Amid concerns abut the risk of hypersensitivity and liver injury with Limbrel, a recall has been issued for the osteoarthritis “medical food” product.
Primus Pharmaceuticals announced a Limbrel recall on January 26, following adverse events reported to the FDA involving users who experienced elevated liver functions and acute hypersensitivity pneumonitis.
Limbrel is marketed as a “medical food”, but the FDA reclassified it as an unapproved new drug late last year.
The agency first warned about potential Limbrel liver and hypersensitivity side effects in a safety alert in November. The investigation followed reports of serious problems occurring among individuals who used the drug, which comes in capsule form for the treatment of osteoarthritis.
“These conditions present in rare cases with varying degrees of severity in patients taking Limbrel for the first time in the initial weeks of exposure, and may go unnoticed by the patient until they consult with their physician or until symptoms develop that require hospitalization,” the recall warns. “There have been no deaths reported with the use of Limbrel, and in all reported cases adverse effects resolved without residual effects after discontinuing use of the product.”
In a follow-up warning issued in December, the FDA indicated that it had received at least 200 adverse events involving Limbrel problems. However, the company’s recall notice claims there were only 30. The FDA also said in December that the company had been reluctant to pull the drug from the market.
Primus claims that its own experts found that there was no basis for claims that Limbrel may cause life-threatening effects, liver failure or respiratory failure, despite claims to the contrary by the FDA. The company said it is enacting the recall to cooperate with the FDA’s request.
The recall affects all unexpired lots of the following Limbrel products:
- Limbrel (flavocoxid) 250 mg capsules, Product Identity Number 68040-601-16
- Limbrel250 (250 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules, Product Identity Number 68040-605-16
- Limbrel (flavocoxid) 500 mg capsules, Product Identity Number 68040-602-16
- Limbrel500 (500 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules, Product Identity Number 68040-606-16
The FDA has recommended patients stop using the recalled products immediately. Patients with questions or who seek to return unopened bottles can go to Limbrel.com or call Primus at 480-483-1410.
Adverse reactions or health problems linked to the use of Limbrel should be reported to the FDA’s MedWatch adverse event reporting program.