FDA Warns Consumers Not to Use Licorice Coughing Liquid
The FDA is warning consumers not to use Licorice Coughing Liquid, a cough syrup product sold over-the-counter, because it contains unidentified morphine. The cough syrup’s labeling contains information written in English and Chinese. The product labeling does not identify the presence of morphine in English. With unidentified morphine, consumers who are hypersensitive to morphine could suffer severe allergic reactions if they take this product. Other effects of morphine can include, but are not limited to, respiratory depression and death. More information
U.S. Marshals seize dietary supplements containing kratom
The U.S. Food and Drug Administration announced that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. “We have identified kratom as a botanical substance that could pose a risk to public health and have the potential for abuse,” said Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. More Information |
Recall: Perrigo Recall in the U.S. Of Children's Guaifenesin Grape and DM Cherry Liquid- Potential Defect with the Dosage Cup Perrigo Company plc (NYSE: PRGO; TASE) of Dublin, Ireland, announced that, following the recent recall of certain dosing cups by its supplier, it has initiated a voluntary product recall in the US to the retail level of 2 batches of its children's guaifenesin grape liquid (100mg/5 mL) and 3 batches of its children's guaifenesin DM cherry liquid. This recall is being initiated because some packages contain an oral dosing cup with incorrect dose markings. More information.
Recall: R Thomas Marketing LLS Issues Nationwide recall of multiple products- Undeclared Sildenafil R Thomas Marketing LLC Issues Nationwide Recall Of Black Ant, Herb Viagra, Real Skill, Weekend Prince, African Black Ant And Stree Overlord Along With Multiple Other Products Due To Undeclared Sildenafil. These products were tested by the FDA and found to contain Sildenafil, a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug. Sildenafil is not listed on the product labels. More Information
Recall: Abbott's Compounding Pharmacy Sterile compounded product- Lack of Sterility Assurance Abbott's Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products due to concerns of lack of sterility assurance. All unexpired lots are subject to the recall. These include injectable medications, sterile solutions, eye drops, and eye ointments. The recall was issued after a series of onsite inspections by the FDA. Out of an abundance of caution, Abbott's Compounding Pharmacy is voluntarily recalling all sterile compounded products within expiry. 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 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:
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
|
FDA approved ofatumumab for extended treatment of patients The U.S. Food and Drug Administration approved ofatumumab (Arzerra Injection, Novartis Pharmaceuticals Corporation) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was previously approved for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy was considered inappropriate and also for patients with CLL refractory to fludarabine and alemtuzumab. More Information
FDA approves Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers The U.S. Food and Drug Administration approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound. 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
|
FDA 2015: A Look Back (and Ahead) – Part 2: Medical Product Safety and Oversight, By: Stephen M. Ostroff, M.D., FDA, Acting Commissioner
In my first look back on FDA’s 2015 accomplishments, I focused on our achievements in medical product innovation and our constant drive to make safe, effective and innovative products available. Because FDA’s responsibility covers the entire life cycle of products, in this second year-end blog post, I will review FDA’s impact on medical product safety and oversight. To read the remainder of Part 2, see FDA Voice Blog, January 06, 2016
FDA 2015: A Look Back (and Ahead) – Part 3: Food, Tobacco, and Antimicrobial ResistanceIn my third and final post reflecting on FDA’s work to protect and promote public health in 2015, we’ll take a look at our achievements in food, antimicrobial resistance, and tobacco product regulation.
To read the remainder of Part 3, see FDA Voice Blog, January 07, 2016 |
Progress and Collaboration on Clinical Trials, By: Barbara D. Buch, M.D., FDA, CBER, Associate Director There are few responsibilities at FDA more important than reviewing the design and outcomes of clinical trials. Understanding the science behind the trials — and the individuals included in them — helps us to ensure that the medical products we approve are safe and effective.
Last year, FDA took important steps to support the inclusion of diverse populations in clinical trials. Following Congress’s directive in Section 907 of the Food and Drug Administration Safety and Innovation Act, FDA is looking more closely at the sex, age, and race/ethnicity data that are collected in clinical trials.
To read the remaining blog, see FDA Voice Blog, January 16, 2016
|
|
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.
Public Meeting: Food and Drug Administration Safety and Innovation Act 907 Public Meeting - Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data.
Date: Monday, February 29, 2016 Register: here Agenda: This public meeting will present FDA’s progress in implementing the “Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data,” required under Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA will also be seeking feedback and recommendations from stakeholder groups: patient groups, consumer groups, regulated industry, academia and other interested parties are welcome. |
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.
|
It's Still Not Too Late to Get Your Flu Vaccine
Meant to get vaccinated in the fall to ward off the flu, but somehow didn’t get around to it? Think it’s too late to get vaccinated now?
Not so. According to the Food and Drug Administration (FDA), vaccinations can be protective as long as flu viruses are circulating. And although seasonal flu outbreaks can happen as early as October, flu activity usually peaks in January or February, and can last well into May.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
Shakti Group USA LLC Recalls L.G Compounded Asafoetida Powder Because Of Possible Health Risk Shakti Group USA LLC of New Brunswick, NJ is recalling 50 gm and 100 gm sizes of L.G Compounded Asafoetida Powder, both coded with Lot Number: 2323 because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 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
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
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 andPublicaciones 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 |
FDA's Smoking Prevention Campaigns: Reaching Teens Where They 'Live'
If you think smoking is part of a bygone, “Mad Men” era, think again. Young people, in particular, are still very much at risk. As a regulator of tobacco products, FDA also makes a strong commitment to educate the public (especially youth) about the harmful effects of using those products.
The Real Cost, launched in 2014, is FDA’s first national youth tobacco prevention campaign and its largest effort to date. The Real Cost aims to reach an estimated 10 million kids ages 12 to 17 who are open to smoking or already experimenting with cigarettes. In 2016, FDA plans to expand The Real Cost to include rural youth at risk of using smokeless tobacco.
To read the remaining article, see For Consumers
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