Medical Food Firm's Production Investigated After Rash Of Adverse Events
This article was originally published in The Rose Sheet
FDA receives 194 adverse event reports regarding Primus Pharmaceuticals''s Limbrel medical food capsules, including two about "potentially life-threatening medical conditions." The agency says a likely relation was found between the product and the conditions reported in 30 of the AERs.
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Primus Pharmaceuticals say an insert in packages of its Limbrel capsules prescribed to manage metabolic processes associated with osteoarthritis advises that the ingredient baicalin could cause the lung condition acute hypersensitive pneumonitis and elevated liver enzymes in users with allergies to the flavonoid.
FDA will bill supplement and conventional food product firms $248 per hour for re-inspections in the US and $285 per hour outside the country in fiscal 2018, but as it has since Congress passed FSMA, the agency will not collect re-inspection and mandatory recall fees.
The trade group and food and drug attorney Scott Bass note FDA's interpretation of medical food stated in its guidance could undermine congressional intent for the category and limit the range of products firms can market as medical foods.