U.S. Food and Drug Administration
Office of Special Health Issues
5600 Fishers Lane, HF-12
Rockville, Maryland 20857 

As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety alerts, product approvals, announcements, upcoming meetings and resources.  We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site. 

PRODUCT SAFETY: 

FDA Announces New Safety Plan for Agents Used to Treat Chemotherapy-Related Anemia (Feb. 16)

FDA approved a risk management program to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis-Stimulating Agents (ESAs). For patients with cancer, the program is also designed to help ensure the appropriate administration of these drugs, which they receive to treat anemia that can occur as a result of chemotherapy. 

Acacia, Inc. Announces Worldwide Voluntary Recall of IV Extension Sets with BD Q-Syte™ Luer Access Device (Feb. 9)

Acacia, Inc. (formally known as MPS Acacia) has voluntarily executed a product recall of certain lots of IV Extension Sets with BD Q-Syte™ Luer Access Device.  The BD Q-Syte™ Luer Access Device is a Needleless Valve manufactured by BD (Becton, Dickinson and Company).  Use of the affected BD Q-Syte™ Luer Access Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.  

BD Announces Worldwide Voluntary Recall ofBD Q-Syte™ Luer Access Devices and BD Nexiva™ Closed IV Catheter Systems (Feb.8)

BD (Becton, Dickinson and Company) has voluntarily executed a product recall of certain lots of BD Q-Syte™ Luer Access Devices and BD Nexiva™ Closed IV Catheter Systems. Use of the affected devices may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. 

FDA Drug Safety Communication: Risk of Progressive Multifocal Leukoencephalopathy (PML) with the use of Tysabri (natalizumab) (Feb. 5)

FDA alerted the public that the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection associated with the use of Tysabri (natalizumab), increases with the number of Tysabri infusions received. 

Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical (Feb. 5) 
FDA and Thomas Medical Products Inc. notified healthcare professionals of a Class I Recall of certain lots of the product, tube-like devices placed into blood vessels to insert  pacing or defibrillator wires and catheters into blood vessels. The sheath tip may break off and separate while the sheath is inside a blood vessel.  If this occurs, the sheath tip could move through the blood vessel into organs such as the lungs and heart or, less commonly, into arteries.

Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall(Feb. 3)

Cardiac Science Corporation initiated  a worldwide voluntary recall after determining that approximately 12,200 automated external defibrillators (AEDs) may not be able to deliver therapy during a resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. 

Zyprexa (olanzapine): Use in Adolescents (Feb. 1)

Lilly and FDA notified healthcare professionals of changes to the Prescribing Information for Zyprexa related to its indication for use in adolescents (ages 13-17) for treatment of schizophrenia and bipolar I disorder [manic or mixed episodes]. 

FDA Announces Safety Risk Associated with HIV Drug (Feb. 1)

Rare, but serious, liver disorder reported in some patients 
FDA announced on January 29 that non-cirrhotic portal hypertension, a rare, but serious, liver disorder, has been reported in some HIV patients taking Videx/Videx EC (didanosine). 

For more product safety information please visit our MedWatch website. 

PRODUCT APPROVAL:  

FDA Approves New Indication for Crestor (Feb. 9) 
FDA approved the cholesterol-lowering medication Crestor (rosuvastatin) for some patients who are at increased risk of heart disease but have not been diagnosed with it.

 FDA Approves Xiaflex for Debilitating Hand Condition (Feb. 2) 
FDA approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, which can affect a person’s ability to straighten and properly use their fingers.

For more information on drug approvals, please visit Drugs@FDA 

ANNOUNCEMENTS: 

FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging (Feb. 9) 
Initiative to focus on 3 types of procedures with high radiation doses

FDA announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography. 

FDA Issues Guidance to Help Streamline Medical Device Clinical Trials (Feb. 5) 
Agency says Bayesian statistical meth