FDA Updates for Health Professionals -- July 05, 2012

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

Dear Colleague,
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: 
Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicator: Safety Communication – Potential Risk of Infection (Jul 3)
An FDA review of ASP data showed that the Sterrad Cyclesure 24 Biological Indicators cannot effectively monitor the sterilization process throughout the indicated 15-month shelf life. After reviewing additional ASP data, the FDA believes that the product may be used with a 6-month shelf life.
Vecuronium Bromide For Injection Preservative Free (Bedford Laboratories): Recall - Particulate Matter (Jun 29)
Bedford Laboratories issued recall of Vecuronium Bromide For Injection, 20 mg vial due to the discovery of particulate matter in a small number of vials.
ev3 Onyx Liquid Embolic System: Safety Communication - Risk of Catheter Entrapment (Jun 29)
FDA notified physicians and patients about the risk of catheter entrapment associated with the use of Onyx. Catheter entrapment happens when the catheter becomes stuck in the implanted Onyx material.
Ondansetron (Zofran) IV – QT Prolongation (Jun 29)
FDA is informing healthcare professionals and the public that preliminary results from a recently completed clinical study suggest that a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.
Cataplex ACP, Cataplex C, and Pancreatrophin PMG Dietary Supplements: Recall - Potential for Contamination With Salmonella (Jun 29)
Standard Process and FDA notified consumers and healthcare professionals of a recall of three dietary supplements due to potential Salmonella contamination.
Dialysate Concentrates Used in Hemodialysis  - Alkali Dosing Errors (Jun 27)
FDA issued a Class I Recall notice for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate.
Cefepime: Label Change- Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney Impairment (Jun 26)
There have been cases of a specific type of seizure called nonconvulsive status epilepticus associated with the use of cefepime, primarily in patients with renal impairment who did not receive appropriate dosage adjustments of cefepime. The Warnings and Precautions and Adverse Reactions sections of the cefepime label are being revised to highlight this risk.
- Spanish Version: La cefepima y el riesgo de convulsiones en pacientes a quienes no se les está regulando la dosis debido a insuficiencia renal.
 Nidek Medical Products Mark 5 Nuvo, Nuvo 8, and Nuvo Lite Oxygen Concentrators: Class I Recall - Risk of Fire, Loss of Supplemental Oxygen(Jun 21)
Capacitor failure may result in a fire hazard and loss of supplemental oxygen. These products may cause serious adverse health consequences, including death.
For more product safety information, please visit our MedWatch website at http://www.fda.gov/medwatch


PRODUCT APPROVALS:
OraQuick In-Home HIV Test (Jul 3)
FDA approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 and type 2.
FDA approves Myrbetriq for the treatment of overactive bladder (Jun 28)
FDA approved Myrbetriq (mirabegron) to treat adults with overactive bladder, a condition in which the bladder muscle cannot be controlled, squeezes too often or squeezes without warning.
FDA approves Belviq to treat some overweight or obese adults (Jun 27)
FDA approved Belviq (lorcaserin hydrochloride), as an addition to a reduced-calorie diet and exercise, for chronic weight management.
FDA allows marketing of first test to identify certain bacteria associated with bloodstream infections (Jun 27)
FDA is allowing the marketing of the first nucleic acid test that can identify 12 different bacterial types known to cause bloodstream infections.
FDA approves first glaucoma stent for use with cataract surgery (Jun 25)
FDA approved the iStent Trabecular Micro-Bypass Stent System, Model GTS100R/L. This is the first device approved for use in combination with cataract surgery to reduce intraocular pressure in adult patients with mild or moderate open-angle glaucoma and a cataract who are currently being treated with medication to reduce intraocular pressure.
                                                                                                                                                
For information on drug approvals, please visit Drugs@FDA 
  

OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:
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 prompts companies to remove certain unapproved oxycodone products from market (Jul 5)
FDA issued a Federal Register notice instructing companies to stop manufacturing and distributing certain unapproved drugs that contain oxycodone.
FDA proposes unique device identification system for medical devices (Jul 3)
FDA has released a proposed rule that most medical devices distributed in the United States carry a unique device identifier, or UDI.
Consumer UpdatesTimely and easy-to-read articles covering all FDA activities and regulated products
-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:
Device Improvements for Pediatric X-ray Imaging (Jul 16)
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: 
 
Continuing Education
Introducing the REMS Program for the Transmucosal Immediate-Release Fentanyl ProductsThe goal of this activity is to provide education about the risk evaluation and mitigation strategy for the transmucosal immediate-release fentanyl products.
Risk Evaluation and Mitigation Strategies: An Introduction for Physicians, Nurses, and PharmacistsThe 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 Perspective
Featuring 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 ProfessionalsAdditional information for Health Professionals may be found on FDA’s Health Professional website.
 
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.
-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