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posted by mrpg on Wednesday February 01 2017, @07:14AM   Printer-friendly
from the parents-these-days dept.

Beth Mole at ArsTechnica has an article about the levels of belladonna in homeopathic teething products made by Hyland's:

After investigating reports that more than 400 babies were sickened and 10 died in connection with homeopathic teething products, the Food and Drug Administration confirmed Friday that it had indeed found elevated levels of the toxic substance, belladonna, in the products.

Belladonna, also known as deadly nightshade, was the prime suspect of the investigation from the beginning, which Ars reported about last fall. Nevertheless, the products' maker, Hyland's, would not agree to recall the products when it was notified of the FDA's conclusion, the agency reported

In a response to Ars, Hyland's has acknowledged that there are some inconsistencies in the amount of belladonna in its products, but the company said that it has not seen any evidence from the FDA indicating that the elevated levels were toxic or excessive. [...]The FDA said it had found inconsistent amounts of belladonna in Hyland's products. Some of the amounts were "far exceeding" what was intended.

[...] As before, the FDA is urging parents to avoid the homeopathic teething products and toss any already purchased. The FDA does not evaluate or approve the homeopathic products, which have no proven health benefit.

Also: Hylands FAQ about the discontinuation.


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  • (Score: 5, Insightful) by sjames on Wednesday February 01 2017, @10:47AM

    by sjames (2882) on Wednesday February 01 2017, @10:47AM (#461610) Journal

    It would be nice if they would state the actual tests run and the actual amounts found. The last time the FDA went into a tizzy about teething drops, they released a weasel worded document claiming they contained an ingredient that could be harmful in larger doses. A statement that is true of literally every approved drug,

    It's worth noting that an adverse event report only claims that something bad happened while a product was in use, not necessarily BECAUSE the product was in use. It's also worth noting that the symptoms of much more serious conditions may initially be mistaken for a reaction to teething and be inappropriately treated.

    Starting Score:    1  point
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  • (Score: 5, Insightful) by Anonymous Coward on Wednesday February 01 2017, @03:56PM

    by Anonymous Coward on Wednesday February 01 2017, @03:56PM (#461670)

    The real issue here is that the FDA has been specifically neutered by lobbying from the multi-billion dollar "natural medicine" industry and the resulting corrupt influence [scienceblogs.com] from Orrin Hatch [newrepublic.com]. If this was real medicine, the onus would be on the provider showing that it is safe. Here, because of Hatch and company, the onus is on the Government to show that it is not safe and the company is basically free to put out anything on the shelf, no matter how dangerous it might be, just as long as they include the weaselly "this product is not intended to treat or cure any disease, etc."

    The FDA looks weak and weaselly to you because Hatch intentionally made them that way. They are trying to do their job with one arm tied behind their back, a shackle on their ankle, and a blindfold on, and the result is that people like you side with the snake oil salesmen because you feel the FDA isn't treating them fairly, and then when people really start dying of stuff like this, they jump and down complaining about the incompetent Government not stopping something like this from happening.

    • (Score: 5, Insightful) by Azuma Hazuki on Wednesday February 01 2017, @04:17PM

      by Azuma Hazuki (5086) on Wednesday February 01 2017, @04:17PM (#461677) Journal

      Modded up because dammit people need to see this. Thank you for pointing it out. This is yet another example of "starve the beast," where these GOP pissfucks cut funding and power for an agency and then when it fails use that as an excuse to get rid of it.

      --
      I am "that girl" your mother warned you about...
    • (Score: 0) by Anonymous Coward on Wednesday February 01 2017, @09:28PM

      by Anonymous Coward on Wednesday February 01 2017, @09:28PM (#461803)

      If [natural medicine] was real medicine, the onus would be on the provider showing that it is safe.

      And just who is going to front the millions of dollars required to prove to the [arbitrary government standards] that the "medicine" is "safe"?

      If I find out that chewing tree leaves makes pain go away, and I want to buy those leaves, then get the hell out of my way and let me spend my own earned resources on a product someone else is selling. As long as there is no fraud and no gross negligence, then there is no crime.

      The FDA just tried to ban tree leaves [scientificamerican.com] by making them decades-long-felonies to possess. The outpouring of unexpected outrage from people actually caused a change in government policy, a rescinding of said emergency ban attempt [latimes.com]. (Like rust, however, government is ultimately unceasing in its invasiveness and destruction of good things, and therefore it is expected that its efforts to impose a tree leaf ban will continue, most likely when it is anticipated that normal people have stopped paying close attention.)

    • (Score: 0) by Anonymous Coward on Wednesday February 01 2017, @10:00PM

      by Anonymous Coward on Wednesday February 01 2017, @10:00PM (#461814)

      the onus is on the Government to show that it is not safe

      It's called freedom. Nobody is forcing you to buy homeopathic products.

      • (Score: 0) by Anonymous Coward on Wednesday February 01 2017, @10:49PM

        by Anonymous Coward on Wednesday February 01 2017, @10:49PM (#461824)

        No, dipshit, its called consumer product safety backed by 100 years of regulation of pharmaceuticals and homeopathic products.

        • (Score: 0) by Anonymous Coward on Wednesday February 01 2017, @11:57PM

          by Anonymous Coward on Wednesday February 01 2017, @11:57PM (#461843)

          If someones decides to shop in the quack aisle of the drug store, that's their responsibility. My wife happens to have a thing for Chinese medicine and sometimes buys those kinds of herbs, which are also unregulated. It's not my thing, but the 2015 Nobel Prize for medicine [nih.gov] recognized a malaria drug based on traditional Chinese herbs. Western medicine, despite its many success, doesn't have a monopoly on healing and often fails. People should have the freedom to explore alternatives.

    • (Score: 2) by sjames on Thursday February 02 2017, @01:40AM

      by sjames (2882) on Thursday February 02 2017, @01:40AM (#461858) Journal

      All they had to do was post actual tests or a reference to them. Death Monkey did find some actual FDA measurements posted seperately. Those do not support the theory that the tablets caused any adverse reactions.

      Personally, I'm glad that the FDA is limited, mostly in the area of herbal medicine. It's all some people can afford. Would you leave them with no options (other than burglarizing a pharmacy) at all?

      I don't advocate just disbanding the FDA, but I would fully support replacing it with an agency more tightly focused on actual safety and rational risk assessment.

  • (Score: 3, Informative) by DeathMonkey on Wednesday February 01 2017, @07:49PM

    by DeathMonkey (1380) on Wednesday February 01 2017, @07:49PM (#461760) Journal
    • (Score: 2) by sjames on Wednesday February 01 2017, @08:52PM

      by sjames (2882) on Wednesday February 01 2017, @08:52PM (#461789) Journal

      Thank you, good information.

      Unfortunately, it confirms my suspicion. The biggest outlier of the lot was a single pill that contained 1.1 MICRO-gram of atropine. The dose used medically is .01-.05 mg/kg. So, definitely don't give the baby 70 pills at once. It seems unlikely that a dose of 1/70th the minimum dose used in medicine is the cause of any deaths.

      It does suggest that tightening up process controls is in order but a mass recall probably is not.