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.
Qualitest Issues Voluntary, Nationwide Recall For One Lot Of Hydrocodone Bitartrate And Acetaminophen Tablets, USP 10 Mg/500 Mg Due To The Potential For Oversized Tablets (Sep 10)
The recall includes Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, NDC 0603-3888-21, 100 count, Lot Number C1440512A, expiry date 12/13.
Nimodipine Capsules, 30 mg, are used to decrease problems due to subarachnoid hemorrhage (bleeding in the brain).
I-Flow ON-Q Pump With ONDEMAND Bolus Button: Class I Recall - Risk Of Continuous Infusion At A Rate Greater Than Expected (Aug 31)
The On-Q pump with ONDEMAND bolus button is used for continuous and intermittent delivery of medicines (such as local anesthetics or narcotics) to or around surgical wound sites and/or to nearby nerves.
Respironics California, Inc., Voluntary Recall Notification Of A Limited Number Of Respironics V60 Ventilators (Aug 31)
A voluntary recall of 116 Respironics V60 Ventilators in the United States due to two reports of blower motor failures.
Revatio (sildenafil) should not be prescribed to children (ages 1 through 17) for pulmonary arterial hypertension (PAH).
Comunicado de la FDA sobre la seguridad de los medicamentos La FDA recomienda que no se use Revatio en niños con hipertensión pulmonary http://www.fda.gov/Drugs/
Baxter Healthcare Corporation, Automix Automated Nutrition Compounder Systems: Class I Recall (Aug 29)
The incorrect key response failure and the intermittent electrical failures may lead to improperly mixed TPN solutions.
For more product safety information, please visit our MedWatch website at http://www.fda.gov/medwatch
Choline C 11 Injection, a Positron Emission Tomography (PET) imaging agent, is used to help detect recurrent prostate cancer.
Bosulif approved for patients with chronic, accelerated or blast phase Philadelphia chromosome positive CML resistant to or intolerant of other therapies, including imatinib.
Xtandi (enzalutamide) approved for men with late-stage (metastatic) castration-resistant prostate cancer previously treated with docetaxel.
For chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C) in adults.
Tbo-filgrastim is intended for use in adults who have cancers other than blood or bone marrow cancers and are taking chemotherapy drugs that cause severe neutropenia.
A new pediatric dosage form of the anti-cancer drug Afinitor (everolimus) used to treat a rare brain tumor called subependymal giant cell astrocytoma (SEGA).
For information on drug approvals, please visit Drugs@FDA http://www.accessdata.fda.gov/
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.
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.
Public Workshop - Leveraging Registries With Medical Device Data For Postmarket Surveillance And Evidence Appraisal Throughout The Total Product Life Cycle, (Sep 12-13)
The meeting will discuss best practices for use of registries with medical device data for postmarket surveillance, clinical studies, and evidence appraisal.
Cardiokine Biopharma's lixivaptan for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone; West-Ward Pharmaceutical's phenylephrine hydrochloride injection to increase blood pressure in acute hypotensive states.
Discuss consideration of the appropriateness of cell lines derived from human tumors for vaccine manufacture.
Discuss hepatitis E virus and blood transfusion safety; Octapharma’s biologics license application for Pooled Plasma (Human, Solvent/Detergent Treated); considerations for strategies to further reduce the risk of bacterial contamination in Platelets; summary of September 6-7, 2012 public workshop on the risks and benefits of hydroxyethyl starch solutions.
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (Sep 21)
Discuss the classification of posterior cervical screws, including pedicle and lateral mass screws.
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 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.
Please visit FDA’s Advisory Committee page (http://www.fda.gov/
AdvisoryCommittees/Calendar/ default.htm) 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.
-Medscape CME/CE: Your Patient Has an Adverse Reaction to a Drug: How to Report to FDA's MedWatch (Released Jul 9)
This article is the first in a series of activities in collaboration with FDA and Medscape Education on how to report safety issues to the FDA and how these reports are used to ensure safe use of drugs and medical products
-Medscape CME/CE: Introducing the REMS Program for the Transmucosal Immediate-Release Fentanyl Products (Released Jun 29)
The goal of this activity is to provide education about the risk evaluation and mitigation strategy for the transmucosal immediate-release fentanyl products.
-Medscape CME/CE: Risk Evaluation and Mitigation Strategies: An Introduction for Physicians, Nurses, and Pharmacists (Released May 15)
The goal of this activity is to provide education to clinicians and pharmacists about risk evaluation and mitigation strategies.
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.
Featuring Dr. Gerald Dal Pan, Acting Director, FDA Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research
Featuring Elliot Cowan, PhD, Chief, Product Review Branch, Division of Emerging and Transfusion Transmitted Diseases, Center for Biologics Evaluation and Research
A video discussing Medwatch Safety Alerts
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.
Your FDA gateway for receiving clinically important safety information on human medical products is now on Twitter. Follow MedWatch on Twitter to receive MedWatch Safety Alerts.
Additional information for Health Professionals on FDA’s Health Professional website.
Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products.
A series of training videos for practicing clinical and community pharmacists.
Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks.
This bi-monthly newsletter provided by the Office of Special Health Issues at the Food and Drug Administration is intended to inform you of FDA-related information on a variety of topics, including new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates.
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 (OSHI)
Food and Drug Administration