The U.S. Food and Drug administration is warning consumers to stop using a dietary supplement for muscle growth linked to serious liver injury.
Category Archives: Drug Safety Information Podcasts
FDA approves breath test to aid in diagnosis of delayed gastric emptying
The U.S. Food and Drug Administration today approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test to aid in the diagnosis of delayed gastric emptying, known as gastroparesis.
Massachusetts dairy operation agrees to permanent injunction to prevent illegal drug residues in animals sold for food
On April 3, 2015, the U.S. District Court for the District of Massachusetts on behalf of the U.S. Food and Drug Administration has filed a consent decree of permanent injunction against Michael P. Ferry Inc., a dairy operation located in Westport, Massachusetts, and owner Michael P. Ferry after the FDA documented multiple violations of federal food laws.
FDA alerts health care professionals and patients not to use products from the Prescription Center pharmacy in Fayetteville, N.C.
The U.S. Food and Drug Administration is joining the North Carolina Board of Pharmacy (NC BOP) to urge health care professionals, including veterinarians, and patients not to use products made and distributed by the Prescription Center pharmacy, located at 915 Hay St., Fayetteville, North Carolina.
FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids
The U.S. Food and Drug Administration today issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.
FDA expands use of CoreValve System for aortic “valve-in-valve” replacement
The U.S. Food and Drug Administration today expanded the approved use of the CoreValve System to treat certain patients who have previously had a tissue aortic valve replacement and are in need of a second one.
California seafood company to cease production of adulterated fish
At the request of the U.S. Food and Drug Administration, a judge has ordered L.A. Star Seafood Company Inc., located in Los Angeles, and its owners, Sima and Sam Goldring, to halt operations until they demonstrate to the FDA that they can process food in compliance with food safety laws and regulations.
FDA approves new treatment for diabetic retinopathy in patients with diabetic macular edema
The U.S. Food and Drug Administration today expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema.
FDA approves treatment for inhalation anthrax
The U.S. Food and Drug Administration today approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.
FDA approves blood pump system to help patients maintain stable heart function during certain high-risk cardiac procedures
The U.S. Food and Drug Administration today approved the Impella 2.5 System, a miniature blood pump system intended to help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention (HRPCI) procedures, such as balloon angioplasty and stenting, which re-open coronary arteries that are narrowed or blocked due to severe coronary artery disease (CAD).