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)
<div align="left" style="color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-stretch: norma