FDA Patient Network Newsletter - January 4, 2017

ZIKV Detect IgM Capture ELISA by InBios International, Inc: FDA Safety Communication - Wait for Confirmatory Test Results Before Making Patient Management Decisions  FDA is alerting physicians who care for pregnant women meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria, that the U.S. commercial testing facility, Laboratory Corporation of America (LabCorp), has reported some false positive results from the ZIKV Detect test.Because confirmation tests may take a week to a month to complete, the FDA is issuing this alert so that health care providers and patients know about a higher likelihood of false positive results.While the FDA has not yet determined if the reported false positives are related to the ZIKV Detect test or the commercial testing facility, it is important to remember that IgM tests remain useful in ruling out Zika exposure but require confirmatory testing. More information. Huvepharma, Inc. Issues Voluntary Nationwide Recall of Duramycin-10 Due to Stability Failure  Huvepharma, Inc. is voluntarily recalling 1 lot of Duramycin-10 Soluble Powder, distributed by Durvet, to the consumer level. The product had a stability failure at the 48 month time point. Risk Statement: The product does not have the potential to result in a health risk to any animals that are indicated for use. Duramycin-10 is used for the control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella species. 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

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 Voluntarily Reported by Manufacturers During the Past 2 Weeks:

• Asparaginase Erwinia Chrysanthemi (Erwinaze)

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

• Anagrelide Hydrochloride Capsules

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

• Etomidate (Amidate) Injection
• Tretinoin Cream (Tretin-X)
• Naratriptan Hydrochloride Tablets

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, incluyendo problemas 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 

FDA Approves First Drug for Spinal Muscular Atrophy FDA approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement. Spinraza is an injection administered into the fluid surrounding the spinal cord.SMA is a hereditary disease that causes weakness and muscle wasting because of the loss of lower motor neurons controlling movement. There is wide variability in age of onset, symptoms and rate of progression. Spinraza is approved for use across the range of spinal muscular atrophy patients. FDA asked the sponsor to conduct an interim analysis as a way to evaluate the study results as early as possible; 82 of 121 patients were eligible for this analysis. Forty percent of patients treated with Spinraza achieved improvement in motor milestones as defined in the study, whereas none of the control patients did. More information.

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

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 - December 2016 Opportunities to Comment - January 2017 Opportunities to Comment - February 2017

Academic Medical Centers and FDA - Working Together for the Future. Robert M. Califf, MD, Commissioner FDA  FDA and the nation’s academic medical centers (AMCs) have a rich history together. Many of us at FDA trained and worked at AMCs, and many of us will go back to AMCs when we leave FDA. AMCs are where much of the basic science of medicine is advanced, and where the fundamental concepts for many of the tools to test for and treat illnesses are initially developed. Increasing numbers of AMCs have regulatory science programs, FDA has memoranda of understanding with numerous AMCs, and we are pleased to host a number of fellows from AMCs annually. All of these intersections advance our shared goals of protecting and promoting public health while also helping to speed innovation. Together, we push the boundaries of the known and possible, and ensure that in doing so the health and safety of patients is the primary concern. To read the rest of this post, see FDA Voice Blog, December 19, 2016.

Clacker Balls and the Early Days of Federal Toy Safety. John P. Swann, PhD, FDA Historian As many of us scramble to find the perfect toy for the children in our lives this holiday season, it’s interesting to note that at one time FDA could very well have been known as the Food Drug and Toy Administration. The 1966 Child Protection Act gave FDA authority to ban toys that had chemical, flammability, or radioactivity hazards and the 1969 Child Protection and Toy Safety Act further defined FDA’s responsibility for ensuring the safety of toys. During FDA’s brief stint as toy regulator, the agency dealt with flammable dolls; infant and toddler playthings that posed serious puncture, laceration, and crushing risks; and the infamous lawn darts. To appreciate FDA’s role at the time, consider what happened with clacker balls. Their origin was unclear, but clacker balls were a veritable craze by January 1971, to the consternation of parents and school districts everywhere. Clackers balls could vary somewhat in design but typically, they were plastic, wooden, or steel balls of about two-inches in diameter.To read the rest of this post, see the FDA Voice Blog, December 22, 2016.

Managing Medical Device Cybersecurity in the Postmarket: At the Crossroads of Cyber-safety and Advancing Technology. Suzanne B. Schwartz, MD, MBA. Associate Director for Science and Strategic Partnerships, at the Center for Devices and Radiological Health Protecting medical devices from ever-shifting cybersecurity threats requires an all-out, lifecycle approach that begins with early product development and extends throughout the product’s lifespan. Today, we’re pleased to announce that industry now has advice from FDA across this product continuum with the release of a final guidance on the postmarket management of medical device cybersecurity. It joins an earlier final guidance on medical device premarket cybersecurity issued in October 2014. To understand why such guidance is so important for patients, caregivers and the medical device community, we need to take a step back and look at how cybersecurity fits into the medical device ecosystem. In today’s world of medical devices that are connected to a hospital’s network or even a patient’s own Internet service at home, we see significant technological advances in patient care and, at the same time, an increase in the risk of cybersecurity breaches that could affect a device’s performance and functionality. To read the rest of this post, see the FDA Voice Blog, December 27, 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 - February 2017 Calendar of FDA Sponsored Public Meetings - March 2017 Calendar of FDA Sponsored Public Meetings - April 2017

 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.

Chantix (varenicline) and Zyban (bupropion) - Mental Health Side Effects Revised Based on an FDA review of a large clinical trial, FDA determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected. The risk of these mental health side effects is still present, especially in those currently being treated for mental illnesses such as depression, anxiety disorders, or schizophrenia, or who have been treated for mental illnesses in the past. However, most people who had these side effects did not have serious consequences such as hospitalization. As a result of the large clinical trial review, FDA is removing the Boxed Warning. 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

La FDA revisa los resultados en nuevas advertencias acerca del uso de anestésicos generales y sedantes en niños pequeños y mujeres embarazadas 
El uso repetido o prolongado de anestésicos generales y sedantes en cirugías o procedimientos en niños menores a 3 años o embarazadas durante el tercer trimestre puede afectar el desarrollo cerebral de los niños. De acuerdo con estudios en animales, recientes estudios en humanos sugieren que una exposición única y relativamente corta a la anestesia general y los sedantes en bebés o niños pequeños es poco probable que tenga efectos negativos sobre el comportamiento o el aprendizaje. Sin embargo, se necesitan más investigaciones para caracterizar por complete la manera en que la exposición temprana a los medicamentos anestésicos afecta el desarrollo cerebral de los niños. Para informar mejor al público acerca de este riesgo potencial, estamos exigiendo que se agreguen advertencias a las etiquetas de anestésicos generales y sedantes (consulte la Lista de anestésicos generales y sedantes afectados por este cambio en la etiqueta). Continuaremos el monitoreo del uso de estos medicamentos en niños y mujeres embarazadas y daremos a conocer actualizaciones al público cuando haya más información disponible. Mas información.

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 LiteracyAnimal 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 UpdatesAnimal 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

Missed the inaugural issue of CTPConnect?  FDA’s Center for Tobacco Products (CTP) recently published its newest issue of CTPConnect, a plainspoken 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.

How Cigarettes are Made and How You Can Make a Plan to Quit Ever wonder why it’s so hard to kick smoking to the curb? Well, we’ve got an answer! CTP recently introduced an infographic that explores how cigarettes are made, highlighting how their very design may be an obstacle to quitting. As people across the country pledge to quit smoking, consider sharing this infographic with someone who could benefit.

Help FDA Protect Americans from Unlawful Tobacco Product Violations
Have you witnessed a potential tobacco product violation, such as a sale to someone under 18 years of age, flavored cigarette sales, or vending machines that give minors access to tobacco products? We hope you will report these and other potential violations to FDA.

FDA’s LGBT Public Education Campaign Makes Headlines 
FDA’s “This Free Life” campaign, designed to prevent and reduce tobacco use among LGBT young adults ages 18-24, recently won the Multicultural Award of Excellence in the LGBT category  at the annual Association of National Advertisers (ANA) Multicultural Marketing & Diversity Conference. Watch the powerful ad and share it with someone you know in the LGBT community to encourage them to live tobacco free!

Bad reaction to a cosmetic? FDA needs to know What do you do if you have a reaction after using a cosmetic product? First, stop using the product and contact your healthcare provider. Next, please report it to FDA. Here’s why that next step is so important: Cosmetic products aren’t required by law to have FDA approval before they go on the market. Companies that market cosmetics have a legal responsibility to ensure product safety, but FDA can only take action if the product is shown to be unsafe after the product is on the market. And, because the law doesn’t require cosmetic companies to share customer complaints or other safety information with FDA, voluntary reports from consumers and healthcare providers are one of the best ways for FDA to learn about any problems. Cosmetics include a range of products people use every day, such as moisturizers, makeup, shampoos and conditioners, face and body washes, deodorants, nail care products, hair dyes and relaxers, and tattoos. More information

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

What to watch for, how to report
You can report an allergic reaction, 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 FDA Food Safety and Modernization Act: An FDA Primer The Rulemaking Process: An FDA Primer What is Regulatory Science Taking Acetaminophen Safely

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. Diabetes Cardiovascular Disease HIV Hepatitis B and C