MedWatch Safety Information: FDA review found no increased cardiovascular risks with Parkinson’s disease drug entacapone
FDA safety review has found no clear evidence of an increased risk of heart attacks, stroke, or other cardiovascular events associated with the use of entacapone for the treatment of Parkinson’s disease. As a result, our recommendations for using Comtan (entacapone) and Stalevo (a combination of entacapone, carbidopa, and levodopa) will remain the same in the drug labels. Patients should discuss any questions they have with their health care professionals. More information and to read the Drug Safety Communication. |
MedWatch Safety Information: Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of Serious Liver Injury
FDA is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, FDA is requiring the manufacturer to include information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels.
Patients taking these medicines should contact their health care professional immediately if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury. Patients should not stop taking these medicines without first talking to their health care professionals. Stopping treatment early could result in drug resistance to other hepatitis C medicines.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. More information and to read the Drug Safety Communication.
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MedWatch Safety Information: Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Requires Drug Interaction Studies
FDA is requiring the Kayexalate manufacturer to conduct studies to investigate Kayexalate’s potential to bind to other medications administered by mouth – drug interactions that could affect how well the other medications work.
The approved labeling for Kayexalate describes its potential to decrease absorption of lithium and thyroxine; however, extensive drug-drug interaction studies with Kayexalate have not been performed. During FDA’s review of another potassium-lowering drug, Veltassa (patiromer), we found that Veltassa bound to about half of the medications tested, some of which are commonly used in patients who require potassium-lowering drugs. Such binding could decrease the effects of these medications. The label for Veltassa contains a warning not to take other orally administered medications within 6 hours of taking Veltassa. More information and to read the Drug Safety Communication.
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MedWatch Safety Information: Downing Labs, LLC Sterile Compounded Products: Recall - Lack of Sterility Assurance
Downing Labs, LLC is voluntarily recalling all lots of sterile products compounded and packaged by Downing Labs and that remain within expiry due to concerns over sterility assurance. The products were distributed nationwide and in the UK to patients and providers between April 20, 2015 and September 15, 2015. If there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. More information and to read thepress release. |
MedWatch Safety Information: Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength
On October 9, 2015, Medline Industries, Inc. 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. More information and to read the press release. |
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 |
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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:
- Formoterol Fumarate (FORADIL® AEROLIZER®) Inhalation Powder
- Dipyridamole (Persantine®) Tablets
- Meloxicam (Mobic) Oral Suspension
- Oxybutynin (GELNIQUE 3%) Gel
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-of-its-kind product for the treatment of melanoma approved
FDA approved Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes.
“Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult to treat,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “This approval provides patients and health care providers with a novel treatment for melanoma.” More information
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New treatment for rare metabolic disorder approved
FDA approved Strensiq (asfotase alfa) as the first approved treatment for perinatal, infantile and juvenile-onset hypophosphatasia (HPP). HPP is a rare, genetic, progressive, metabolic disease in which patients experience devastating effects on multiple systems of the body, leading to severe disability and life-threatening complications. It is characterized by defective bone mineralization that can lead to rickets and softening of the bones that result in skeletal abnormalities. More information |
A new therapy for certain types of advanced soft tissue sarcoma is approved
FDA approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline.According to the National Cancer Institute, STS is a disease in which cancer cells form in the soft tissues of the body, including the muscles, tendons, fat, blood vessels, lymph vessels, nerves and tissues around joints. More information |
Onivyde a new treatment for advanced pancreatic cancer approvedFDA approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.
According to the National Cancer Institute, there will be 48,960 new cases of pancreatic cancer diagnosed in the U.S. in 2015, and nearly the same number of deaths caused by the disease (40,560). Pancreatic cancer can be difficult to diagnose early and treatment options are limited, especially when the disease has spread to other parts of the body (metastatic disease) and surgery to remove the tumor is not possible. More information
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Veltassa a new drug to treat hyperkalemia approved
FDA approved Veltassa (patiromer for oral suspension) to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. “Too much potassium in the blood can lead to dangerous, even fatal, changes in heart rhythm,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “It is important to have treatment options for hyperkalemia available to patients.” More information |
Praxbind, approved as the first reversal agent for the anticoagulant Pradaxa
FDA granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects. “The anticoagulant effects of Pradaxa are important and life-saving for some patients, but there are situations where reversal of the drug’s effects is medically necessary,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. More information
First Factor X concentrate to treat patients with rare hereditary bleeding disorder approvedFDA approved Coagadex, Coagulation Factor X (Human), for hereditary Factor X (10) deficiency. Until today’s orphan drug approval, no specific coagulation factor replacement therapy was available for patients with hereditary Factor X deficiency. In healthy individuals, the Factor X protein activates enzymes to help with normal blood clotting in the body. Factor X deficiency is an inherited disorder, affecting men and women equally, where the blood does not clot as it should. 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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- Request for comment by October 30, 2015: Public Workshop - Medical Device Patient Labeling
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. FDA held this public workshop to obtain stakeholder input on medical device patient labeling. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop. The deadline for submitting comments regarding this public workshop is October 30, 2015. To read the entire Federal Register Notice and to make comments electronically.
Do you have questions about the Patient Engagement Advisory Committee?
If so, the Center for Devices and Radiological Health is hosting an opportunity to ask your questions about the Patient Engagement Advisory Committee.
Date: November 5, 2015
Time: 1:00 PM EST Call-in Number: 1-888-989-9821 Participant passcode: 4385958
A replay recording of this call will be available one hour after the live call ends until December 5, 2015 10:59 PM (CT). To hear the replay recording call Toll free: 1-800-677-4914
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Want to Help the FDA? Become a Consumer Representative on an FDA Advisory Committee, by: CAPT Dornette Spell-LeSane, M.S.N., M.H.A., A.N.P.-B.C., is Deputy Director of FDA’s Advisory Committee Oversight and Management Staff
Have you ever wanted to be part of the food and drug regulatory process? Do you have a history of public interest or a passion for consumer advocacy? Do you have experience analyzing scientific data?
If you answered “Yes,” here’s your opportunity to become an advocate for consumers! The Food and Drug Administration continually seeks input from consumers on scientific and medical issues by including Consumer Representatives on Agency advisory committees.
Participation as a Consumer Representative requires a modest time commitment. Travel expenses are paid and representatives receive reasonable compensation.
To read the rest of this post, see FDA Voice Blog, October 22, 2015
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The Merging of Medical Products: Enhancing review of therapeutic and diagnostic combination products, by: Robert M. Califf, M.D., is FDA’s Deputy Commissioner for Medical Products and Tobacco andJill Hartzler Warner, J.D., is FDA’s Associate Commissioner for Special Medical Programs.
Combination products – medical products that do not fit into the traditional categories of drugs, devices, or biological products – are a growing and important category of therapeutic and diagnostic products under FDA’s regulatory authority.
These products, that combine drugs, devices, and/or biological product (“constituent parts”) with one another, come in three configurations. The constituent parts may be physically or chemically combined, co-packaged, or separately distributed with specific labeling for their combined use.
Products in this category range from familiar products such as prefilled syringes and surgical kits to novel and innovative products, which target and enhance therapies. Examples of groundbreaking combination products include antibodies combined with drugs for targeted cancer therapy and products that mimic or replace organs, such as an artificial pancreas.
To read the rest of this post, see FDA Voice Blog, October 15, 2015
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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.
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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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Novelty Makeup
Face paints can be fun on Halloween and other special occasions. Here are tips to help keep your fun from leaving you with a rash, swollen eyelids, or other reaction.
Decorating your face with face paint or other makeup lets you see better than you can if you're wearing a mask. A mask can make it hard to see where you're going and watch out for cars. But make sure your painted-on designs don't cause problems of their own.More information
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'Lucky 13' Tips for a Safe Halloween
Whether you’re goblin or ghoul, vampire or witch, poor costume choices—including decorative contact lenses and flammable costumes—and face paint allergies can haunt you long after Halloween if they cause injury.
Enjoy a safe and happy Halloween by following the “lucky 13” guidelines from FDA, the Consumer Product Safety Commission, and the Centers for Disease Control and Prevention:
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Halloween Food Safety Tips for Parents
Even though it’s not an official holiday, Halloween is much beloved by children and adults alike. What could be more fun than trick-or-treating, apple bobbing, or costume parties?
To make sure treats are safe for children, follow these simple steps:
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Decorative Contact Lenses: Is Your Vision Worth It?
Wouldn’t it be cool to have Twilight vampire eyes for Halloween? Or deep violet eyes to match your purple sweater? How about your favorite sports team’s logo on your eyes just for fun?
You can have all of these looks with decorative contact lenses (also called fashion contact lenses or colored contact lenses, among other names). These lenses don’t correct vision—they just change the appearance of the eye. More information and En Español
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Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You
If you buy imported products marketed as “dietary supplements” and nonprescription drug products from ethnic or international stores, flea markets, swap meets or online, watch out. Health fraud scams abound. According to Cariny Nunez, M.P.H., a public health advisor in the Office of Minority Health at the Food and Drug Administration (FDA), health scammers often target advertising to people who prefer to shop at nontraditional places, especially those who have limited English proficiency and limited access to health care services and information.
“These scammers know that ethnic groups who may not speak or read English well, or who hold certain cultural beliefs, can be easy targets,” Nunez says. For example, Native Americans, Latinos, Asians and Africans may have a long tradition of turning to more herbal or so-called “natural” remedies. Many advertisers put the word “natural” somewhere on the package of a product, knowing it inspires trust in certain groups. More information and En Español
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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.
But as many as half of the people with atrial fibrillation who could benefit from a blood thinner don’t take them. There are two main reasons for this: Anticoagulants don’t affect how patients feel, and they can cause bleeding. 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
US Marshals seize adulterated crab products for food safety violations
At the request of the U.S. Food and Drug Administration and the U.S. Attorney for the District of Massachusetts, U.S. Marshals have seized about 5,000 cases of ready-to-eat frozen Jonah crab products processed by Rome Packing Company Inc. (Rome Packing). FDA investigators determined the products have been prepared, packed and held under unsanitary conditions and may present a risk to human health. More information |
Center for Food Safety and Applied Nutrition Education Resource Library
FDA’s Center for Food Safety - Applied Nutrition (CFSAN) Education Resource Library is a compilation of printable educational materials on topics related to food safety, nutrition (including labeling - dietary supplements) - cosmetics.
These materials are intended for educators, teachers, dietitians - health professionals as well as for general consumer education. Materials are available in PDF format for immediate download - may also be ordered in larger quantities. 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 |
Treating Cushing's Disease in Dogs
Your 9-year old dog has been drinking a lot more lately and eating everything in sight. Plus, he's developed a potbelly and is losing hair. A visit to the vet and some diagnostic tests confirm that he has hyperadrenocorticism, commonly known as Cushing's disease. Cushing's disease results when the body produces too much of a hormone called cortisol. Cortisol is produced and stored by the adrenals, two small glands that sit on top of the kidneys.
Dogs, cats, and horses, as well as humans, can get Cushing's disease. It is more commonly found in dogs than in cats or horses. More information and En Español
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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 information and 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’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 and to watch a video on Voluntary Reporting of Animal Food Problems.
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October 28, 2015 is Lung Health Day
Lung cancer is the leading cancer killer of American men and women.1 Smoking is directly responsible for approximately 90% of lung cancer deaths.2 FDA's Center for Tobacco Products, established in 2009, has joined in the fight against lung cancer by working to:
You may be familiar with some of the statistics, but if you, a co-worker, friend, or loved one is a smoker, it's worth taking another look at what cigarettes can do to our bodies. 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 Campaigns
We are investing in a number of public education campaigns, such as Fresh Empireand 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 and for 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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