WARNING: DPP-4 inhibitors for type 2 diabetes may cause severe joint painThe type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. We have added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4 (DPP-4) inhibitors.
Patients should not stop taking their DPP-4 inhibitor medicine, but should contact their health care professional right away if they experience severe and persistent joint pain. More Information |
MedWatch Safety Alert: OmniPod (Pod) Insulin Management System by Insulet Corporation: Recall - Possibility of a Higher Rate of Failure
Insulet Corporation initiated a lot-specific voluntary recall of 40,846 boxes (10 Pods per box) of the OmniPod (Pod) Insulin Management System. This field corrective action is due to the possibility that some of the Pods from these lots may have a higher rate of failure than Insulet's current manufacturing standards. This recall does not affect the OmniPod Personal Diabetes Manager (PDM).
There are two ways in which these Pods can fail at a rate that is higher than Insulet's current standard. The cannula may either completely retract or fail to fully deploy, which may result in the patient not receiving the expected insulin dose. Or the Pod may trigger an audible alarm indicating it will no longer deliver insulin and will need to be replaced. Both situations can result in the interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis (DKA). More information |
WARNING: Severe adverse events reported with application of Picato (ingenol mebutate) gel for skin condition. Label changes required.Reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel (ingenol mebutate) require labeling changes to warn about safety rists. Also reported: severe eye injuries and skin reactions associated with the application of Picato gel. Some cases were associated with Picato gel not being used according to the instructions for use on the label. More information
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Contact Lenses
Contact lenses are the number one choice for many people with vision correction needs. For many, contact lenses provide flexibility and convenience. There are many different lenses available for a variety of needs and preferences. Contact lenses can be used to correct a variety of vision disorders such as Myopia (nearsightedness), Hyperopia (farsightedness), Astigmatism, and Presbyopia (poor focusing with reading material and other near vision tasks).
This website gives information about the latest innovations on contact lenses. It provides general information and is not meant to replace a discussion with your eye care professional. You can buy contact lenses only if you have a current, valid prescription. For more information and To learn more about safe contact lens care, please view our video. |
Comunicaciones de la FDA sobre la seguridad de los medicamentos en españolDescargo 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
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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:
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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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New drug treatment approved for nausea and vomiting from chemotherapy
FDA approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy.
Nausea and vomiting are common side effects experienced by cancer patients undergoing chemotherapy. Symptoms can persist for days after the chemotherapy drugs are administered. Nausea and vomiting that occurs from 24 hours to up to 120 hours after the start of chemotherapy is referred to as delayed phase nausea and vomiting, and it can result in serious health complications. Prolonged nausea and vomiting can lead to weight loss, dehydration and malnutrition in cancer patients leading to hospitalization. More information |
FDA Extends use of Promacta in young children with rare blood disorderThe approved drug, Promacta (eltrombopag) is designed to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these children when they have not achieved an appropriate response using other ITP medicines or surgery to remove the spleen. More Information
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Repatha to treat certain patients with high cholesterolRepatha (evolocumab) injections are approved for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options. Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, is approved for use in addition to diet and maximally-tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of 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.
CDER’s Drug Safety Communications: Ensuring postmarket safety
When a drug gains FDA approval, it says that the known benefits of the drug outweigh any known risks. After drug products are approved and on the market, CDER continues to review safety information from various sources. Once a problem bubbles to the surface, CDER’s drug review experts and staff determine when and how to notify the public about the issue through a Drug Safety Communication.
Drug Safety Communications outline information for patients, consumers, and health care professionals on new drug warnings, drug label changes and other safety information. Let’s look at how these drug safety messages are researched, developed, and communicated. More information |
HHS announces proposal to update rules governing human research participants
The U.S. Department of Health and Human Services Secretary announced proposed revisions to the regulations that govern research on individuals who participate in research.
The current regulations that protect individuals who participate in research, which have been in place since 1991, are often referred to as the Common Rule. They were developed at a time when research was predominantly conducted at universities, colleges and medical institutions, and each study generally took place at a single site. The expansion of research into new scientific disciplines, such as genomics and national security, along with an increase in multisite studies and significant advances in technology, has highlighted the need to update the regulatory framework. Notably, a more participatory model of research has also emerged, with individuals looking for more active engagement with the research enterprise.
In July 2011, HHS issued an Advance Notice of Proposed Rulemaking to seek the public’s input on updating the Common Rule. The Notice of Proposed Rulemaking issued today reflects that input and requests comments for HHS to consider as it drafts the final rule. 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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Patient-Focused Drug Development Meeting: Huntington's and Parkinson's Disease
Date: September 22, 2015
Location: FDA White Oak Campus - 10903 New Hampshire Ave, Silver Spring, MD. 20993
Agenda: The purpose of this Patient-Focused Drug Development meeting is to obtain patient perspectives on the impact of Huntington’s disease and Parkinson’s disease on daily life and patient views on treatment approaches.
Public Workshop: Medical Device Patient LabelingDate: September 29, 2015 8:00 am to 5:00 pm
Date: September 30, 2015, 8:00 am to 5:00 pm
Location: FDA White Oak Campus - 10903 New Hampshire Ave, Silver Spring, MD. 20993
Agenda: The purpose of the public workshop is to discuss issues associated with the development and use of medical device patient labeling including content, testing, use, access, human factors, emerging media formats, and promotion and advertising. The Center for Devices and Radiological Health (CDRH) is seeking input into these topics from patients and advocacy groups, academic and professional organizations, industry, standards organizations, and governmental Agencies. Ideas generated during this workshop will help facilitate development or revision of guidances and/or standards for medical device patient labeling.
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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. |
Vaccines for Children- A Guide for Parents and CaregiversVaccines have contributed to a significant reduction in many childhood infectious diseases, such as diphtheria, measles, and Haemophilus influenzae type b (Hib). Some infectious diseases, such as polio and smallpox, have been eliminated in the United States due to effective vaccines. It is now rare for children in the United States to experience the devastating and often deadly effects of these diseases that were once common in the United States and other countries with high vaccination coverage. More Information
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Naming and Biological Products" by Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research and Karen Midthun, M.D., Director, Center for Biologics Evaluation and ResearchTo create market competition among biological products and lower costs, the Affordable Care Act created a new approval pathway for products that are biosimilarto and interchangeable with FDA-licensed biological products. The FDA is committed to encouraging the development of these biosimilar and interchangeable products. Biological products derived from living organisms can treat patients with cancer, chronic kidney diseases and auto‐immune diseases, such as rheumatoid arthritis and inflammatory bowel disease.
Earlier this year, the agency approved the first biosimilar, and other products are in development. But one key issue is how to name biological products to ensure safe use and foster acceptance of these new products.
So today we are releasing a draft guidance that details the FDA’s proposal on the nonproprietary naming of biological products. |
More Consumer UpdatesFor previously published Consumer Update articles that are timely and easy-to-read and cover all FDA activities and regulated products. More information
En EspañolLa 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
Information about Expanded AccessExpanded 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.
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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 |
Center for Food Safety and Applied NutritionThe 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
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Safe Food Handling: What You Need to KnowTambién disponible en español (Spanish). The food supply in the United States is among the safest in the world. However, when certain disease-causing bacteria or pathogens contaminate food, they can cause foodborne illness, often called “food poisoning.”
The Federal government estimates that there are about 48 million cases of foodborne illness annually – the equivalent of sickening 1 in 6 Americans each year. And each year these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths.
Since foodborne illness can be serious — or even fatal — it is important for you to know and practice safe food handling behaviors to help reduce your risk of accidentally getting sick from contaminated food. More information |
FDA Food Safety Modernization Act (FSMA)The FDA has submitted the final preventive controls rules for human and animal food to the Federal Register for publication, as required by the court. Documents submitted to the Federal Register can publish several days after they are submitted, with larger documents taking longer to process and display. The FDA is committed to sharing information about the final rules and how food facilities can comply as soon as we are able to do so. More information
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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
Animal and Veterinary UpdatesAnimal and veterinary updates provide information to keep your pets healthy and safe. More information
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Please have as much of the following information available when submitting your complaint: Consumers often transfer dry pet food into other containers for easier handling. 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 |
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FDA takes action against three tobacco manufactureres for making "additive-free" and/or "natural" claims on cigarette labeling The U.S. Food and Drug Administration issued warning letters to three tobacco manufacturers — ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd. — who describe their cigarettes on product labeling as “additive-free” and/or “natural.” The warning letters are for violations of section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More Information
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Comment Period for Nicotine Exposure Warnings and Child-Resistant Packaging ANPRM extendedThe comment period for the Advance Notice of Proposed Rulemaking (ANPRM) on Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products has been extended until September 30, 2015. 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 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
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FDA BasicsEach 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
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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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Patient Network - Bring Your Voice to FDAAn 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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