FDA 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.

PRODUCT SAFETY: 
New England Compounding Center (NECC) Potentially Contaminated Medication: Fungal Meningitis Outbreak (updated Oct 6)
On October 4, 2012, the CDC and FDA recommended that all health care professionals cease use and remove from their pharmaceutical inventory any product produced by NECC.
Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 Ml, Flexible Containers: Recall - Mold Contamination (Oct 5)
FDA and Hospira announced it is initiating a voluntary user-level recall of one lot of Lactated Ringer’s and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09.
Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Safety Communication - Reports of Serious Tissue Damage (Oct 5)
FDA and Stryker received one report of serious injury and one report of death as a result of tissue damage resulting from use of the Neptune 2 Ultra Waste Management System.
For more product safety information, please visit our MedWatch website at http://www.fda.gov/medwatch


PRODUCT APPROVALS:

FDA approves Humira to treat ulcerative colitis (Sept 28)
FDA expanded the approved use of Humira (adalimumab) to include treatment of moderate-to-severe ulcerative colitis in adults.
FDA approves first subcutaneous heart defibrillator (Sept 28)
FDA approved a heart defibrillator that helps to restore regular heart rhythms with leads that can be implanted subcutaneously instead of connected directly into the heart.
FDA approves new treatment for advanced colorectal cancer (Sept 27)
FDA approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body.
For information on drug approvals, please visit Drugs@FDA    


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. Submit comments by November 7, 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. Submit comments by November 6, 2012.

ANNOUNCEMENTS: 

Nut Butter Recall Expands (Oct 8)
FDA along with the CDC and state and local officials are investigating a multi-state outbreak of Salmonella Bredeney infections.
FDA Celebrates Public Health Milestone (Oct 5)
This year FDA celebrates the anniversary of the passage of the Kefauver-Harris drug amendments, which have ensured prescription drug effectiveness and safety for 50 years.
FDA takes action against thousands of illegal Internet pharmacies (Oct 4)
FDA, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Available in Spanish 
BeSafeRx Educates Public About Online Pharmacies (Sept 28)
FDA launched a national campaign to raise public awareness about the prevalence of fraudulent Internet pharmacies, which can be dangerous to patient health, and to help consumers make safe purchases. Available in Spanish
ClinicalTrials.gov: New Style and New Content 
Visitors to the National Institutes of Health (NIH) ClinicalTrials.gov Web site will see an updated graphic design with new and reorganized written content. New features include additional background on searching for studies, submitting study information, and learning about the site.

UPCOMING MEETINGS: 
POSTPONED: Gastrointestinal Drugs Advisory Committee Meeting (Oct 15)
Discuss the need for and design of clinical development programs necessary to support approval of parenteral lipid emulsion products as nutritional support.
Gastrointestinal Drugs Advisory Committee Meeting (Oct 16)
Discuss GATTEX (teduglutide) for subcutaneous injection, by NPS Pharmaceuticals, Inc, for adult patients with short bowel syndrome.
Endocrinologic and Metabolic Drugs Advisory Committee Meeting (Oct 17)
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.
Endocrinologic and Metabolic Drugs Advisory Committee Meeting (Oct 18)
Discuss mipomersen injection, by Genzyme Corporation, as an adjunct to maximally tolerated lipid-lowering medications and diet in patients with homozygous familial hypercholesterolemia.
Radiological Devices Panel of the Medical Devices Advisory Committee Meeting (Oct 24)
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.
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.
Anti-Infective Drugs Advisory Committee Meeting (Nov 2)
Discuss biologics licensing application (BLA) 125346, raxibacumab injection, by Human Genome Sciences, Inc. for the treatment of inhalational anthrax.
Oncologic Drugs Advisory Committee Meeting--CANCELLED (Nov 8)
Discuss pomalidomide, by Celgene Corporation for use with dexamethasone for patients with relapsed and refractory multiple myeloma in the morning.  Discuss Exjade (deferasirox), by Novartis Pharmaceutical Corporation for chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes.
Nonprescription Drugs Advisory Committee Meeting (Nov 9)
Discuss MSD Consumer Care, Inc., new drug application for the partial switch from prescription to over-the-counter of the oxybutynin transdermal system for “overactive bladder in women.”
FDA's Clinical Investigator Training Course (Nov 13-15)
This course is designed for physicians, nurses, pharmacists and other health care professionals involved in clinical trials.
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:
 
Articles

- Serious risks associated with using Quinine to prevent or treat nocturnal leg cramps

Interviews
- The New Opioid REMS: The FDA View
Featuring Gerald J. Dal Pan, MD, MHS, Director, Office of Surveillance and Epidemiology, FDA Center for Drug Evaluation and Research.
Other Resources
Consumer UpdatesTimely and easy-to-read articles covering all FDA activities and regulated products
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.
- BeSafeRx: FDA Helping Consumers Avoid Risks of Online Prescription Drug Purchases



Best regards,

Office of Special Health Issues
Food and Drug Administration