Teething Medication and You #illumedati


Hey everyone, it’s Medicine Mondays and I didn’t really have a post in mind for this Medicine Mondays post. So this is kind of a random post about “Teething Medication and You”. I thought this would be a short post, but it ended up being long.

Random

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Teething Medication and You

I was at a doctor’s appointment on Saturday and had my blood drawn to check my Cholesterol since it was “borderline” last time. Also, I got my flu shot at the same time, which I would recommend that everyone get.

I brought my daughter in with me to the appointment. The reason was because she had been running around the house on Wednesday and then fell on the kitchen tile, resulting in her first “fat lip”. It was looking better, but we figured we’re bring her to get it checked out just in case.

As you might expect, we were assured she was fine. I asked about whether she needed any topical meds to alleviate discomfort, and immediately Orajel came to mind. Our clinician told us that she really didn’t need anything and even mentioned that Orajel “for kids” was taken off the market.

I had remembered hearing something about that a little while ago, so I looked into it.

Here’s the post from the FDA September 2016:

FDA warns against the use of homeopathic teething tablets and gels

The TL;DR is:

“Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online.”

“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives.”

I vaguely remembered this back article from back in 2016. However, I do also remember that back when my children were teething, we had a very difficult time. I can imagine other parents were the same way and would be willing to try any “over the counter” medication that may help.

Although these teething meds are mostly water, some of them were supposed to have trace amounts of belladonna (also known as deadly nightshade). Unfortunately, it seems some of these products had more than belladonna than expected.

The FDA released this post January 2017:

FDA confirms elevated levels of belladonna in certain homeopathic teething products

The TL;DR is:

“The U.S. Food and Drug Administration announced today that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.” (emphasis mine)

And here is the the FDA Recall Statement April 2017:

Standard Homeopathic Company Issues Nationwide Recall of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets Due to Mislabeling

The TL;DR from that statement is:

” “Standard Homeopathic Company is recalling all lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets sold in retail stores to the consumer level. The U.S. Food & Drug Administration (FDA) has concluded that the medicines have been found to contain inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the products’ labels.”

“FDA believes that belladonna represents a serious health hazard to children and that the effects of belladonna are unpredictable. The Agency has stated to the Company, “There is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it.” ” (emphasis mine)


So what is the take home message from all this?

The take home message is that just because something is “over the counter”, that doesn’t mean it’s “safe”.

This is because the FDA does not regulate everything you might see in your local neighborhood pharmacy in the same way.

There is a good article from The American Cancer Society( cancer.org) which explains this difference:

FDA regulation of drugs versus dietary supplements

“In general, the FDA considers new drugs to be unsafe until they are proven safe through clinical trials. And the FDA must approve any new drug before it can be legally sold in the US. Clinical trials are studies done under well-controlled conditions on human volunteers. These tests must be done on all drugs – even those that are sold over the counter (without a prescription). ” (emphasis mine)

“In 1994, the Dietary Supplement Health and Education Act (DSHEA) defined dietary supplements as a category of food, which put them under different regulations than drugs. They are considered safe until proven otherwise.(emphasis mine)

Drugs are guilty until proven innocent whereas Food is innocent until proven guilty. That logic may work for our justice system, but I don’t think it’s great here. I think it seems a little lax for products that are so readily available.

Being in the category of “food” means that the FDA can not regulate it like they can “drugs”. The FDA can only look into a “food” product if problems of safety hazards have been raised.

From the same article:

“A more serious trend today is extra ingredients in supplements. Some “herbal” supplements have been found to contain prescription drugs or other compounds that are not listed on their labels. For example, some supplement ads are targeted to men as “enhancers” or muscle builders. Certain of these so-called “supplements” have been found to contain substances much like Viagra® or Cialis®, and have been recalled. ” (emphasis mine)

“ “Prostate health” supplements have been found to contain terazosin, a prescription drug used to treat the symptoms of an enlarged prostate. Other ads target women and tout the supplement as an aid to weight loss. Some of these “weight loss supplements” contained the weight loss drug sibutramine, which was banned in the United States because of the risk of heart attack and stroke. The supplement makers recall these only after they have been found to have these illegal additives. Then the FDA can seize these drugs and prosecute the companies who make them.”  (emphasis mine)

“There are also times that new ingredients with little-known effects are slipped into supplements. In one situation, supplements were labeled as being made from geranium but turned out to contain the stimulant drug dimethylamylamine (DMAA). This type of supplement was sold as a “natural stimulant,” but it contained DMAA, a man-made drug. The DMAA-containing supplements were exposed after some serious events, including several deaths, leading the FDA to send warning letters to US manufacturers in 2013.”  (emphasis mine)


What does this all mean?

Look for a disclaimer that says “This product has not been evaluated by the FDA”.

If you see this, it basically means that product is a “food” in the realm of dietary supplements, alternative medicine, homeopathy, etc. and not a drug.

Let me ask you this:

Have you seen a box labeled “Zicam” in your pharmacy? It’s a “pre-cold” remedy, and it comes in a bright orange and white box. It looks very impressive and it’s even sold right next to Benadryl and Nyquil. Do you know what’s in it? Me neither. That’s because it’s a homeopathic remedy. 

Or what about “asthma spray” at your pharmacy? A common brand is Safecare. This looks like an inhaler and it even says “asthma” on the box. This is just an over the counter available inhaler right? Nope. It’s a homeopathic spray.

What can I do?

Just be aware. I don’t think the FDA will be getting an additional regulatory power over these products as long as they are under the “food” category. To be honest, prior to writing this post, I didn’t know some of the products I always see in the pharmacy aisle were homeopathic remedies. I knew some of them were, but I was surprised to hear about others. I was also surprised by the sheer amount of “dietary supplements” out there.

Buyer beware.


TL;DR

There is no real Teething Medication or Teething Aid.

Homeopathic teething aids have been recalled because of inconsistent amounts of belladonna.

The FDA can not regulate the “food” category in the same way as “drugs”.

Drugs are guilty until proven innocent whereas Food is innocent until proven guilty. That logic may work for our justice system, but I don’t think it’s great here.

Look for a disclaimer that says “This product has not been evaluated by the FDA”.

Buyer beware.

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About Sensei

A young attending physician trying to navigate the mine field that is life after medical school…

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