The U.S. Food and Drug Administration today approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children older than 6 years who have had inadequate response to conventional therapy.
Category Archives: Drug Safety Information Podcasts
FDA: Over-the-counter asthma inhalers containing chloroflouorocarbons (CFCs) will no longer be made or sold after Dec. 31, 2011
The U.S. Food and Drug Administration says users of epinephrine inhalers containing chlorofluorocarbons (CFCs) should plan now to get a prescription for a replacement product because these inhalers will not be made or sold after Dec. 31, 2011.
FDA confirms Listeria monocytogenes on Jensen Farms’ Rocky Ford-brand cantaloupes
Today, the Food and Drug Administration announced that it found Listeria monocytogenes in samples of Jensen Farms’ Rocky Ford-brand cantaloupe taken from a Denver-area store and on samples taken from equipment and cantaloupe at the Jensen Farms’ packing facility. Tests confirmed that the Listeria monocytogenes found in the samples matches one of the three different strains of Listeria monocytogenes associated with the multi-state outbreak of listeriosis.
FDA Drug Safety Podcast for Healthcare Professionals: Abnormal heart rhythms may be associated with use of Zofran (ondansetron)
On September 15, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public of an ongoing safety review of the anti-nausea drug Zofran, active ingredient ondansetron, ondansetron hydrochloride and their generics.
FDA establishes foodborne illness outbreak response network
The U.S. Food and Drug Administration (FDA) announced today a streamlined, integrated approach to effectively and rapidly respond to human and animal foodborne illness outbreaks: the FDA Coordinated Outbreak Response and Evaluation (CORE) Network.
FDA: Minnesota companies agree to halt sale of amino-acid products with unapproved claims
The U.S. Food and Drug Administration announced today that two Minnesota companies have agreed to halt distribution of amino-acid products marketed to treat a number of diseases, until requirements of the Federal Food, Drug, and Cosmetic Act are met.
FDA investigates multistate outbreak of listeriosis
The U.S. Food and Drug Administration is working closely with the Centers for Disease Control and Prevention and state health agencies to investigate a multi-state outbreak of listeriosis.
FDA announces changes in drug center’s oncology office
Today, the U.S. Food and Drug Administration announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies. The Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products has been reorganized and renamed the Office of Hematology and Oncology Products (OHOP).
FDA warns consumers of botulism risk in La Ruche tapenade, spreadable tomato paste
The FDA is warning consumers not to eat tapenade or spreadable dried tomato paste manufactured by the French food company La Ruche. French health authorities have reported an outbreak of botulism in France linked to the company’s products sold under the brand names “Les délices de Marie-Claire,” “Terre de Mistral” and Les Secrets d’Anaïs.” Eight adults are currently suffering from respiratory failure as a result of eating foods containing the neurotoxin produced by Clostridium botulinum.
FDA: Pilot projects to explore ways to trace sources of foodborne illness
The U.S. Food and Drug Administration today said that two new pilot projects will enhance the agency’s and industry’s ability to trace products responsible for foodborne illness outbreaks.