Biotin (vitamin B7): Safety Communication — May interfere with lab tests. AUDIENCE: Laboratory, Health Professional, Patient ISSUE: The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. Biotin in blood or other…
FDA Investigating Possible Life-Threatening Health Problems Linked To Limbrel
Limbrel capsules by Primus Pharmaceuticals: FDA Advisory — Linked to potentially life-threatening health problems. AUDIENCE: Consumer, Health Professional ISSUE: The FDA is investigating serious adverse events involving Limbrel, a product in capsule form currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis. While a range of adverse events have…
FDA To Evaluate Heart-Related Death Risks From Takeda Gout Medicine
Febuxostat (brand name Uloric): Drug Safety Communication — FDA to evaluate increased risk of heart-related death. AUDIENCE: Rheumatology, Internal Medicine, Patient ISSUE: FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. FDA required the…
Unapproved Dermal Fillers May Cause Disfigurement, Regulators Caution
The U.S. Food and Drug Administration has issued a safety communication to warn consumers and health care practitioners about the serious injuries and disfigurement that can result from using injectable silicone or products being falsely marketed as FDA-approved dermal fillers for the purpose of enhancing the size of their buttocks, breasts, and other body parts.…
FDA Investigates ‘Adverse Events’ From Compounded Injectable Product
Compounded gutamine, arginine, and carnitine product for injection by United Pharmacy: Compounding risk alert — FDA investigates two adverse events. ISSUE: FDA received an adverse event report stating that two patients developed what is described in the report as tissue erosion at the injection site following the administration of an injectable glutamine, arginine, and carnitine…
