FDA Updates for Health Professionals

August 14, 2013

PRODUCT SAFETY Recall: Hospira Blood Sets - Instances Of Outer Wall Of Blood Bags Punctured With Piercing Pin Hospira, Inc. announced a recall of certain blood sets. There have been reports from customers of instances in which the outer wall of blood bags were punctured with the piercing pin on certain Hospira blood sets during insertion of the pin into the blood bag. If the piercing pin on this product punctures the outer wall of a blood bag, it may result in spillage of the blood and blood products stored in the bag, resulting in a delay/interruption in therapy. More information  FDA Alert: Specialty Compounding Sterile Products - Bacterial Infections Specialty Compounding, LLC has announced a voluntary nationwide recall of all lots of unexpired sterile products. The recall applies to all unexpired sterile compounded products dispensed since May 9, 2013, including all strengths and dosage forms.  More information  July 2013 Safety Labeling Changes The MedWatch July 2013 Safety Labeling Changes posting includes 34 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. More information Class I Recall: Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit - Potential for Incorrect Recommended Infusion Rate The Dose Error Reduction System (DERS) can potentially give an incorrect recommended value for the pump infusion rate during the initial infusion setup. A device malfunction can result in an increased risk of over-infusion or under-infusion if the infusion is started with this rate value. More information Class I Recall: Cordis Optease Retrievable Inferior Vena Cava (IVC) Filter - Labeling Correction Cordis and FDA notified healthcare professionals and their organizations of a product labeling correction to provide clarification and additional information to minimize likelihood of implanting the filter backwards. More information Recall: Benztropine Mesylate Injection (Nexus Pharmaceuticals) - Visible Particulate Matter Nexus Pharmaceuticals Inc. is recalling two lots of Benztropine Mesylate Injection, USP, 2 mg/2mL (1mg/mL) in 2 mL single dose vials due to the presence of visible particulate matter in the vials. The product is manufactured by Allergy Laboratories, Inc. and was distributed by Nexus Pharmaceuticals Inc. Affected product includes Lot Numbers 030712, 112911. More information Class I Recall: CareFusion Alaris PC unit (model 8015) with version 9.12 Keyboard Processor - Potential Loss of Communication Between Main Processor and Keyboard CareFusion has reported that if the Alaris PC unit model 8015 voltage is 1.4 volts, rather than the 1.8 volts required for operation, the device could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor. A device malfunction can result in the sudden unintended discontinuation of medications. More information Drug Safety Communication: Acetaminophen - Association with Risk of Serious Skin Reactions FDA notified healthcare professionals and patients that acetaminophen has been associated with a risk of rare but serious skin reactions. Acetaminophen is a common active ingredient to treat pain and reduce fever; it is included in many prescription and over-the-counter (OTC) products.  These skin reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal. More information Recall: Beacon Hill Medical Pharmacy/Rxtra Solutions - Lack of Sterility Assurance Beacon Hill Medical Pharmacy and FDA is notifying health professionals and consumers of the recall of all lots of certain sterile products. FDA has raised a question of sterility assurance for the affected products.The products were distributed nationwide to outlets including hospitals, clinics, and patients who have received orders by directly placing phone calls or faxed prescriptions to the Beacon Hill Medical pharmacy facility in Southfield,Michigan. More information Class I Recall: DePuy Orthopaedics-LPS Lower Extremity Dovetail Intercalary Component - Potential for Fracture of Device FDA and DePuy Orthopaedics notified healthcare professionals of the Class I recall of the LPS Lower Extremity Dovetail Intercalary Component due to the potential for fracture of the female component, at the dovetail, when exposed to normal physiologic loads while walking. This may also lead to additional pain, infection, loss of function, loss of limb, neurovascular injury or need for revision surgery. Patients greater than 200 pounds and/or those with high levels of activity are at higher risk of fracture. 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 approves new drug to treat HIV infection FDA approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs. More information   FDA approves first rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies FDA approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as an aid in the diagnosis of HIV-1 and HIV-2 infection, the Alere Determine HIV-1/2 Ag/Ab Combo test is also the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test. 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 Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry This guidance document is intended to assist industry and FDA staff in identifying and appropriately addressing specific considerations related to the incorporation and integration of radio frequency (RF) wireless technology in medical devices. This guidance discusses issues that may affect the safe and effective use of medical devices that incorporate RF wireless technology, including selection of wireless technology, quality of service, coexistence, security, and electromagnetic compatibility, and provides recommendations for information to be included in FDA premarket submissions for such devices. 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 Reopening of Comment Period:Human Immunodeficiency Virus Patient-Focused Drug Development and Human Immunodeficiency Virus Cure Research FDA requested public comment regarding patients' perspective on current approaches to managing HIV, symptoms experienced because of HIV or its treatment, and issues related to HIV cure research. FDA is reopening the comment period to allow interested persons additional time to submit comments. Comments are due by September 3, 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 awards contract to develop promising new technology to test radiation countermeasures FDA has awarded a $5.6 million contract to Harvard University’s Wyss Institute for Biologically Inspired Engineering to apply its  breakthrough organs-on-chips technology to assess medical countermeasures for treating acute radiation syndrome (ARS), also known as radiation sickness. More information  Innovative New Drugs Are Reaching Patients at a Fairly Constant Rate: New FDA Study Reports on 25-year record of approvals FDA examined NME approvals over the 25 years from 1987 to 2011. We identified three distinct subcategories of novel new drugs: 1) first-in-class, which represents novel drugs that use new mechanisms to treat or prevent disease 2) advance-in-class, drugs that work in ways similar to, but demonstrate significant advantages over, existing drugs, and 3) addition-in-class, essentially representing new drugs that work and perform similarly to ones we already have on the market. More information Anesthesia: Is it Safe for Young Brains? FDA and the International Anesthesia Research Society (IARS) started an initiative called SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots). SmartTots seeks to ensure that children under age 4 will be as safe as possible when they need anesthesia during surgery. Studies have shown that this is a period of significant brain development in young children. More information   Laser Toys: Not Always Child's Play When operated unsafely, or without certain controls, the highly-concentrated light from lasers—even those in toys—can be dangerous, causing serious eye injuries and even blindness. And not just to the person using a laser, but to anyone within range of the laser beam. FDA is particularly concerned about this potential danger to children and those around them, and has issued a draft guidance document on the safety of toy laser products. More information Improving Patient Care by Making Sure Devices Work Well Together Interoperability refers to the ability of medical devices to interact and for electronic health record systems to talk to each other using a common vocabulary. It is similar to the concept of “plug and play” computer attachments like a web cam or mouse, which are made so that products can operate with different brands and models of computers. More information FDA defines “gluten-free” for food labeling FDA  published a new regulation defining the term "gluten-free" for voluntary food labeling.  This will provide a uniform standard definition to help the up to 3 million Americans who have celiac disease, an autoimmune digestive condition that can be effectively managed only by eating a gluten free diet. 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. 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 Pediatric Ethics Subcommittee of the Pediatric Advisory Committee (Sept 9 & 10) The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss ethical issues in pediatric product development, including medical counter measures, focusing on the concepts of minimal risk, disorder or condition, and exposure of pediatric subjects to risks under 21 CFR 50.54.  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   Circulatory System Devices Panel of the Medical Devices Advisory Committee (Sept 11 & 12) The committee will discuss and make recommendations regarding the proposed classification of external cardiac compressor (ECC), external pacemaker pulse generators (EPPGs), and membrane lung for long-term pulmonary support systems. More information Oncologic Drugs Advisory Committee (Sept 12) The committee will discuss supplemental biologics license application 125409/51, with the trade name PERJETA (pertuzumab) injection, application submitted by Genentech, Inc. The proposed indication (use) for this product is in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive, locally advanced, inflammatory, or early stage breast cancer (tumor greater than 2 cm in diameter) as part of a complete early breast cancer regimen containing either fluorouracil, epirubicin, and cyclophosphamide or carboplatin. 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  Pediatric Advisory Committee (Sept 19 & 20) The Pediatric Advisory Committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Public Law 107-109) and the for Pediatric Research Equity Act (Public Law 108-155). 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 Great Lakes cGMP & Regulatory Science Forum (Sept 24-25) This 2-day forum in Chicago, IL will feature experts from FDA, industry, and academia who will discuss the current initiatives to enhance regulatory science, pharmaceutical manufacturing and product quality. 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  Anti-Infective Drugs Advisory Committee Meeting (Oct 17) The purpose of the meeting is to discuss susceptibility interpretive criteria for systemic antibacterial drugs and for dosing recommendations in product labeling. We will seek input on the role of pharmacokinetic data in setting susceptibility interpretive criteria. We will also discuss revising dosing recommendations in product labeling based on pharmacokinetic data and clinical safety and efficacy data. More information Anti-Infective Drugs Advisory Committee (Oct 18) The committee will discuss the safety and effectiveness of new drug application (NDA) 204684, miltefosine capsules, submitted by Paladin Therapeutics, Inc., for the proposed indication of treatment of patients with visceral (involving internal organs), mucosal (involving areas such as inside the mouth and nose), and cutaneous (involving the skin) leishmaniasis, an infection caused by a parasite. More information Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop (Oct 21 & 22) FDA Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and the Pediatric IBD Foundation, is announcing a 2-day public workshop entitled “Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II).” Partners and stakeholders planning the workshop also include patients and representatives from the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health. 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