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FDA Pushes for Limbrel Recall Following Reports of Liver and Lung Injury

The U.S. Food and Drug Administration (FDA) is urging Primus Pharmaceuticals to recall its product Limbrel after reports of liver and lung injuries.

What is Limbrel?

Limbrel was initially marketed by Primus as “medical food” meant to address “the metabolic processes associated with osteoarthritis.” However, the FDA announced this week that it considers Limbrel to be an unapproved drug that comes with the risk of liver injury and an adverse lung condition.

Still, the FDA is powerless to remove the product from market as it lacks the authority to require Primus to recall Limbrel.

In November, the FDA issued a warning urging anyone taking Limbrel to immediately discontinue treatment with the drug. The FDA cited 194 adverse event reports, acknowledging that at least 30 were already found to be likely associated with the product.

Among the adverse events associated with Limbrel were:

  • Liver injury
  • Jaundice
  • Nausea
  • Fatigue
  • Hypersensitivity pneumonitis
  • Trouble breathing
  • Fever
  • Cough

What is Medical Food?

Medical food is a strictly defined regulatory category which includes products recommended by doctors because of certain nutritional components shown to help manage aspects of a disease or condition. The FDA has ruled that Limbrel does not meet the criteria necessary to be designated a medical food.

That has not stopped Primus Pharmaceuticals from advertising Limbrel as a medical food with it’s website claiming “unlike drugs, prescription medical foods generally do not cause severe adverse events or dangerous drug-on-drug interactions.”

Limbrel is currently only available by prescription.

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