FDA Updates for Health Professionals -- July 18, 2012

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

Dear Colleague,
July 18, 2012
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.

PRODUCT SAFETY: 
Hospira Injectable Drug Products: Recall - Visible Particulates from Defective Glass Vials (Jul 16)Hospira and FDA notified healthcare professional of a nationwide recall of certain injectable drug products, due to visible particles embedded in the glass located at the neck of the vial.
Maquet Medical Systems USA FLOW-i Anesthesia System: Class 1 Recall - Device Field Correction (July 11)FDA notified healthcare professionals of a Class I Recall of the Maquet Medical Systems USA FLOW-i Anesthesia System (software). A technical alarm may be generated on the FLOW-i system when using the Manual/Automatic (MAN/AUTO) switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the "on" or "off" position but remains in between the two positions.
Alere Triage Diagnostic Tests (Multiple Tests): Class I Recall - Potential for Significantly Decreased Precision (Jul 11)FDA notified healthcare professionals of a Class I Recall of Alere Triage products. Identified lots may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results.
GE Healthcare Aestiva/5 7900 Ventilator - Class 1 Recall - Potential for Unrecognized Overdose (Jul 11)FDA notified healthcare professionals of a Class I Recall of the GE Healthcare Aestiva/5 7900 Ventilator. There is a potential for two vaporizers to deliver each agent at the same time.
iFlora Kids Multi-Probiotic and iFlora 4-Kids Powder Dietary Supplements: Recall - Possible Salmonella Contamination (Jul 10)Sedona Labs announced that its supplier of Galactooligosaccharide (GOS) has recalled this ingredient due to a possible Salmonella contamination.
Leucovorin Calcium Injection (Bedford Laboratories): Recall - Visible Particulate Matter (Jul 6)Bedford Laboratories issued a nationwide recall of three lots of Leucovorin Calcium Injection, due to the discovery of visible crystalline particulate matter in a small number of vials. To date, there have been no reports of any adverse events for the lots being recalled
CareFusion Airlife Infant Breathing Circuit: Class I Recall - Potential for Leak in Closed Ventilation System (Jul 6)FDA notified healthcare professionals of the Class 1 recall of the Airlife infant breathing circuit due to the risk that the Y-adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system.
Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicator: Safety Communication – Potential Risk of Infection (Updated Jul 6)The FDA issued a clarification for personnel at facilities that utilize Sterrad sterilizers. The voluntary recall is for only certain lots of Sterrad Cyclesure 24 Biological Indicators.
-Spanish Version: Comunicado de la FDA sobre la seguridad de los medicamentos: Nueva información sobre la prolongación del intervalo QT con ondansetrón (Zofran)El 29 de julio, La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) está informando a los profesionales de la salud y al público que los resultados preliminares de recientes pruebas clínicas indican que una sola dosis intravenosa de 32 mg de ondansetrón (Zofran, hidrocloruro de ondansetrón y genéricos) puede alterar la actividad eléctrica del corazón (prolongación del intervalo QT), lo cual puede predisponer a los pacientes a producir un ritmo cardiaco anormal y potencialmente mortal conocido como Torsade de Pointes.
For more product safety information, please visit our MedWatch website
 
PRODUCT APPROVALS:
FDA approves weight-management drug Qsymia (Jul 17)FDA approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie diet and exercise for chronic weight management.
FDA approves new colon-cleansing drug for colonoscopy prep (Jul 17)The FDA approved Prepopik (sodium picosulfate, magnesium oxide and citric acid) to help cleanse the colon in adults preparing for colonoscopy.One dose of Prepopik consists of two packets of powder, each dissolved in cold water and taken at separate times. Patients should take Prepopik the night before colonoscopy and the morning of colonoscopy (Split-Dose regimen). If this is not possible, patients may take Prepopik in the afternoon and evening before the colonoscopy (Day-Before regimen).
FDA approves first drug for reducing the risk of sexually acquired HIV infection (Jul 16)FDA approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners.
FDA approves genetic test to help some colon cancer patients, physicians considering Erbitux therapy (Jul 6)FDA approved the first genetic test that can help some colorectal cancer (CRC) patients and their doctors determine if the drug Erbitux (cetuximab) would be an effective treatment based on the absence of a gene mutation.
FDA approves first DNA test to help manage CMV infection in organ transplant patients (Jul 5)FDA approved the first DNA test to help health care professionals gauge the progress of anti-viral treatment in solid organ transplant patients undergoing cytomegalovirus (CMV) antiviral therapy.                                          

For information on drug approvals, please visit Drugs@FDA 
OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:
Draft Guidance for Industry and FDA Staff Medical Devices: The Pre-Submission Program and Meetings with FDA Staff (Jul 13)The purpose of this guidance is to update the pre-IDE program to reflect this broader scope and make important modifications to reflect changes in the premarket program areas as a result of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85). You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
Proposed Rule: Unique Device Udientification System (UDI) The FDA is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Request for Comments: Assessment Program for the Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act VThe Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (the
Program). Submit electronic or written comments by August 6, 2012.
Draft Guidance for Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Labeling for Products That Contain Acetaminophen This draft guidance provides drug manufacturers alternative liver warning labeling to minimize potential consumer confusion and to ensure appropriate dosing of over-the-counter acetaminophen-containing products. Submit either electronic or written comments on the draft guidance by September 4, 2012.
Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence RecommendationsFDA is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. Submit either electronic or written comments on the draft and revised draft product-specific BE recommendations listed in this notice by August 13, 2012.
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.
Draft Guidance for Industry and Food and Drug Administration Staff - Pediatric Information for X-ray Imaging Device Premarket NotificationsThe Agency intends for this guidance to minimize uncertainty during the premarket review process of 510(k)s for x-ray imaging devices for pediatric use, to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notifications, and to provide recommendations on information to support such indications. Submit either electronic or written comments by September 7, 2012.
Draft Guidance for Industry on Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint To Support Accelerated ApprovalThis draft guidance is intended to assist applicants in designing trials to support marketing approval of drugs to treat breast cancer in the neoadjuvant setting using pathologic complete response as a surrogate endpoint that could support approval under the accelerated approval regulations.  Submit either electronic or written comments on the draft guidance by July 30, 2012.
ANNOUNCEMENTS: 
FDA seeks to halt production, distribution of dietary supplements at NY company (Jul 13)FDA is seeking an injunction requiring Kabco Pharmaceuticals Inc., and owner Abu Kabir, of Amityville, N.Y., to stop producing and distributing dietary supplements until they comply with the Federal Food, Drug and Cosmetic Act and current good manufacturing practice (cGMP) requirements for dietary supplements.
FDA introduces new safety measures for extended-release and long-acting opioid medications (Jul 9)FDA approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids, highly potent drugs approved for moderate to severe, persistent pain that requires treatment for an extended period.
FDA MedWatch Safety Labeling Changes (Jun 2012)The MedWatch June 2012 Safety Labeling Changes posting includes 35 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT
Consumer UpdatesTimely and easy-to-read articles covering all FDA activities and regulated products
-FDA Approves First Medication to Reduce HIV Risk
-Genome Project for Food Pathogens Launched
-FDA Works to Reduce Risk of Opioid Pain Relievers
-First Home-Use HIV Kit Approved for Self-Testing
-How Long Should You Take Osteoporosis Drugs?
-Should You Put Sunscreen on Infants? Not Usually

UPCOMING MEETINGS:
Oncologic Drugs Advisory Committee Meeting (Jul 24)
Oncologic Drugs Advisory Committee Meeting (Jul 25)
Dermatologic and Ophthalmic Drugs Advisory Committee Meeting (Jul 26)
Gastrointestinal Drugs Advisory Committee Meeting (Aug 28)
Drug Safety and Risk Management Advisory Committee Meeting (Oct 29-30)
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: 
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 the Food and Drug Administration (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.
FDA's Clinical Investigator Training CourseTo help develop a cadre of well-trained investigators, FDA has launched a Clinical Investigator Training Course targeted at medical professionals (experts who sign FDA Form 1572 before participating in an investigation).
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
-BioCentury This Week Interview: Patient-Centered Regulation. FDA’s Richard Klein on integrating patient advocates into a formal agency framework for risk-benefit decisions. National Health Council’s Marc Boutin on how benefit-risk is at the “intersection of data and values.”
Other Resources
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.
For Health Professionals
Additional information for Health Professionals may be found on FDA’s Health Professional website.
 
FDA Voice
FDA 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.
-FDA’s Mini-Sentinel exceeds 100 million lives (and counting) (Jun 29)A major Milestone in developing a Nationwide rapid-response electronic medical product safety surveillance program.
 
Best regards,

Office of Special Health Issues
Food and Drug Administration