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Primus voluntarily suspends sale of Limbrel®

by
Optum Workers' Comp
| Jan 11, 2018

In response to the request by the U.S. Food and Drug Administration (FDA) to recall Limbrel, Primus Pharmaceuticals announced it has voluntarily suspended promotion and sale of this medical food pending a request to meet with and receive safety data held by the FDA. Limbrel is a prescription medical food used to manage the metabolic processes associated with osteoarthritis.

We have been providing updates about this situation since November when the FDA issued its first warning to consumers and health professionals regarding potential adverse events, including two life-threatening health problems associated with Limbrel.

In a recent letter from Primus to the FDA, the manufacturer maintains they have complied with all the FDA requests and have provided feedback from independent medical experts stating that Limbrel’s safety is exemplary and the adverse events are not life threatening. In addition, Primus states they have informed patients and prescribers about the FDA’s concerns and safety of Limbrel. At this time, until further notice, Primus is voluntarily taking the steps outlined below and will:

  • Immediately suspend manufacturing, promotion and further shipments of current Limbrel formulations
  • Quarantine all Limbrel retail stock that is currently in Primus’ possession
  • Inform the FDA as soon as possible (after receipt of the FDA’s health hazard evaluation and the adverse events) of Primus’ decision whether to recall Limbrel formulations currently in distribution 

For more information on the statement from Primus, please click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources

  1. U.S. Food and Drug Administration Public Health Alert. FDA Alerts Consumers About Potentially Life-Threatening Health Problems Linked to Limbrel. December 5, 2017. Available at: http://s2027422842.t.en25.com/e/es?s=2027422842&e=26783&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=85238886d7da440aa96da6f23295c07d&elqaid=1627&elqat=1[Accessed 5 Dec. 2017]
  2. Limbrel. Primus Pharmaceuticals Inc.  FDA Advisory. Limbrel Safety Update. Dear Doctor Letter. November 2017. Available at: http://www.limbrel.com/downloads/fda_advisory_limbrel_safety_update_dear_doctor_november_2017.pdf.   [Accessed 5 Dec. 2017]
  3. Limbrel FDA Alert. Primus Pharmaceuticals Inc.  Available at: http://www.limbrel.com/.  [Accessed 8 Jan. 2018]