Medwatch Safety Alert: Plavix (clopidogrel): Drug Safety Communication - Long-term Treatment Does Not Change Risk of Death
An FDA review has determined that long-term use of the blood-thinning drug Plavix (clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. FDA evaluation of the Dual Antiplatelet Therapy (DAPT) trial and several other clinical trials also does not suggest that clopidogrel increases the risk of cancer or death from cancer.
In order to investigate the increased risk of death and cancer-related death reported with clopidogrel in the DAPT trial, FDA examined the results of the DAPT trial and other large, long-term clinical trials of clopidogrel with data available on rates of death, death from cancer, or cancer reported as an adverse event. More information
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MedWatch Safety Alert: Auvi-Q (epinephrine injection, USP): Recall - Potential Inaccurate Dosage Delivery
Sanofi US is voluntarily recalling all Auvi-Q (epinephrine injection, USP). The recall involves all Auvi-Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery. More information. |
Adverse Event Reporting: How to Report a Cosmetic-Related Problem to FDA
The law does not require cosmetic companies to report problems to FDA. Therefore, the information you report is very important in order to help FDA monitor the safety of cosmetics on the market. You should also remember that FDA does not provide medical advice.
In the case of a reaction or problem with a cosmetic product, the first step is to stop using the productand contact your healthcare provider. Then, report the problem to FDA. More information and También en Español
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Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información importante sobre seguridad de los medicamentos en idiomas distintos al inglés. Hacemos lo mejor posible para proporcionar versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en inglés y la de español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information en druginfo@fda.hhs.gov.Comunicaciones de la FDA |
FDA recognizes the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. When issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, FDA works closely with the firm to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the firm to restore supplies while also ensuring safety for patients. More information
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Drug Shortages Reported to be Resolved 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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Cotellic approved as part of combination treatment for advanced melanoma
FDA approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation).Melanoma is the most aggressive and dangerous form of skin cancer in the United States. It forms in the skin cells that develop the skin’s pigment and if not diagnosed early, the cancer is likely to spread to other parts of the body. More information |
New treatment for HIV approved
FDA approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. The CDC estimates that 1.2 million persons ages 13 years and older are living with HIV infection, and that more than another 150,000 persons in this age range have HIV but are unaware of their infection. Over the past decade, the number of people living with HIV has increased, while the annual number of new HIV infections has remained relatively stable. More information |
Nucala approved to treat severe asthma
FDA approved Nucala (mepolizumab) for use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older. Nucala is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines. Asthma is a chronic disease that causes inflammation in the airways of the lungs. During an asthma attack, airways become narrow making it hard to breathe. Severe asthma attacks can lead to asthma-related hospitalizations because these attacks can be serious and even life-threatening. More information |
Yervoy approved to reduce the risk of melanoma returning after surgery
FDA expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery. Melanoma, the most aggressive type of skin cancer, is the leading cause of death from skin cancer. Melanoma is more likely to spread to other parts of the body than other forms of skin cancer and has been on the rise over the past several decades, according to the National Cancer Institute, with an estimated 73,870 new cases and 9,940 deaths from the disease this year. 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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Medication Adherence (October 2015)
Poor medication adherence can interfere with the ability to treat many diseases, leading to greater complications and a lower quality of life. FDA Drug Info Rounds Pharmacists discuss strategies pharmacists can use to help patients break through common barriers to medication adherence. Watch Medication Adherence video and to see more Drug Info Rounds Video's |
Chagas Disease: An Emerging Public Health Concern
On April 28, 2015, FDA met with patients during one of FDA’s Patient-Focused Drug Development meetings to discuss patients’ concerns regarding their symptoms and treatment options for Chagas disease. These meetings are important as patients have the opportunity to convey their concerns about current medications and the types of medications they would like to see in the future.
No drugs have yet been shown to meet standards of safety and efficacy for FDA approval for the treatment of Chagas’ disease, but several potential treatments are in various stages of clinical investigation. Two investigational drugs are available through the Center for Disease Control and Prevention (CDC), at a doctor’s request. More information or Enfermedad de Chagas PDF
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CDER From our perspective: The importance of the physical characteristics of generic drugs
Generic drugs approved by FDA have the same high quality, strength, purity, and stability as their brand name counterparts. Generics provide safe and effective alternatives to brand name drugs at lower costs through an abbreviated approval pathway introduced in the 1980s. This abbreviated new drug application (ANDA) process eliminates repetition of the very expensive clinical safety and efficacy studies as well as pre-clinical animal studies, allowing manufacturers to bring a generic copy to market at a significantly reduced cost. The affordability of generic drugs has led to a sharp increase in their use; about 86 percent of all prescriptions in the United States are now filled by a generic drug product. More information |
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Twitter Chat on Lung Cancer: November 12, 2015
Host: @FDA_Drug_Info
November is Lung Cancer Awareness Month. Please join our FDA experts from the Center for Drug Evaluation and Research (CDER) Office of Hematology and Oncology products (OHOP), Dr. Gideon Blumenthal and Dr. Sean Khozin, for a discussion on lung cancer. Learn about new therapies and FDA resources on lung cancer. More information
November is Lung Cancer Awareness Month. Please join our FDA experts from the Center for Drug Evaluation and Research (CDER) Office of Hematology and Oncology products (OHOP), Dr. Gideon Blumenthal and Dr. Sean Khozin, for a discussion on lung cancer. Learn about new therapies and FDA resources on lung cancer. 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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Consumer Updates
To read previously published Consumer Update articles that are timely and easy-to-read and cover all FDA activities and regulated products. More information
To read 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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"Natural" on Food Labeling
Because of the changing landscape of food ingredients and production, and in direct response to consumers who have requested that the FDA explore the use of the term “natural,” the agency is asking the public to provide information and comments on the use of this term in the labeling of human food products.
The FDA is taking this action in part because it received three Citizen Petitions asking that the agency define the term “natural” for use in food labeling and one Citizen Petition asking that the agency prohibit the term “natural” on food labels. We also note that some Federal courts, as a result of litigation between private parties, have requested administrative determinations from the FDA regarding whether food products containing ingredients produced using genetic engineering or foods containing high fructose corn syrup may be labeled as “natural.” More information and to submit comments throughwww.regulations.gov
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Nutrition Facts Label: Read the Label Youth Outreach Campaign
Welcome to Read the Label, the “next generation” of FDA’s award-winning Spot the Block outreach campaign! Originally launched in 2007, this comprehensive program from the FDA has evolved into a nationwide grassroots initiative. Through this hands-on campaign, kids, families and community outreach leaders unite with the goal of using the Nutrition Fact Label as their everyday tool for making smart and healthful food choices.
The Read the Label Youth Outreach Campaign is an exciting initiative that challenges kids (ages 9 to 13) to look for and use the Nutrition Facts Label on food and beverage packages. The campaign includes fun, easy tips and targeted education to help make label reading a key component through which today’s young people are equipped to achieve a healthy childhood weight. With engaging content plus hands-on parent information and community outreach, kids and families across the U.S. can use the label to compare foods today and every day. More information
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Juice manufacturer to cease operations
FDA ordered Sun Valley Juice Company of Ketchum, Idaho, to stop receiving, processing, preparing, packing, holding, and distributing juice until the agency determines that the company is in compliance with laws and regulations applicable to producing food that is safe.
Sun Valley Juice Company has received a letter ordering it to cease all operations, and confirm within five days that it has complied with the letter. The company complied with those demands of the letter.More information
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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 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
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FDA issues first product marketing orders through premarket tobacco application pathway
Following a rigorous, science-based review, the U.S. Food and Drug Administration announced today that for the first time it has authorized the marketing of new tobacco products through the premarket tobacco application (PMTA) pathway. This action permits the tobacco products to be sold in the U.S., but does not mean that they are safe or “FDA approved.” All tobacco products are potentially harmful and addictive and those who do not use tobacco products should continue to abstain from doing so. More information |
Enforcement action against retailers who have repeatedly sold tobacco products to minors
Last week the FDA filed complaints initiating the first-ever No-Tobacco-Sale Order (NTSO) actions for a group of retailers who have repeatedly violated certain restrictions on the sale and distribution of tobacco products, including sales to minors. Under the law, the FDA may pursue an NTSO against retailers that have a total of five or more repeated violations of those restrictions during compliance inspections within 36 months. 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 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 |
CDER's Director's Corner Podcasts
Drug Compounding Listen to Dr. Woodcock discuss Drug Compounding from both a safety and regulatory standpoint. Download podcast or view the transcript |
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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