Clozapine: Drug Safety Communication - FDA Modifies Monitoring for Neutropenia; Approves New Shared REMS Program
Due to ongoing implementation challenges with the new Clozapine REMS Program, FDA is extending the November 23, 2015 prescriber certification deadline and the December 14, 2015 pharmacy certification deadline to help ensure that health care professionals have sufficient time to complete this process and that patient access to clozapine is maintained. FDA is also carefully evaluating next steps regarding the December 14, 2015 pre-dispense authorization (PDA) launch. FDA will communicate the revised certification deadlines and additional information about the PDA launch as soon as possible. More information |
Recall: Acetaminophen Tablets by Medline Industries - Mislabeling with Incorrect Strength
Medline Industries, Inc. has announced that it will initiate a voluntary nationwide recall of lot # 45810 of Acetaminophen tablets, 500mg, uncoated compressed tablets to the consumer level. The Acetaminophen 500mg, Tab 100/BT (OTC20101) has been found to be mislabeled displaying “Acetaminophen 325mg” (OTC10101) instead of “Acetaminophen 500mg”. The Acetaminophen tablets, 500mg is incorrectly labeled as 325 mg tablets. This error is not easily identifiable by the user or prescriber. If the product is taken at the maximum labeled dose, every four hours, five doses a day, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure. See the Firm Press Release for further details. More information
FDA Drug Safety Communication: FDA advises of rare cases of underactive thyroid in infants given iodine-containing contrast agents for medical imaging
FDA is advising that rare cases of underactive thyroid have been reported in infants following the use of contrast media containing iodine, also called “contrast dye,” for X-rays and other medical imaging procedures. In all of the reported cases, the infants were either premature or had other serious underlying medical conditions. Available evidence leads us to believe that this rare occurrence is usually temporary and resolves without treatment or any lasting effects. More information |
FDA orders recall under consent decree for all Custom Ultrasonics automated endoscope reprocessors
FDA ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to the firm’s continued violations of federal law and a consent decree entered with the company in 2007. The identified violations could result in an increased risk of infection transmission. The FDA ordered this recall under the terms of the consent decree. The agency also issued a safety communication today recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible. More information
FDA ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to the firm’s continued violations of federal law and a consent decree entered with the company in 2007. The identified violations could result in an increased risk of infection transmission. The FDA ordered this recall under the terms of the consent decree. The agency also issued a safety communication today recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible. 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
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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:
- Clonidine Hydrochloride and Chlorthalidone Tablets, USP (Clopres)
- Quinapril Hydrochloride and Hydrochlorothiazide Tablets
- Clemastine Fumarate Tablet, USP
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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First seasonal influenza vaccine containing an adjuvant is approved
FDA approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and older.
Fluad, which is manufactured using an egg-based process, is formulated with the adjuvant MF59, an oil-in-water emulsion of squalene oil. Squalene, a naturally occurring substance found in humans, animals and plants, is highly purified for the vaccine manufacturing process. Adjuvants are incorporated into some vaccine formulations to enhance or direct the immune response of the vaccinated individual. More information
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Portrazza approved to treat advanced squamous non-small cell lung cancer
The FDA approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer. Portrazza is a monoclonal antibody that blocks activity of EGFR, a protein commonly found on squamous NSCLC tumors. More information |
Vaccine approved for use after known or suspected anthrax exposure
FDA approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure. BioThrax is the first vaccine to receive approval based on the Animal Rule. The Animal Rule allows animal efficacy data to be used as a basis for approval when human efficacy studies are not ethical or feasible. More information |
Opdivo approved to treat advanced form of kidney cancer
FDA approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy. Renal cell carcinoma is the most common form of kidney cancer in adults and forms in the tissues of the kidney that make urine. Additionally, Opdivo’s extended indication, from melanoma and non-small cell lung cancer to renal cell cancer, demonstrates how immune therapies can benefit patients across a wide range of tumors. More information |
Ninlaro approved to treat multiple myeloma
FDA granted approval for Ninlaro (ixazomib) in combination with two other therapies to treat people with multiple myeloma who have received at least one prior therapy. Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, produce an abnormal protein and push out other healthy blood cells from the bone marrow. Ninlaro is a type of cancer drug called a proteasome inhibitor and works by blocking enzymes from multiple myeloma cells, hindering their ability to grow and survive. Ninlaro is the first oral proteasome inhibitor and is approved in combination with another FDA-approved treatment for multiple myeloma called Revlimid (lenalidomide) and dexamethasone (a type of corticosteroid). More information |
FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose
FDA has approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose. Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illegal drug heroin. Drug overdose deaths, driven largely by prescription drug overdoses, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. In 2013, the Centers for Disease Control and Prevention reported the number of drug overdose deaths had steadily increased for more than a decade. When someone overdoses on an opioid, it can be difficult to awaken the person, and breathing may become shallow or stop – leading to death if there is no medical intervention. If naloxone is administered quickly, it can counter the overdose effects, usually within two minutes. “Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, M.D., acting commissioner, Food and Drug Administration. “We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.” More information
FDA approves Darzalex (daratumumab) for patients with previously treated multiple myeloma
FDA has granted accelerated approval to daratumumab injection (DARZALEX, Janssen Biotech, Inc.), administered as a single agent for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent. Daratumumab is the first monoclonal antibody approved for the treatment of multiple myeloma. The approval was based on a multi-center, open-label study evaluating response rates in 106 patients with relapsed or refractory multiple myeloma treated with daratumumab monotherapy. The objective response rate was 29% (95% CI: 21-39%) with a median response duration of 7.4 months (range: 1.2 to 13.1+ months). More information |
New pill approved to treat certain patients with non-small cell lung cancer
FDA granted accelerated approval for an oral medication to treat patients with advanced non-small cell lung cancer (NSCLC). Tagrisso (osimertinib) is now approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy. Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute. More information |
Modified antihemophilic factor approved for hemophilia A
FDA approved Adynovate, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A. Adynovate is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihemophilic Factor when used to reduce the frequency of bleeding. Adynovate is approved for on-demand (as needed) treatment and control of bleeding episodes and to reduce the frequency of bleeding episodes (prophylaxis) in patients with Hemophilia A. 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 patients and caregivers.
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Update on Essure Permanent Birth Control
The FDA is reviewing information from the September panel meeting, the public docket, as well as additional medical literature and adverse event reports which have been published or received since the panel meeting. In this review, we are focusing attention on the concerns identified by the public speakers and the feedback and recommendations provided by the panel (See Advisory Committee meeting summary and panel transcript).
This is a high priority issue for the Agency, and we are working expeditiously to conduct an evidence-based review of the available information and identify appropriate next steps. We anticipate communicating our actions publically at the end of February 2016. More information
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Antibiotic Resistance Drug Info Rounds Video
Drug Info Rounds, a series of training videos for practicing clinical and community pharmacists. Drug Info Rounds is brought to you by the Division of Drug Information (DDI). Pharmacists in DDI answer hundreds of questions everyday about drug products and FDA actions. DDI's goal is to provide important and timely drug information to pharmacists so they can help patients make better medication decisions. This month's Drug Info Rounds discusses how patients and pharmacists play an important role in combating antibiotic resistance. View video |
CDER perspective: Ensuring the safety and effectiveness of sunscreens; by Theresa M. Michele, M.D., Director of FDA’s Center for Drug Evaluation and Research’s Division of Nonprescription Drug Products
Sunscreens are a preventive treatment for sunburn. Certain sunscreens also help reduce the risk of skin cancer and premature skin aging caused by the sun when used as directed with other sun protection measures. When sunscreens first came on the market, they were used occasionally at the beach and often as tanning aids. Now, many different groups, including dermatology societies, the Surgeon General, and FDA, encourage people of all ages, ethnicities, and complexions to use sunscreens liberally and reapply frequently whenever they are out in the sun. In fact, FDA and CDC recommend that consumers use broad-spectrum sunscreens with a sun protection factor (SPF) of 15 or more in conjunction with other sun-protective measures like seeking shade at peak hours and wearing protective clothing, hats, and sunglasses. More information |
Why FDA Should Oversee Laboratory Developed Tests, by Peter Lurie, M.D., M.P.H., FDA's Associate Commissioner for Public Health Strategy and Analysis
FDA has issued a report that illustrates the real and potential harms to patients and to public health from certain laboratory developed tests (LDTs) – tests that are designed, manufactured and used in a single laboratory. When FDA first began regulating medical devices under the Medical Device Amendments in the 1970s, we chose not to enforce applicable regulatory requirements for LDTs because they were relatively simple tests generally confined to local labs, and often used for rare conditions. But times have changed.
To read the rest of this post, see FDA Voice Blog, November 16, 2015.
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FDA takes action to protect consumers from potentially dangerous dietary supplements
FDA, in partnership with other government agencies, today announced the results of a yearlong sweep of dietary supplements to identify potentially unsafe or tainted supplements. The sweep resulted in civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Among the cases announced today is a criminal case charging USPlabs LLC and several of its corporate officers. USPlabs was known for its widely popular workout and weight loss supplements, which it sold under names such as Jack3d and OxyElite Pro. Led by the U.S. Department of Justice, the sweep included the FDA, the Internal Revenue Service’s Criminal Investigation Division, the Federal Trade Commission, the U.S. Postal Inspection Service, the Department of Defense and the U.S. Anti-Doping Agency. More information
FDA, in partnership with other government agencies, today announced the results of a yearlong sweep of dietary supplements to identify potentially unsafe or tainted supplements. The sweep resulted in civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Among the cases announced today is a criminal case charging USPlabs LLC and several of its corporate officers. USPlabs was known for its widely popular workout and weight loss supplements, which it sold under names such as Jack3d and OxyElite Pro. Led by the U.S. Department of Justice, the sweep included the FDA, the Internal Revenue Service’s Criminal Investigation Division, the Federal Trade Commission, the U.S. Postal Inspection Service, the Department of Defense and the U.S. Anti-Doping Agency. More information
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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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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Have Atrial Fibrillation? Blood Thinners Can Prevent Strokes, Save Lives
If you’re one of the 2.7 million Americans who have atrial fibrillation, you have an increased risk of a stroke. You can greatly reduce the risk of a stroke by 50% to 60% by taking a blood thinner (anticoagulant). A stroke occurs when blood flow to the brain is blocked by a clot, depriving brain cells of oxygen. In people with atrial fibrillation, blood flow is sluggish in the top chambers of the heart, and blood clots can form there. When a piece of a clot breaks off, it can travel to the brain and cause a stroke. That’s where blood thinners come in. Blood thinners, or anticoagulants, decrease the chances of blood clots forming in the heart, reducing the risk of stroke.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
Holiday Food Safety
Many people don't realize that food safety is the most important ingredient in preparing food for the holidays. Below are some helpful food safety resources to keep your holidays happy. |
Refrigerator Thermometers: Cold Facts about Food Safety
When it comes to protecting yourself and your family from foodborne illness, one of your most effective tools is the kitchen refrigerator. In fact, at room temperature, the numbers of bacteria that cause foodborne sickness can double every 20 minutes! Chilling foods to proper temperatures is one of the best ways to slow the growth of these bacteria.
To ensure that your refrigerator is doing its job, it’s important to keep its temperature at 40 °F or below; the freezer should be at 0 °F. Since few refrigerator controls show actual temperatures, using an inexpensive freestanding appliance thermometer will allow you to monitor the temperature and adjust the setting of the refrigerator and/or freezer if necessary. Buy one for the fridge, one for the freezer, and check them often. More information
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FDA Has Determined That the AquAdvantage Salmon is as Safe to Eat as Non-GE Salmon
After an exhaustive and rigorous scientific review, FDA has arrived at the decision that AquAdvantage salmon is as safe to eat as any non-genetically engineered (GE) Atlantic salmon, and also as nutritious.
The FDA scientists rigorously evaluated extensive data submitted by the manufacturer, AquaBounty Technologies, and other peer-reviewed data, to assess whether AquAdvantage salmon met the criteria for approval established by law; namely, safety and effectiveness. The data demonstrated that the inserted genes remained stable over several generations of fish, that food from the GE salmon is safe to eat by humans and animals, that the genetic engineering is safe for the fish, and the salmon meets the sponsor’s claim about faster growth. More information and en Español
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FSMA Final Rule on Produce Safety
FDA today released groundbreaking final rules that will help produce farmers and food importers take steps to prevent food safety problems before they occur. The agency also released a Final Environmental Impact Statement on the rule’s provisions. View theFinal Register Notice and a fact sheet on the Final Rule. |
FDA takes several actions involving genetically engineered plants and animals for food
Based on sound science and a comprehensive review, the U.S. Food and Drug Administration is taking several important steps today regarding food from genetically engineered (GE) plants and animals, including the first approval for a genetically engineered animal intended for food, AquAdvantage Salmon. The agency is also issuing two guidances for manufacturers who wish to voluntarily label their products as containing ingredients from GE or non-GE sources: a draft guidance on labeling foods derived from Atlantic salmon, and a final guidance on foods derived from GE plants. More information
Based on sound science and a comprehensive review, the U.S. Food and Drug Administration is taking several important steps today regarding food from genetically engineered (GE) plants and animals, including the first approval for a genetically engineered animal intended for food, AquAdvantage Salmon. The agency is also issuing two guidances for manufacturers who wish to voluntarily label their products as containing ingredients from GE or non-GE sources: a draft guidance on labeling foods derived from Atlantic salmon, and a final guidance on foods derived from GE plants. 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
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 |
No Bones About It: Reasons Not to Give Your Dog Bones
You’ve just finished a big weekend family dinner and you are wondering what to do with the bones from the ham and roast, when in trots your big black Labrador Retriever. It’s hard to resist those longing, puppy-dog eyes.
Your veterinarian has told you it’s a bad idea to give bones to your dog, but you’ve done so in the past with no harm done. What to do? 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 informationand Publicaciones 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’sFDA 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 code, 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.
Public Education Campaigns
We 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 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 |
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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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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