The FDA, keeping us safe, as usual.

Teething TabletsThank goodness we have the FDA. It keeps us safe.

For example, when the FDA learned conclusively that the Benzocaine in teething relief products such as Baby Orajel has caused the deaths of some of our infants, it issued a warning. They did add to their warning that it wasn’t every age group who suffered the most severe reactions to the Benzocaine in the Baby Orajel, ” The cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething.” Oh PHEW….

So, provided we use BABY Orajel on our children that are older than two years of age, we should feel safe.

Though… how many American parents use Baby Orajel, or any teething product, on children older than two?

Is Baby Orajel not aimed at babies? Am I stupid to have presumed that it is? Maybe it was named Baby Orajel because it comes in a wittle, bitty tube.

I just have to wonder how many babies have to die from a temporary teething relief product before the products manufacturer gets pressured by the FDA to stop selling the product or even just to start packaging it in single dose blister packs instead of the squeeze tube that can dispense too much of the medicine at once?

At any rate, while the FDA has allowed Baby Orajel on the market, even though it’s associated with some infant deaths, I feel much safer knowing that they issued a warning. Don’t you?

The FDA is looking out for us!

I know this because they pressured for the voluntary recall of Hyland’s homeopathic teething tablets… TO KEEP US SAFE. See, Hyland’s teething tablets are made from ***gasp*** poisonous berries. And while the amount of the poisonous berry alkaloid in the teething tablets is not even really measurable, (Your baby would have to ingest six entire bottles of Hyland’s teething tablets at once before you’d see the very first indications of any kind of negative side effects, which, incidentally is not death, but rather “dry mouth.”) the FDA is looking out for us. Even though there have been no actual documented, conclusive cases of negative side effects from Hyland’s teething tablets, the FDA doesn’t want to take any chances. Our babies’ safety is paramount.

Our babies’ safety is paramount to the FDA. That’s why they issued the warning about Baby Orajel. That way, when you’re at the grocery store and you see Baby Orajel, you will remember (from when you were perusing the FDAs ginormous website in your free time) that even if you use the proper amount of the Orajel, your baby could still turn blue, your baby’s blood could still become deprived of oxygen, and your baby could still die. See…. Our babies’ safety is paramount.

I know you’re asking, “Why they don’t just pull Baby Orajel from the shelves…” but that wouldn’t be fair to all of the teething two, three and four year olds out there. Besides, most babies don’t have a reaction to it if used in the proper amount. So, you see, they can’t pull Baby Orajel from the shelves. YOU just need a warning. YOU just need to know that you probably should think carefully before you give Baby Orajel to babies. Save it for the older kids, for when they are teething.

And don’t you even for a second start to question why the Hyland’s teething tablets were pushed into a recall but the  Humphrey’s teething tablets stay on the shelves even though they have the same amount of toxic berries in them. It isn’t because Hyland’s is a much larger company. It isn’t because Hyland’s teething tablets were available everywhere from Rite Aide to Walmart. It isn’t because Hyland’s teething tablets were cutting into the Baby Motrin or Baby Orajel sales.  The FDA doesn’t work like that. It doesn’t play favorites. Don’t you for one second think that any of the huge pharmaceutical companies and the FDA are buddy-buddy or anything. That would be a conflict of interest. And conflicts of interest are not tolerated in government agencies.

Thank goodness we have the FDA. It keeps us safe.

 

 

15 Comments

  1. Amy

    On the Hyland’s site, they say it was a voluntary recall — do you have more information about it? Very curious about this whole thing…. wish I’d stocked up!!!!

    • It was a voluntary recall. That is true. About as voluntary as when you hand your lunch money over to the school bully so he won’t punch you in the face though… It is made clear that Hyland’s was pressured into the recall in this FDA official statement, “An ongoing inspection at the manufacturer also indicates substandard control of the manufacturing operation. After consultation with the FDA today, the manufacturer of the product, Standard Homeopathic Company agreed to voluntarily recall Hyland’s Teething Tablets from the market.”

      I know that without FDA interference we would have never had to go without our beloved teething tablets. I know this because I know they are 100% safe. I also know that Hyland’s, having been making them for over 60 years without incident, knows that they are 100% safe. I know these things to be true because I understand how homeopathy works.

      This quote from the National Center of Homeopathy explains it perfectly, “For example, to make the remedy Cuprum metallicum 200c, you begin with 1 gram of very thin pure copper. This solid is then triturated (i.e., ground in a mortar and pestle) together with 99 grams of milk sugar into a 1c remedy. One gram of this 1c is then further triturated with 99 grams of milk sugar to make 2c. One gram of the 2c remedy is triturated with 99 grams of milk sugar yet again to make a 3c. The 1c, 2c, and 3c strengths can then be stored in a pharmacy, serving as the master mixtures for a very large supply of medicine. Once one of these remedies has been created, it will not need to be made again, barring issues of accessibility and distribution.”

  2. Tim

    Can someone explain to me how on earth Humphreys is still on the market?? This past Tuesday my child suffered greatly from this product. Extreme Hive like rash, trouble breathing etc etc…..I have reported it to the FDA as well as to Wallgreens where the product was purchased. This is horrible and I just dont get it!!!!

    • I can’t imagine what on earth would cause a reaction in them. The only ingredients besides homeopathic remedies are corn starch nf (non-gmo), sucrose nf (sugar), and in the flavored, there is natural berry flavoring.

      Given that I understand how homeopathy works, I know that it’s not chemically possible that the homeopathic remedies in it caused this. I would look to other environmental factors (or perhaps your child is allergic to berries if it was a flavored pellet.) It’s not possible that it was the homeopathic remedy itself because of their very nature. If you read more about how homeopathy works, you will understand.

      I say this not to contradict you, but because I feel that you may be missing a potentially life threatening allergy in your child and correlating it to the Humphreys.

      • Tim

        No other changes had taken place in the last few weeks, Some of the major side affects caused by Belladonna he got, including: Rapid Heartbeat, Flushing, Paleness followed by a red rash….I am sorry to say that the affects are too on spot with the affects of Belladonna…..I am pushing this far with the FDA and have spoken to investigators with them at length today.

        • Do you realize that chemically speaking, a baby would have to have many entire bottles of teething tablets at one time before the quantity of belladonna in teething tablets needed to cause even dry mouth (the first sign of belladonna toxicity) would be seen?

          “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.”

          And that goes the same for Humphreys.

          What did they say at the ER? Was there a blood draw?

  3. julia

    Tim could you please answer a few questions for me to help me understand why you feel this reaction was caused by Humphrey’s?
    1. how old is your child?
    2. how many doses of Humphreys did you give him?
    3. are you involved with media marketing for either Orajel or the FDA?

    • Also, this is from the FDA website:

      “The belladonna alkaloids, which contain atropine (d, dl hyoscyamine) and scopolamine (l- hyoscine), are probably safe for oral use at dosages that have been used in marketed cough-cold products (0.2 milligram) but there are inadequate data to establish general recognition of the effectiveness of these ingredients as an anticholinergic for cough-cold use.”

      OK, so .2 mg is considered probably safe in OTC cough-cold medicines. Got it.

      But… 0.0002 mg of Belladonna alkaloids in teething tablets… well…. that’s RISKY BUSINESS.

      Wait… WHAT?!

  4. Pingback: Baltic Amber Teething Necklaces — Everything Birth's Blog on Midwifery, Attachment Parenting, Cloth Diapers and More

Leave a Reply

Your email address will not be published. Required fields are marked *