FDA Alerts
FDA Alerts Healthcare Providers of Recall by Med Prep Consulting
The US Food and Drug Administration is alerting healthcare providers and patients of a voluntary nationwide recall of all lots of all products produced by Med Prep Consulting Inc. of Tinton Falls, NJ, a specialty pharmacy licensed by the state of New Jersey.
FDA Investigating Risk of Pancreatitis in Type 2 Diabetes Meds
The US Food and Drug Administration (FDA) is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics.
FDA Approves Lymphoseek to Help Locate Lymph Nodes
The US 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.
Azithromycin (Zithromax or Zmax) and the Risk of Potentially Fatal Heart Rhythms
The US Food and Drug Administration (FDA) is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm.
FDA Issues Draft Guidance to Accurately Label Medical Products Not Made with Natural Rubber Latex
The US 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 Suspends Pediatric Clinical Trials of Sensipar After Report of Death
The US Food and Drug Administration (FDA) has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after the recent death of a 14-year-old patient in a trial.
FDA Approves Osphena for Postmenopausal Women Experiencing Pain During Sex
The US 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 US 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 no longer respond to other FDA-approved treatments for this disease.
FDA Approves New Treatment for Late-Stage Breast Cancer
The US Food and Drug Administration today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.
FDA Approves new Silicone Gel-Filled Breast Implant
The US 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.