CIENCIASMEDICASNEWS: FDA Patient Network Newsletter

Reducing Risks Associated with Medical Device MisconnectionsPatients in health care settings receive food, medication and other therapies through a variety devices, or delivery systems, such as syringes, catheters, and tubing sets that connect to each other. Connectors are the parts of devices that attach tubing, catheters and syringes to other medical devices.

Medical devices are often packaged together in tubing sets or co-packaged with another device (e.g. feeding set and enteral feeding tube). These sets comprise all the parts needed to use the tubing for its intended purpose, including the connectors that attach tubes to the other parts of the set or to other devices. Medical device misconnections may occur when one type of medical device is mistakenly attached to another type of medical device that performs a different function. More information

Drug Safety Communication: Direct-Acting Antivirals for Hepatitis C - Risk of Hepatitis B Reactivating
FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. HBV reactivation usually occurred within 4-8 weeks.

As a result, FDA is requiring a Boxed Warning, our most prominent warning, about the risk of HBV reactivation to be added to the drug labels of these DAAs directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment. This warning will also be included in the patient information leaflet or Medication Guides for these medicines. More information

FDA warns against the use of homeopathic teething tablets and gels
FDA is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession.

Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online.

Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels. More information

Safety Communication: Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices
FDA is providing information and recommendations regarding St. Jude Medical’s advisory on Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) batteries that may fail earlier than expected. FDA and St. Jude Medical are alerting patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. Due to problems with these batteries, patients do not have the normal 3-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert. St. Jude Medical has initiated a recall and correction of the affected devices.

ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires called “leads” that go into the heart. Patients need an ICD or CRT-D if their heart beat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure. 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 importante sobre seguridad de los medicamentos 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 inglés y la de 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

Empty Medicine Cabinet with Empty Medicine Bottle

FDA knows the major public health consequences that can result from drug shortages. These shortages occur for many reasons including manufacturing and quality problems, delays and discontinuations. When issues are discovered, FDA works closely with the company to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the company to restore supplies while also ensuring safety for patients. More information

Drug Shortages Reported to be Resolved by Manufacturers During the Past 2 Weeks:

Drug Discontinuation Voluntarily Reported by Manufacturers During the Past 2 Weeks:

Information about blood and biologic shortages, resolved shortages, and discontinuations

La FDA reconoce las consecuencias significativas para la salud pública que pueden resultar de la escasez de medicamentos y hace un gran esfuerzo dentro de sus facultades legales para abordar yprevenir la escasez de medicamentos. La escasez se produce por muchas razones, incluyendoproblemas de fabricación y calidad, retrasos y discontinuación del producto. Cuando los problemas son descubiertos por la empresa o el público y reportados a la FDA o se descubren por inspecciones de la FDA, la FDA trabaja en estrecha colaboración con la empresa para hacer frente a los riesgosinvolucrados y evitar daños a los pacientes. La FDA también considera el impacto que una escaseztendría en la atención médica del paciente y al acceso del producto y trabaja con la empresa pararestablecer el suministro al tiempo que garantiza la seguridad de los pacientes. Más información

First automated insulin delivery device approved for type 1 diabetes
On September 28, 2016 Medtronic’s MiniMed 670G hybrid closed looped system was approved. The first FDA-approved device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes.

The human pancreas naturally supplies a low, continuous rate of insulin, known as basal or background insulin. In patients with diabetes, the body’s ability to produce or respond to insulin is impaired. More information

For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.

Draft Guidance: Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in Food and Drug Administration Advisory Committees
This draft guidance addresses FDA's process, under Government-wide Federal regulations, for evaluating whether an advisory committee member has an appearance issue that raises concerns about the member's participation in an advisory committee meeting and describes FDA's process for determining whether to authorize a member with an appearance issue to participate in the advisory committee meeting. This draft guidance is not final nor is it in effect at this time.

FDA is requesting comment on whether FDA should request that each advisory committee member who has an appearance issue and who has received an authorization from FDA to participate in an advisory committee meeting voluntarily publicly disclose the authorization.

The original closing date for comments on this draft guidance document was September 27, 2016. However, FDA is still accepting comments on this draft. More information

View FDA's Comments on Current Draft Guidance page, for a list of current draft guidances and other topics of interest for patients and caregivers.

Opportunities to Comment - October 2016
Opportunities to Comment - November 2016
Opportunities to Comment - December 2016

Our 20th Patient-Focused Drug Development meeting: Enhancing the patient’s voice in FDA’s approach to drug review and development, by: Theresa M. Mullin, Ph.D., Director of FDA’s Office of Strategic Programs in the Center for Drug Evaluation and Research
Since the launch of the Patient Focused Drug Development program as part of the fifth authorization of the Prescription Drug User Fee Act(PDUFA V), we have worked intensively to explore ways to enhance the patient’s voice in drug development. Recently we reached a particularly gratifying milestone in this important work — our 20th Patient-Focused Drug Development (PFDD) public meeting.

The PDUFA program provides much needed funding from the pharmaceutical industry to support FDA’s premarket review activities and the agency’s work to encourage drug development. Under PDUFA V, FDA committed to obtain patients’ views in at least 20 disease areas over the course of the program’s five year period, which ends in September, 2017. That means conducting a public meeting for each disease area to obtain patient perspectives on the impact of the condition on daily life and current treatment approaches. Our 20th PFDD meeting, with patients who have received organ transplants, took place on September 27th. With that meeting completed, we fulfilled our commitment — one year ahead of schedule.

To read the rest of this Post, see the FDA Voice Blog, October 4, 2016.

National Prescription Drug Take-Back Day
On October 22, 2016 from 10:00 AM - 2:00 PM, the National Prescription Drug Take-Back Day aims to provide a safe, convenient, and responsible means of disposing of prescription drugs, while also educating the general public about the potential for abuse of medications. More information or to Locate A Collection Site Near You

FDA Statement from Todd Simpson, FDA Chief Information Officer (CIO) on GAO Report Regarding FDA’s IT Security Program
Information security and the protection of industry and public health information are among the FDA’s highest priorities and we do not take lightly the recommendations provided by the Government Accountability Office (GAO) in its August 2016 report. The FDA has worked quickly to address the concerns outlined by the GAO - already fully implementing 80 percent (12 of 15) of GAO’s program recommendations, and 61 percent (102 of 166) of GAO’s technical recommendations. We anticipate completing the remaining three program recommendations in the next few months, and the remaining technical recommendations in the next year. More information

The Artificial Pancreas Device System
The FDA supports and fosters medical device innovation as it upholds its mission of ensuring that medical devices are safe and effective. The FDA is helping advance the development of an artificial pancreas device system, an innovative device that automatically monitors blood glucose and provides appropriate insulin doses in people with diabetes who use insulin.

Sometimes an artificial pancreas device system is referred to as a "closed-loop" system, an "automated insulin delivery" system, or an "autonomous system for glycemic control." More information

Where We Are/What We Have Done – Two Years After Releasing Our FDASIA 907 Action Plan, by Janice Soreth, M.D., Chair of the FDA Safety and Innovation Act Section 907 Steering Committee and the Acting Associate Commissioner for Special Medical Programs
Since it’s been more than two years since FDA unveiled its Action Plan to advance the inclusion of diverse populations in clinical trials, we’d like to update you on how much we have accomplished, and acknowledge that continued commitment is critical in order to build on this foundation.

The Congressional mandate under Section 907 of the FDA Safety and Innovation Act of 2012 required FDA to develop a reportexamining the extent to which various demographic groups were included in clinical trials and their outcomes reported in labeling for medical products for which applications were submitted to FDA. The legislation also required FDA to develop an Action Plan based on the report findings and input from stakeholders, issued in August 2014. The Action Plan identified 27 discrete actions for FDA to take within the three priority areas: improving data quality, encouraging greater clinical trial participation, and ensuring more data transparency.

To read the rest of this post, see the FDA Voice Blog, October 11, 2016.

In this section you will find a comprehensive list of all the meetings that the FDA is involved with. The meetings may include advisory committee meetings, public workshops and public conferences that are seeking to hear from patients and caregivers.

Most FDA meetings are free to the public and do not require the public to register. 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.

Calendar of FDA Sponsored Public Meetings - October 2016
Calendar of FDA Sponsored Public Meetings - November 2016
Calendar of FDA Sponsored Public Meetings - December 2016

View FDA's Patient Network Calendar of Public Meetings page for a complete list of meetings and workshops.

For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.

Dealing with ADHD: What You Need to Know
Is your child in constant motion? Does he or she talk incessantly? Or have trouble focusing and prefer to daydream?

Then your child may have attention deficit hyperactivity disorder, or ADHD.

This disorder often begins between the ages of 3 and 6 years, according to the National Institute of Mental Health (NIMH). And it’s not just a childhood disease: ADHD may continue through the teenage years and into adulthood (see sidebar). According to the Centers for Disease Control and Prevention (CDC), approximately 11% of children 4-17 years of age (6.4 million) have been diagnosed with ADHD as of 2011. More information

-October is Health Literacy Month- Making Decisions for Your Health: Getting the Info You Need
When your doctor prescribes a medication for your child, do you know what the correct dosage is or how to measure it?

Are you comfortable asking your doctor questions when you receive a lab report and don’t understand the results?

Do you understand how to use the information on the Nutrition Facts Label on food products when you shop at the grocery store?

If you can answer “yes” to these questions, you might have high health literacy, says Jodi Duckhorn, a social scientist and Director of Risk Communications at the Food and Drug Administration (FDA). Duckhorn’s team is responsible for making sure that messages FDA sends out are understandable to their intended target audiences—a key component of health literacy. More information

Traumatic Brain Injury: FDA Research and Actions
A car accident. A football tackle. An unfortunate fall. These things—and more—can cause head injuries. Head injuries can happen to anyone, at any age, and they can damage the brain.

Here’s how damage can happen: A sudden movement of the head and brain can cause the brain to bounce or twist in the skull, stretching and injuring brain cells and creating chemical changes. This damage is called a traumatic brain injury, or “TBI.”

As kids prepare for school sports, and many adults look ahead to fall activities, the U.S. Food and Drug Administration is researching TBI—and encouraging the development of new medical devices to help diagnose and treat it. More information

More Consumer Updates
For previously published Consumer Update articles that are timely and easy-to-read and cover all FDA activities and regulated products. More information

En Español
La información en esta página es para el público en general, y para profesionales y educadores de salud. Esta información puede ser distribuida y publicada sin previa autorización. En Español

FDA Investigates Outbreak of Salmonella Oranienburg Linked to Shell Eggs
On October 2, 2016, FDA reported a Salmonella illnesses linked to shell eggs distributed by Good Earth Egg Company. The investigation is being conducted between FDA, the Centers for Disease Control and Prevention (CDC), and Missouri state and local officials. More information

FDA Investigates Sammy’s Milk Baby Food (Infant Formula) for Improper Manufacturing, Safety Concerns

The Safety Reporting Portal
The Safety Reporting Portal (SRP) streamlines the process of reporting product issues to the Food and Drug Administration and the National Institutes of Health. Whatever your role, (manufacturer, health care professional, researcher, public health official, or concerned citizen), when you submit a safety report through this Portal, you make a vital contribution to the safety of America's food supply, medicines, and other products that touch us all. More information

Center for Food Safety and Applied Nutrition
The Center for Food Safety and Applied Nutrition, known as CFSAN, carries out the mission of FDA. The Center provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics. More information

Food Facts for You
The Center for Food Safety and Applied Nutrition, known as CFSAN, issues food facts for consumers to keep you and your family safe. More information

Animal Health Literacy
Animal Health Literacy means timely information for the benefit of all animals and their humans. With continuous communication and outreach, the Center for Veterinary Medicine (CVM) strives to enhance the public trust, promote safe and effective use of the animal health products we regulate, and share our scientific endeavors. CVM provides reliable, science-based information to promote animal and human health. More information and Publicaciones en Español del FDA

Animal and Veterinary Updates
Animal and veterinary updates provide information to keep your pets healthy and safe. More information

How to Report a Pet Food Complaint
You can report complaints about a pet food product electronically through the Safety Reporting Portal or you can call your state’s FDA Consumer Complaint Coordinators. Please provide as much information as possible in your complaint, such as exact name of product, type of container, lot number, UPC codes, how the food was stored, and purchase date and exact location where purchased. If possible, please save the original packaging until the pet food has been consumed. The packaging contains IMPORTANT information often needed to identify the variety of pet food, the manufacturing plant, and the production date.More information

Have you used the new safety reporting portal?
CTP recently updated its Safety Reporting Portal, an online tool for reporting suspected problems with tobacco products. Whether you’re a consumer, manufacturer, clinical investigator, or health professional, let FDA know about products that seem to be damaged, defective, contaminated, or that smell or taste wrong.

CTP’s Public Education Campaigns
CTP is investing in a number of public education campaigns, such as “The Real Cost,” “Fresh Empire,” and “This Free Life” to help educate the public—especially youth—about the dangers of tobacco products. Achieving its mission to reduce tobacco-related death and disease requires a comprehensive, innovative approach. Most of the campaigns focus on changing the attitudes and beliefs that lead young people to start smoking by developing messages and tactics through a scientific, evidence-based process.

Miss the inaugural issue of CTPConnect?
FDA’s Center for Tobacco Products (CTP) recently published its first edition of CTPConnect, aplainspoken digest with the latest stories from the Center. Want the full experience? Sign up today to receive the next issue of CTPConnect and other important updates from CTP directly to your inbox.

Share the image below and support those who matter to you most!
Do you know someone who could benefit from CTP’s messages about tobacco? Sharing information about the health effects of tobacco has never been so easy. Simply save the image and post it to your social media account, such as Facebook or Twitter.

Novelty Makeup: Halloween Special - Safety tips to keep face-painting fun
Face paints can be fun on Halloween and other special occasions. Here are tips to help keep your fun from leaving you with a rash, swollen eyelids, or other reaction. Decorating your face with face paint or other makeup lets you see better than you can if you're wearing a mask. A mask can make it hard to see where you're going and watch out for cars. But make sure your painted-on designs don't cause problems of their own. More information

What is a Cosmetic?The Federal Food, Drug, and Cosmetic Act defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance". Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. More information

Recalls and Alerts
To see safety alerts and recent recalls related to cosmetics and other products regulated by FDA. More information

How to report a problem
You can report a rash, redness, burn, hair loss, headache, infection, illness, or any other unexpected reaction, whether or not it required medical treatment. You can also report a bad smell, color change, or other sign of contamination.

You can choose the way you’d prefer to report:

Call an FDA Consumer Complaint Coordinator if you want to speak directly to a person about your problem.
Complete an electronic Voluntary MedWatch form online.
Complete a paper Voluntary MedWatch form that you can mail to FDA.

More information

Information about Expanded Access
Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices. More information

Learn about what your physician should do before submitting a request for individual patient expanded access use of an investigational medical product, who may be eligible for expanded access, associated costs, FDA contacts and more. Information for Patients

Learn about your responsibilities under the expanded access pathway, how to submit a request for expanded access for an individual patient (including for emergency use), which forms to use, FDA contacts and more. Information for Physicians

FDA Patient Network
The FDA Patient Network contains a series of webpages, webinars and presentations on topics related to patient engagement, FDA regulations, understanding medical product (Drugs, Biologics, and Devices) approval and medical product safety updates, Take me to the FDA Patient Network or take me to FDA Webinars.

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

Educational Videos

healthfinder.gov
Welcome to healthfinder.gov, a government Web site where you will find information and tools to help you and those you care about stay healthy.More information /más información

FDA Email Updates
Sign up for one of the FDA disease specific e-mail list that delivers updates, including product approvals, safety warnings, notices of upcoming meetings, and notices on proposed regulatory guidances.