Achieving Zero Contains Hidden Drug Ingredient
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Achieving Zero, a product promoted and sold for weight loss on various websites such as www.amazon.com. FDA laboratory analysis confirmed that Achieving Zero contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking. More information |
FDA's Role in Ensuring American Patients Have Access to Safe and Effective Medical Device TechnologyOver the past five years, the Food and Drug Administration's device program has shown a pattern of markedly improved performance. Today it is performing strongly across a wide range of performance measures. At the same time, FDA has implemented a range of initiatives to promote access to safe and effective medical devices for American patients.
These improvements include those to 510(k) and premarket approval (PMA) review times along with a reduction in Investigational Device Exemption (IDE) review times of almost a full year-which means many devices investigated in the United States now reach the market a full year sooner than they did at the beginning of this decade. Performance in FDA's review of novel, moderate risk devices has also improved markedly, demonstrating the success of FDA's efforts to expand use of its de novo review pathway. More information
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MedWatch Safety Alert: OxyTOTE Portable Oxygen Unit by Western/Scott Fetzer Company: Class I Recall - May Ignite and Burst
The company received reports that when the OxyTote is mishandled or dropped, the oxygen cylinder may ignite causing an internal flash fire and the canister to burst. See FDA Recall notice for a list of affected Lot and Model numbers. The firm has received a total of 2 reports of incidents in which the device has malfunctioned, including 1 injury and 1 death. When the injury occurred, the unit was dropped from 4 feet; where the death occurred, the employee did not drop the gas cylinder, but set it down by his side.
Portable oxygen units provide oxygen to patients to help regulate their breathing while allowing them to travel around. Pressurized oxygen is stored in a special container and is delivered to the patient through tubing that is placed in the nostrils or through a mask.More information
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MedWatch Safety Alert: Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy: Recall - Lack of Sterility Assurance
Moses Lake Professional Pharmacy is voluntarily recalling human and veterinary sterile compounded drugs which are unexpired to the consumer level due to lack of sterility assurance.The company has not received any reports of product contamination or adverse events to date, and is issuing this voluntary recall out of an abundance of caution following a recent inspection which identified an issue with sterility assurance. If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. More information
MedWatch Safety Alert: Mammograms at Boston Diagnostic Imaging in Orlanda, Florida: FDA Safety Communication - Quality Problems
FDA is alerting patients who had mammograms at Boston Diagnostic Imaging located in Orlando, Florida, anytime on or after May 13, 2013, about possible problems with the quality of their mammograms.
The American College of Radiology (ACR) conducted a clinical image review of mammograms performed by Boston Diagnostic Imaging between May 13, 2013, and May 13, 2015. The review was conducted after deficiencies were noted in the clinical cases that were submitted with the facility’s accreditation renewal application. The ACR revoked the facility’s application for mammography accreditation effective July 29, 2015. The FDA suspended the facility’s Mammography Quality Standards Act (MQSA) certificate on August 13, 2015, and directed the facility to cease performing mammography. 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:
Drug Shortages Reported to be Resolved by Manufacturers During the Past 2 Weeks:
Upgraded Drug Shortages app for Android devices adds alert feature
The Food and Drug Administration released Drug Shortages 2 mobile application for Android devices. Android device users are able to receive notifications when there is new or updated information about a shortage of a drug product or about a drug within selected therapeutic categories.
Designed for Android devices, Drug Shortages 2 sends alerts when the Agency adds or updates shortage information about a drug product or about a drug within selected therapeutic categories. We are currently working on notifications for the iOS version of the Drug Shortage mobile app, which will be available soon. Download the Drug Shortages 2 app for Android devices
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- More information about drug shortages, drug shortages resolved, and drugs to be discontinued
- Information about blood and biologic shortages, resolved shortages, and discontinuations
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
First treatment for sexual desire disorder approved
FDA approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.” 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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Disease Natural History Database Development-(U24)
The FDA announced the availability of grant funds for the support of Natural History Database Development. The National Organization for Rare Disorders (NORD) is developing an Internet-based data collection tool with promise to further the accumulation of natural history data for many rare diseases. The goal of this grant is to enable NORD to further develop, refine, and disseminate the database tool.More information
The FDA announced the availability of grant funds for the support of Natural History Database Development. The National Organization for Rare Disorders (NORD) is developing an Internet-based data collection tool with promise to further the accumulation of natural history data for many rare diseases. The goal of this grant is to enable NORD to further develop, refine, and disseminate the database tool.More information
Frances Oldham Kelsey, Ph.D., M.D.: A Pioneer in Public Health and Protection of Patients, by: Stephen M. Ostroff, M.D., is Acting Commissioner of the Food and Drug Administration
Last week our nation lost a true pioneer in public health and consumer protection.
Frances Oldham Kelsey, Ph.D., M.D., who joined FDA in 1960 as a medical officer, was known worldwide as a leader in drug safety and the protection of patients. She established that reputation in one of first FDA assignments: reviewing the marketing application for a drug called thalidomide, which was already available in dozens of countries around the world.
Despite constant pressure from the company, Dr. Kelsey refused to approve thalidomide because of inadequate evidence about its safety. As a result of Dr. Kelsey’s expertise, diligence, and integrity, the drug was never approved in the United States and Americans were largely spared the tragic birth defects and deaths experienced by patients in those countries where thalidomide was available.
To continue reading this post, see FDA Voice posted on August 11, 2015
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Kicking off the PDUFA VI Reauthorization Process, by: Theresa M. Mullin, Ph.D., is Director of FDA’s Office of Strategic Programs in the Center for Drug Evaluation and Research
The Prescription Drug User Fee Act (PDUFA) authorizes FDA to collect fees from pharmaceutical companies to help fund the agency’s drug review work. PDUFA’s intent is to provide additional funding for FDA to hire staff, improve systems, and establish a better-managed review process that enables us to do more timely reviews of human drug applications.
As a result, many important new drug therapies have been made available to patients sooner without compromising FDA’s high standards for safety, efficacy, and quality.
As part of FDA’s agreement with industry during each reauthorization of the Act, the agency agrees to certain performance goals to enhance the process of drug review. The goals, now 30 in total, apply to many review processes, including the review of original new drug applications, resubmissions, and supplemental applications.
To continue reading this post, see FDA Voice posted on August 18, 2015
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Advancing precision medicine by enabling a collaborative informatics community, by: Taha A. Kass-Hout, M.D., M.S., is FDA’s Chief Health Informatics Officer and Director of FDA’s Office of Health Informatics. and David Litwack, Ph.D., is Policy Advisor, Office of In Vitro Diagnostics and Radiological Health, at FDA’s Center for Devices and Radiological Health.
FDA plays an integral role in President Obama’s Precision Medicine Initiative, which foresees the day when an individual’s medical care will be tailored in part based on their unique characteristics and genetic make-up. Yet while more than 80 million genetic variants have been found in the human genome, we don’t understand the role that most of these variants play in health or disease. Achieving the President’s vision requires working collaboratively to ensure the accuracy of genetic tests in detecting and interpreting genetic variants. We are working towards that goal by developing an informatics community and supporting platform we call precisionFDA.
To continue reading this post, see FDA Voice posted on August 5, 2015
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Influenza Virus Vaccine for the 2015-2016 Season
FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Silver Spring, Maryland, on March 4, 2015, to select the influenza viruses for the composition of the influenza vaccine for the 2015-2016 U.S. influenza season. During this meeting, the advisory committee reviewed and evaluated the surveillance data related to epidemiology and antigenic characteristics of recent influenza isolates, serological responses to 2014-2015 vaccines, and the availability of candidate strains and reagents.
FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Silver Spring, Maryland, on March 4, 2015, to select the influenza viruses for the composition of the influenza vaccine for the 2015-2016 U.S. influenza season. During this meeting, the advisory committee reviewed and evaluated the surveillance data related to epidemiology and antigenic characteristics of recent influenza isolates, serological responses to 2014-2015 vaccines, and the availability of candidate strains and reagents.
The committee recommended that the trivalent formulation influenza vaccines for the U.S. 2015-2016 influenza season contain the following:
- an A/California/7/2009 (H1N1)-like virus
- an A/Switzerland/9715293/2013 (H3N2)-like virus
- a B/Phuket/3073/2013-like virus
The committee also recommended that quadrivalent influenza vaccines contain the above three strains and the following additional B strain:
- a B/Brisbane/60/2008-like virus
Flu vaccine lots that have been released by FDA and are available for distribution by the manufacturers.More information
Pediatric pain management options, by: Sharon Hertz, M.D.Director, Division of Anesthesia, Analgesia, and Addiction Products, Office of New Drugs, Center for Drug Evaluation and Research, FDA
Thankfully, not many children experience the types of cancer pain, extensive trauma or surgeries that require long-term pain management. However, few pain management products have specific information in their label about their safety and effectiveness in pediatric patients. This even includes several new pain medications that have been approved for use in adults. To manage pain in pediatric patients, physicians often have to rely on their own experience to interpret and translate adult data into dosing information for pediatric patients.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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Healthy Breakfasts for Kids: It's All about Balance
A healthy breakfast is a must for kids. Skip it and your kids will be playing nutritional catch-up for the rest of the day, says Carole L. Adler, M.A., R.D., a dietitian at the Food and Drug Administration (FDA).
When kids skip breakfast, they don't get what they need to be at their best, says Adler. “Growing bodies and developing brains need regular, healthy meals,” she says. According to the Academy of Nutrition and Dietetics, studies show that school children who eat breakfast perform better in the classroom.
As with other meals, it’s a good idea for your kids (and you) to eat a healthy balance of fruits and vegetables, proteins, grains and dairy—not just for breakfast but throughout the day. More information
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Vaccines: FDA Guide Tells You What You Need to Know
As parents and caregivers fill out a multitude of forms at the start of the school year, they may have questions about some requirements, including the vaccine schedule.
According to Marion Gruber, Ph.D., director of the Office of Vaccines Research and Review at the Food and Drug Administration (FDA), vaccines are integral to get children off to a healthy start.
"Parents should know that vaccines protect children from many serious illnesses from infectious diseases. The risk of being harmed by vaccines is much smaller than the risk of serious illness from infectious diseases," she says. More information
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Dealing with ADHD: What You Need to Know
Is your child in constant motion? Does he or she talk incessantly? Or have trouble focusing and prefer to daydream?
Then your child may have attention deficit hyperactivity disorder, or ADHD.
This disorder often begins between the ages of 3 and 6 years, according to the National Institute of Mental Health (NIMH). And it’s not just a childhood disease: ADHD may continue through the teenage years and into adulthood (see sidebar). According to the Centers for Disease Control and Prevention (CDC), approximately 11% of children 4-17 years of age (6.4 million) have been diagnosed with ADHD as of 2011.
Three types of ADHD are recognized:
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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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Federal judge approves consent decree with Iowa drug and dietary supplement maker, Iowa Select Herbs
U.S. District Judge Edward J. McManus for the U.S. District Court for the Northern District of Iowa entered a consent decree of permanent injunction against Iowa Select Herbs LLC, a manufacturer and distributor of drugs and dietary supplements, and its two co-owners, Gordon L. Freeman and Lois A. Dotterweich. The complaint, filed by the U.S. Department of Justice, sought a permanent injunction against the company and its owners for unlawfully manufacturing and distributing unapproved new drugs, misbranded drugs, adulterated dietary supplements and misbranded dietary supplements. More information
FDA acts to stop Sacramento tofu and sprout manufacturer from selling adulterated food
U.S. Magistrate Judge Carolyn K. Delaney in the U.S. District Court for the Eastern District of California entered a consent decree against Henh Wong Fresh Produce, a tofu and sprout manufacturer and distributor, and its owner, current manager, and former manager after the U.S. Food and Drug Administration documented multiple violations of federal food safety laws and regulations. The U.S. Department of Justice sought the consent decree on behalf of the FDA. More information
Federal judge enters permanent injunction against Wisconsin dietary supplement manufacturers
Three dietary supplement companies, under the same ownership and located in Wautoma, Wisconsin, will not be allowed to manufacture or sell dietary supplement products until FDA has determined that the businesses are in compliance with federal manufacturing regulations and other requirements, according to a federal court order signed Aug. 4, 2015. 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 |
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.
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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 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 |
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
Disposal of Unused Medicines: What You Should Know
Medicines play an important role in treating many conditions and diseases and when they are no longer needed it is important to dispose of them properly to help reduce harm from accidental exposure or intentional misuse. More information |
The Director’s Corner is a quarterly audio podcast series featuring the director of FDA’s Center for Drug Evaluation and Research and produced by CDER’s Office of Communications.
- Working with patient advocacy groups.
08/17/2015 - Dr. Woodcock discusses regulatory guidances drafted and submitted to FDA by patient advocacy groups. Download Podcast - Download Transcript - Looking back and moving forward
02/12/2015 - Dr. Woodcock discusses major events of 2014 and priorities for 2015. Download Podcast - Download Transcript
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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