FDA reminds health care professionals not to use drug products intended to be sterile from Medaus
The U.S. Food and Drug Administration is reminding health care professionals and patients not to use drugs intended to be sterile that were produced by Medaus Inc., due to lack of sterility assurance. The FDA has issued a formal request to the Birmingham, Alabama, compounding pharmacy to recall all non-expired lots of drug products intended to be sterile. More information
PharMEDium Sterile Preparations Compounded With a Single Recalled Lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl): Recall - Presence of Glass Particulate MatterPharMEDium Services, LLC is voluntarily recalling the codes/lots of sterile preparations compounded with a single recalled lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl) to the hospital level. Fresenius Kabi recalled the specific lot at issue due to identification of particulate matter, characterized as glass, during reserve sample inspection. The list of affected codes/lots can be found on PharMEDium’s website at http://www.pharmedium.com/. More information
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Aripiprazole (Abilify, Abilify Maintena, Aristada): FDA Warns About New Impulse-control Problems FDA is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized. More information
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Brintellix (vortioxetine): Brand Name Change to Trintellix, to Avoid Confusion With Antiplatelet Drug Brilinta (ticagrelor) FDA has approved a brand name change for the antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (ticagrelor). The new brand name of the drug will be Trintellix, and it is expected to be available starting in June 2016. No other changes will be made to the label or packaging, and the medicine is exactly the same. Because of the lag time associated with manufacturing bottles with the new brand name, health care professionals and patients may continue to see bottles labeled with the brand name Brintellix during the transition period. More information
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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 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
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Drug Shortages Voluntarily Reported by Manufacturers During the Past 2 Weeks:
Drug Shortages Reported to be Resolved by Manufacturers During the Past 2 Weeks:
Drugs Reported to be Discontinued by Manufacturers During the Past 2 Weeks:
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
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FDA approves first drug to treat hallucinations and delusions associated with Parkinson’s diseaseThe U.S. Food and Drug Administration today approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease. People who experience them see or hear things that are not there (hallucinations) and/or have false beliefs (delusions). The hallucinations and delusions experienced with Parkinson’s disease are serious symptoms, and can lead to thinking and emotions that are so impaired that the people experiencing them may not relate to loved ones well or take appropriate care of themselves. More information
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FDA approves first generic CrestorThe U.S. Food and Drug Administration today approved the first generic version of Crestor (rosuvastatin calcium) tablets for the following uses: in combination with diet for the treatment of high triglycerides (hypertriglyceridemia) in adults; in combination with diet for treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia), for adult patients with homozygous familial hypercholesterolemia, a disorder associated with high low-density lipoprotein (LDL) cholesterol. More information
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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.
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FDA takes significant steps to protect Americans from dangers of tobacco through new regulation The Food and Drug Administration finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This historic rule helps implement the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009 and allows the FDA to improve public health and protect future generations from the dangers of tobacco use through a variety of steps, including restricting the sale of these tobacco products to minors nationwide. More information
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What We Mean When We Talk About EvGen Part II: Building Out a National System for Evidence Generation In an earlier FDA Voice blog post, we discussed a pair of concepts – interoperability and connectivity – that are essential prerequisites for the creation of a successful national system for evidence generation (or “EvGen”). In this post, we take a look at how we would apply these constructs as we go about building such a system. Creating knowledge requires the application of proven analytical methods and techniques to biomedical data in order to produce reliable conclusions. More information
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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.
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View FDA's Calendar of Public Meetings page for a complete list of meetings and workshops.
- Calendar of FDA Sponsored Public Meetings - May 2016
- Calendar of FDA Sponsored Public Meetings - June 2016
- Calendar of FDA Sponsored Public Meetings - September 2016
Public Workshop: Developing an Expanded Access Navigator for Individual Patient Access to Investigational DrugsDate: May 16, 2016 Time: 8:30 am to 11:45 AMAgenda: A public workshop, co-hosted by the Reagan-Udall Foundation for the FDA and the Food and Drug Administration, to solicit feedback on a proposed Expanded Access Navigator. The objective of the meeting is to hold an open discussion with interested stakeholders on the concept of an Expanded Access Navigator. The intent of the EA Navigator is to provide a coordinated resource for healthcare providers and patients seeking information on the single-patient IND (expanded access/compassionate use) request process. The workshop presents an opportunity for the public to provide input on the design, necessity, and refinement of the Expanded Access Navigator proposal. Please register for this public workshop, to attend either in person or via web cast, before May 9, 2016. There is no fee to attend this workshop, but attendees should register in advance. Space is limited and will be on a first-come, first-served basis. More information
Public Meeting: Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives
Date: May 20, 2016 The meeting will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA is seeking this input from a variety of stakeholders--industry, academia, patient advocates, professional societies, and other interested parties.More information |
Medical Device Panel Advisory Committee Meeting: Circulatory System
Date: May 24, 2016 Location: Hilton Washington DC North/Gaithersburg The committee will discuss, make recommendations and vote on information related to the premarket approval application regarding St. Jude Medical's AMPLATZER Patent Foramen Ovale (PFO) Occluder. More information |
Drugs Advisory Committee Meeting: Endocrinologic and Metabolic
Date: May 24, 2016 The committee will discuss the safety and efficacy of new drug application (NDA) 208583 for insulin degludec and liraglutide injection, submitted by Novo Nordisk Inc., for the proposed indication: adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus. More information |
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.
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Food Recall Of Sweet And Salty Trail Mix –Because Of Possible Health Risk, Due To Potential Presence Of Listeria Monocytogenes Rucker’s Wholesale and Service Co. of Bridgeport, IL is voluntarily recalling the specific code dates listed below of Uncle Bucks Sweet & Salty Trail Mix peg bag, due to the potential presence of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although, healthy individuals may suffer only short-term symptoms, such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. More information
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A Tattoo for You? Seven Key Questions to Consider There are many tattooed Americans. Surveys estimate that about one in five Americans now has at least one. And with the rising popularity of tattoos, the U.S. Food and Drug Administration (FDA) is also seeing an increase in reports of people developing infections from contaminated tattoo inks, as well as having bad reactions to the inks themselves, according to Linda Katz, M.D., M.P.H., director of FDA’s Office of Cosmetics and Colors. More information
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Five Tips for New Moms Mother’s Day is a special time for new moms. But this can also be a stressful time for new parents—moms and dads—facing the responsibility of caring for a newborn or infant.Your health care provider can be a great resource. A good time to check in is during preventive “well-child” health visits with your child’s pediatrican, says Donna L. Snyder, M.D., F.A.A.P., a pediatrician with FDA’s Division of Pediatric and Maternal Health. These visits can continue at intervals throughout childhood and adolescence. More information
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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
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 YouThe Center for Food Safety and Applied Nutrition, known as CFSAN, issues food facts for consumers to keep you and your family safe. More information |
Gluten and Food Labeling In August of 2013, the U.S. Food and Drug Administration (FDA) issued a regulation that defined the term “gluten-free” for food labeling. The definition provided consumers – especially those with celiac disease – the assurance that “gluten-free” claims on food products will be consistent and reliable across the food industry, and gave them a standardized tool for managing their health and dietary intake. FDA’s regulation for gluten-free food labeling standardized what “gluten-free” means on the food label. More information
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Calorie Labeling on Restaurant Menus and Vending Machines Calorie labeling on restaurant menus and vending machines can help you make informed and healthful decisions about meals and snacks. In today’s busy world, Americans are eating and drinking about one-third of their calories away from home. Although consumers can find calories and other nutrition information on the Nutrition Facts Label on packaged foods and beverages they buy in stores, this type of labeling is generally not available in restaurants or visible on food from vending machines. More information
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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 |
FDA Releases Guide on Pet Food Diets Intended to Treat Diseases The U.S. Food and Drug Administration released a Compliance Policy Guide (CPG) that explains the criteria FDA will consider when determining whether to take enforcement action regarding dog and cat food diets intended to treat a disease. The CPG, “Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases,” explains to FDA staff and industry that the agency intends to exercise enforcement discretion over the labeling and marketing of these diets under certain circumstances. More information
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How to Report a Pet Food Complaint
You can report complaints about a pet food product electronically through theSafety 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 |
FDA launches public education campaign to prevent and reduce tobacco use among LGBT young adults The U.S. Food and Drug Administration today announced the launch of a historic public education campaign aimed at preventing and reducing tobacco use among lesbian, gay, bisexual and transgender (LGBT) young adults ages 18-24. Of the more than 2 million LGBT young adults in the U.S., more than 800,000 smoke occasionally. The “This Free Life” campaign is designed to specifically reach the occasional or “social” smokers in the LGBT community to help prevent tobacco-related disease and the loss of tens of thousands LGBT lives to tobacco use each year. More information
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Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS) Vaporizers, vape pens, hookah pens, electronic cigarettes (E-Cigarettes), and e-pipes are some of the many types of Electronic Nicotine Delivery Systems (ENDS).These products use liquid containing nicotine, as well as varying compositions of flavorings, propylene glycol, glycerin, and other ingredients. The liquid is heated into an aerosol that the user inhales. More information
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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.
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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
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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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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
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Learn About FDA Advisory Committees
When a scientific, technical, or policy question arises, such as whether an unapproved product is safe and effective, FDA often relies on Advisory Committees to provide independent advice. Committee members include scientific experts—such as physician-researchers and statisticians—and members of the public, including a FDA Patient Representative. More information |
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. |
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