FDA Updates for Health Professionals -- August 15, 2012

U.S. Food and Drug Administration
Office of Special Health Issues
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
August 15, 2012

Dear Colleague,
PRODUCT SAFETY:
Codeine use in certain children: Safety Communication - Use after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death (Aug 15)
The FDA is reviewing reports of children who developed serious adverse effects or died after taking codeine for pain relief after tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome.
Covidien Shiley Adult Tracheostomy Tubes: Class I Recall - Reports Of Volume Leakage And/or Disconnection Between The Inner And Outer Cannulae (Aug 15)
Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to reports of volume leakage and/or disconnection between the inner and outer cannulae, which were observed during mechanical ventilation of patients.
July 2012 Monthly Safety Labeling Changes (Aug 10)
The monthly safety labeling changes includes 41 products with revisions to Prescribing Information.
Stryker Wingspan Stent System: Safety Communication - Narrowed Indications for Use (Aug 8)
The FDA is informing health care providers and patients that the indications for use and labeling for the Wingspan stent have changed to limit the use of Wingspan to a narrow, select group of patients and conditions.
For more product safety information, please visit our MedWatch website
PRODUCT APPROVALS:
FDA approves vaccine formulation for 2012-2013 influenza season (Aug 13)
FDA announced that it has approved the 2012-2013 influenza (flu) vaccine formulation for all six manufacturers licensed to produce and distribute the vaccines in the United States.
FDA approves Lucentis to treat diabetic macular edema (Aug 10)
FDA approved Lucentis (ranibizumab injection) for the treatment of diabetic macular edema, a sight-threatening eye disease that occurs in people with diabetes.
FDA approves Marqibo to treat rare type of leukemia (Aug 9)
FDA approved Marqibo (vincristine sulfate liposome injection) to treat adults with a rare type of leukemia called Philadelphia chromosome negative acute lymphoblastic leukemia.
FDA approves first generic versions of Singulair to treat asthma, allergies (Aug 3)
FDA approved the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies. 
FDA approves Zaltrap for metastatic colorectal cancer (Aug 3)
FDA approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer.
For information on drug approvals, please visit Drugs@FDA at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:
Proposed Rule: Unique Device Identification System (UDI)
FDA is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act by section 226 of the Food and Drug Administration Amendments Act of 2007.
Reclassification from schedule 3 to 2, of combination hydrocodone productsOctober 29-30, 2012 Drug Safety and Risk Management (DsaRM) Advisory Committee Meeting will discuss the reclassification from schedule 3 to 2, of combination hydrocodone products. The Committee will discuss the potential for abuse of drugs containing hydrocodone either combined with other analgesics or as an antitussive.  FDA opened docket number FDA-2012-N-0548. Submit comments by November 6, 2012.
UPCOMING MEETINGS:
Gastrointestinal Drugs Advisory Committee Meeting (Aug 28)
Abbott's Humira, for reducing signs and symptoms, and achieving clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
Anti-Infective Drugs Advisory Committee Meeting (Sept 5)
Novartis Pharmaceuticals' tobramycin inhalation powder for the management of cystic fibrosis patients infected with the bacterium Pseudomonas aeruginosa.
Pediatric Advisory Committee Meeting (Sept 11)
Discuss pediatric-focused safety reviews for Kapvay, Vyvanse, Ofirmev, ella, Beyaz, LoLoestrin Fe, Aridol, Augmentin XR, Afinitor, Moxeza, and Lastacaft. Discuss the safety of and the ongoing propriety of the humanitarian device exemption for the Melody Transcatheter Pulmonary Valve and Ensemble Delivery System and the Elana Surgical Kit.
Cardiovascular and Renal Drugs Advisory Committee Meeting (Sept 13)
Cardiokine Biopharma's lixivaptan for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone; West-Ward Pharmaceutical's phenylephrine hydrochloride injection to increase blood pressure in acute hypotensive states.
Cardiovascular and Renal Drugs Advisory Committee Meeting (Sept 14)
Novartis Pharmaceuticals' imatinib mesylate for the treatment of pulmonary arterial hypertension to improve exercise capacity and cardio-pulmonary hemodynamics in patients who remain symptomatic despite treatment with two or more approved vasodilator therapies.
Public Meeting - Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices (Sept 27-28)
The Food and Drug Administration (FDA) is announcing a public meeting entitled "Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices." The purpose of this meeting is to obtain input from academia, Government, industry and other stakeholders on the clinical application and scientific and technological challenges for performance validation of radiation biodosimetry devices.
Public Workshop - Medical Countermeasures (MCM) for a Burn Mass Casualty Incident (Sept 27-28)
The Food and Drug Administration (FDA) is announcing a public workshop entitled “Medical Countermeasures (MCM) for a Burn Mass Casualty Incident.” This workshop will engage stakeholders across the public and private sector in strategic dialogue related to development, evaluation, deployment and monitoring of medical countermeasures to mitigate the adverse health consequences arising from public health emergencies, specifically those involving radiological, nuclear or chemical threats.
FDA 2nd Annual Health Professional Organizations Conference (Oct 4)
The aim of the conference is to further the public health mission of the FDA through training, collaboration, and structured discussion between health professional organizations and FDA staff.
Drug Safety and Risk Management Advisory Committee Meeting (Oct 29-30)
Discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive.
Public Workshop - ASTM-FDA Workshop on Absorbable Medical Devices: Lessons Learned from Correlations of Bench Testing and Clinical Performance (Nov 28)
The Food and Drug Administration (FDA) is announcing a public Workshop entitled "ASTM-FDA Workshop on Absorbable Medical Devices: Lessons Learned from Correlations of Bench Testing and Clinical Performance." FDA is co-sponsoring the workshop together with ASTM International, an organization responsible for the development and delivery of international voluntary consensus standards.
Please visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops. 
RESOURCES: 
Continuing Education
Safe Disposal CE - Continuing Education Program for Nurses: August 23, 2012 1:00 pm - 2:00 pm eastern time
Mark your calendar for the upcoming continuing education program, “Safe Disposal of Medications and Sharps in the Home Setting”, a joint effort of the American Nurses Association and FDA.
Medscape CME/CE: Your Patient Has an Adverse Reaction to a Drug: How to Report to FDA's MedWatch (Released Jul 9)
This article is the first in a series of activities in collaboration with FDA and Medscape Education on how to report safety issues to the FDA and how these reports are used to ensure safe use of drugs and medical products.
Medscape CME/CE: Introducing the REMS Program for the Transmucosal Immediate-Release Fentanyl Products (Released Jun 29)
The goal of this activity is to provide education about the risk evaluation and mitigation strategy for the transmucosal immediate-release fentanyl products.
Medscape CME/CE: Risk Evaluation and Mitigation Strategies: An Introduction for Physicians, Nurses, and Pharmacists (Released May 15)
The goal of this activity is to provide education to clinicians and pharmacists about risk evaluation and mitigation strategies.
Videos
A Short Tutorial on REMS: The FDA PerspectiveFeaturing Dr. Gerald Dal Pan, Acting Director, FDA Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research
Interviews
At-Home Rapid HIV Testing: An Interview With FDAFeaturing Elliot Cowan, PhD, Chief, Product Review Branch, Division of Emerging and Transfusion Transmitted Diseases, Center for Biologics Evaluation and Research
Other Resources
Consumer UpdatesTimely and easy-to-read articles covering all FDA activities and regulated products
- CORE Has an Action Packed First Year
- Outsmarting Poison Ivy and Other Poisonous Plants
- Improving Access to HIV/AIDS Drugs Abroad
MedSun Medical Product Safety NetworkThe Medical Product Safety Network (MedSun) improves FDA’s understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The MedSun Web page is a newsletter-based website which provides monthly updates about timely medical device issues that may impact patient safety.
FDA VoiceFDA Voice is the official blog from FDA's senior leadership and staff. FDA Voice is a new forum and through upcoming blog posts you will find news, background, announcements and other information about the work done at the FDA on behalf of the American public.
- Information Technology, Tools, Tobacco Products and Public Health

As part of our ongoing efforts to keep you informed about FDA issues, we want to make you are aware of recent safety alerts, announcements, opportunities to comment on policy issues, product approvals, 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. 
Best regards,
Office of Special Health Issues
Food and Drug Administration