jueves, 24 de noviembre de 2016

Patient Network Newsletter: November 23, 2016

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This bi-weekly newsletter from the Food and Drug Administration (FDA) Office of Health and Constituent Affair is intended to inform patients and patient advocates of FDA-related information on new product approvals,significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest. 

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drug alert
Cantrell Drug Company Issues Voluntary Recall of Select Sterile Drug Products Due to Lack of Sterility AssuranceLittle Rock, AK - Cantrell Drug Company is voluntarily recalling certain unexpired sterile drug products due to lack of sterility assurance More information

Tri-Coast Pharmacy Inc. Voluntarily Recalling All Sterile Products Prepared Between May 17, 2016 and November 17, 2016 Due to Concern Over Lack of Sterility AssuranceJuno Beach, FL – Tri-Coast Pharmacy Inc. is voluntarily recalling all sterile products prepared between May 17, 2016 and November 17, 2016 and that remain within expiry due to the FDA concerns over the lack of sterility assurance of the drugs named in this recall. More information
Gray Pointer
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

MedWatch Report a Problem 2015

Drug Shortages
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:

Gray Pointer
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 
Medical Product Approvals
NEw
FDA approved Intrarosa for postmenopausal women experiencing pain during sex
The FDA approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA).
During menopause, levels of estrogen decline in vaginal tissues, which may cause a condition known as VVA, leading to symptoms such as pain during sexual intercourse.
"Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women," said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive, and Urologic Products (DBRUP) in the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER). "Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA." More information
For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.

What you think matters
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.

sun
FDA’s Sunscreen Guidance outlines safety and effectiveness data recommended for additional active ingredients, by: Theresa M. Michele, M.D., Director of the Division of Nonprescription Drug Products, Office of New Drugs, at FDA’s Center for Drug Evaluation and ResearchAmerican consumers rely extensively on over-the-counter (OTC) sunscreens to help prevent sunburn. Certain sunscreens are also used, along with other protective measures, to reduce the risks of skin cancer and early skin aging caused by the sun.

The vast majority of sunscreens available in the United States are marketed under a regulatory framework called the OTC Monograph System. FDA reviews the active ingredients in these products to determine whether the ingredients are generally recognized as safe and effective (GRASE) for OTC sunscreen use.
The Sunscreen Innovation Act (SIA) of 2014 established an alternative process for the review of safety and effectiveness of additional active ingredients for use in sunscreens, and set deadlines for reviewing the ingredients and taking certain other actions. But SIA did not eliminate the need for a GRASE determination for new sunscreen active ingredients before reaching the market without an approved marketing application, and it did not relax the scientific standards for these products. Further, FDA’s review deadlines are only triggered after the data have been submitted to the agency. To read the rest of this post,  see the FDA Voice Blog November 22, 2016

Meet
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.
 View FDA's Patient Network Calendar of Public Meetings page for a complete list of meetings and workshops.
Gray Pointer
For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.


Woman
What Women Should Know About Essure Permanent Birth ControlThe FDA continues to advise women to carefully consider the benefits and risks associated with permanent birth control devices, like the FDA-approved Essure device, along with other birth control options.
That’s why FDA recently approved important labeling changes for Essure. Among other changes, Bayer, the company that makes Essure, will include a boxed warning and patient decision checklist in the labeling to help ensure that women receive and understand the benefits and risks of these permanent birth control devices.
What does this mean? Bayer’s new checklist in the patient information brochure summarizes key benefit and risk information about Essure. The checklist aims to encourage women to read the information brochure, understand Essure’s benefits and risks, and discuss the information with their doctor before making an informed decision on whether to use this device. More information
OP
What to Ask Your Doctor Before Taking Opioids
  1. Why do I need this medication — is it right for me?
  2. How long should I take this medication?
  3. Can I have an Rx for naloxone?
Every patient should ask questions when getting a new prescription. This is especially important when your doctor, dentist or other health care professional prescribes you an opioid, such as hydrocodone, oxycodone, codeine and morphine.
What should you ask? More information
Cochlear
Cochlear Implants: A Different Kind of 'Hearing'Your elderly uncle is hard of hearing and has a difficult time understanding conversation — so much so that he’s feeling frustrated and left out. His hearing aids aren’t helping much.
Your one-year-old daughter was diagnosed with severe hearing loss in both ears, and you’re worried about her ability to learn and understand speech. How will she learn to communicate?
For both of these cases, a cochlear implant may be an option.
What are cochlear implants? Who uses them and why? And how does the FDA play a role? The cochlea is the part of the inner ear that contains the endings of the nerve which carries sound to the brain. A cochlear implant is a small, electronic device that when surgically placed under the skin, stimulates the nerve endings in the cochlea to provide a sense of sound to a person who is profoundly deaf or severely hard of hearing. More information
Diabetes
Beware of Illegally Marketed Diabetes TreatmentsAs the number of people diagnosed with diabetes continues to grow, illegally marketed products promising to prevent, treat, and even cure diabetes are flooding the marketplace.
The FDA is advising consumers not to use such products—for many reasons. For example, they may contain harmful ingredients or may improperly be marketed as over-the-counter (OTC) products when they should be marketed as prescription products. Illegally marketed products carry an additional risk if they cause people to delay or discontinue effective treatments for diabetes. Without proper disease management, people with diabetes are at a greater risk for developing serious health complications. 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

Thanksgiving
Holiday Food Safety
Many people don't realize that food safety is the most important ingredient in preparing food for the holidays. Below are some helpful food safety resources to keep your holidays happy.

Holiday Food Safety Success KitThe Holiday Food Safety Success Kit , developed by the non-profit Partnership for Food Safety Education, provides tips on how to make sure holiday meals are safe as well as delicious. Recipes, shopping checklist, food safety tips, and children's activities are included in the multi-media program. More information
Food Safety
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 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
Sick dog
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



Smoking can block
Missed the Last Issue of CTPConnect?FDA’s Center for Tobacco Products (CTP) publishes a regular periodical known as CTPConnect, a plainspoken digest with the latest stories from the Center. 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 QuitEver wonder why it’s so hard to kick smoking to the curb? Well, we’ve got an answer! CTP recently introduced an infographic that exploreshow 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.
Pa
CTP Reporting Portal
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.
FDA’s LGBT Public Education Campaign Makes HeadlinesFDA’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!
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Share the image 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 either image in this section and post it to your social media account, such as Facebook or Twitter.


FDA Cosmetics
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:


Expanded Access Image
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
For Patients Logo
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
For Physicians
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


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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
New HealthFinder.GOV
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.

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