viernes, 28 de septiembre de 2012

FDA Updates for Health Professionals

Updates for Health Professionals
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.


Hydrocodone Bitartrate And Acetaminophen Tablets, USP 10 Mg/500 Mg (Watson Laboratories): Recall - Potential For Oversized And Superpotent Tablets (Sep 24)

The effected lot numbers are 519406A and 521759A, both with the expiry date April 2014, and were distributed between 6/27/2012 and 7/18/2012 to wholesale distributors and retail pharmacies nationwide.

Testing revealed the presence of undeclared tadalafil and sildenafil, the active ingredients in FDA-approved drugs for Erectile Dysfunction (ED).

Results of recent studies suggest a potential risk of heart failure that needs further review of available data.

As part of an ongoing and proactive effort to monitor food safety and address contaminants in food, FDA released preliminary data on arsenic levels in certain rice and rice products.

Intestinominica contains the prescription drug ingredient, chloramphenicol, which was withdrawn from the United States market in July 2012 due to the risk of serious and life threatening injuries. 
For more product safety information, please visit our MedWatch website at


FDA Approves First Breast Ultrasound Imaging System For Dense Breast Tissue (Sep 18)
For use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer.
                                                                                                                                  For information on drug approvals, please visit Drugs@FDA    


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.

October 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.


The Antibacterial Drug Development Task Force will assist in developing and revising guidance related to antibacterial drug development, as required by the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012. 

The REMS Program Companies would like to make your organization aware of grant funds available to support accredited independent continuing education for the ER / LA class-wide opioid analgesics REMS.


Discuss the humanitarian device exemption (HDE) application for the Argus II Retinal Prosthesis System sponsored by Second Sight Medical Products, Inc. 

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.

Discuss the need for and design of clinical development programs necessary to support approval of parenteral lipid emulsion products as nutritional support.

Discuss GATTEX (teduglutide) for subcutaneous injection, by NPS Pharmaceuticals, Inc, for adult patients with short bowel syndrome (SBS).

Discuss lomitapide capsules, by Aegerion Pharmaceuticals, Inc., as an adjunct to a low-fat diet and other lipid-lowering drugs in patients with homozygous familial hypercholesterolemia.

Discuss mipomersen injection, by Genzyme Corporation, as an adjunct to maximally tolerated lipid-lowering medications and diet in patients with homozygous familial hypercholesterolemia.

Discuss a premarket approval application supplement to expand the indications for use of the Selenia Dimensions 3D System with C-View Software Module, sponsored by Hologic, Inc.

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.

Discuss biologics licensing application (BLA) 125346, raxibacumab injection, by Human Genome Sciences, Inc. for the treatment of inhalational anthrax.

Discuss new drug application (NDA) 204026, pomalidomide, by Celgene Corporation for use with dexamethasone for patients with relapsed and refractory multiple myeloma in the morning. Discuss supplemental New Drug Application (sNDA) 021882/015, Exjade (deferasirox), by Novartis Pharmaceutical Corporation for chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes in the afternoon.

Discuss MSD Consumer Care, Inc., new drug application (NDA) 202211, for the partial switch from prescription to over-the-counter (OTC) of the oxybutynin transdermal system (proposed trade name OXYTROL FOR WOMEN) for “overactive bladder in women.”

This course is designed for physicians, nurses, pharmacists and other health care professionals involved in clinical trials.

Discuss new drug application (NDA) 22407, VIBATIV (telavancin hydrochloride, by Theravance, Inc., for nosocomial pneumonia.

A presentation on pediatric provisions mandated by the Food and Drug Administration Safety and Innovation Act. Information will be presented regarding pediatric development plans for four products that are in development for an adult oncology indication.
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 (


Featuring Elliot Cowan, PhD, Chief, Product Review Branch, Division of Emerging and Transfusion Transmitted Diseases, Center for Biologics Evaluation and Research

Please visit Articles of Interest ( to access articles produced by FDA and written for a health professional audience. These articles include FDA News for Health Professionals articles, as well as articles that were published in health professional journals.


MedWatch Safety Information Resources for Busy Physicians
A video discussing Medwatch Safety Alerts

Other Resources

Consumer Updates
Timely and easy-to-read articles covering all FDA activities and regulated products

The 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 Voice is the official blog from FDA's senior leadership and staff.

FDA MedWatch Twitter!/FDAMedWatch
Your FDA gateway for receiving clinically important safety information on human medical products is now on Twitter. Follow us on Twitter to receive the MedWatch Safety Alerts:

For Health Professionals
Additional information for Health Professionals may be found on FDA’s Health Professional website.
MedWatch Safety Alerts for Human Medical Products
Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products.

FDA Drug Info Rounds
A series of training videos for practicing clinical and community pharmacists.

Device Use Safety Tips
Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks.

FDA Patient Safety News
FDA Patient Safety News is a televised series for health care personnel, carried on satellite broadcast networks aimed at hospitals and other medical facilities across the country. It features information on new drugs, biologics and medical devices, on FDA safety notifications and product recalls, and on ways to protect patients when using medical products.

FDA Basics
Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA.

Best regards,

Office of Special Health Issues
Food and Drug Administration

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