Notebook

FDA Updates

 

FDA Warnings

  1. FDA and industry reach agreement in principle on medical device user fees - The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.
  2. FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer - The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.
  3. FDA approves Kalydeco to treat rare form of cystic fibrosis - The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.
  4. FDA takes action against New York cheese manufacturer - The U.S. Food and Drug Administration is asking a federal court to prevent a New York cheese manufacturer from operating because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria.
  5. FDA approves new treatment for most common type of skin cancer - Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).
  6. FDA approves Inlyta to treat patients with a type of advanced kidney cancer - The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.
  7. Department of Justice files Consent Decree of Permanent injunction against Ranbaxy - Generic drug manufacturer agrees to remedy deviations from the current good manufacturing practice requirements and to correct data integrity problems at numerous facilities
  8. Maine company holds cold smoked salmon product after FDA order - A Maine food processing and storage company destroyed its cold smoked salmon product under the supervision of the U.S. Food and Drug Administration after inspectors found Listeria monocytogenes within the firm’s facility and on processing equipment
  9. FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri - Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD).
  10. FDA approves Voraxaze to treat patients with toxic methotrexate levels - The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure. Methotrexate is a commonly used cancer chemotherapy drug normally eliminated from the body by the kidneys. However, patients receiving high doses of methotrexate may develop kidney failure.

 

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. Consumer Update Analytics - This page contains links to all past Consumer Update Analytics web pages.
  2. FDA's MedWatch Safety Alerts: December 2011 - FDA gives updated safety information on ADHD drugs and heart disease in adults, dietary supplements that could be contaminated with Salmonella, and a blood thinner that may lead to bleeding problems. Learn about these and other safety alerts at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucmXXXXXX.htm
  3. Jan. 18 Webinar: Reporting Bad Reactions From Cosmetics - Learn how to report a bad reaction to a beauty, personal hygiene or makeup product. Click here to find out how to connect to this 30-minute webinar.
  4. FDA Warns About Stem Cell Claims - Don't be fooled by unscrupulous people who offer hope through unapproved stem cell therapies for diseases or conditions for which few treatments exist.
  5. FDA Targets Risks From Reused Medical Devices - The Food and Drug Administration is taking steps to ensure that reusable medical devices, especially endoscopes, are properly cleaned and disinfected to reduce the risk of infection.
  6. FDA's MedWatch Safety Alerts: November 2011 - FDA warns about a home massager that has caused a death, and gives updated safety information on ADHD drugs and heart disease in children, and TNF blocker drugs that have been linked to reports of cancer. Learn about these safety alerts and others: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm283962.htm
  7. Know Concentration Before Giving Acetaminophen to Infants - FDA is urging consumers to examine the labels of liquid infant's acetaminophen to avoid giving the wrong dose as a less concentrated form of the popular medicine arrives in stores.
  8. FDA Targets Gastric Band Weight-Loss Claims - Beware of ads that glamorize this surgery without giving the risks. Learn more at www.fda.gov/ForConsumers/ConsumerUpdates/ucm279301.htm
  9. FDA Widens Look at Arsenic in Apple Juice - FDA is enhancing its surveillance of arsenic in apple juice while remaining confident in the overall safety of this juice for consumers.
  10. FDA and Partners Working to Prevent Surgical Fires - The Food and Drug Administration (FDA) is building a coalition of public and private healthcare organizations to prevent a medical error - the surgical fire.