FDA Updates for Health Professionals

July 31, 2013 PRODUCT SAFETY Class I Recall: GE Healthcare Nuclear Medicine Systems - Serious Injuries or Deaths Could Occur GE Healthcare became aware of an incident at a VA Medical Center facility in the US. A patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. On July 03, 2013 GE notified hospitals that they were recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. More information Drug Safety Communication: Mefloquine Hydrochloride - Label Changes Due To Risk of Serious Psychiatric and Nerve Side Effects FDA is advising the public about strengthened and updated warnings regarding neurologic and psychiatric side effects associated with the antimalarial drug mefloquine hydrochloride. A boxed warning, the most serious kind of warning about these potential problems, has been added to the drug label. FDA has revised the patient Medication Guide dispensed with each prescription and wallet card to include this information and the possibility that the neurologic side effects may persist or become permanent.  More information Recall: Nova Max Glucose Test Strips - May Report False, Abnormally High Blood Glucose Result Nova Diabetes Care initiated a voluntary recall of 21 lots of the Nova Max Glucose Test Strips distributed both in the USA and outside the continental USA. Nova Max Plus glucose meter kits that include test strips from the recalled lots are also included in this voluntary recall. More information FDA Health Risk Warning: Healthy Life Chemistry By Purity First B-50 - Undeclared Ingredients FDA is warning consumers that they should not use or purchase Healthy Life Chemistry By Purity First B-50, marketed as a vitamin B dietary supplement. A preliminary FDA laboratory analysis indicated that the product contains two potentially harmful anabolic steroids—methasterone, a controlled substance, and dimethazine. These ingredients are not listed in the label and should not be in a dietary supplement. More information Drug Safety Communication: Nizoral (ketoconazole) - Potentially Fatal Liver Injury, Risk of Drug Interactions and Adrenal Gland Problems FDA is taking several actions related to Nizoral (ketoconazole) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems, and advising that it can lead to harmful drug interactions with other medications. FDA has approved label changes and added a new Medication Guide to address these safety issues. As a result, Nizoral oral tablets should not be a first-line treatment for any fungal infection. Nizoral should be used for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated. More information Class I Recall: LeMaitre Vascular, Inc., Albograft Vascular Graft - Blood Leak Models: AMC1408, AMC1506, AMC1608, AMC1809, AMC1810, AMC2010, AMC4007, AMC4008, AMC6006, AMC6007, AMC6008, ATC1526, ATC1530, ATC3016, ATC3018, ATC3024, ATC3026, Batch 56890A LeMaitre Vascular, Inc. recalled the Albograft Vascular Graft due to blood leaking from the surface of the graft after implantation. This product may cause serious adverse health consequences, including death.Within the U.S., this device was only distributed in Pennsylvania. More information Diabetes Treatments: FDA Alerts of Illegal Sales - Undeclared Ingredients FDA is taking action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications. To date, the FDA is not aware of any reports of injury or illness associated with the illegally sold products, but is taking action to protect the public health from potential harm related to these violative products. More information Class I Recall: MedStream Programmable Infusion Pump - Malfunction In The Fill Level Sensor The Fill Level Sensor (FLS), a component of the Medstream Programmable Infusion Pump, may malfunction. The Fill Level Sensor is intended to measure the contents of the pump drug reservoir. The malfunction in the Fill Level Sensor may cause the pump’s low reservoir alarm, normally set at 3 ml, to sound too early or too late. More information Class I Recall: Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube - Mislabeled Packaging The outside of the device packaging stated a 3.0mm neonatal tube. The product inside the box was actually a 3.0mm pediatric tube. Although the neonatal and pediatric tubes have the same inner diameter, the pediatric tube is 4.0mm longer for this particular model. An oversized tracheostomy tube may cause permanent injury to the trachea. This product may cause serious adverse health consequences, including 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 AND CLEARANCES FDA permits marketing of first U.S. test labeled for simultaneous detection of tuberculosis bacteria and resistance to the antibiotic rifampin FDA allowed marketing of the Xpert MTB/RIF Assay, the first FDA-reviewed test that can simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain genetic markers that makes them resistant to rifampin, an important antibiotic for the treatment of TB. 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: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products FDA is proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and to rename them sunlamp products. Submit either electronic or written comments on this proposed order by August 7, 2013. More information Request for Comments: Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information This draft guidance provides recommendations on when to use a Dear Health Care Provider (DHCP) Letter, the types of information to include in a DHCP letter, how to organize that information, and formatting techniques to make the information more accessible. The draft guidance is intended to improve the quality of DHCP letters to make them more effective communication tools for new information about marketed products. Comments are due by August 8, 2013. More information Request for Comments: Food and Drug Administration Safety and Innovation Act Title VII--Drug Supply Chain; Standards for Admission of Imported Drugs, Registration of Commercial Importers and Good Importer Practices FDA is seeking public comment on how to implement the drug supply chain provisions found in Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. Under Title VII FDA is authorized to require that importers submit information demonstrating that their drug complies with applicable requirements of the Federal Food, Drug and Cosmetic Act before their products can enter the U.S. In addition, commercial importers must register with FDA and meet good importer practices. Comments are due by August 12, 2013. More information Request for Comments: Current Good Manufacturing Practice for Positron Emission Tomography Drugs The CGMP regulations are intended to ensure that approved PET drugs meet the requirements of the FD&C Act as to safety, identity, strength, quality, and purity. The regulations address the following matters: Personnel and resources; quality assurance; facilities and equipment; control of components, in-process materials, and finished products; production and process controls; laboratory controls; acceptance criteria; labeling and packaging controls; distribution controls; complaint handling; and recordkeeping. Comments are due by August 19, 2013. More information Request for Comments: Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics: Availability The purpose of this draft guidance is to provide a single resource for information on FDA's policies and procedures related to expedited drug development and review programs. The following programs are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of serious or life-threatening conditions (expedited programs): Fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation. Comments are due by August 26, 2013. More information Request for Comments: Testing Communications on Medical Devices and Radiation-Emitting Products This notice solicits comments on communication studies involving medical devices and radiation-emitting products regulated by FDA. This information will be used to explore concepts of interest and assist in the development and modification of communication messages and campaigns to fulfill the Agency's mission to protect the public health. Comments are due by September 09, 2013. More information Request for Comments: Establishment of a Public Docket for Comment on the Report Prepared Under the Food and Drug Administration Safety and Innovation Act Section 1138 On July 9, 2012, President Obama signed FDASIA (Pub. L. 112-144) into law. Section 1138 of FDASIA requires that FDA review and modify, as necessary, the FDA communication plan to inform and educate health care providers and patients on the benefits and risks of medical products, with particular focus on underrepresented subpopulations, including racial subgroups.Section 1138 of FDASIA requires that FDA shall publicly post the communication plan on the Internet Web site of the Office of Minority Health of FDA, and provide links to any other appropriate Internet Web site, and seek public comment on the communication plan. Comments are due by September 9, 2013. More information  Request for Comments: Administrative Detention of Drugs Intended for Human or Animal Use FDA is proposing a regulation to implement administrative detention authority with respect to drugs intended for human or animal use as authorized by amendments made to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Food and Drug Administration Safety and Innovation Act (FDASIA). Once the applicable regulation is finalized, FDA's administrative detention authority with respect to drugs will allow FDA to better protect the integrity of the drug supply chain. Comments are due by September 13, 2013. More information Request for Comments: Format and Content Requirements for Over-the-Counter Drug Product Labeling This notice solicits comments on the standardized format and content requirements for the labeling of over-the-counter (OTC) drug products. Submit comments by September 23, 2013. More information Request for Comments: Menthol in Cigarettes, Tobacco Products FDA is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the potential regulation of menthol in cigarettes. FDA is also making available its preliminary scientific evaluation of public health issues related to the use of menthol in cigarettes. The preliminary scientific evaluation indicates there is likely a public health impact of menthol in cigarettes.Comments are due by September 23, 2013. More information Request for Comments: Possible Role of Independent Third Parties in Industry-Sponsored Tobacco Product Research FDA is establishing a public docket for interested parties to submit to FDA comments on the Institute of Medicine’s (IOM) recommendation regarding third-party governance of industry-sponsored tobacco product research. FDA is interested in receiving information on whether some form of third-party governance should be considered for other types of industry-sponsored tobacco product research, including research to support premarket tobacco product applications and other submissions to FDA, as well as research designed to contribute to general knowledge regarding tobacco products. Comments are due by September 30, 2013. More information  ANNOUNCEMENTS FDA's Drug Shortages Website FDA’s Drug Shortages website has a new feature: Therapeutic Categories. In addition to the A-Z index, Therapeutic Categories are now available. The A-Z index lists drugs in alphabetical order by generic name or active ingredient. The new Therapeutic Categories tab shows drugs in shortage by categories. Therapeutic Category is based on indications and commonly used population, as in Pediatrics, Oncology, Anesthesia, and more. The category designation does not indicate FDA approval status. For FDA approved drug products, continue to refer to Drugs@FDA. If you have questions or feedback, please notify Drug Shortages at drugshortages@fda.hhs.gov.  Breast Implants: The View From the FDA  In June FDA approved the most recent silicone gel-filled breast implant, bringing the total number of approved products to 5. Although the FDA believes that approved breast implants have a reasonable assurance of safety and effectiveness when used as labeled, the agency emphasizes that breast implants are not lifetime devices and that women should be provided with essential information about the unique features of each device. More information FDA Reminds Consumers to Always Use Acetaminophen Safely Hundreds of over-the-counter (OTC) and prescription medicines contain acetaminophen. Many people taking these products may not be aware they contain this active ingredient. Taking too much acetaminophen can damage your liver. So it’s important to check your products, both OTC and prescription, before taking to see if they contain acetaminophen and to make sure you know how to take safely. More information Guidance Webinar Series FDA's Guidance Webinar series aims to foster collaboration and transparency in the development of guidance documents through direct outreach to affected stakeholders. Archived webinars, transcripts, and audience questions are available. More information UPCOMING MEETINGS FDA advisory committee 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. Cardiovascular and Renal Drugs Advisory Committee (Aug 5) The committee will discuss new drug application 204441, tolvaptan tablets, for the proposed indication of slowing kidney disease in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease. More information  Cardiovascular and Renal Drugs Advisory Committee (Aug 6) The committee will discuss new drug application (NDA) 204819, proposed trade name ADEMPAS (riociguat coated tablet), submitted by Bayer HealthCare Pharmaceuticals Inc., for the treatment of: (1) Chronic thromboembolic pulmonary hypertension World Health Organization (WHO) Group 4 to improve exercise capacity and WHO functional class and (2) pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity, improve WHO functional class, and to delay clinical worsening. More information Risk Communications Advisory Committee (Aug 16) On August 16, 2013, the Committee will discuss how FDA can communicate more effectively with health care professionals and other stakeholders about the public health risks posed by counterfeit and unapproved drugs, in addition to safe purchasing practices, and how FDA can evaluate that communication and its impact. More information  Public Workshop: Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Steatohepatitis (Sept 5 & 6) FDA's Center for Drug Evaluation and Research in cosponsorship with the American Association for the Study of Liver Diseases (AASLD) is announcing a 2-day public workshop entitled “Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic fatty liver disease (NAFLD).” There are no approved treatments for NAFLD and its complications of nonalcoholic steatohepatitis (NASH) and liver fibrosis and cirrhosis. This workshop will provide a forum to discuss trial design, including endpoints for clinical trials in NAFLD, to promote efficient drug development in this area and thus improved treatments for patients. More information Public Meeting: FDA Patient Network Annual Meeting; Demystifying FDA - An Exploration of Drug Development (Sept 10) This meeting will serve as a forum for FDA’s patient stakeholders and the general public, including health professionals, academia, and industry to learn about regulatory issues related to drug development, analyze where in the process patient input may be most practical and most valuable, and explore practicable approaches to incorporating meaningful patient input that will represent broad patient perspectives in medical product development and regulatory decision-making. More information The Patient Preference Initiative: Incorporating Patient Preference Information Into the Medical Device Regulatory Processes: Public Workshop; Request for Comments (Sept 18 & 19) The purpose of the workshop is to discuss ways to incorporate patient preferences on the benefit-risk tradeoffs of medical devices into the full spectrum of the Center for Devices and Radiological Health (CDRH) regulatory decision making. It also aims to advance the science of measuring treatment preferences of patients, caregivers, and health care providers. The information learned from this workshop and public comments will benefit regulators, industry, providers, patients, and device innovators. More information Food Advisory Committee (Sept 23 & 24) The Food Advisory Committee will meet to discuss detection signals for noteworthy chemical hazards in foods, dietary supplements, and cosmetics and consider possible sources of information, data on chemical hazards, and how CFSAN might recognize and best take advantage of those data. More information Narcolepsy Public Meeting on Patient-Focused Drug Development (Sept 24) The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of narcolepsy on daily life as well as the available therapies for narcolepsy. More information Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (Sept 25) The committee will discuss optimal strategies for the evaluation, interpretation, and communication of drug-drug interaction (DDI) information. FDA will seek input on: (1) Best practices in DDI communication through prescription drug product labels (i.e., “package inserts”), namely: (a) Appropriate format for presentation (e.g. tables, graphs, text) of DDI information; (b) level of detail of DDI study results; and (c) appropriate wording for clinical recommendations based on empirical data versus anticipated interactions; (2) appropriate criteria for determining whether or not to describe DDI information derived from the literature in product labels; and (3) how package insert information on DDIs is used by various end-users (e.g., prescribers, dispensers, DDI database curators) in decision making and/or communication. More information Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products; Public Workshop (Oct 7) The purpose of the public workshop is to bring together a broad range of stakeholders to discuss current and future standards development activities involving cellular therapies and regenerative medicine products. More information  Cellular, Tissue and Gene Therapies Advisory Committee (Oct 22 & 23) The Committee will discuss oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility. The Committee will also hear updates on guidance documents issued from the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research (CBER), and discuss considerations for the design of early-phase clinical trials of cellular and gene therapy products. More information Third Annual Food and Drug Administration Health Professional Organizations Conference (Oct 24) FDA is announcing a conference for representatives of Health Professional Organizations. Topics on the agenda include FDA Updates, an overview of FDA's Network of Experts (public/private partnerships), and a FDA Town Hall. The FDA Town Hall will feature FDA senior executives including Jeffrey Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health; Douglas C. Throckmorton, M.D., Deputy Director for Regulatory Programs of the Center for Drug Evaluation and Research; and Michael R. Taylor, Deputy Commissioner for Foods and Veterinary Medicine. 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