The FDA claimed safety as the basis of its unilateral actions, but the incidence, severity and reversibility of these adverse events from 13 years of in-market experience stand in stark contrast to the actions taken by the FDA. From early November through mid-January, Primus fully cooperated with the FDA, during its 11 home-office inspections and many follow-up conference calls and email requests. This facility was inspected again because of the Limbrel investigation, which also resulted in no compliance issues.
Upon analysis it was apparent that either the database that the FDA sent was incomplete and represented of the reports the FDA claimed in its negative Limbrel Safety Alerts and Updates, or that the FDA had misstated the number of reports. Of note, the reports were for all types of cases and was supposed to include the 30 cases of concern regarding elevated liver enzymes and acute hypersensitivity pneumonitis.
Recognized scientific and medical experts wrote opinion letters to the FDA supporting the urgency of continued access to Limbrel. These letters are underpinned with clinical trials and real-world clinical experience, and supported with scientific and medical literature. These established that the adverse events the FDA publicized were reversible and not life threatening, based on the established safety record of Limbrel and the medical literature on the AEs in question.
Further, all patients on Limbrel are monitored by prescribers and the AEs in question are fully described in the Limbrel package insert. The fact that these and similar ingredients have been widely researched and used in medicinal products in other countries also supports biacalin and catechin's safety and effectiveness. Limbrel provides levels of these flavonoids needed to meet the distinctive nutritional requirements of people with osteoarthritis and cannot be obtained through simply changing the diet.
Each capsule of Limbrel provides mg or mg of flavocoxid and each capsule of Limbrel also contains 50 mg of citrated zinc bisglycinate, which provides 10 mg of elemental zinc. Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
Leval X, et al. Chalasani, R. Vuppalanchi, V. Navarro, R. Fontana, H. Bonkovsky, H. Barnhart, D. Kleiner, and J. A Case Series. Related Articles. Foods for Erectile Dysfunction. Arthritis Treatment Goals and Options. What's Available for Treating Rheumatoid Arthritis?
What Are Digestive Enzymes? What Is Butea Superba? What Is Serrapeptase Silkworm Enzyme? The labeling states that the products contain two types of flavonoids: baicalin from Scutellaria baicalensis and catechin from Acacia catechu. Some dosages also contain zinc. The FDA has concerns with all Limbrel products, including those with and without zinc. If you have experienced any of the above-mentioned symptoms or other health problems while taking Limbrel, work with your health care provider to report your symptoms to the FDA through the MedWatch Safety Information and Adverse Event Reporting Program.
Health care providers who are aware that their patients are taking Limbrel should advise them to immediately stop taking the product. If your patients have experienced any of the above-mentioned symptoms or other health problems while taking Limbrel, the FDA encourages you to work with them to provide clinical information through the MedWatch Safety Information and Adverse Event Reporting Program.
The agency will update this page as more information becomes available.
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