FDA Updates for Health Professionals

May 8, 2013

PRODUCT SAFETY Recall: SexVoltz, Velextra, and Amerect by Beomonstar Products - Undeclared Drug Ingredient Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. More information Public Notification: Bullet Proof:  - Undeclared Drug Ingredient Testing revealed the product contains tadalafil, which may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. More information Lightning Rod Capsules: Recall - Undeclared Drug Ingredient Testing revealed the product contains an analogue of sildenafil, which may interact with nitrates found in prescription drugs such as nitroglycerin, and lower blood pressure to dangerous levels. More information Class 1 Recall: Maquet SERVO-i Ventilator Battery Module - Battery Run Time Shorter Than Expected May result in unexpected ventilator shut downs, which can result in serious adverse health consequences, including death. More information Class 1 Recall: Medtronic - Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit Use of lead cap may cause lead damage. Lead replacement may be required or optimal therapy may not be provided. More information FDA Safety Communication: Covidien Surgical Stapler Reloads - Devices Stolen Before They Were Sterilized Use of these non-sterile products could increase the risk of infection in surgical patients. More information Class 1 Recall: Cardinal Health - Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit Plastic packaging may become lodged in the filter potentially causing an obstruction in airflow, which may result in low blood oxygen (hypoxia), suffocation and death. More information Drug Safety Communication: Valproate Anti-Seizure Products  - Contraindicated for Pregnant Women for Prevention of Migraine Headaches Based on a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant. More information Drug Safety Communication: Kadcyla (ado-trastuzumab emtansine) - Potential Medication Errors Resulting from Name Confusion Use of the incorrect nonproprietary name for Kadcyla in some medication-related electronic systems poses a risk of mix-up with Herceptin (trastuzumab). More information Recall: American Lifestyle Vicerex and Black Ant Capsules - Undeclared Drug Ingredient Laboratory analysis has found tadalafil and sildenafil. More information Recall: Hospira Inc., GemStar Infusion System - Lithium Battery Low Voltage Damage from battery leakage may cause the device to shut off without warning.  More information Class I Recall: Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators - Unit Goes Into Internal Backup Battery Sooner Than Expected The screen on the ventilator may indicate that the Power Pac battery is fully charged when it is not, or the unit may switch to backup battery power as soon as it is removed from AC power. More information Recall: Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit By Fenwal - Labeling Issue Identified The platelet container is incorrectly labeled as “AS-1 Red Blood Cell Adenine-Saline added”.  More information Drug Safety Communication: Samsca (Tolvaptan) - FDA Limits Duration and Usage Due To Possible Liver Injury Leading to Organ Transplant or Death An increased risk of liver injury was observed in recent large clinical trials evaluating Samsca. More information Recall: Piperacillin and Tazobactam for Injection, USP 40.5 grams - Precipitation or Crystallization in IV Bag or IV Line Upon Reconstitution Administration of precipitated Piperacillin/Tazobactam can lead to serious adverse events. More information Drug Safety Communication: Potiga (Ezogabine) - Linked To Retinal Abnormalities And Blue Skin Discoloration Pigment changes in the retina have the potential to cause serious eye disease with loss of vision. More information Recall: Eba Multivitamin Supplement By Saratoga Therapeutics LLC - Allergy Alert On Undeclared Milk Components Incidents of being sick and experiencing anaphylactic reactions have been reported by customers taking Eba Multivitamins. More information Recall: Sodium Chloride Injection 0.9 percent USP, 100 mL Flexible Containers by Hospira - Particulate Matter Use may result in local inflammation, phlebitis, and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the body. 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 Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older FDA announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older. More information FDA approves Procysbi for rare genetic condition FDA approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare disease or condition. More information FDA approves Kcentra for the urgent reversal of anticoagulation in adults with major bleeding FDA approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States. 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 510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device; Public Meeting; Request for Comments FDA is holding this meeting on June 13, 2013, from 9 a.m. to 5 p.m. to obtain information on its interpretation of the 510(k) device modifications regulations, and specifically, deciding when a 510(k) should be submitted for a change to a 510(k)-cleared device. To permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the meeting topics. FDA would like to receive these comments by May 30, 2013.  More information Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors; Availability FDA is announcing the availability of a draft guidance for industry entitled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.”Submit either electronic or written comments on the draft guidance by June 24, 2013. More information FDA proposes new food safety standards for foodborne illness prevention and produce safety; Request for Comments 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 FDA issues proposal to increase consumer awareness of tanning bed risks FDA issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices. More information Consumer Update: FDA to Investigate Added Caffeine FDA has announced that, in response to a trend in which caffeine is being added to a growing number of products, the agency will investigate the safety of caffeine in food products, particularly its effects on children and adolescents. More information Consumer Update: Fighting the Impact of Antibiotic-Resistant Bacteria The resistance of bacteria to antibiotics and similar drugs—called antimicrobials—is considered a major public health threat by the FDA and its counterparts around the world. More information Consumer Update: Clinical Trials Shed Light on Minority Health FDA is working to increase the participation of people in racial, ethnic and other minority groups in the clinical trials that test new medical products. More information Medwatcher mobile app MedWatcher is a mobile application (app) that allows individuals to submit voluntary reports of serious medical device problems to the FDA using a smart phone or tablet. The app makes it easier and faster for healthcare professionals, patients and caregivers to send voluntary reports of medical device problems to the FDA, compared to the traditional reporting methods - mail, phone or online. More information The FDA Office of Special Health Issues Has a New Name! The former Office of Special Health Issues, the FDA’s flagship contact for patients and healthcare professionals, will now be called the Office of Health and Constituent Affairs (OHCA). The Office will continue its core function of serving the needs of patients and healthcare professionals and managing the MedWatch program, but the new name showcases the emphasis placed on building a more robust and centralized office for all stakeholder engagement. 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. Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice Conference (May 15-16) FDA is announcing an educational conference co-sponsored with the Society of Clinical Research Associates (SOCRA). The conference on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. More information Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (May 21-22) On May 21, the committee will discuss the classification of one of the remaining preamendments class III devices, shortwave diathermy for all other uses except for the treatment of malignancies. On May 22, the committee the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 (Docket No. FDA-2009-M-0101).  More information Peripheral and Central Nervous System Drugs Advisory Committee Meeting (May 22) The committee will discuss new drug application for Suvorexant tablets. The proposed indication is for insomnia characterized by difficulties with sleep onset and/or maintenance.  More information Reagan-Udall Foundation Public Meeting (May 23) The Reagan-Udall Foundation for the Food and Drug Administration, which was created by Title VI of the Food and Drug Amendments of 2007, is announcing an annual open public meeting. The Foundation will provide an overview of its history, project updates, as well as projected activities going forward. More information 2013 Medical Countermeasures Initiative Regulatory Science Symposium (May 30) FDA is announcing the following meeting: 2013 Medical Countermeasures initiative (MCMi) Regulatory Science Symposium. The symposium is intended to provide a forum for the exchange of ideas for medical countermeasure development, highlight work on regulatory science as it applies to the development and advancement of medical countermeasures, facilitate innovative directions, and inform stakeholders on medical countermeasure.  More information  Food and Drug Administration/National Institutes of Health/National Science Foundation Public Workshop on Computer Methods for Medical Devices (Jun 11-12) FDA is announcing its fifth public workshop on Computer Methods for Medical Devices entitled “FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices.” More information FDA/International Society for Pharmaceutical Engineering Co-Sponsorship Educational Workshop: Redefining the `C' in CGMP (Current Good Manufacturing Practices): Creating, Implementing, and Sustaining a Culture of Quality (Jun 11-13) The conference will span 3 days and is dedicated to teaching the principles of CGMP, reaping the benefits that come from establishing and maintaining a state of control, implementing continual improvement, enhancing regulatory compliance, and meeting quality objectives every day. The conference will take place in Baltimore, MD More information Center for Devices and Radiological Health: Health of Women Program; Public Workshop; Request for Comments (Jun 24) FDA is announcing the following public workshop: “The Center for Devices and Radiological Health (CDRH) Health of Women (HoW) Program: Educate, Enable, Enlist and Explore—HoW to Improve the Health of Women.” CDRH is developing the HoW Program to explore unique issues in the regulation of medical devices related to the health of women and seeks public input on the priority activities. The deadline for submitting comments related to this public workshop topic is July 31, 2013. Register now Food and Drug Administration/National Institutes of Health/National Science Foundation Public Workshop on Computer Methods for Medical Devices (Jun 11-12) FDA is announcing its fifth public workshop on Computer Methods for Medical Devices entitled “FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices.” More information Center for Devices and Radiological Health: Health of Women Program; Public Workshop; Request for Comments (Jun 24) FDA is announcing the following public workshop: “The Center for Devices and Radiological Health (CDRH) Health of Women (HoW) Program: Educate, Enable, Enlist and Explore—HoW to Improve the Health of Women.” CDRH is developing the HoW Program to explore unique issues in the regulation of medical devices related to the health of women and seeks public input on the priority activities. The deadline for submitting comments related to this public workshop topic is July 31, 2013. More information Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (Jul 24-25) On July 24 the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. On July 25 the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. 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