U.S. Food and Drug Administration
Office of Special Health Issues
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
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).
Mirapex (Pramipexole): Drug Safety Communication - Ongoing Safety Review, Possible Risk Of Heart Failure (Sep 19)
Results of recent studies suggest a potential risk of heart failure that needs further review of available data.
Comunicado de la FDA sobre la seguridad de los medicamentos: Estudio de seguridad en curso sobre el medicamento Mirapex (pramipexole) para la enfermedad de Parkinson y el posible riesgo de insuficiencia cardíaca
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.
La FDA publica datos preliminares sobre los niveles de arsénico en los productos derivados del arroz y el arroz
FDA Issues Safety Alert On Intestinomicina, Drug Product Marketed As Treatment For Infectious Diarrhea (Sep 18)
Intestinominica contains the prescription drug ingredient, chloramphenicol, which was withdrawn from the United States market in July 2012 due to the risk of serious and life threatening injuries.
La FDA publica una alerta de seguridad relacionada con la Intestinomicina, un medicamento comercializado para el tratamiento de la diarrea infecciosa
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.
OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:
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.
Request for (Grant) Applications (RFA): Extended-Release and Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS)
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.”
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.
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 (http://www.fda.gov/
Featuring Elliot Cowan, PhD, Chief, Product Review Branch, Division of Emerging and Transfusion Transmitted Diseases, Center for Biologics Evaluation and ResearchArticles
Please visit Articles of Interest (http://www.fda.gov/
MedWatch Safety Information Resources for Busy Physicians
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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.
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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.
Office of Special Health Issues
Food and Drug Administration