New Shared REMS Program for all Clozapine medicines for treatment of Schizophrenia due to modified monitoring for neutropenia
FDA is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about a serious blood condition called severe neutropenia. Severe neutropenia is a dangerously low number of neutrophils, white blood cells that help fight infections. Severe neutropenia can be life-threatening.
Treatment with clozapine may improve the symptoms of schizophrenia in patients who do not respond adequately to standard antipsychotic treatments. Symptoms of schizophrenia include hearing voices, seeing things that are not there, and being suspicious or withdrawn. Clozapine is also effective in reducing the risk of repeated suicidal behavior in patients with schizophrenia or schizoaffective disorder. More Information
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WARNING: Revisions to diabetes drug canagliflozin Invokana, Invokamet) labeling to include updates on bone fracture risk and new information on decreased bone mineral density
FDA has strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures and added new information about decreased bone mineral density. Bone mineral density relates to the strength of a person’s bones. To address these safety concerns, we added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet drug labels. More Information |
Miracle Diet 30 and Miracle Rock 48 Capsules by The One Minute Miracle Inc.: Recall - Due to Presence of Undeclared Drug Products
The One Minute Miracle Inc. is voluntarily recalling all lots of Miracle Diet 30, capsules and Miracle Rock 48, capsules to the consumer level. These products have been recalled due to FDA analysis revealing that these dietary supplements contain undeclared drug products making them unapproved drugs.
Miracle Diet 30 has been found to contain undeclared phenolphthalein, phenolphthalein was an ingredient used in over-the counter laxatives but was removed from the market because of concerns of carcinogenicity. There is a reasonable probability that the health risks of long term phenolphthalein consumption could include serious gastrointestinal disturbances, irregular heartbeat, and cancer with long term use. More information
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Medistat RX Sterile Drug Products: Recall - Possible Contamination
FDA alerted health care professionals and patients of a voluntary recall of all non-expired drug products produced for sterile use and distributed nationwide by Medistat RX, LLC, in Foley, Alabama, due to possible contamination. During an ongoing inspection, FDA investigators and Alabama state inspectors observed significant deficiencies that raise concerns about Medistat’s ability to assure the sterility of drug products that it produced. The recalled products were distributed between November 1, 2014, and September 3, 2015.
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. 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 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
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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
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Xuriden, an orphan drug used to Autosomal Recessive Disorder Drug gains approvalThe FDA approved Xuriden (uridine triacetate) treatment for patients with hereditary orotic aciduria. Hereditary orotic aciduria is a rare metabolic disorder, which has been reported in approximately 20 patients worldwide. Symptoms of the disease include blood abnormalities (anemia, decreased white blood cell count, decreased neutrophil count), urinary tract obstruction due to the formation of orotic acid crystals in the urinary tract, failure to thrive, and developmental delays. 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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Another tool helping developers navigate the difficult road to approval of drugs for rare diseases, by: Jonathan Goldsmith, M.D., F.A.C.P., is FDA’s Associate Director, Rare Diseases Program, Center for Drug Evaluation and Research
If you personally know 100 people living in the U.S., chances are that almost 10 will suffer from some form of a rare disease. If that makes it sound like rare diseases are not actually very rare in this country, that’s because there are 7,000 different rare diseases, 80% of which are caused by faulty genes. A rare disease is defined as a condition that affects fewer than 200,000 people living in the U.S., a country with almost 320 million people. When we do the math, it turns out there are roughly 30 million Americans who suffer from a rare disease. And sadly, about 50% are children.
With the vast majority of rare diseases still without FDA-approved treatments, we have recently released a new resource for drug developers — a draft guidance document — designed to help them navigate the difficult and unique challenges of developing and bringing to market new FDA-approved drugs to treat rare diseases. To continue reading this post, see FDA Voice posted on September 15, 2015
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FDA Taking Genomic Testing to the Next Level, by: Adam Berger Ph.D., Senior Staff Fellow, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health and Zivana Tezak, Ph.D., Associate Director for Science and Technology, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health
President Obama’s Precision Medicine Initiative (PMI) envisions a day when the specific differences between people – genetic, environmental, lifestyle – will be used to customize the healthcare that we receive. Many of the current efforts toward achieving this goal have focused on analyzing and interpreting a person’s unique genetic makeup, including the identification of genetic alterations that may impact his or her health.
Next generation sequencing (NGS) technologies have significantly advanced the ability to derive more comprehensive genetic information on individuals in a relatively inexpensive and fast manner. In order to help achieve the goals of the PMI, FDA is developing new regulatory strategies for NGS-based clinical tests. To continue reading this post, see FDA Voice posted on September 8, 2015
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OpenFDA Makes Medical Device-Related Data Easier to Access and Use by Taha Kass-Hout, M.D., Chief Informatics Officer, Office of the Chief Scientist, Roselie A. Bright, Sc.D, M.S., P.M.P, Manager (openFDA), Office of the Chief Scientist and Ann Ferriter, Director of Analysis and Program Operations, Office of Compliance, Center for Devices and Radiological Health
OpenFDA is releasing information on medical devices that could spur innovation and advance scientific research. Its Application Programming Interface (API) expands on the previous openFDA resources concerning medical device-related adverse events and recalls by incorporating information from the medical device product life cycle. This includes current data on device classification (6,000 records), 24,000registrations of device companies and establishments, and the companies’ listings of more than 100,000 devices. To continue reading this post, see FDA Voice posted on September 3, 2015 |
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.
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Patient-Focused Drug Development Meeting:Huntington's and Parkinson's Disease
Date: September 22, 2015 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.
Medical Devices Advisory Committee Meeting: Obstetrics and Gynecology Devices Panel
Date: September 24, 2015, 8:00 am to 6:00 pm Agenda: The committee will discuss the risks and benefits of Bayer HealthCare's Essure System for permanent female sterilization. The system, originally approved in November 2002, under P020014, consists of a delivery system and nickel-containing permanent implants. The implants are placed without a skin incision, through the vagina, within each fallopian tube; they elicit tissue ingrowth, which over time results in tubal occlusion. |
Patient-Focused Drug Development Meeting: Alpha-1 Antitrypsin Deficiency (AATD)
Date: September 29, 2015, 9:00 am to 3:30 pm Agenda: The purpose of this Patient-Focused Drug Development meeting is to obtain input on the symptoms and other impacts that matter most to patients with AATD. FDA also intends to seek patients' perspectives on current approaches to treating this disorder. FDA expects that this information will come directly from patients, caregivers, and patient advocates. |  |
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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Injectable Skin Lightening Products: What You Should KnowSome consumers seeking to change their skin color are turning to injectable products marketed to whiten or lighten their complexion. These products are potentially unsafe and ineffective, and might contain unknown harmful ingredients or contaminants. FDA has not approved any injectable drugs for skin whitening or lightening.
Beyond the potential harm from the product itself, improper or unsafe injection practices may transmit disease, cause infection and result in serious injury. 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
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. |
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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Preventative Controls for Human and Animal Food: Final Rules Announced
The Preventive Controls for Human Food rule and Preventive Controls for Animal Food rule are now final, and compliance dates for some businesses begin in September 2016.
The preventive controls final rules announced today are the result of an extensive outreach effort, and incorporate thousands of public comments, including valuable input from farmers, consumers, the food industry and academic experts, to create a flexible and targeted approach to ensuring food safety.
To read the FDA Consumer Update
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Multistate Outbreak of Salmonella Poona Linked to CucumbersThe FDA, CDC, and state and local officials are investigating a multistate outbreak of Salmonella Poona linked to “slicer” cucumbers, supplied by Andrew and Williamson Fresh Produce and grown in Baja, Mexico. This type of cucumber can also be called “American” cucumbers. More information
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"Statement on the Release of Menu Labeling Guidance" by Susan Mayne, Director, Center for Food Safety and Applied Nutrition
Food and Drug Administration (FDA) [has] issued a draft guidance document that will help companies to comply with the menu labeling final rule, which requires that calorie information be listed on menus and menu boards in chain restaurants and similar retail food establishments with 20 or more locations. In July, FDA extended the compliance date an additional year, beyond the original December 2015 compliance date, to help facilitate efficient compliance across all covered establishments. The guidance document issued today is an important resource in our efforts to assist those in covered establishments to comply with the rule by December 1, 2016. Ultimately, consumers will be able to make more informed choices for themselves and their families. To read the rest of this statement, click here |
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 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 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 issued orders that will stop the further sale and distribution of four currently marketed R. J. Reynolds Tobacco Company cigarette products-including it Camel Crush Bold brand-because the company's submissions for these products did not meet requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act). 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 Campaigns
We 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 Tobacco
We 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 |
 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
FDA Food Safety and Modernization Act: An FDA PrimerThe Rulemaking Process: An FDA Primer What is Regulatory Science Taking Acetaminophen Safely |
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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