The U.S. Food and Drug Administration announced today that it has approved Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) to treat patients showing signs of botulism following documented or suspected exposure to botulinum neurotoxin. The product is derived from horse plasma and contains a mixture of antibody fragments that neutralize all of the seven botulinum nerve toxin serotypes known to cause botulism.
Category Archives: Drug Safety Information Podcasts
FDA alerts health care providers and patients of the nationwide recall of all lots of sterile products distributed by Clinical Specialties Compounding Pharmacy
The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary recall of all lots of sterile products produced and distributed by Clinical Specialties Compounding Pharmacy (CSCP) of Augusta, Ga. The recall of all sterile products is due to the FDA’s preliminary findings of practices at the site which raise concerns about a lack of sterility assurance. This expanded recall is due to reports of five patients who have been diagnosed with serious eye infections associated with use of Avastin (bevacizumab) repackaged into syringes by CSCP.
FDA approves Dotarem, a new magnetic resonance imaging agent
The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey
The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of all products produced by Med Prep Consulting Inc. of Tinton Falls, N.J, a specialty pharmacy licensed by the State of New Jersey. The recall was announced after health care providers at a hospital in Connecticut observed floating particles, later identified to be a fungus, in five bags of magnesium sulfate intravenous solution.
FDA warns consumers not to eat certain ProtiDiet High Protein Chocolate Dream Bars manufactured by Pro-Amino International, Inc., Quebec, Canada
Pro-Amino International Inc., of Saint-Eustache, Quebec, Canada, is recalling the ProtiDiet High Protein Chocolate Dream Bars. The recalled product may contain Salmonella.
Federal judge approves consent decree with New Jersey bakery
The U.S. Food and Drug Administration announced that a federal judge has approved a consent decree of permanent injunction against Butterfly Bakery Inc., a bakery based in Clifton, New Jersey, and its president, Brenda Isaac, for unlawfully distributing misbranded food products, such as muffins and snack cakes.
FDA approves Lymphoseek to help locate lymph nodes in patients with certain cancers
The U.S. Food and Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.
FDA issues draft guidance for manufacturers to accurately label medical products that are not made with natural rubber latex
The U.S. Food and Drug Administration today issued draft recommendations to medical product manufacturers for providing consumers with accurate information about products that are not made with natural rubber latex (NRL).
FDA approves Osphena for postmenopausal women experiencing pain during sex
The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
FDA approves Stivarga for advanced gastrointestinal stromal tumors
The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and that no longer respond to other FDA-approved treatments for this disease.