consistent amounts of belladonna, leading to potential overdose and poisoning. The product labeling for the tablets indicates that each tablet contains a 3X (or 1:1,000) dilution of belladonna. As far as homeopathic products go, that's not very dilute and is very likely to contain biologically active amounts of belladonna, much like recalled Zicam nasal products contained active amounts of zinc (2X dilutions). Further exacerbating the issue is the fact that the bottles do not use child-resistant caps.

Already knowing a bit about drug regulations, I decided to take a look at Hyland's site a bit further. In particular, I looked at their FAQ on whether or not homeopathic "remedies" are regulated. Hyland's is correct that homeopathic products are regulated as drugs under the Food, Drug and Cosmetic Act. What they fail to mention, however, is that such products are exempt from certain regulations that apply to other drugs, namely:

1. Section 211.137 (Expiration dating) specifically exempts homeopathic drug products from expiration dating requirements.

2. Section 211.165 (Testing and release for distribution): In the Federal Register of April 1, 1983 (48 FR 14003), the Agency proposed to amend 21 CFR 211.165 to exempt homeopathic drug products from the requirement for laboratory determination of identity and strength of each active ingredient prior to release for distribution.

That second point is important in this case. Because homeopathic products are generally so dilute as to contain little or no active ingredient, lab testing for the presence and strength of active ingredients (such as Hyland's belladonna) does not make a whole lot of sense. However, simply using an active ingredient that is in the Homeopathic Pharmacopeia of the United States, labeling your product as homeopathic and listing ingredients using homeopathic amounts (e.g., 3X instead of 1mg/mL) is enough to get around the regulations that normally apply to drugs: i.e., making sure that the product you are selling is actually safe and that each dose has a consistent amount of the active ingredients.

What this boils down to is that conventional drugs are required to undergo rather significant testing for safety and efficacy before they are marketed. Homeopathic products, on the other hand, do not. At best, they must follow Good Manufacturing Practice regulations, but they do not need to apply for marketing approval. Because of this, FDA cannot take any action on a homeopathic remedy until after it is already on the market.

This state of affairs leads to potentially unsafe and ineffective products hitting the market, like Zicam or, as we see here, Hyland's Homeopathic Teething Tablets.

With Zicam, consumers ran the risk of loss of smell, potentially permanently. All in all, while not pleasant, that's not as bad as the potential for harm from products like these teething tablets. Belladonna poisoning can be quite serious, even resulting in death.

This episode illustrates, yet again, the flaws in how "alternative" health products are regulated. Manufacturers have a responsibility to ensure that their products are safe and effective. Thanks to the kind of regulations we see for real drugs, the majority of harmful products never even make it to market, and of those drugs that are approved, quite a bit is known about not only the benefits, but also the risks posed. There are, of course, drugs that make it to market that shouldn't have, but such products are relatively rare.

The same cannot be said of homeopathic products.

A decent essay on this issue can be found here (PDF).

Update: FDA has a Q&A about this recall. Standard Homeopathic, the manufacturer, has also issued a press release indicating that they are voluntarily complying with the recall.

10 comments:

  1. Belladonna? BELLADONNA??? Okay, I can sorta understand the makers of Zicam. They had learned that zinc was known to have some helpful properties in cold treatment (also some serious negative ones, which they conveniently ignored), and, not wanting to bother with expensive research, got it marked "homeopathic" and started selling it. Dishonest and lazy, but at least they had a reason to think it might do something helpful.

    But belladonna? At 3X, they had to have felt it had an actual effect (not one which needed to be diluted away and potentized to unlock its inverse effect) that would encourage people to buy the product some more. Belladonna was traditionally used as a beauty aid (hence "belladonna", or "lovely lady") by dialating the pupils, making the woman appear sexually aroused. The common name of "belladonna" is more frightening: deadly nightshade. How could they not know that it has major adverse side effects? It's one of the most famous herbal poisons. This time of year, it shows up on cheap Halloween props -- labels on fake potion bottles, and such. (Also, if the weather cooperates and the vines die back at the right time, it makes a lovely Halloween decoration -- when the weather turns slowly enough, the leaves go a wonderful purplish black.)

    Wow. Knowingly selling belladonna to be given to infants. What's next -- hemlock tea?

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  2. To be fair, belladonna does have legitimate medicinal uses. However, I could not find any research on its safe or effective use in infants. I did find a small case study reporting serious adverse effects for belladonna drops given to treat colic, though.

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  3. Yep, it's where we get atropine. Used in eyedrop form to dilate the pupils for examination of the retina, and is important in resuscitation of people in cardiac arrest. (Be careful, though, because it will make ischemia worse, so not all cardiac arrests can be treated with atropine.) Also helps treat certain kinds of poisoning. Overdose is traditionally described as "hot as a hare, blind as a bat, dry as a bone, red as a beet, and mad as a hatter."

    Like a lot of herbal things (digitalis, for instance) it has medicinal uses and can kill you. But belladonna's common and scientific names ought to be a serious clue to use caution: "deadly nightshade" we know, but the scientific name is Atropa belladonna -- named for Atropos, the eldest of the three Greek Fates, and the one responsible for cutting the thread of life.

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  4. I guess the lesson to learn here is:

    Parents, if your going to give something to your infant, make sure the damn thing is safe! Effective is good, too, but safety first and all that.

    Though I could understand some people seeing it labeled as homeopathic and therefore think it's safe, since true homeopathic products are nothing but water, sugar or alcohol (depending on the vehicle used), but still, people! Do your friggin' homework! (And shame on the manufacturers for not rising to the respectable level of actually testing their product before it hits the market.)

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  5. Homeopathy IS SAFE and EFFECTIVE. It is clear to me that the FDA recalled the product because it was reported by a pharmaceutical company, just like Zicam. If any of you would take the time to read about homeopathy and understand its principles of cure you would also understand that it is impossible for the minute amount of belladonna to harm anyone INCLUDING an infant. Homeopathy is based on the law of similars. "Like cures like". What that means is that a substance that can cause symptoms (like a poisoning) in a healthy individual can cure those same symptoms if made into a homeopathic medicine or remedy. Hyland teething tablets have been a tried and true treatment for dentition for at least 25 years (and I am sure much longer). These products ARE tested, but because they use a different scientific model to do the testing some how the tests are rendered invalid!! This is all about fear and ignorance and it is a shame so many children will suffer needlessly because of narrow-minded people.

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  6. @goodscience

    "These products ARE tested, but because they use a different scientific model to do the testing some how the tests are rendered invalid!"

    Perhaps you could point me to the clinical trials of Hyland's Teething Tablets that show that they work better than a placebo. I was unable to find any studies for this product.

    Also, unless you can substantiate that a pharmaceutical company reported it to FDA (not to mention that some pharmaceutical companies have subsidiaries that produce homeopathic products), spare me the conspiracy theories.

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  7. @goodscience

    And you kind of miss the point. This product was recalled due to inconsistent amounts of belladonna, illustrating that there is a serious lack of quality control. Were homeopathic products subject to the same regulations as drugs, this probably would never have happened.

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  8. @goodscience: also, how is it homeopathic if there is a measurable amount of deadly nightshade in it? Zicam, meanwhile, is a fraud, and the homeopathic establishment is its willing accomplices. I wonder how much the manufacturer paid them to get 2X zinc (as in, way more zinc than is generally considered safe) listed as "homeopathic" when it has nothing to do with either of Hahnemann's laws (the law of similars and the law of infinitesimals) and in fact pretty blatantly violates the very principles of homeopathy.

    How is that homeopathic? How is that safe? Why are you, a supporter of homeopathy, not outraged by this?

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  9. goodscience, please read the FDA Q&A link in the update. In it you will read: "FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. An ongoing FDA inspection at the manufacturer indicates substandard control of the manufacturing operation."

    It received reports, possibly from the doctors attending the sick children.

    In the future, goodscience, it would be better to not to use argument by assertion, but provide some actual proof for your statements. If the company tested the tablets, please show us those papers on PubMed.

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