FDA Warns Consumers Not to Use Viansilk’s “Crema Piel De Seda” (“Silky Skin Cream”): Risk of Mercury PoisoningThe Food and Drug Administration (FDA) is warning consumers not to purchase or use a skin whitening cream called “Crema Piel De Seda,” due to the risk of mercury poisoning.
FDA laboratory analysis identified mercury in the product. Exposure to mercury can cause serious health problems, such as kidney and nervous system damage. Mercury can also interfere with brain development in children. Signs and symptoms of mercury poisoning include, irritability, shyness, tremors, changes in vision or hearing, memory problems, depression, and numbness and tingling in hands, feet or around the mouth. More information
Pink Bikini and Shorts on The Beach Dietary Supplements by Lucy's Weight Loss System: Recall - Undeclared Drug IngredientLucy's Weight Loss System of Arlington, TX, is voluntarily recalling all lots of Pink Bikini and Shorts on the Beach Capsules in all colors, 30 count (750MG per capsule) to the consumer level. Pink Bikini and Shorts on the Beach may contain an undeclared active pharmaceutical ingredient.
FDA analysis of Pink Bikini (white capsules, blue capsules and gold capsules) and Shorts on the Beach (blue capsules and gold capsules) found these products to be tainted with Sibutramine, Phenolphthalein, and/or Diclofenac, and that this active ingredients are not declared on the label of the product. More information
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FDA warns consumers about health risks with Alikay Naturals – Bentonite Me Baby – Bentonite Clay: Elevated levels of leadThe Food and Drug Administration (FDA) is warning consumers not to use “Bentonite Me Baby” by Alikay Naturals because of a potential lead poisoning risk. “Bentonite Me Baby” is sold online and in retail outlets, including Target stores, Amazon.com, and Sally Beauty Supply, and is marketed as medicinal clay. The product’s labeling indicates that it can be ingested and applied topically to hair and skin for a variety of conditions.
Consumers should not purchase or use “Bentonite Me Baby.” Anyone who has used this product or provided it to a child should consult a health care professional immediately. More information
SPOTCHEM II Test Strips by Arkray: Class I Recall - Inaccurate Blood Sugar Readings Arkray is recalling the SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip because they may report falsely low blood glucose levels. Because the test strips are reporting falsely low blood glucose when the true levels are above 265 mg/dL, there is a risk that the health care provider would not diagnose hyperglycemia (high blood sugar) including Diabetic Ketoacidosis and Hyperosmolar Hyperglycemic Syndrome in a timely manner and fail to treat elevated blood glucose levels. 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:
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 Zepatier for treatment of chronic hepatitis C genotypes 1 and 4 FDA approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients. More information
FDA approves first drug to show survival benefit in liposarcoma FDA approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug. More information
FDA approves new use for the PD-L1 IHC 28-8 PharmDx Diagnostic Test
FDA approved the test as a complementary diagnostic for testing tumor specimens from patients with non-small cell lung cancer. This approval expands the indication to tumor specimens from patients with melanoma. |
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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2016: The Year of Diversity in Clinical Trials, By Robert M. Califf, M.D., FDA’s Deputy Commissioner for Medical Products and TobaccoControlled clinical trials provide a critical base of evidence for evaluating whether a medical product is effective before the product is approved for marketing. One challenge that remains for FDA is ensuring that research participants are representative of the patients who will use the medical product.
Moving from the result of a clinical trial to applying it in practice is complex. But it’s generally agreed that the composition of the population enrolled in a trial should help FDA reviewers, clinicians, or policy makers to have confidence that the trial results will apply to future practice. To read the remaining blog, see FDA Voice Blog January 27, 2016 |
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Modernizing Pharmaceutical Manufacturing to Improve Drug Quality: Ensuring a Safe and Adequate Supply of Drugs, By: Michael Kopcha, Ph.D., R.Ph., FDA’s Director, Office of Pharmaceutical Quality, CDER
FDA is working with drug makers in a new way to help the industry adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective — with an eye toward avoiding drug shortages. When manufacturing problems arise in drug manufacturing facilities, drug shortages may follow. In fact, 65 percent of all drug shortages are caused by manufacturing and quality issues. This underscores the need for a safe and reliable drug supply chain. In recent years, hundreds of drug shortages have been reported to FDA.
To read the remaining blog, see FDA Voice Blog February 1, 2016
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Show us How Much You Love Your Heart! This February, in honor of American Heart Month,FDA’s Office of Minority (OMH) would like for you to participate in the #ILoveMyHeart campaign. Take a picture of yourself with a dry erase board or poster board stating why taking care of your heart is important to you. Show us pictures of you preparing healthy meals, engaging in a physical activity, taking your medication, or doing any activity that keeps your heart healthy.
Post a picture on Twitter mentioning @FDAOMH and using the #ILoveMyHeart hashtag. And, don’t be shy- feel free to send in multiple pictures! Every Monday, we will pick the best three photos and post them in the FDA Facebook page.
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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.
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. |
Public Workshop: Food and Drug Administration Patient and Medical Professional Perspectives on the Return of Genetic Test Results
Date: Wednesday, March 2, 2016 Register: HereAgenda: The purpose of this workshop is to understand patient and provider perspectives on receiving genetic test results. The topic(s) to be discussed will focus on better defining the specific information patients and providers prefer to receive, how those results should be returned, and what information is needed to understand the results so that they may effectively aid in medical decision making. Federal Register Notice
Public Workshop: Navigating CDER: What You Should Know for Effective Engagement
Date: Thursday, March 31, 2016 The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled Navigating CDER: What You Should Know for Effective Engagement. The purpose of this public workshop is to help the public and patient advocacy groups gain a better understanding of how to effectively engage CDER. There will be an opportunity for questions and answers following each presentation. There is no registration fee to attend the public workshop. Early registration is recommended because seating is limited, and registration will be on a first-come, first-served basis. There will be no on-site registration. A webcast will be available for those unable to attend in person.
Persons interested in attending this workshop either in person or via webcast must register online atREGISTRATION.
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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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5 Tips for Traveling to the U.S. With MedicationsYou’re returning from a trip overseas and want to bring back over-the-counter drugs from Europe that aren’t available here. Can you? Your mother-in-law is visiting from Mexico to help with the new baby and runs out of her blood pressure medication. Can she refill her prescription at a U.S. pharmacy? Your foreign exchange student forgot his allergy medication. Can his parents mail it to him from Japan?
Those are just some of the questions people ask the FDA. So what are the rules for flying with or shipping medications? Here are some answers to common queries. 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
FDA Investigates Multistate outbreak of Listeria in Dole Leafy Green products produced in facility in Springfield, OhioThe FDA, CDC and state and local officials are investigating a multi-state outbreak of listeriosis. According to the CDC, WGS (whole genome sequencing) has been performed on clinical isolates from all ill people and has shown that the isolates are highly related genetically.
Dole reported to FDA and CDC that it ceased production of all packaged salads at its processing facility in Springfield, Ohio. Additionally, the company reported that it is withdrawing all packaged salads currently on the market that were produced at this facility. More information |
Braga Organic Farms Issues Voluntary Recall of Pistachios Due to Possible Health RiskBraga Organic Farms announces the voluntary recall of pistachios due to potential contamination with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella can experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. 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 andPublicaciones en Español del
Animal and Veterinary Updates
Animal and veterinary updates provide information to keep your pets healthy and safe. More information
Heartworm Prevention in Your PetHeartworm is a difficult-to-treat and potentially fatal disease in dogs and cats, but it can be prevented with drugs approved by the Food and Drug Administration (FDA). Owners have a variety of products to choose from to help keep their pets heartworm-free. More information
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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.
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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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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.
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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 |
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