ANNOUNCEMENTS
FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs
FDA proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.
FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care
FDA announced a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. The agency created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. This approach is intended to aid health care professionals in making more informed prescribing decisions that will both benefit their patients and prevent the spread of resistant bacteria.
*Updated*Laparoscopic Power Morcellators
Laparoscopic power morcellators are Class II medical devices used during laparoscopic (minimally invasive) surgeries to cut tissue into smaller pieces so the tissue can be removed through a small incision site (typically 2 cm long or less). These devices are commonly used in gallbladder, kidney, liver, and spleen removal surgery. They are also used in hysterectomy (surgical procedure to remove a women’s uterus) and myomectomy (surgical procedure to remove uterine fibroids which are noncancerous growths in the lining of a women’s uterus).
FDA's efforts to support more efficient development of targeted therapies
from FDA Commissioner Scott Gottlieb, M.D.; In recent years, the medical community has experienced a shift in the way health care is practiced. Rather than focusing solely on how to treat an overall disease type, medical innovators are now exploring how to tailor treatments that target unique characteristics of an individual’s disease, such as the genetic profile of a person's tumor. Innovation in this modern, targeted approach to medicine has already led to new more targeted medicines and, in some cases, therapies that are tailored to individual patients.
FDA issues final rule on safety and effectiveness for certain active ingredients in over-the-counter health care antiseptic hand washes and rubs in the medical setting
The FDA has finalized a rule first proposed in 2015 that finds that triclosan and 23 other active ingredients are not generally recognized as safe and effective (GRASE) for use in over-the-counter (OTC) health care antiseptic products – including health care personnel hand washes and rubs, surgical hand scrubs and rubs, and patient antiseptic skin preparations — because no additional safety and effectiveness data were provided to the FDA to support monograph conditions for these 24 active ingredients.
FDA's efforts to support more efficient and effective food recalls
from FDA Commissioner Scott Gottlieb, M.D.; One of our most important jobs at the U.S. Food and Drug Administration is ensuring the safety of the U.S. food supply. When we learn about a food in the marketplace that may be unsafe, we must act quickly to keep people from getting sick or being harmed. If foodborne illness has already occurred, we also must act quickly to keep more people from becoming ill. The re-issued, final version of the report by the Office of the Inspector General (OIG), which examined our food recall practices over the time period from Oct. 1, 2012 to May 4, 2015, raised some significant concerns for me.
Drug Shortages
Drug Discontinuation Voluntarily Reported by Manufacturers During the Past 2 Weeks:
- Bumetanide Injection, USP
- Memantine Hydrochloride (NAMENDA) Oral Solution
- Fluvoxamine Tablets
- Acetazolamide (Diamox Sequels) Extended Release Capsules
- Albiglutide (Tanzeum) Injection
PRODUCT APPROVALS & CLEARANCES
FDA approved novel gene therapy to treat patients with a rare form of inherited vision loss
FDA approved approved Luxturna (voretigene neparvovec-rzyl), a new gene therapy, to treat children and adult patients with an inherited form of vision loss that may result in blindness. Luxturna is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene.
FDA approved drug to treat dangerously low blood pressure
FDA approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. "Shock, the inability to maintain blood flow to vital tissues, can result in organ failure and death," said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. "There is a need for treatment options for critically ill hypotensive patients who do not adequately respond to available therapies."
FDA cleared stereotactic radiotherapy system for use in treating breast cancer
FDA cleared a new noninvasive stereotactic radiotherapy system intended for use in treating cancer in breast tissue. “With today’s clearance, patients will have access to a treatment option that provides greater accuracy in delivering radiation therapy to breast tumors while saving surrounding breast tissue,” said Robert Ochs, Ph.D., acting deputy director for radiological health in the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
Tasigna label updated to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response
FDA updated the product label for the cancer drug Tasigna (nilotinib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). With today’s updated dosing recommendations, patients with early (chronic) phase CML who have been taking Tasigna for three years or more, and whose leukemia has responded to treatment according to specific criteria as detected by a test that has received FDA marketing authorization, may be eligible to stop taking Tasigna.
For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed
PRODUCT SAFETY
Linezolid Injection by Auromedics Pharma: Recall 600mg/300mL flexible bags- Due to Presence White Particle Matter
AuroMedics Pharma is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017. The product was found to contain white particulate matter that has been identified as mold.
Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS): Drug Safety Communication
FDA's most prominent warning, the Boxed Warning, about asthma-related death has been removed from the drug labels of medicines that contain both an ICS and LABA. A FDA review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone. A description of the four trials is now also included in the Warnings and Precautions section of the drug labels. These trials showed that LABAs, when used with ICS, did not significantly increase the risk of asthma-related hospitalizations, the need to insert a breathing tube known as intubation, or asthma-related deaths, compared to ICS alone.
Pantoprazole Sodium for Injection 40 Mg Per Vial: Recall - Presence of Glass Particles
AuroMedics Pharma LLC is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. The product was found to contain glass particles in the vial. This problem was discovered as a result of a product complaint in which the contents of one vial from one batch was found to contain a piece of glass.
Blue Pearl All Natural Male Enhancement Supplement: Recall - Undeclared Drug Ingredient
Marmex Corp is voluntarily recalling all lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg to the consumer level. FDA analysis has found the products to contain sildenafil. The presence of the undeclared active ingredients renders them unapproved drugs for which safety and efficacy have not been established.
Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication - Retained in Body; New Class Warnings
FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.
Defibrillation Electrodes for Lifepak AEDs by Physio-Control: Class I Recall - Incorrect Placement Instructions for Infants Depicted on Artwork
Physio-Control Inc. is recalling infant/child defibrillation electrodes because the artwork on the pads within the packaging shows incorrect placement instructions for infants. There is no issue with the performance or function of the defibrillation electrodes. However, incorrect placement of the electrodes on an infant may result in failure to deliver an effective shock to an infant in cardiac arrest. A delay in therapy could result in serious injury and/or death.
For important safety information on human drugs, medical devices, dietary supplements and more, or to report an adverse event or problem with a medical product, please visit MedWatch, The FDA Safety Information and Adverse Event Reporting Program.
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 a complete list and more information. Please visitMeetings, Conferences, & Workshops for more information on other agency meetings.
JANUARY
Public Workshop: Self-Collection Devices for Pap Test
Date: January 11, 2018, 9:00 am to 4:00 pm
Location: FDA White Oak Campus, Great Room, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Agenda: The purpose of the workshop is to obtain feedback about how the feasibility, benefits and risks impact the current standard of care and least burdensome validation approaches for self-collection cervical sampling devices for the purpose of cervical cancer screening by Pap testing. Comments and suggestions generated through this workshop will guide the development of an appropriate least burdensome regulatory framework for the evaluation of cervical sample self-collection devices to be used for cervical cancer screening of patients.
Public Hearing: FDA Approach to Evaluating Nicotine Replacement Therapies
Date: January 26, 2018, 9:00 am to 5:00 pm
Location: FDA White Oak Campus, Great Room, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Agenda: To hear public comments on FDA’s approach to evaluating the safety and efficacy of nicotine replacement therapy (NRT) products, including how they should
be used and labeled.
Public Meeting: Opioid Policy Steering Committee- Prescribing Information - Exploring a Strategy for Implementation
Date: January 30, 2018, 8:30 am to 4:30 pm
Location: FDA White Oak Campus, Great Room, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Agenda: The Food and Drug Administration is announcing the following public meeting entitled “Opioid Policy Steering Committee— prescribing intervention – exploring a strategy for implementation." The purpose of the public meeting is to receive stakeholder input on how FDA might, under its Risk Evaluation and Mitigation Strategy (REMS) authority, improve the safe use of opioid analgesics by curbing over-prescribing to decrease the occurrence of new addictions and limit misuse and abuse of opioid analgesics.
FEBRUARY
Public Workshop: Tenth Annual Sentinel Initiative
Date: February 7-8, 2018, 9:00 am to 4:30 pm
Location: Hyatt Regency Bethesda, 1 Bethesda Metro Center, Bethesda, MD 20814
Agenda: The purpose of this 2-day public workshop is to bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Day 1 will be convened by the Duke-Margolis Center for Health Policy at Duke University with support by a cooperative agreement with FDA. Key discussion topics will include an update on the state of FDA's Sentinel Initiative, key safety surveillance activities, and emerging uses of the Sentinel System. In addition, panelists, representing diverse stakeholder perspectives, will provide comments on Sentinel and opportunities to expand its analytic capabilities. This workshop will also provide an opportunity for stakeholder engagement and input on Sentinel's continued modernization.
Register: To attend the public workshop on Day 1, you must register before February 6, 2018, by visiting https://healthpolicy.duke.edu/
RESOURCES
Opportunities for Comment
The Federal Register website was developed to make it easier for citizens and communities to understand the regulatory process and to participate in Government decision-making. The Office of the Federal Register of the National Archives and Records Administration and the U.S. Government Publishing Office jointly administer the FederalRegister.gov website.
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.
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.
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.
FDA Voice
FDA voice is the official blog from FDA's senior leadership and staff.
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