Scottsdale, Ariz.-based Primus Pharmaceuticals took its osteoarthritis treatment Limbrel off the market at the FDA's request, according to azcentral.
While Primus markets Limbrel as a medical food, the agency in December ruled the product was an unapproved drug and cited 194 adverse events — including liver injury, pancreatitis and hypersensitivity pneumonitis — the product has been linked to in the past decade. The agency requested Primus halt distribution of Limbrel and recall four formulations of the product Dec. 18.
"We are not shipping. We're not promoting. We're not sampling doctors," Primus President and CEO James Weir told azcentral. "We have terminated all of those activities in good faith even though we don't believe our product is life threatening."
More than 2 million packages of Limbrel have been sold or sampled to an estimated 450,000 patients over the last 14 years, according to a letter Primus sent to the FDA. During this period, the company has received very few reports of adverse events. When health issues do occur, they are usually temporary and reversible once a patient stops taking Limbrel, according to Mr. Weir.
Primus plans to meet with FDA officials to discuss Limbrel's safety and why the product should be designated as a medical food.
"We are hopeful we can work with them so the product can be available," Mr. Weir told azcentral. "We don't understand why this product has been on the market for so long with such consistent feedback and use, and now it is an issue."
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