FDA Updates for Health Professionals

February 27, 2013

PRODUCT SAFETY Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication - FDA Suspends Pediatric Clinical Trials After Report Of Death FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after the recent death of a 14-year-old patient in a trial. More information Lumenis VersaCut Tissue Morcellator: Class 1 Recall - Labeling Correction - Potential For Air Embolisms To Occur If Tubing Is Hooked Up Backwards This product may cause serious adverse health consequences, including death. More information Maxiloss Weight Advanced Softgels: Recall - Undeclared Drug Ingredient Product marketed as dietary supplement contains drug ingredient Sibutramine, and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. More information DePuy Orthopaedics LPS Diaphyseal Sleeve: Class I Recall - Taper Connection May Not Accommodate Physiologic Loads Fracture of the sleeve at the taper joint may lead to loss of function or loss of limb, infection, compromised soft tissue or death. More information Vistide (Cidofovir Injection) by Gilead: Recall - Presence Of Particulate Matter Gilead Sciences, Inc. is voluntarily recalling lot B120217A of Vistide® (cidofovir injection) to the user level due to the presence of  particulate matter found in some vials of this lot. More information Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots - Serious Hypersensitivity Reactions Affymax, Inc. and Takeda Pharmaceutical Company Limited along with FDA are informing the public of a voluntary recall of all lots of OMONTYS® (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. More information GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems and Mask Resuscitation Systems: Class 1 Recall - Potential reversal of oxygen/air The oxygen and air wall inlet fittings and/or labels on the back panel of the resuscitation systems may have been reversed during assembly. As a result, this could potentially reverse the air/oxygen concentrations. More information Comunicaciones de la FDA sobre la seguridad de los medicamentos en español Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible  para proporcionar  versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information en druginfo@fda.hhs.gov. Comunicaciones de la FDA  For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch PRODUCT APPROVALS FDA approves Osphena for postmenopausal women experiencing pain during sex FDA approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause. More information FDA approves Stivarga for advanced gastrointestinal stromal tumors FDA expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease. More information FDA approves new treatment for late-stage breast cancer FDA approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer. More information FDA approves new silicone gel-filled breast implant FDA approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. More information FDA approves first retinal implant for adults with rare genetic eye disease FDA approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa. More information For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed OPPORTUNITIES FOR COMMENT / GUIDANCES Request for Comments: Draft Guidance for Industry and FDA Staff - Design Considerations for Devices Intended for Home Use FDA is announcing the availability of the draft guidance entitled “Design Considerations for Devices Intended for Home Use.” This document is intended to assist manufacturers in designing and developing home use medical devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. Home use devices are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. This document identifies several factors that manufacturers should consider, especially during device design and development, and provides recommendations for reducing or minimizing these unique risks. Comments are due by March 13, 2013. More information Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments To assist FDA in drafting a strategic plan on drug shortages as required by the Food and Drug Administration Safety and Innovation Act, the Agency is seeking public comment from interested persons on certain questions related to drug and biological product shortages. Comments are due by March 14, 2013. More information Request for Comments: Draft Guidances for Industry on Abuse-Deterrent Opioids - Evaluation and Labeling This draft guidance is intended to provide industry with a framework for evaluating and labeling abuse-deterrent opioid products. The draft guidance discusses how the potentially abuse-deterrent properties of an opioid analgesic formulated to deter abuse should be studied, specifically addressing in vitro studies, pharmacokinetic studies, human abuse potential studies, and postmarket studies. The draft guidance also describes the types of information and claims that may be suitable for inclusion in labeling. Comments are due by March 15, 2013. More information Request for Comment: Smokeless Tobacco Product Warning Statement FDA is establishing a public docket to obtain comments, supported by scientific evidence, regarding what changes to the smokeless tobacco product warnings, if any, would promote greater public understanding of the risks associated with the use of smokeless tobacco products. Comments are due by April 1, 2013. More information Request for Comments: Impact of Approved Drug Labeling on Chronic Opioid Therapy FDA invites comments on the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. Over the past several years, the role of opioid drugs in treating chronic pain has been an increasingly common subject of public discussion. FDA and other policymakers have been at the forefront of these debates, striving to find a balance between minimizing opioid drug abuse and misuse, while simultaneously enabling appropriate access to pain-relieving drugs. Comments are due by April 8, 2013. More information Request for Comments: Draft Guidance for Industry on Alzheimer's Disease - Developing Drugs for the Early Stage Disease This guidance outlines FDA's current thinking as to how a sponsor could demonstrate efficacy in clinical trials in patients in the early stages of Alzheimer's disease (AD) that occur before the onset of overt dementia. Specifically, this guidance addresses FDA's current thinking regarding the selection of patients with early AD, or who are determined to be at risk of developing AD, for enrollment into clinical trials. Comments are due by April 9, 2012. More information Request for Comments: Draft Guidance for Industry and FDA Staff - Providing Information About Pediatric Uses of Medical Devices This proposed rule would require each applicant who submits an humanitarian device exemption, premarket approval (PMA), supplement to a PMA, or product development protocol to include, if “readily available,” a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure, and the number of affected pediatric patients. FDA is proposing to codify a definition of “readily-available” and also issue a draft guidance document to explain the Agency's current thinking on the meaning of “readily-available information” and how to comply with the requirements set forth in section 515A of the FD&C Act. Comments are due by April 22, 2013. More information Requirements; Availability Request for Comments: FDA proposes new food safety standards for foodborne illness prevention and produce safety FDA proposed two new food safety rules that will help prevent foodborne illness. The proposed rules implement the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) and are available for public comment for the next 120 days. The FDA encourages Americans to review and comment on these important proposed rules. Since January 2011, FDA staff have toured farms and facilities nationwide and participated in hundreds of meetings and presentations with global regulatory partners, industry stakeholders, consumer groups, farmers, state and local officials, and the research community. Comments are due by May 16, 2013. More information ANNOUNCEMENTS FDA enters into consent decree with Chicago sprout producer due to unsanitary conditions U Joo Foods, a Chicago sprout grower and processor and the company’s owner and president, Kiyoung Chin have agreed to enter into a consent decree of permanent injunction sought by the Justice Department on behalf of FDA. More information FDA seeks input on minimizing disruptions to medical device supply chain during extreme weather events FDA is seeking input from industry and the public on the effects of extreme weather and natural disasters on the production and supply of medical devices. The FDA will use the information to identify steps that the agency, manufacturers, and the public can take to prepare for such events. More information Consumer Update: Generic Drugs: Same Medicine, Lower Cost Answer your questions about these often-used products; and see photos of the FDA research that helps ensure they are as good as the name brands. More information Consumer Update: 5 Things to Know About Breast Implants Online FDA tools can help with the decision. More information Consumer Update: Post-Surgery Codeine Puts Kids at Risk FDA is taking steps to warn about the use of codeine to relieve children's pain after surgery to remove their tonsils or adenoids. More information Consumer Update: Kids Have Problem With Medical Product? Consumers can play a critical role in helping FDA assure children's access to safe medical products. More information UPCOMING MEETINGS FDA advisory committe meetings are free and open to the public.  No prior registration is required to attend.  Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Other types of meetings listed may require prior registration and fees.  Click on "more information" for details about each meeting.  Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings. Public Workshop on Minimal Residual Disease (Mar 4) FDA in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to an efficacy/response biomarker in evaluating new drugs for the treatment of acute myeloid leukemia (AML). More information Reproductive Health Drugs Advisory Committee Meeting     (Mar 4) The committee will discuss New Drug Application (NDA) gabapentin 600 mg tablets for treatment of moderate to severe vasomotor symptoms due to menopause and NDA paroxetine mesylate 7.5 mg capsules for treatment of moderate to severe vasomotor symptoms associated with menopause. More information Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Meeting (Mar 5) The committees will discuss whether the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis outweighs a potential risk of cancer. Calcitonin salmon products approved for the treatment of osteoporosis include Miacalcin (calcitonin salmon) injection and nasal spray; Fortical (calcitonin salmon recombinant) nasal spray; and the generic equivalents of these products. More information Pulmonary-Allergy Drugs Advisory Committee Meeting (Mar 7) The committee will discuss the new drug application (NDA) 204275 for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREO ELLIPTA) for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease. More information Transmissible Spongiform Encephalopathies Advisory Committee Meeting (Mar 14) The committee will meet in open session to discuss FDA's draft risk assessment model for potential exposure to the variant Creutzfeldt-Jakob disease agent in Red Blood Cells for transfusion in the US. More information Pediatric Advisory Committee Meeting (Mar 14) The committee discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Acterma, Alimta, Creon, Gadavist, Hizentra, Inomax, Invega, Kedbumin, Kytril Injection, Lamictal XR, Menactra, Moxeza, Natroba, Nexium, Nexium IV, Uroxatral, and Zenpep. Also, there will be an Informational Update on Codeine. More information Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (Mar 20) The committee will discuss the premarket approval application for the MitraClip Delivery System. The system consists of three major components: the delivery catheter, the steerable sleeve, and the MitraClip device. The MitraClip device is a single sized, percutaneously implanted mechanical clip for the reduction of mitral regurgitation. More information Public Conference - Detecting and Evaluating Drug-Induced Liver Injury; What's Normal, What's Not, and What Should We Do About It? (Mar 20-21) The conference purpose is to discuss, debate, and build consensus among stakeholders in the pharmaceutical industry, academia, health care providers, patient groups, and regulatory bodies on how best to detect and assess the severity, extent, and likelihood of drug causation of liver injury and dysfunction in people using drugs for any medical purpose. More information Psychopharmacologic Drugs Advisory Committee Meeting     (Mar 21) The committee will discuss NDA 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant and its safety and efficacy for the proposed indication of maintenance treatment of opioid dependence. More information Public Workshop: Innovations in Breast Cancer Drug Development – Neoadjuvant Breast Cancer Workshop (Mar 22) This workshop will provide a forum to discuss issues related to breast cancer drug development in the neo-adjuvant setting: (1) how Neoadjuvant trials can expedite drug development, (2) the Collaborative Trials in Neoadjuvant Breast Cancer meta-analysis results, and (3) the draft FDA Guidance for Industry: Use of Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early Stage Breast Cancer as an Endpoint to Support Accelerated Approval. More information Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (Apr 5) The committee will discuss and make recommendations regarding the possible reclassification of Shortwave Diathermy devices. More information Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (Apr 8) The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Trulign Toric posterior chamber intraocular lens sponsored by Bausch and Lomb. The Trulign Toric posterior chamber intraocular lens is intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision and reduction of residual refractive cylinder. More information Device Good Manufacturing Practice Advisory Committee Meeting (Apr 11) The committee will discuss the potential effects of extreme weather and natural disasters on medical device manufacturing chain processes and marketed medical device safety and quality. More information Public Workshop - Accessible Medical Device Labeling in a Standard Content and Format (Apr 29-30) The purpose of the workshop is to discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers may access and utilize device labeling as efficiently and effectively as possible. More information Oncologic Drugs Advisory Committee Meeting (May 2) The committee will discuss NDA 204408, with the established name tivozanib capsules, indicated for the treatment of advanced renal cell carcinoma, and NDA 201848, a drug/device combination product with the proposed trade name Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), indicated for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver. More information Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee (May 3) The committees will discuss the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. More information RESOURCES 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. More information FDA Voice FDA voice is the official blog from FDA's senior leadership and staff. More information Medical Product Safety Network (Medsun) 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 newsletter provides monthly updates about timely medical device issues that may impact patient safety.  More information