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posted by Fnord666 on Thursday August 17 2017, @09:51PM   Printer-friendly
from the garbage-in-garbage-out dept.

Arthur T Knackerbracket has found the following story:

The Food and Drug Administration advised consumers and healthcare providers Friday to avoid all liquid products made by PharmaTech LLC of Davie, Florida after finding dangerous Burkholderia cepacia bacteria in the water system used to manufacture its products. Those products include liquid drugs and dietary supplements labeled under Rugby Laboratories, Major Pharmaceuticals, and Leader Brands.

An outbreak of B. cepacia infections affecting at least 60 people in eight states led the FDA and Centers for Disease Control and Prevention to PharmaTech. Late last year, the agencies tracked the source to more than 10 lots of PharmaTech's oral liquid docusate sodium, a stool softener. But suspicion of contamination crept to the company's other products, and this month PharmaTech issued a voluntary nationwide recall of its other liquid products, such as its liquid vitamin D drops and liquid multivitamins that are marketed for infants and children.

"B. cepacia poses a serious threat to vulnerable patients, including infants and young children who still have developing immune systems," FDA Commissioner Scott Gottlieb said in a statement. "These products were distributed nationwide to retailers, health care facilities, pharmacies and sold online—making it important that parents, patients and health care providers be made aware of the potential risk and immediately stop using these products."

-- submitted from IRC


Original Submission

Related Stories

FDA to More Strictly Regulate Homeopathic Drugs 47 comments

The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products (alternative medicine):

To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA's existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.

Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency's enforcement policies since 1988.

"In recent years, we've seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren't adequately tested or disclosed to patients," said FDA Commissioner Scott Gottlieb, M.D. "Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm."

FDA draft guidance (8 pages).

Also at Ars Technica and STAT News.

Related: Probiotics Come with Bold Health Claims, but the Science is Shaky
What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
Supplement Maker on FDA Blacklist After Deadly Bacteria Found in Water System
FDA Designates MDMA as a "Breakthrough Therapy" for PTSD; Approves Phase 3 Trials
Homeopathic "Healing Bracelet" Poisons Baby With High Levels of Lead
FDA: Love is Not an Ingredient
FDA Cracking Down on Unsubstantiated Cannabidiol Health Claims
FDA Blocks More Imports of Kratom, Warns Against Use as a Treatment for Opioid Withdrawal
Biohackers Disregard FDA Warning on DIY Gene Therapy


Original Submission

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  • (Score: -1, Offtopic) by Anonymous Coward on Thursday August 17 2017, @10:30PM (1 child)

    by Anonymous Coward on Thursday August 17 2017, @10:30PM (#555597)

    Good. There are too many poor-as-shit people and not enough no-skill jobs [soylentnews.org] for them. Fortunately rich-as-fuck highly-skilled in-demand Soylentils shall be exempt from the culling, because we here on SN are the fucking elite of the entire universe.

    • (Score: -1, Offtopic) by Anonymous Coward on Thursday August 17 2017, @10:56PM

      by Anonymous Coward on Thursday August 17 2017, @10:56PM (#555604)

      Offtopic really?

      Apparently one is obliged to be explicit with this crowd of mouth breathing idiots.

      "Good! Cull the poor by poisoning their vitamin supplements!!"

      Jesus L Christ you rich fuckers aren't worth your pay. Elite scum of SN.

  • (Score: 5, Insightful) by Anonymous Coward on Thursday August 17 2017, @10:54PM (5 children)

    by Anonymous Coward on Thursday August 17 2017, @10:54PM (#555603)

    Isn't it time we took off the training wheels and let the capitalist free market run riot in our country? I'm so tired of the nanny state "detecting lethal bacteria in the water" and boring crap like that. Take the chains off and let's see how fast this thing can fly!

    • (Score: 0) by Anonymous Coward on Thursday August 17 2017, @10:58PM

      by Anonymous Coward on Thursday August 17 2017, @10:58PM (#555605)

      Caveat asspoor. Buyer be dead.

    • (Score: 2) by c0lo on Thursday August 17 2017, @11:17PM (3 children)

      by c0lo (156) on Thursday August 17 2017, @11:17PM (#555613) Journal

      Isn't it time we took off the training wheels and let the capitalist free market run riot in our country?

      Being masochistic doesn't run contrary to the human rights.

      --
      https://www.youtube.com/watch?v=aoFiw2jMy-0
      • (Score: 0) by Anonymous Coward on Thursday August 17 2017, @11:28PM (2 children)

        by Anonymous Coward on Thursday August 17 2017, @11:28PM (#555619)

        institutionally enforced masochism does however.

        Remember modern BDSM has safe words for a reason.

        • (Score: 0) by Anonymous Coward on Thursday August 17 2017, @11:37PM

          by Anonymous Coward on Thursday August 17 2017, @11:37PM (#555626)

          It's great to save a safe word to stop it when it gets out of hand.

        • (Score: 2) by c0lo on Friday August 18 2017, @12:03AM

          by c0lo (156) on Friday August 18 2017, @12:03AM (#555638) Journal

          Remember modern BDSM has safe words for a reason.

          (What good is a safe word if you are unable to speak? [youtube.com]).

          Free market won't be restricted by modern BDSM, otherwise it will not be free! (grin)

          --
          https://www.youtube.com/watch?v=aoFiw2jMy-0
  • (Score: 0) by Anonymous Coward on Thursday August 17 2017, @11:21PM (3 children)

    by Anonymous Coward on Thursday August 17 2017, @11:21PM (#555617)

    Trigger warning! Editors using color-associated term in headline!

    I call racism and demand reparations!

    • (Score: 0) by Anonymous Coward on Thursday August 17 2017, @11:24PM (2 children)

      by Anonymous Coward on Thursday August 17 2017, @11:24PM (#555618)

      Bacterial Lives Matter

      • (Score: 0) by Anonymous Coward on Thursday August 17 2017, @11:32PM (1 child)

        by Anonymous Coward on Thursday August 17 2017, @11:32PM (#555624)

        Feces is up to 13.5% bacterial biomass.

        • (Score: 0) by Anonymous Coward on Thursday August 17 2017, @11:59PM

          by Anonymous Coward on Thursday August 17 2017, @11:59PM (#555635)

          The bacteria were quoted as saying, "This is some good shit!"

  • (Score: 0) by Anonymous Coward on Thursday August 17 2017, @11:29PM (2 children)

    by Anonymous Coward on Thursday August 17 2017, @11:29PM (#555621)

    --nomsg

    • (Score: 0) by Anonymous Coward on Thursday August 17 2017, @11:31PM (1 child)

      by Anonymous Coward on Thursday August 17 2017, @11:31PM (#555623)

      ...by a SOUTH Florida company at that! No sir, totally on the up and up.

      • (Score: -1, Offtopic) by Anonymous Coward on Thursday August 17 2017, @11:41PM

        by Anonymous Coward on Thursday August 17 2017, @11:41PM (#555630)

        Just the tip, he said, just to see what it feels like, he said.

  • (Score: 3, Informative) by EvilSS on Friday August 18 2017, @12:45AM

    by EvilSS (1456) Subscriber Badge on Friday August 18 2017, @12:45AM (#555650)
    These guys are a full fledged pharmaceutical company. They make OTC generics used mostly in hospitals, clinics, etc., although you can buy them retail (Amazon for example).
  • (Score: 0) by Anonymous Coward on Friday August 18 2017, @01:59AM

    by Anonymous Coward on Friday August 18 2017, @01:59AM (#555670)

    Get rid of the fda deciding what "works" or not and put all the funding to making sure the labels are accurate, etc; like it was originally. This is a good example.

  • (Score: 1) by nitehawk214 on Friday August 18 2017, @03:10AM

    by nitehawk214 (1304) on Friday August 18 2017, @03:10AM (#555687)

    I would not use any product form a company named "Major Pharmaceuticals" or "Leader Brands". That is spam level sleaziness right there.

    Sounds like the sort of company that would send unsolicited emails promising cheap V1AGR4. No thanks.

    --
    "Don't you ever miss the days when you used to be nostalgic?" -Loiosh
  • (Score: 0) by Anonymous Coward on Friday August 18 2017, @08:20AM

    by Anonymous Coward on Friday August 18 2017, @08:20AM (#555766)

    SN is starting to see a quite robust level of trolling. Why, it brings a tear to my eye. But this story reminds me of a place I worked that had a system for recycling wash water (used on raw apples). It was treated with a chemical called tsunami, nevertheless there were some biofilms that managed to take hold inside the equipment. One time a blob of goo broke loose and was seen in the product stream. Anyway, the FDA got a funding and headcount boost within the past couple years and they've been up in everybody's business (more than before anyway). I'm surprised it took this long for a recall, considering the other linked FDA advisory was from Oct of last year. After finding contamination in the water I would have thought they'd shut down the whole operation until that problem was eliminated, and require regular testing of water samples to make sure it stays clean.

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