Yahoo

FDA urges maker to recall Limbrel after liver and lung injury reports

The FDA lifted a clinical hold on Sarepta’s early-stage clinical trial for a gene therapy for Duchenne muscular dystrophy, putting the company's plans back on schedule. The Food and Drug ...
Capitalbolsa

Primus Announces A Voluntary Nationwide Recall Of All Lots Within Expiry Of Prescription Medical Food Limbrel® Due To Rare But Serious And Reversible Adverse Events While ...

SCOTTSDALE, Ariz., Jan. 26, 2018 /PRNewswire/ -- Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) ...
Becker's Hospital Review

Primus Pharma halts production, marketing of Limbrel in response to FDA safety concerns

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, ...
Medical Xpress

Arthritis treatment linked to liver problems in study

(HealthDay) -- A "medical food" called Limbrel, which doctors prescribe to treat osteoarthritis of the knee, was linked to several cases of liver disease in a small study, but the effects so far seem ...
Monthly Prescribing Reference

FDA: Potentially Life-Threatening Adverse Events Linked to Limbrel

The FDA is continuing to investigate Primus Pharmaceuticals and the manufacturing process for Limbrel, and will share updates as they become available. The Food and Drug Administration (FDA) has ...
Reuters

‍U.S. FDA says is advising consumers not to use Limbrel

* ‍FDA - is issuing warning on use of Limbrel because of its investigation into a rise in cases of serious adverse events * ‍FDA says serious adverse events from use Limbrel include drug-induced liver ...