 UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler System: FDA Safety Communication Heater-cooler devices are commonly used during cardiothoracic surgeries, as well as other medical and surgical procedures, to warm or cool a patient in order to optimize medical care and improve patient outcomes. Heater-cooler devices have water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device and aerosolize, transmitting bacteria through the air and through the device's exhaust vent into the environment and to the patient. In October 2015, FDA issued a Safety Communication to provide recommendations to help minimize patient risk of infections associated with heater-cooler devices. More information |
 HeartWare Recalls Ventricular Assist Device Pumps Due to Contamination Causing Electrical Issues HeartWare Inc. is recalling the HVAD pumps due to a design problem with the driveline connector. The driveline is a tube that connects the HVAD's pump to the external controller and power source. Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death. More information |
 Radiation Therapy Devices by Multidata Systems International: Discontinue Use – Concerns about Risks to Patients FDA is concerned about the risks to patients from the use of devices manufactured and sold by Multidata Systems International Corporation ("Multidata"). FDA knows of at least two Multidata medical devices that the company manufactured and distributed in the United States for which FDA never received nor reviewed 510(k) premarket notifications. These devices include: (1) accessories to radiation therapy devices including the Real Time Dosimetry (RTD) Waterphantom System and (2) the Dual Channel Electrometer. In addition, Multidata has not registered or listed their devices with the FDA, as required by federal law. FDA is concerned that health care providers may be unaware of the risks associated with these devices. At this time, it is not known how many devices manufactured by Multidata are currently in use in hospitals and clinics throughout the United States. More information |
 Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang: Class I Recall - Connector Compatibility Issue Automatic external defibrillators (AEDs) are used to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Defibrillation electrodes are connected to the AED to help the device analyze a patient’s heart rhythm and deliver an electrical shock to restore normal heart rhythm when needed. The Leonhard Lang defibrillation electrode is being recalled due to a connector compatibility issue with the Welch Allyn AED model 10. The user may not be able to connect the electrodes to the defibrillator when a shock is needed. This may result in a delay in delivering the electrical therapy needed to revive a patient in cardiac arrest. More information |
Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence
Prescription testosterone products are FDA-approved as hormone replacement therapy for men who have low testosterone due to certain medical conditions. Examples of these conditions include failure of the testicles to produce testosterone because of genetic problems, or damage to the testicles from chemotherapy or infection. FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other AAS. Testosterone and other AAS are abused by adults and adolescents, including athletes and body builders. Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system. The new Warning will alert prescribers to the abuse potential of testosterone and the serious adverse outcomes, especially those related to heart and mental health that have been reported in association with testosterone/AAS abuse. More information
Prescription testosterone products are FDA-approved as hormone replacement therapy for men who have low testosterone due to certain medical conditions. Examples of these conditions include failure of the testicles to produce testosterone because of genetic problems, or damage to the testicles from chemotherapy or infection. FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other AAS. Testosterone and other AAS are abused by adults and adolescents, including athletes and body builders. Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system. The new Warning will alert prescribers to the abuse potential of testosterone and the serious adverse outcomes, especially those related to heart and mental health that have been reported in association with testosterone/AAS abuse. 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 knows the major public health consequences that can result from drug shortages. These shortages occur for many reasons including manufacturing and quality problems, delays and discontinuations. When issues are discovered, FDA works closely with the company 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 company to restore supplies while also ensuring safety for patients. More information |
Drug Shortages Reported to be Resolved by Manufacturers During the Past 2 Weeks:
- Docetaxel Injection
- Sumatriptan (Sumavel DosePro) Injection
- Esterified Estrogens, USP (Menest) Tablets
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, incluyendo problemas 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 |
 FDA Grants Accelerated Approval to New Treatment for Advanced Soft Tissue Sarcoma FDA granted accelerated approval to Lartruvo (olaratumab) with doxorubicin to treat adults with certain types of soft tissue sarcoma (STS), which are cancers that develop in muscles, fat, tendons or other soft tissues. Lartruvo is approved for use with the FDA-approved chemotherapy drug doxorubicin for the treatment of patients with STS who cannot be cured with radiation or surgery and who have a type of STS for which an anthracycline (chemotherapy) is an appropriate treatment. The National Cancer Institute estimates that 12,310 new cases of STS and nearly 5,000 deaths are likely to occur from the disease in 2016. The most common treatment for STS that cannot be removed by surgery is treatment with doxorubicin alone or with other drugs. STS includes a wide variety of tumors arising in the muscle, fat, blood vessels, nerves, tendons or the lining of the joints. More information |
FDA Approved Atezolizumab (TECENTRIQ, Genentech Oncology)
FDA approved atezolizumab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab. Atezolizumab is a programmed death-ligand 1 (PD-L1) blocking antibody that previously received FDA accelerated approval for the treatment of locally advanced or metastatic urothelial carcinoma that has progressed after platinum-containing chemotherapy. More information
FDA approved atezolizumab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab. Atezolizumab is a programmed death-ligand 1 (PD-L1) blocking antibody that previously received FDA accelerated approval for the treatment of locally advanced or metastatic urothelial carcinoma that has progressed after platinum-containing chemotherapy. More information
 FDA Approved Pembrolizumab (KEYTRUDA) Checkpoint Inhibitor FDA approved pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test.This is the first FDA approval of a checkpoint inhibitor for first-line treatment of lung cancer. This approval also expands the indication in second-line treatment of lung cancer to include all patients with PD-L1-expressing NSCLC. 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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 FDA’s Opioids Action Plan: A Midyear Checkup As FDA works to address the opioid epidemic of abuse, misuse and addiction, it’s valuable to see firsthand some of the ways the crisis is affecting our communities. This summer, I toured areas hard-hit by the opioid crisis in Tennessee, West Virginia, and Kentucky, visiting with survivors of opioid addiction and overdose as well as community activists, government officials, and health care providers, all of whom are working diligently and creatively to address and overcome this crisis. My visit to the nationally-recognized neonatal intensive care unit at East Tennessee Children’s Hospital was deeply moving and set the stage for the rest of my tour and underscored the urgency of fighting this epidemic. More than a third of the babies admitted to the NICU have neonatal opioid withdrawal syndrome (NOWS), a condition which can be life-threatening if not recognized and treated. To read the rest of this post, see FDA Voice Blog October 24, 2016. |
 FDA is Working With Hospitals to Modernize Data Collection About Medical Devices, by Jeffrey Shuren, M.D., J.D., Director of FDA's Center for Devices and Radiological Health America’s hospitals and their dedicated staff helps us fight disease and suffering by delivering life-saving and life-enhancing care every day in an astounding variety of ways. Hospital staff use a variety of medical devices: imaging machines, EKGs and in vitro tests to make diagnoses; infusion pumps, ventilators and robotics to provide treatment, and an array of implants to replace diseased joints and organs. Hospitals are also uniquely positioned to help identify new safety problems with devices as well as changes in the frequency of already known safety problems because they use these technologies in the real-world setting of clinical practice, outside of the more controlled setting of a clinical trial. FDA is looking to improve the way we work with hospitals to modernize and streamline data collection about medical devices. To read the rest of this post, see FDA Voice Blog, October 24, 2016. |
 New FDA/EMA rare diseases and patient engagement clusters underway Drug development and approval happens across the globe and we at FDA strive to collaborate with other countries and international regulatory agencies to ensure public health. One of our most valuable collaborators is the European Medicines Agency (EMA) — our counterpart agency for drug regulation in Europe that coordinates a network of 4,500 scientists and evaluates and supervises medicines for more than 500 million people in 31 countries. For more than a decade, FDA and EMA scientists have collaborated to help solve some of our biggest challenges. We work with them in groups called “clusters.” The first cluster was initiated in 2004. Since then clusters have been formed to focus on treatments for children; establish effective measures for the development and use of biosimilar medications as cost effective alternatives to brand name biologic drugs; evaluate new treatments for patients with cancer; set standards to help develop medicines personalized to a patient’s genetic makeup, and much more. To read the rest of this post, see FDA Voice Blog, October 18, 2016. |
 FDA Awards 21 Grants to Stimulate Product Development for Rare Diseases FDA announced that it has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry with research spanning domestic and international clinical sites. FDA awards the grants through the Orphan Products Clinical Trials Grants Program to encourage clinical development of drugs, biologics, medical devices, or medical foods for use in rare diseases. The grants are intended for clinical studies evaluating the safety and effectiveness of products that could either result in, or substantially contribute to, the FDA approval of products. More information |
 In this section you will find a comprehensive list of all the meetings that the FDA is involved with. The meetings may include advisory committee meetings, public workshops and public conferences that are seeking to hear from patients and caregivers. Most FDA meetings are free to the public and do not require the public to register. 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.
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 Public Workshop - CDRH Veteran Amputee Device Workshop, Date: October 31, 2016 Time: 9:00 a.m. - 4:00 p.m. Location: FDA White Oak Campus; The Great Room (1503) FDA is announcing the “CDRH Veteran Amputee Device Workshop.” The purpose of this workshop is to engage all stakeholders involved in the research, development, and marketing of prosthetic limb medical devices used by Veteran amputees. A specific goal is to engage veteran amputees who use prosthetic limb medical devices and hear their views on these devices so that these perspectives may be considered in the total product life cycle of prosthetic limb devices. More information |
 Lecture - Sex Considerations in the FDA Drug Review Pipeline:The Where, When, and How Date: November 1, 2016 Time: 2-3 p.m. Location: FDA White Oak Campus; Building 2 Room 2047W Join the Office of Women’s Health to learn about current FDA practice regarding the consideration of sex differences in non-clinical and clinical review of drug applications. The regulatory history of the inclusion of women in research activities and clinical trials will be reviewed. More information |
 Public Workshop - The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for SurveillanceDate: December 5, 2016 Time: 8:30 a.m. to 5:00 p.m. Location: Fishers Lane Conference Center Terrace Level; 5635 Fishers Lane, Rockville, MD 20852 FDA is announcing a public workshop entitled “The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance.” Hospitals play a critical role in the development of these national capabilities, leading to more robust evidence generation. Recently, the role of hospital reporting of device-related adverse events in device surveillance and, more generally, device evaluation, has garnered increased scrutiny. This public workshop will further explore the critical role of hospitals in the evolution of device surveillance and in creating more robust surveillance capabilities. More information |
View FDA's Patient Network Calendar of Public Meetings page for a complete list of meetings and workshops.
 For additional information on other agency meetings please visit Meetings, Conferences, & Workshops. |
 Mammography: What You Need to Know Did you know that mammograms are still the best tool for breast cancer screening? It’s true, and FDA certifies facilities that perform mammography —and clears and approves new mammography devices— to help keep you safe. A mammogram is a low-dose X-ray picture of the breast. Getting a mammogram is the best way to find breast cancer early, because it can show breast lumps when they are too small for you or your health care provider to feel them. More information |
 '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. 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
 The Safety Reporting Portal The Safety Reporting Portal (SRP) streamlines the process of reporting product issues to the Food and Drug Administration and the National Institutes of Health. Whatever your role, (manufacturer, health care professional, researcher, public health official, or concerned citizen), when you submit a safety report through this Portal, you make a vital contribution to the safety of America's food supply, medicines, and other products that touch us all. 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 |
 Halloween Food Safety Tips for Parents Even though it’s not an official holiday, Halloween is much beloved by children and adults alike. To make sure treats are safe for children, follow these simple steps: Snacking: Children shouldn’t snack on treats from their goody bags while they’re out trick-or-treating. Give them a light meal or snack before they head out – don’t send them out on an empty stomach. Urge them to wait until they get home and let you inspect their loot before they eat any of it. Safe treats: Tell children not to accept – and especially not to eat – anything that isn’t commercially wrapped. Inspect commercially wrapped treats for signs of tampering, such as an unusual appearance or discoloration, tiny pinholes, or tears in wrappers. Throw away anything that looks suspicious. Food Allergies: If your child has a food allergy, check the label to ensure the allergen isn’t present. Do not allow the child to eat any home-baked goods he or she may have received. Choking hazards: If you have very young children, be sure to remove any choking hazards such as gum, peanuts, hard candies, or small toys. More information |
 Think Food Safety and Be Salmonella Safe! Salmonella are a group of bacteria that can make people and animals sick from a foodborne illness called salmonellosis. The illness is called “foodborne” because the bacteria are carried, or “borne,” in or on food. Salmonella live in the intestines of people and animals. Some animals, especially cows, pigs, chickens, rodents (like mice), reptiles (like turtles, snakes, and lizards), and amphibians (like frogs and salamanders) can naturally carry Salmonella in their intestines and on their bodies, but look and act healthy. More information |
 Leave Chocolate Out of Rover's Celebrations Holidays and chocolate seem to go together. For birthdays, Valentines Day, Halloween and Christmas - chocolate is everywhere. But, there is one place chocolate should never be and that's in your dog. Chocolate is toxic to dogs and it can kill them! Here are the facts: Chocolate contains theobromine, a compound in the same family as caffeine, and theophylline (an asthma drug). In certain quantities, theobromine is toxic to dogs. One of the most important things in chocolate toxicity is the kind of chocolate your dog ate. Different types of chocolate contain different amounts of theobromine. If you think your dog has eaten chocolate, call your veterinarian immediately! Only your vet can determine the proper treatment for your pet. More information |
 Animal Health LiteracyAnimal 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 FDA Animal and Veterinary UpdatesAnimal 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 provide as much information as possible in your complaint, such as exact name of product, type of container, lot number, UPC codes, 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.
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Public Education CampaignsWe 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 TobaccoWe 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
 Warning Letters Address Drug Claims Made for Products Marketed as Cosmetics FDA Warning Letters highlight an important legal distinction, the difference between a cosmetic and a drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the FD&C Act, a product intended to diagnose, mitigate, treat, or prevent disease, or to affect the structure or function of the body is classified as a drug (FD&C Act, Section 201(g)). FDA issued Warning Letters to the following firms, citing drug claims associated with topical skin care, hair care, and eyelash/eyebrow preparations, noted on both product labeling and Web sites. Some examples of the drug claims cited are acne treatment, cellulite reduction, stretch mark reduction, wrinkle removal, dandruff treatment, hair restoration, and eyelash growth. More information |
 What is a Cosmetic?The Federal Food, Drug, and Cosmetic Act defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance". Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. More information |
Recalls and Alerts
To see safety alerts and recent recalls related to cosmetics and other products regulated by FDA. More information
To see safety alerts and recent recalls related to cosmetics and other products regulated by FDA. More information
How to report a problem
You can report a rash, redness, burn, hair loss, headache, infection, illness, or any other unexpected reaction, whether or not it required medical treatment. You can also report a bad smell, color change, or other sign of contamination.
You can report a rash, redness, burn, hair loss, headache, infection, illness, or any other unexpected reaction, whether or not it required medical treatment. You can also report a bad smell, color change, or other sign of contamination.
You can choose the way you’d prefer to report:
- Call an FDA Consumer Complaint Coordinator if you want to speak directly to a person about your problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form that you can mail to FDA.
 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. More information |
 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 |
 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 |
 FDA Patient Network The FDA Patient Network contains a series of webpages, webinars and presentations on topics related to patient engagement, FDA regulations, understanding medical product (Drugs, Biologics, and Devices) approval and medical product safety updates, Take me to the FDA Patient Network or take me to FDA Webinars. 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 |
 Counterterrorism and Emerging Threats FDA plays a critical role in protecting the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats. FDA ensures that medical countermeasures --including drugs, vaccines and diagnostic tests—to counter these threats are safe, effective, and secure. The FDA Medical Countermeasures Initiative (MCMi) coordinates medical countermeasure development, preparedness and response. More information. |
 Zika Virus Response Updates from FDA Zika virus is spread to people primarily through the bite of an infected Aedes species mosquito. Most people never know that they have been infected with the virus. It is estimated that four out of five people with Zika virus infections have no symptoms at all. When symptoms do occur, the most common symptoms are fever, rash, joint pain, and conjunctivitis (red eyes). Even in those who develop symptoms, the illness is usually mild, with symptoms lasting from several days to a week. More information. |
 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 Email Updates Sign up for one of the FDA disease specific e-mail list that delivers updates, including product approvals, safety warnings, notices of upcoming meetings, and notices on proposed regulatory guidances. |
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