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Primus Pharmaceuticals Inc., Scottsdale, AZ has voluntarily but reluctantly withdrawn its osteoarthritis capsule Limbrel from the market following a strong recommendation from the Food and Drug Administration (FDA) that the product may cause drug-induced liver injury, and a lung condition called hypersensitivity pneumonitis.
In a letter to James D. Weir, president and chief executive officer of Primus, the FDA requested that the company cease distribution and immediately institute a recall of specific Limbrel lots, including:
* Limbrel (flavocoxid) 250 mg capsules
* Limbrel250 (250 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules
* Limbrel (flavocoxid) 500 mg capsules
* Limbrel500 (500 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules
“The FDA has determined that these Limbrel products are unapproved new drugs and represent a serious health hazard,” the agency wrote in the letter to Weir. “Between January 1, 2007, and November 9, 2017, FDA received 194 adverse event reports associated with the use of Limbrel products.”
The FDA further stated...