Food and Drug Adminstration (FDA): Patient Safety News

Recalls and Safety Alerts: Update on Femur Fracture Risk with Bisphosphonates

12/31/2010 11:00 PM
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), ...

Recalls and Safety Alerts: Recall of Actavis Fentanyl Patches

12/31/2010 11:00 PM
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...

Recalls and Safety Alerts: New Precaution when Calculating Carboplatin Doses

12/31/2010 11:00 PM
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...

Recalls and Safety Alerts: Update on Radiation Overdoses from CT Perfusion

12/31/2010 11:00 PM
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 ...

Recalls and Safety Alerts: Diabetes/Cardiovascular Risk with Prostate Cancer Drugs

12/31/2010 11:00 PM
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...

Recalls and Safety Alerts: New Pediatric Dosing Recommendations for Valcyte

12/31/2010 11:00 PM
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 ...

Preventing Medical Errors: Alarming Monitor Problems

12/31/2010 11:00 PM
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 ...

Preventing Medical Errors: Avoiding Patient Injuries with Resectoscopes

12/31/2010 11:00 PM
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 Consumer Corner: Stop Using Hyland?s Teething Tablets

12/31/2010 11:00 PM
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...

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