U.S. Food and Drug Administration Updates for Health Professionals
As part of the FDA’s efforts to keep health professionals informed about FDA issues, below is 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. (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 (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 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.
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.
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 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 issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.
Commissioner Hamburg announced the launch of a new risk-assessment tool to ensure the safety of imported food and drugs. The web-based PREDICT system will rank the risk hazards of food and drugs as they enter the country and allow inspectors to focus on the most likely threats to public health.
FDA Collaboration Seeks to Speed Development of Pneumococcal Vaccines for Children in Developing Countries (Feb. 1)
PATH supports FDA advancement of a key step in vaccine development
FDA announced a collaboration with PATH to advance development of a vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia.