miércoles, 2 de agosto de 2017

FDA Patient Network Newsletter: August 2, 2017

FDA Template Logo

Man of Steel Issues Voluntary Nationwide Recall of Man of Steel 1 and Man of Steel 2 Due to Tainted SupplementsMan of Steel is voluntarily recalling 175 lots of Man of Steel 1 and Man of Steel 2, 4000mg at the retail level. The products have been found to contained undeclared Sildenafil.
Risk Statement: The product has/potentially could result in death. The groups affected are men with diabetes, high blood pressure, high cholesterol, or heart disease. Man of Steel has received reports from the FDA lab but not received any reports of adverse events related to this recall.
The product is used as a male enhancement supplement and is packaged in individual blister package. The affected product Man of Steel lots include the following expiration dates 10-17-18. The product can be identified by name, Man of Steel. Man of Steel was distributed throughout local convenience stores in Sacramento, California. More information
EZ Weight Loss TX LLC Issues Voluntary Nationwide Recall of Atomic and Xplode Capsules Due to the Presence of Undeclared SibutramineSibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons. The presence of sibutramine in these products renders it an unapproved drug for which safety and efficacy have not been established and, therefore subject to recall.
Sibutramine is known to increase blood pressure and/or pulse rate in some patients and may present a risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Sibutramine may also interact, in life-threatening ways with other medications a consumer may be taking. To date, EZ Weight Loss TX has not received any reports of adverse events related to this recall.
These tainted products are marketed as dietary supplements. Atomic is packaged in 60- count bottles and Xplode is packaged in 30-count bottles. All lots and codes of Atomic and Xplode are included in this recall and were sold Nationwide through internet sales starting in 2015. More information
Ultra Shop Supplement Issues Voluntary Nationwide Recall of Super Panther 7K Due to Presence of Undeclared Sildenafil and TadalafilFDA analysis found samples of Super Panther 7K to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterate 5-inhibitors (PDE-5), used to treat erectile dysfunction (ED). The presence of sildenafil and tadalafil in Super Panther 7K renders it an unapproved drug for which safety and efficacy have not been established and, therefore subject to recall.
Consumers who take this product for erectile dysfunction could have underlying cardiovascular disease.  Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE-5 can lead to fatal cardiovascular collapse. To date, Ultra Shop Supplement has not received any reports of adverse events related to this recall. More information
Gray Pointer
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.govComunicaciones de la FDA
MedWatch Report a Problem 2015

Drug Shortages
Empty Medicine Cabinet with Empty Medicine Bottle
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 Voluntarily Reported by Manufacturers During the Past 2 Weeks:
Drug Discontinuation Voluntarily Reported by Manufacturers During the Past 2 Weeks:

    Gray Pointer
    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 

    Medical Product Approvals
    FDA Approved
    FDA approves new targeted treatment for relapsed or refractory acute myeloid leukemiaThe FDA approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML.
    “Idhifa is a targeted therapy that fills an unmet need for patients with relapsed or refractory AML who have an IDH2 mutation,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The use of Idhifa was associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions.” More information
    For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.

    What you think matters
     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.

      Patient Reps
      Patient Reps – Bringing the Voice of Patients to FDA, By: Jack Kalavritinos, FDA's Associate Commissioner, Office of External Affairs
      At FDA we never lose sight of the fact that the work we do in evaluating and approving new medical products is done to benefit patients.
      Increasingly, that means taking into account the views and expertise of patients and their caregivers, because they provide a unique voice and perspective and know best what they are living with on a day-to-day basis. Earlier this month, for instance, we announced the creation of the first advisory committee made up solely of patients and caregivers, who will provide advice on complex issues related to medical devices.
      Another way we incorporate the patient viewpoint is through FDA’s Patient Representative Program. This program brings patients – and their caregivers – and the extraordinary breadth of knowledge and personal experience in more than 300 diseases and conditions they possess, directly into the regulatory medical product development and review process. They serve on 47 FDA Advisory Committees and panels to advise on drugs, devices and biologics currently being considered for approval or clearance. They also serve as a consultant for the review divisions (doctors and scientists who review data to determine whether the medical product’s benefits outweigh the potential risks), and as presenters at FDA meetings and workshops on disease-specific or regulatory and health policy issues.

      Every year our team at FDA’s Office of Health and Constituent Affairs brings new FDA patient representatives to the Washington, D.C. area, for training and orientation. They receive briefings on everything from medical product review policies and clinical trials to the life cycles of drugs, biologics, and devices, and even a brief primer on statistical analysis.
      To read the rest of this post, see FDA Voice Blog, July 26, 2017
      FDA Sets Inaugural Meeting of First-Ever Patient Engagement Advisory Committee, By: Kathryn O’Callaghan, Assistant Director for Strategic Programs, FDA’s Center for Devices and Radiological Health  and Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological HealthImagine checking your blood sugar levels several times a day with a glucose meter to keep your diabetes under control. Or maybe you’ve had a hip joint replaced or a stent inserted in your coronary artery to treat a heart blockage. Maybe you participated in a clinical trial to help researchers or a manufacturer better understand a new device to treat a condition.
      It’s possible that you had some unexpected experiences with the device or clinical trial and you’d like to share what happened with your physician, the manufacturer, other patients or even FDA.
      Now, there’s a way. For the first time, an FDA advisory committee will focus on patient-related issues. On Oct. 11-12, 2017, FDA will hold the inaugural meeting of the new Patient Engagement Advisory Committee (PEAC). The topic will be the challenges of clinical trial design, conduct, and reporting identified by patients.
      FDA chose this subject because patients often have concerns about participating in clinical trials or drop out once they have enrolled in a trial. Inconsistent or minimal participation in clinical trials can make it difficult to reach reliable conclusions or to determine the level of benefit for patients. It also can take longer to bring technological advances to the patients who need them. To read the rest of this post, see FDA Voice Blog, July 25, 2017
      The Expanded Access Navigator – Helping Patients In Need of Potentially Life-Saving Drug Treatments, By: Richard A. Moscicki, FDA’s Deputy Center Director for Science Operations, Center for Drug Evaluation and Research
      Patients with serious or immediately life-threatening diseases or conditions who have no comparable or satisfactory alternative therapy and who seek access to potentially life-saving investigational drugs will have another option to guide them through the process – thanks to the launch today of a new online tool called the Expanded Access NavigatorThe development of the Navigator was a team effort led by the Reagan-Udall Foundation in collaboration with patient advocacy groups, the pharmaceutical industry, FDA, and others in the Federal government.

      When a patient has a serious or immediately life-threatening disease or condition for which there is no FDA-approved treatment, they may be able to gain access to an investigational drug under the FDA Expanded Access process. Expanded Access permits the product’s manufacturer, with the authorization of FDA, to provide an investigational drug for a patient, even though the drug is still in development or under review for FDA approval. Each year FDA receives more than 1,000 applications requesting authorization of expanded access through individual patient, intermediate or large-size expanded access programs. To read the rest of this post, see FDA Voice Blog, July 24, 2017

      Meeting Image
      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.
      Webinar for Stakeholders: Notice
      Date: August 23, 2017, 12:30 p.m. to 2 p.m. EDT.
      Agenda: The FDA will hold a webinar for stakeholders on August 23, 2017, to provide stakeholders with a status update on the process of FDA and industry discussions on an Over-the-Counter (OTC) Monograph user fee program that began in July 2016. FDA will also provide an overview of proposed performance goals and procedures related to a potential new OTC monograph user fee program. This webinar is intended to be a followup to the June 10, 2016, public meeting and the September 6, 2016, stakeholder webinar on a potential new OTC monograph user fee program.
      Advisory Committee Meeting: Patient Engagement
      Date: October 11, 2017, 1:00 pm to 5:00 pm
      Date: October 12, 2017, 8:00 am to 5:00 pm
      Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877
      Agenda: The committee will discuss and make recommendations on the topic of patient input into medical device clinical trials.  This meeting will provide the opportunity to bring patients, patient organization, FDA, industry, and other medical and scientific experts together for a broader discussion on this important patient-related issue. This meeting is a key part of FDA's goal to help assure the needs and experiences of patients are included as part of FDA's deliberations involving the regulation of medical devices and their use by patients. 
       View FDA's Patient Network Calendar of Public Meetings page for a complete list of meetings and workshops.
      Gray Pointer
      For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.

      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
      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

      Food Safety
      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

      Good Dog, Bad Food: Foods for People That Are Bad for Your DogIf you consider the family dog, well, family—and are apt to toss him a piece of your food now and then—proceed with caution. Some foods meant for human consumption can be dangerous, and even deadly, to your dog.
      How are people and animals different when it comes to food?
      According to Carmela Stamper, D.V.M., a veterinarian at the U.S. Food and Drug Administration (FDA), an animal’s body processes food much differently. “Our bodies may break down foods or other chemicals that a dog’s can’t tolerate,” she says.
      And while sometimes people can have severe allergic reactions to foods, it’s different for dogs. “Allergies in animals tend to manifest themselves more in skin or ear issues,” she explains.
      Moreover, a food might harm one dog and not another. It depends on a number of factors, including the animal’s genetic makeup and size, as well as the amount that animal eats. “A big lab that eats a bar of dark chocolate may not have any problems,” she says, whereas a Chihuahua could get dangerously ill. More information
      Animal Health Literacy
      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
      Sick dog
      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

      The FDA announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. To make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also providing targeted relief on some timelines described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products. The agency will also seek input on critical public health issues such as the role of flavors in tobacco products. More information
      Missed the last issue of CTPConnect?The Center also publishes a regular periodical known as CTPConnect, a plainspoken digest with the latest stories from the Center. Sign up todayto receive the next issue of CTPConnect and other important updates from CTP directly to your inbox.
      FDA releases age calculator app for tobacco retailersTakings steps to protect youth from the harms of tobacco, the FDA recently released a voluntary smartphone application, “FDA Age Calculator,” on the Google Play and iTunes app stores designed to help tobacco retailers comply with age restriction laws. Retailers will now be able to use their personal smartphones to help determine if a purchaser is old enough under federal law to buy tobacco products. Find out more about FDA’s efforts to prevent tobacco use among youth.
      CTP Reporting Portal
      Center for Tobacco Products updated safety reporting portal
      CTP recently updated its Safety Reporting Portal, an online tool for reporting suspected problems with tobacco products. Whether you’re a consumer, manufacturer, clinical investigator, or health professional, let FDA know about products that seem to be damaged, defective, contaminated, or that smell or taste wrong. More information and to report a safety concern online.
      How cigarettes are made and how you can make a plan to quit
      Ever wonder why it’s so hard to kick smoking to the curb? Well, we’ve got an answer! CTP created an infographic that explores how cigarettes are made, highlighting how their very design may be an obstacle to quitting. As people across the country pledge to quit smoking, consider sharing this infographic with someone who could benefit. 
      FDA’s Center for Tobacco Products celebrates 8th anniversary of tobacco oversightIt has been eight years since the landmark Family Smoking Prevention and Tobacco Control Act was signed into law in June 2009. During this period, the agency has taken many strides towards public health protection, as shown by the CDC’s and FDA’s recent findings from the 2016 National Youth Tobacco Survey. Despite these and other encouraging indications of progress, a great deal of work remains to be done in further reducing the death and disease toll of tobacco. Learn about the 2016 National Youth Tobacco Survey findings.
      Comments invited as FDA reviews “modified risk” tobacco product applicationsThe public can now comment on modified risk tobacco product (MRTP) applications submitted by Philip Morris Products S.A., for its IQOS system and three types of Marlboro Heatstick products. By law, tobacco products may not be marketed as being less harmful or presenting lower risk of tobacco-related disease without a written order from FDA, and there are no authorized MRTPs currently on the market in the United States. You can view related Philip Morris Products S.A. documents as they become publicly available, and comment through Dec. 12.
      Tips to help avoid "vape" battery explosions You may have heard that e-cigarettes, or "vapes," can explode and seriously injure people. To help reduce the risk of vape battery overheating, fires, and explosions, the FDA has developed an infographic with five key tips, a video on how to report adverse events to the FDA’s Safety Reporting Portal, and shareable and downloadable content to help spread the word about vape battery safety.
      FDA’s LGBT Public Education Campaign Makes Headlines
      FDA’s “This Free Life” Campaign was recently recognized at the annual Association of National Advertisers (ANA) Multicultural Marketing & Diversity Conference. Winning the Multicultural Award of Excellence in the LGBT category, FDA made its mark among other category winners such as Coca-Cola, Toyota, and McDonalds. Watch the Ad and learn more about FDA’s “This Free Life” campaign!
      CTP Patient Newsletter Image
      Share the image and support those who matter to you most!
      Do you know someone who could benefit from CTP’s messages about tobacco? Sharing information about the health effects of tobacco has never been so easy. Simply save either image in this section and post it to your social media account, such as Facebook or Twitter.

      Warning Letters Address Drug Claims Made for Products Marketed as CosmeticsThe Warning Letters appearing below illustrate 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)). If such a product is not generally recognized by qualified experts as safe and effective when used as labeled, it is a “new drug” (FD&C Act, Section 201(p)) and requires an approved New Drug Application to be marketed legally in the United States (FD&C Act, Section 505(a)). 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
      FDA Cosmetics
      Bad reaction to a cosmetic? FDA needs to know
      What do you do if you have a reaction after using a cosmetic product? First, stop using the product and contact your healthcare provider. Next, please report it to FDA.
      Here’s why that next step is so important: Cosmetic products aren’t required by law to have FDA approval before they go on the market. Companies that market cosmetics have a legal responsibility to ensure product safety, but FDA can only take action if the product is shown to be unsafe after the product is on the market.
      And, because the law doesn’t require cosmetic companies to share customer complaints or other safety information with FDA, voluntary reports from consumers and healthcare providers are one of the best ways for FDA to learn about any problems.
      Cosmetics include a range of products people use every day, such as moisturizers, makeup, shampoos and conditioners, face and body washes, deodorants, nail care products, hair dyes and relaxers, and tattoos. More information
      Recalls and Alerts
      To see safety alerts and  recent recalls related to cosmetics and other products regulated by FDA. More information
      What to watch for, how to report
      You can report an allergic reaction, 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:

      Expanded Access
      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
      For Patients Logo
      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
      For Physicians
      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

      Follow us on twitter
      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 , Follow uson twitter 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
      New 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.

      No hay comentarios:

      Publicar un comentario