
FDA Warnings
- - The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these products should not be administered to patients.
- - The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration (FDA), is seeking a preliminary injunction in the U.S. District Court for the Eastern District of New York against New York City Fish, Inc., and several key employees for manufacturing and distributing ready-to-eat fish products under insanitary conditions causing them to become adulterated.
- - The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
- - The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.
- - On May 10, the U.S. Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was available only as a liquid-filled gel capsule.
- - The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC).
- - The U.S. Food and Drug Administration has released a new tool to help bolster the food industry’s defense measures against an act of intentional food contamination. The Food Defense Plan Builder is a comprehensive, easy-to-use software program designed to help owners and operators of food facilities—ranging from primary production and manufacturing to retail and transportation—develop customized plans to minimize the risk of intentional contamination at their individual food facilities.
- - The U.S. Food and Drug Administration is warning consumers not to consume any juice products or other beverages from Juices Incorporated (aka Juices International and Juices Enterprises) of Brooklyn, N.Y. The company's carrot and beet juice products have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause botulism, a serious and potentially fatal foodborne illness. Consumers are warned not to consume these products even if they do not look or smell spoiled.
- - The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.
- - The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.
FDA Recalls
- - The FDA has issued updated information on atypical fractures of the femur associated with the use of bisphosphonates to treat osteoporosis. These drugs include Fosamax (alendronate sodium), Actonel (risedronate sodium), Boniva (ibandronate sodium), ...
- - Actavis is recalling certain lots of the company's fentanyl transdermal patches because they may release the active ingredient faster than they should. An accelerated release of fentanyl, a strong opioid narcotic, could lead to adverse events such a...
- - FDA is informing oncologists that recent changes in how serum creatinine is measured could lead to the wrong carboplatin dose.
All clinical labs in the U.S. will soon be using a newly standardized method to measure serum creatinine -- Isotope Di...
- - The FDA has issued an update on its continuing investigation of excessive radiation exposure from CT brain perfusion scans, including expanded recommendations for radiology personnel performing these procedures.
FDA is now aware of 385 patients ...
- - The labeling for Gonadotropin-Releasing Hormone (GnRH) agonists is being updated to describe an increased risk of diabetes and certain cardiovascular diseases in patients being treated for prostate cancer. GnRH agonists are sold under a variety of b...
- - FDA is notifying healthcare professionals about updated pediatric dosing recommendations for Valcyte oral tablets and solution. Valcyte is an antiviral medication used to prevent cytomegalovirus (CMV) disease in pediatric patients who have undergone ...
- - An FDA article in the journal Nursing2009 describes problems that can arise with the use alarms on patient monitoring equipment. From 2005 through 2008, FDA received 566 reports of patient deaths related to the alarms on monitoring devices. Part of ...
- - Resectoscopes are devices used to remove tissue during endoscopy procedures. Unless they are assembled properly before each procedure, these devices can fail. For example, FDA has a report about a 2-month-old infant undergoing cystoscopy to incise ...
- - FDA is warning people not to use Hyland's Teething Tablets because they may pose a risk to babies and children. The product, which is being recalled by the manufacturer, is intended to temporarily relieve a child's teething symptoms.
Hyland's Te...
FDA Consumer Updates
- - FDA has taken steps on multiple fronts to protect consumers from the skin damage that can be caused by too much exposure to the sun. This is the first summer in which FDA's new rules governing sunscreen labeling are in effect. And FDA is supporting "Don’t Fry Day" on May 24.
- - GMOs, genetically modified organisms, biotech foods, or genetically engineered foods - whatever name they're called - seem to be a captivating topic. Learn more about them and how they are regulated in this FDA Consumer Update.
- - Pregnant and breastfeeding women can turn to FDA's Office of Women's Health for important health information, including details about the risks and benefits of taking medication during this special time.
- - Keep Listeria at bay by keeping your refrigerator temperature low and carefully cleaning kitchen surfaces.
- - Exposure to ultraviolet (UV) radiation - whether outdoors from the sun, or indoors under a sunlamp - causes damage to your skin, including skin cancer. Find out how FDA is proposing to change how it regulates sunlamps, including requiring labeling recommending that young people not use these devices.
- - This page contains links to all past Consumer Update Analytics web pages.
- - Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor discusses his concerns about the increasing number of caffeinated products and their impact on children.
- - David White, chief science officer in FDA's Office of Food and Veterinary Medicine, and Edward Cox, director of FDA's Office of Antimicrobial Products, explain the efforts FDA is making to combat the public health impact of antibiotic-resistant bacteria.
- - FDA is working to increase minority participation in the clinical trials that test new medical products. Members of minority groups are move vulnerable to certain diseases, but are under-represented in these trials.
- - A tool invented by FDA scientists is being deployed in a partnership to fight counterfeit malaria drugs. Testing is planned in Ghana. More than a third of malaria drugs in Sub-Saharan Africa and Southeast Asia are counterfeit or substandard.