The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfield, Ill., due to reports of anaphylaxis, a serious and life-threatening allergic reaction. Omontys is used to treat anemia in adult dialysis patients.
Category Archives: Drug Safety Information Podcasts
FDA approves new treatment for late-stage breast cancer
The U.S. Food and Drug Administration today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.
FDA enters into consent decree with Chicago sprout producer due to unsanitary conditions
U Joo Foods, a Chicago sprout grower and processor and the company’s owner and president, Kiyoung Chin have agreed to enter into a consent decree of permanent injunction sought by the Justice Department on behalf of the U.S. Food and Drug Administration.
FDA seeks input on minimizing disruptions to medical device supply chain during extreme weather events
Today the U.S. Food and Drug Administration is seeking input from industry and the public on the effects of extreme weather and natural disasters on the production and supply of medical devices. The FDA will use the information to identify steps that the agency, manufacturers, and the public can take to prepare for such events.
FDA approves new silicone breast implant
The U.S. Food and Drug Administration today approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. Natrelle 410 implants are manufactured by Allergan, Inc.
FDA approves first retinal implant for adults with rare genetic eye disease
The U.S. Food and Drug Administration today approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa (RP). The device, which includes a small video camera, transmitter mounted on a pair of eyeglasses, video processing unit (VPU) and an implanted retinal prosthesis (artificial retina), replaces the function of degenerated cells in the retina (a membrane inside the eye) and may improve a patient’s ability to perceive images and movement. The VPU transforms images from the video camera into electronic data that is wirelessly transmitted to the retinal prosthesis.
U.S. Marshals seize drug products distributed by a Florida company
U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration, today seized tainted dietary supplements from Globe All Wellness, LLC (Globe All), in Hollywood, Fla. The products may be unsafe because they contain an undisclosed active pharmaceutical ingredient.
FDA Commissioner Margaret A. Hamburg’s Statement on the Institute of Medicine’s Report “Countering the Problem of Falsified and Substandard Drugs”
The U.S. Food and Drug Administration commends the Institute of Medicine (IOM) for its thorough discussion and recommendations outlined in its report, “Countering the Problem of Falsified and Substandard Drugs.” The report identifies causes and public health consequences of substandard and falsified drugs and recommends a range of strategies to address the problem and to promote global dialogue and action.
Court shuts down U.S. operations of California drug, dietary supplement manufacturer
A federal judge has ordered a California company and its owner to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act (the Act).
FDA approves Pomalyst for advanced multiple myeloma
The U.S. Food and Drug Administration today approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.