FDA Updates for Health Professionals

March 13, 2013

PRODUCT SAFETY FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms FDA is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias. More information Safety Labeling Changes: February 2013 The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections   More information Class I Recall: Ad-Tech Macro Micro Subdural Electrodes: Concern the microelectrodes are defective and may cause injury to the brain Class I recall due to concern the microelectrodes are defective and may cause injury to the brain. These devices are intended for temporary (less than 30 days) use on patients with epilepsy for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. There is the potential for abrasion of brain  tissue and for broken pieces to remain in the brain tissue when the physician removes the electrode. This may lead to hemorrhaging or a seizure, as well as death.  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 Lymphoseek to help locate lymph nodes in patients with certain cancers FDA apprapproved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.  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 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  Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments FDA is announcing the availability of a draft 5-year plan describing the Agency's approach to further developing and implementing a structured framework for benefit-risk assessment in the human drug and biologic review process and the opportunity for public comment on the draft plan. This plan is part of FDA's commitments that were made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). Comments are due by May 7, 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.  Comments are due by May 16, 2013. More information  Draft Guidance for Industry and Food and Drug Administration Staff - Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex The purpose of this guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product or product container.  FDA is concerned that statements submitted for inclusion in medical product labeling, such as “latex-free,” “does not contain natural rubber latex,” or “does not contain latex” are not accurate because it is not possible to reliably assure that there is an absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product. Comments are due by June 10, 2013.  More information ANNOUNCEMENTS Attention Prescribers: FDA seeks your help in curtailing the U.S. opioid epidemic FDA is asking all prescribers of opioids to ensure they have thorough knowledge of the FDA-approved product labeling for the opioids they prescribe, and to ensure they have adequate training in opioid therapy.  We encourage all prescribers to help curb our nation's opioid epidemic!  More information  Consumer Update: 6 Tip-offs to Rip-offs: Don’t Fall for Health Fraud Scams  Been scammed? Don’t be duped into buying fraudulent health products. More Information Consumer Update: There's No Guarantee of 'Latex Free' To avoid giving a false sense of security to people who are allergic to natural rubber latex, FDA is recommending that manufacturers of FDA-regulated medical products stop using statements on labels such as “latex-free” or “does not contain latex.” More information Consumer Update: FDA Team Advances Women's Health FDA’s Office of Women’s Health conducts research specific to women’s health issues, ensures that women are involved in clinical trials, sponsors training and disseminates critical information in a variety of ways. More information   Consumer Update: Know Active Ingredients in Children's Meds If your child is taking more than one medication at the same time, there could be dangerous health consequences if those medicines have the same active ingredient. It’s important to be aware of the active ingredients in each medication.  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. 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  Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting (Apr 17) On April 17, 2013, the committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Laboratory of Chemistry, Division of Therapeutic Proteins, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA. More information Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis; Public Workshop (Apr 25-26) A public workshop to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME). FDA has determined that CFS and ME are serious conditions for which there are no approved drug treatments. More information Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (Apr 25-26) The committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as methotrexate enzyme immunoassays,  phencyclidine (PCP) enzyme immunoassays, PCP radioimmunoassays, and isoniazid test strips. 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 Prouct 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