Although many different adverse events have been reported to the FDA, two are potentially life threatening: drug-induced hepatotoxicity and hypersensitivity pneumonitis. The FDA has received reports of 194 adverse events for Limbrel, of which 57 cases contained enough information for further detailed analysis of whether Limbrel was associated with the adverse event. In 30 of these cases, causality of the adverse event existed.
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On Nov. 8, 2017, the FDA contacted Primus Pharmaceuticals, the manufacturer of Limbrel, and requested information about its formula, which is now being reviewed. Presently, the FDA has alerted patients and healthcare providers about the potential effect to health and is advising patients not to use this treatment. The FDA will share updates when they are available.
Patients should immediately stop taking Limbrel and contact their healthcare provider. If patients develop any symptoms, such as jaundice, nausea, fatigue, gastrointestinal discomfort, fever, chills, headache, cough, chronic bronchitis, shortness of breath, trouble breathing and/or fatigue, while taking Limbrel, report them to a healthcare professional. An FDA Med Watch form should also be submitted through the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- U.S. Food and Drug Administration. Limbrel capsules by Primus Pharmaceuticals: FDA Advisory—linked to potentially life-threatening health problems. 2017 Nov. 21.