FDA Updates for Health Professionals

UPDATES FOR HEALTH PROFESSIONALS

Office of Health and Constituent Affairs

• ANNOUNCEMENTS
• OPPORTUNITIES FOR COMMENT / GUIDANCES
• PRODUCT APPROVALS & CLEARANCES
• PRODUCT SAFETY
• UPCOMING MEETINGS
• RESOURCES

ANNOUNCEMENTS

FDA advises testing for Zika virus in all donated blood and blood components in the US As a further safety measure against the emerging Zika virus outbreak,FDA issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.The revised guidance recommends that all states and U.S. territories screen individual units of donated Whole Blood and blood components with a blood screening test authorized for use by the FDA under an investigational new drug (IND) application, or a licensed test when available. More information

FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use

After an extensive review of the latest scientific evidence, FDA is requiring class-wide changes to drug labeling, including patient information, to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of central nervous system (CNS) depressant drugs called benzodiazepines.Among the changes, the FDA is requiring boxed warnings – the FDA’s strongest warning – and patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines – nearly 400 products in total – with information about the serious risks associated with using these medications at the same time.  More information

FDA issues final rule on safety and effectiveness of antibacterial soaps FDA issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed. Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Washing with plain soap and running water remains one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others. More information

Treating Head Lice

An estimated 6 to 12 million cases of head lice infestation occur each year in the United States in children 3 to 11 years of age, according to the Centers for Disease Control and Prevention. Head lice are most common among preschool children attending child care, elementary school children, and household members of children who have lice. More information

Antibacterial Soap? You Can Skip It -- Use Plain Soap and Water

When you buy soaps and body washes, do you reach for products labeled “antibacterial” hoping they’ll keep your family safer? Do you think those products will lower your risk of getting sick, spreading germs or being infected? According to the FDA, there isn’t enough science to show that over-the-counter (OTC) antibacterial soaps are better at preventing illness than washing with plain soap and water. To date, the benefits of using antibacterial hand soap haven’t been proven. In addition, the wide use of these products over a long time has raised the question of potential negative effects on your health. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Comment Request on Medical Devices - Third-Party Review Under the Food and Drug Administration Modernization Act This notice solicits comments on the information collection associated with medical devices third-party review under the Food and Drug Administration Modernization Act. More information

Bioequivalence Recommendations for Risperidone Draft Guidance

FDA is announcing the availability of a revised draft guidance for industry on generic risperidone injection, entitled “Bioequivalence Recommendations for Risperidone.” The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for risperidone injection. More information 

PRODUCT APPROVALS & CLEARANCES

FDA approves Erelzi, a biosimilar to Enbrel FDA approved  Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998. Erelzi is administered by injection for the treatment of: moderate to severe rheumatoid arthritis, moderate to severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and chronic moderate to severe plaque psoriasis. More information

FDA allows marketing of clot retrieval devices to reduce disability in stroke patients

FDA allowed marketing of two Trevo clot retrieval devices as an initial therapy for strokes due to blood clots (ischemic) to reduce paralysis, speech difficulties and other stroke disabilities. These devices should be used within six hours of symptom onset and only following treatment with a clot-dissolving drug, which needs to be given within three hours of symptom onset. More information

For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA orDailyMed

PRODUCT SAFETY

Need Safety Information? For more important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch. To receive MedWatch Safety Alerts by emailsubscribe here.

Drug Safety Communication: Opioid Pain or Cough Medicines Combined With Benzodiazepines - FDA Requiring Boxed Warning About Serious Risks and Death

FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. In an effort to decrease the use of opioids and benzodiazepines, or opioids and other CNS depressants, together, FDA is adding Boxed Warnings to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines. More information

Safety Communication: Mass Spectrometers by Sciex - Incorrect Assignment of Test Results

 FDA is alerting lab staff and health care professionals about a software defect in Sciex mass spectrometers. This software defect may cause the devices to incorrectly assign results to samples analyzed. A potential inaccurate clinical diagnosis or treatment decision may lead patients to experience serious adverse health consequences. More information

Vascu-Guard Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers - Potential Risk of Severe Bleeding and Hematomas

 FDA has recently received multiple adverse event reports associated with Baxter International Inc.’s Vascu-Guard Peripheral Vascular Patch during carotid endarterectomy (CEA). FDA is concerned that the Vascu-Guard patch may not be performing as intended and that patients who are treated with the product may be at risk for serious adverse health consequences, such as severe bleeding, hematomas, and death. More information

Recall: Dietary Supplements by Ton Shen Health/Life Rising - Elevated Lead Levels

Ton Shen Health/Life Rising Corporation is expanding its recall of “DHZC-2” Tablets to all lots purchased before August 24, 2016 because they have the potential to be contaminated with elevated levels of lead. Consumers should not purchase or consume these products out of an abundance of caution. More information

Recall: Lamotrigine Orally Disintegrating Tablet 200 mg by Impax- Incorrect Labeling of Blister Cards

Impax Laboratories, Inc. issued a voluntary nationwide retail level recall for one lot of Lamotrigine Orally Disintegrating Tablet (ODT). Unit-of-use blister packs (a 10 count blister card contained in a single plastic shell-pack) may contain 100 mg product instead of 200 mg product, and as a result, it is possible that consumers could take less than their intended lamotrigine dose. A reduction in dose may lead to reduced therapeutic effects of lamotrigine and reemergence of epilepsy or bipolar disorder symptoms. More information

FDA Safety Communication: Programmable Syringe Pumps - Problems With Fluid Flow Continuity at Low Infusion Rates

FDA is informing health care professionals that when using programmable syringe pumps to infuse therapies at low rates, a lack of flow continuity can result in serious clinical consequences, including delay of therapy, over-infusion or under-infusion. 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; Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval (Sep 8)

The Food and Drug Administration is announcing a public workshop entitled, “Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval.” More information

Pediatric Clinical Investigator Training; Public Workshop (Sep 12 & 13)

The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. More information

Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (Sep 14)

The committees will discuss a completed postmarketing-requirement randomized, placebo controlled trial of the neuropsychiatric effects of CHANTIX (varenicline), ZYBAN (bupropion), and nicotine replacement therapy, along with relevant published observational studies to determine whether the findings support changes to product labeling. More information

National Mammography Quality Assurance Advisory Committee Meeting  (Sep 15)

The Committee will discuss and make recommendations on: Compliance analysis; Inspection Enhancement Project; the approved alternative standard American College of Radiology Full Field Digital Mammography Quality Control Manual; issues related to breast density; and future challenges for MQSA. More information

Anti-Infective Drug Development in Neonates (Sep 15)

This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. Government Agencies, public health organizations, academic experts, and industry on various aspects of drug development for new and currently marketed anti-infective drugs for neonates and young infants. More information

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee and the Pediatric Advisory Committee (Sep 15 & 16)

The purpose of this public advisory committee meeting is to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation. More information

FDA-ASCO: Hematology and Oncology Fellows Day Workshop (Sep 16)

At the close of this intimate, day-long workshop with intensive interaction with approximately two dozen FDA oncologists, the participants will have a basic knowledge of: Oncology drug regulation; the Investigational New Drug (IND) process; expanded access programs; disease-specific considerations; and more. This workshop is open to physicians who have completed at least one year of hematology/ oncology fellowship training in an accredited U.S. training program and are currently in good standing in their fellowship program. More information 

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (Sept 20-21)

The Committee will discuss and make recommendations regarding the classification of certain wound care products containing antimicrobials and other drugs as part of the routine process for device classification. The meeting will be open to the public. FDA is establishing a docket for public comment. More information

Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices (Sep 30)

A Public Workshop cosponsored by FDA, American Academy of Ophthalmology (AAO), American Academy of Optometry (AAOpt), American Association for Pediatric Ophthalmology and Strabismus (AAPOS), American Optometric Association (AOA), American Society of Cataract and Refractive Surgery (ASCRS), and Contact Lens Association of Ophthalmologists, Inc. (CLAO). The purpose of the workshop is to discuss the increasing prevalence of myopia and to obtain consensus for clinical trial design attributes when contact lenses or other medical devices are studied for controlling the progression of myopia. More information

Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (Oct 5)

FDA announces a forthcoming public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee.  The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The topic to be addressed will be reclassification of quantitative Cytomegalovirus (CMV) viral load devices from class III (Premarket approval) to class II (510(k)). More information

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management (Oct 5) 

The committees will be asked to discuss naloxone products intended for use in the community, specifically the most appropriate dose or doses of naloxone to reverse the effects of life-threatening opioid overdose in all ages, and the role of having multiple doses available in this setting. The committees will also be asked to discuss the criteria prescribers will use to select the most appropriate dose in advance of an opioid overdose event and the labeling to inform this decision, if multiple doses are available. More information

Vaccines and Related Biological Products Advisory Committee Meeting (Oct 13) 

The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2017 southern hemisphere influenza season. Committee members will participate via teleconference. More information

Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (Oct 19)

The committee will discuss the efficacy and safety of new drug application (NDA) 201656 (desmopressin), 0.75 mcg/0.1 mL and 1.5 mcg/0.1 mL nasal spray, submitted by Serenity Pharmaceuticals, LLC, for the proposed treatment of adult onset nocturia. More information

Allergenic Products Advisory Committee Meeting (Oct 27)

The committee will hear updates of research programs in the Laboratory of Immunobiochemistry of the Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. More information

RESOURCES

For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch

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 endruginfo@fda.hhs.gov. Comunicaciones de la FDA

MedWatchLearn - Practice Reporting to FDA! This web-based learning tool teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA.More information

FDA Expert Commentary and Interview Series on Medscape

As part of the continuing collaboration between FDA and Medscape, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices More information  

Cardiovascular and Endocrine Liaison Program The Cardiovascular and Endocrine Liaison Program serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. Discover how you or your organization can collaborate with FDA. 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

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