Drug Safety Communication: Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR) - Strengthened Kidney Warning
FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.
Patients should seek medical attention immediately if they experience signs and symptoms of acute kidney injury. This is a serious condition in which the kidneys suddenly stop working, causing dangerous levels of wastes to build up in the body. Signs and symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet. Patients should not stop taking their medicine without first talking to their health care professionals. Doing so can lead to uncontrolled blood sugar levels that can be harmful. More information
|
MedWatch Safety Alert: Zecuity (sumatriptan) Migraine Patch: Drug Safety Communication - FDA Evaluating Risk of Burns and Scars
Zecuity manufacturer Teva Pharmaceuticals has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity patch. Health care professionals should discontinue prescribing Zecuity, and patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine. Please refer to the Dear Health Care Provider letter for more information. The previous alert was posted on June 6, 2016. |
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 endruginfo@fda.hhs.gov. Comunicaciones de la FDA |
FDA recognizes the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. When issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, FDA works closely with the firm 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 firm to restore supplies while also ensuring safety for patients. More information
|
Drug Shortages Voluntarily Reported by Manufacturers During the Past 2 Weeks:
Drug Shortages Reported to be Resolved by Manufacturers During the Past 2 Weeks:
- No newly reported drug shortage resolutions
Drugs Reported to be Discontinued by Manufacturers During the Past 2 Weeks:
- No newly reported drug discontinuations
- More information about drug shortages, drug shortages resolved, and drugs to be discontinued
- Information about blood and biologic shortages, resolved shortages, and discontinuations
AspireAssist device approved to treat obesity
FDA approved a new obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal.
The AspireAssist device should not be used on patients with eating disorders, and it is not intended to be used for short durations in those who are moderately overweight. It is intended to assist in weight loss in patients aged 22 and older who are obese, with a body mass index of 35 to 55, and who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy. More information
|
Vaccine approved to prevent cholera for travelers
FDA approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine for the prevention of cholera.
Cholera, a disease caused by Vibrio cholerae bacteria, is acquired by ingesting contaminated water or food and causes a watery diarrhea that can range from mild to extremely severe. 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.
|
FDA and European Medicines Agency Patient Engagement Cluster
FDA and the European Medicines Agency (EMA) have created a new work group on patient engagement called the FDA/EMA Patient Engagement Cluster.
The FDA/EMA Patient Engagement cluster joins a series of currently existing EMA/FDA clusters. The cluster allows FDA and EMA to share best practices involving patients along drug and biologic regulatory life cycles. Information that is discussed is covered by confidentiality agreements signed by the FDA and EMA.
The clusters will focus on specific topic areas where the FDA and EMA can benefit from a greater exchange of information and strengthen collaboration. More information
|
Important steps toward streamlining access to investigational drugs for patients in need, by: Richard A. Moscicki, M.D., Richard A. Moscicki, M.D., is FDA’s Deputy Center Director for Science Operations, Center for Drug Evaluation and Research
FDA is only too aware that there are many patients who have a serious or life-threatening medical condition for which there is no available FDA-approved therapy. For such patients, one option may be to obtain access to an investigational drug that has not yet been approved by FDA. To do this, a physician submits an application to the FDA requesting authorization to use the investigational drug in the treatment of their patient. This is called expanded access to investigational drugs.
While FDA has been helping physicians navigate the system for many years, we are aware there have been physician and patient concerns about this process, which can be time consuming and difficult to understand. Consequently, FDA has recently made significant changes to streamline and simplify the process for single patient expanded access requests. To make the expanded access process more efficient, we’ve just introduced a much simpler application form called the Form FDA 3926, which will be the form doctors now will typically fill out when they want to provide an investigational drug for a patient through expanded access. More information
|
Shirley’s Story: Diversity is Critical to Making Better Medical Products
FDA’s Office of Minority Health has released a collection of six PSAs to promote clinical trial participation among minority groups. The videos feature Shirley Miller, an FDA patient representative, who graciously shares her story about living with sickle cell disease, while also letting others know why clinical trials are important. Dr. Luciana Borio, FDA’s Acting Chief Scientist, also stars in a PSA on why clinical trial diversity matters from FDA’s perspective.
Our agency’s Commissioner, Dr. Robert Califf, has declared 2016 the Year of Clinical Trial Diversity, and you can support us by sharing our PSAs with your friends and family. Historically, minority participation has been low in clinical trials, despite some groups being disproportionately affected by chronic diseases such as diabetes, cancer, and heart disease. Together, we can help raise awareness to help ensure that clinical trials participants represent the diverse patients who will ultimately use the medical products being tested.
For more information, visit our “Minorities in Clinical Trials” webpage and read our latest blog from Dr. Jonca Bull, FDA’s Assistant Commissioner for Minority Health.
New FDA #ClinicalTrialsChampion Videos:
|
FDA targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX
FDA, in partnership with international regulatory and law enforcement agencies, announced that it took action this week against 4,402 websites that illegally sell potentially dangerous, unapproved prescription drugs to U.S. consumers. This effort was part of Operation Pangea IX, the Ninth Annual International Internet Week of Action (IIWA), a global cooperative effort, led by INTERPOL, to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products on the internet.
“Preventing illegal internet sales of dangerous unapproved drugs is critical to protecting consumers’ health,” said George Karavetsos, director of the FDA’s Office of Criminal Investigations. “Operation Pangea IX demonstrates the FDA’s continuing commitment to stand united with our international partners to protect consumers in the United States and throughout the world from criminals who put profit above the health and safety of consumers.” More information
|
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization.
FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. More information and to submit your name.
|
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.
|
View FDA's Calendar of Public Meetings page for a complete list of meetings and workshops.
Please visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.
Coping With Memory Loss
Everyone has mild memory lapses from time to time. You can’t find your car keys one day, and your reading glasses go missing the next.
These are usually just signs of a normal brain that’s constantly prioritizing, sorting, storing, and retrieving all types of information. But how do you know when memory loss is abnormal – and should be evaluated by a health care professional? Here are some questions to consider: Does the memory loss disrupt daily living, such as driving, balancing a checkbook, and maintaining personal hygiene? More information
|
Adding Folic Acid to Corn Masa Flour May Prevent Birth Defects
If you’re a Latina who’s expecting a baby, your diet may be missing a key ingredient believed to help prevent certain kinds of birth defects.
That ingredient? Folic acid, which has long been used to fortify, or strengthen, certain enriched grains.
However, as Jonca Bull, M.D., director of FDA's Office of Minority Health notes, “Many Hispanic women don’t benefit from the folic acid in cereal grain products because those products are not a mainstay of their regular diets—which often are corn masa-based.” More information
|
Problems with E-Cigarettes, Vape Products, Hookah, Cigarettes or Tobacco? Tell FDA
Are you using a tobacco product—from e-cigs to cigars and cigarettes, hookah to smokeless—that you believe is defective or is causing an unexpected health problem? Does it have a strange taste or smell?
The U.S. Food and Drug Administration (FDA) wants to hear from you—and has updated the online tool you can use to report a problem.
The Department of Health and Human Services’ Safety Reporting Portal (SRP) provides a standardized way for consumers, health care professionals, manufacturers, and clinical investigators to let FDA know about an unexpected health or safety issue with a tobacco product. 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
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 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
Statement on HHS OIG Early Alert on FDA food recall initiation process
Public health is our top priority and FDA works hard to ensure the U.S. food supply remains among the safest in the world.
During a nearly three-year period recently reviewed by the HHS Office of Inspector General (OIG), FDA oversaw thousands of food recalls, with an average time for recall initiation of less than a week. A small number of these recalls fell well outside of that average, with months passing before all impacted products were taken off shelves, even though the FDA notified the companies involved of a contamination as soon as it had evidence. 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
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 |
Public Health Education
Tobacco products are harmful, yet widely used, consumer products that are responsible for severe health problems in both users and non-users. These health problems include cancer, lung disease, and heart disease, which often lead to death.
|
Public Education CampaignsWe are investing in a number of public education campaigns, such as Fresh Empire and The Real Cost, to help educate the public – especially youth – about the dangers of regulated tobacco products. Rooted in science, these efforts are directly linked to our authority to regulate the marketing and sales of tobacco products. More information
Youth and TobaccoWe are working to protect the health of America’s children and ultimately reduce the burden of illness and death caused by tobacco use. 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
|
Patient Network Webinars
Through our webinars and presentations, the Office of Health and Constituent Affairs brings information to you on many topics related to patient engagement, medical product (Drugs, Biologics, Devices) approval and medical product safety updates. More information
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 E-list
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.
You may wish to sign up for other email updates from the FDA - see other email updates.
|
Patient Network - Bring Your Voice to FDA
An interactive tool for educating patients, patient advocates, and consumers on how their medications - both prescription and over-the-counter - and medical devices move from the realm of idea to the realm of the marketplace. More information |
.png)
No hay comentarios:
Publicar un comentario