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The Food and Drug Administration has asked Primus Pharmaceuticals to recall a product touted to address “the metabolic processes associated with osteoarthritis” but that the agency says comes with a risk of liver injury and a lung condition.

Primus markets the product, Limbrel, as a “medical food” — a distinct regulatory category — but this week, the FDA said it considers Limbrel to be an unapproved drug. The FDA cannot require the company to recall Limbrel.

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  • limbrel was a life saver for me , I can not take antinflammatories due to past kiddy promblems , I have my blood checked ever 90 days for the past 4 years and have nor had any trouble with limbrel its works to relive the pain , please put it back on the market , there are a lot of people like myself that needs this drug, thank u David G Puryear 65 yrs old

  • I’m a pharmacist and saw too many patients bitten by medical foods being purported to do amazing things only to end up paying hundreds or thousands of dollars of their hard-earned money for something that doesn’t work or worse, as in the case of Limbrel, can hurt them.

  • I have used Limbrel for approx. 15 yrs. I am so upset that this was pulled from the market. This medical food made me feel better than most other drugs..No side affects..I absolutely miss it….

    • I have used Limbrel for 10 years with no issues and it has improved my hip OA dramatically. I’ve been off of it now for 10 days due to the recall and my pain is back. This is a fantastic product and it is unjust that it has been recalled. I am a licensed pharmacist and EVERY drug on the market has rare side effects. This is a complete over reaction and many patients will now suffer as they have to go back to far more toxic drugs like NSAIDs and acetaminophen.
      Mark Brockway, PharmD

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