Notebook

FDA Updates

 

FDA Warnings

  1. FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy - 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.
  2. FDA seeks preliminary injunction against New York fish manufacturer - 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.
  3. FDA approves Simponi to treat ulcerative colitis - 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.
  4. FDA approves new drug for advanced prostate cancer - 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.
  5. FDA approves Nymalize--first nimodipine oral solution for use in certain brain hemorrhage patients - 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.
  6. FDA approves first companion diagnostic to detect gene mutation associated with a type of lung cancer - 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).
  7. FDA releases new tool to help prevent intentional food contamination - 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.
  8. FDA warns consumers about potential health risk with Juices Incorporated juice products - 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.
  9. FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease - 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.
  10. FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop - 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

  1. Recalls and Safety Alerts: Update on Femur Fracture Risk with Bisphosphonates - 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), ...
  2. Recalls and Safety Alerts: Recall of Actavis Fentanyl Patches - 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...
  3. Recalls and Safety Alerts: New Precaution when Calculating Carboplatin Doses - 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...
  4. Recalls and Safety Alerts: Update on Radiation Overdoses from CT Perfusion - 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 ...
  5. Recalls and Safety Alerts: Diabetes/Cardiovascular Risk with Prostate Cancer Drugs - 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...
  6. Recalls and Safety Alerts: New Pediatric Dosing Recommendations for Valcyte - 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 ...
  7. Preventing Medical Errors: Alarming Monitor Problems - 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 ...
  8. Preventing Medical Errors: Avoiding Patient Injuries with Resectoscopes - 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 ...
  9. FDA Consumer Corner: Stop Using Hyland?s Teething Tablets - 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

  1. Stay Safe in the Summer Sun - 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.
  2. FDA's Role in Regulating Safety of GE Foods - 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.
  3. Pregnancy: A Time for Special Caution - 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.
  4. Keep Listeria Out of Your Kitchen - Keep Listeria at bay by keeping your refrigerator temperature low and carefully cleaning kitchen surfaces.
  5. Know the Risks of Indoor Tanning - 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.
  6. Consumer Update Analytics - This page contains links to all past Consumer Update Analytics web pages.
  7. FDA to Investigate Added Caffeine - 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.
  8. Fighting the Impact of Antibiotic-Resistant Bacteria - 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.
  9. Clinical Trials Shed Light on Minority Health - 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.
  10. FDA Invention Fights Counterfeit Malaria Drugs - 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.