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: 
Updates on Fungal Meningitis (Nov 2)
Latest information on the New England Compounding Center Meningitis Outbreak
Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events (Nov 2)
FDA evaluated new information about the risk of serious bleeding associated with use of the anticoagulants dabigatran (Pradaxa) and warfarin (Coumadin, Jantoven, and generics). Available in Spanish
FDA Reports Voluntary Recall of All Ameridose Drug Products (Oct 31)
FDA announced that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo.
Hospira Symbiq Infusion System Touchscreen: Class 1 Recall - May Not Respond to Selection (Oct 29)
FDA notified healthcare professionals and provider organizations of the Class 1 recall of the Symbiq pump touchscreen.
Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall - User Difficulty With Firing Stapler Devices (Oct 26)
FDA notified healthcare professionals of a Class I Recall of these products because of difficulty users have firing the stapler devices, resulting in incomplete firing stroke and incomplete staple formation.
Over-The-Counter Eye Drops and Nasal Sprays: Drug Safety Communication - Serious Adverse Events From Accidental Ingestion by Children (Oct 25)
FDA is warning healthcare professionals and the public that accidental ingestion by children of over-the-counter eye drops used to relieve redness and nasal decongestant sprays can result in serious and life-threatening adverse events.
For more product safety information, please visit our MedWatch website.

PRODUCT APPROVALS:
FDA Approves Xeljanz for Rheumatoid Arthritis (Nov 6)
FDA approved Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate.
FDA Expands Use of Xarelto to Treat, Reduce Recurrence of Blood Clots (Nov 2)
FDA expanded the approved use of Xarelto (rivaroxaban) to include treating deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment.
FDA Approves Synribo for Chronic Myelogenous Leukemia (Oct 26)
FDA approved Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia, a blood and bone marrow disease.                                                                                                                                                    

For information on drug approvals, please visit Drugs@FDA  


OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES: 

Guidance for Industry - FDA and Industry Actions on Premarket Notification 510(k) Submissions: Effect on FDA Review Clock and GoalsThe Medical Device User Fee Amendments of 20121 (MDUFA III), amended the Federal Food, Drug, and Cosmetic Act (the act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2012, including premarket notification submissions (510(k)s).
Request for Comments: Clinical Development Programs for Disease-Modifying Agents for Peripheral Neuropathy; Public WorkshopFDA will be holding an open public hearing and workshop to further the understanding of the development of disease-modifying agents for the treatment of painful peripheral neuropathies. Comments for the open public hearing due by February 1, 2013. Written comments due by March 1, 2013.

ANNOUNCEMENTS: 

FDA Warns Tennessee Company That Online Product Claims Violate Federal Law (Nov 5)
FDA issued a Warning Letter to The Avalon Effect Inc., for its marketing of a light therapy product that claims to cure or treat symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus, concussions, Lyme disease, and other diseases.
Federal Judge Grants Permanent Injunction Against Oregon Herb and Supplement Manufacturer (Oct 25)
A federal judge has granted FDA a permanent injunction against Truman J. Berst, doing business as Alternative Health & Herbs Remedies of Albany, Ore., for selling products represented as herbs and supplements with claims for treating diseases.
FDA Enters Consent Decree with New York Dietary Supplement Manufacturer, Venus Pharmaceuticals (Oct 25)
Venus Pharmaceuticals International Inc. has agreed to stop production and distribution of dietary supplements into U.S. commerce and recall and destroy affected product produced prior to January 2012, due to repeated violations of current good manufacturing practice regulations.

UPCOMING MEETINGS: 

Endocrinologic and Metabolic Drugs Advisory Committee Meeting - UPDATED: LOCATION CHANGE (Nov 8):
The Committee will discuss Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart), for the treatment of diabetes mellitus.  The location for this meeting has changed from the DoubleTree by Hilton Hotel Silver Spring, Maryland to FDA White Oak Campus Silver Spring, Maryland.
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)
FDA’s Center for Drug Evaluation and Research/Office of Medical Policy and the Duke University Office of Continuing Medical Education are cosponsoring a 3-day training course for clinical investigators on scientific, ethical, and regulatory aspects of clinical trials.
Vaccines and Related Biological Products Advisory Committee Meeting (Nov 14-15)
On November 14, the Committee will discuss the safety and immunogenicity of an Influenza A (H5N1) Virus Monovalent Vaccine. On November 15, the Committee will discuss the safety and efficacy of a Hepatitis B Vaccine.
Anti-Infective Drugs Advisory Committee Meeting (Nov 28)
The Committee will discuss bedquiline for the treatment of patients with multi-drug resistant tuberculosis (MDR-TB). 
Anti-Infective Drugs Advisory Committee Meeting (Nov 29)
The Committee will discuss VIBATIV (telavancin hydrocholoride) for the treatment of hospital-acquired bacterial pneumonia. 
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting (Dec 4)
The Subcommittee will discuss issues relating to the development of products for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate. The four products under consideration are: (1) Trametinib, application submitted by GlaxoSmithKline, LLC; (2) TH-302, application submitted by Threshold Pharmaceuticals, Inc.; (3) volasertib (BI 6727), application submitted by Boehringer Ingelheim Pharmaceuticals, Inc.; and (4) blinatumomab (MT 103), application submitted by Amgen Inc.
Drug Safety and Risk Management Advisory Committee Meeting (Dec 12-13)
On December 12, the Committee will meet to discuss the various strategies used by the Agency to define and address teratogenic risk, including requiring REMS with ETASU. On December 13, the Committee will discuss two common risk management tools used to minimize the risk of teratogens – contraception and pregnancy testing.
Arthritis Advisory Committee Meeting (Dec 20)
The committee will discuss rintatolimod injection (proposed trade name AMPLIGEN) for the treatment of patients with chronic fatigue syndrome.

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: 
 
The Value of Unique Device Identification (UDI) Implementation for Healthcare Systems and ProvidersArchived audio and presentation materials are available from the November 5, 2012 webinar.
Consumer Updates- Timely and easy-to-read articles covering all FDA activities and regulated products including:
- Medication Errors Happen to Pets, Too
Interviews
- Contact Lenses: The Risks You Need to Know -  Featuring Bernard P. Lepri, OD, MS, MEd, FDA Office of Device Evaluation, CDRH
- Decorative Contact Lenses: Truly Frightening - Featuring Michelle Tarver, MD, PhD, FDA Office of Device Evaluation, CDRH


Best regards,

Office of Special Health Issues
Food and Drug Administration