Wednesday, September 4, 2013

Food & Drug Safety News for Patients (9-4-2013)






Product Safety Bar



Drug Safety Caution SignEvil Root and Pro Power Max Due to Undeclared Sildenafil

Upon request of the FDA, Hardmenstore.com is voluntarily recalling 1000 lots of 72HP, Evil Root and Pro Power Max at the consumer level. According to representatives of the FDA, 72HP, Evil Root and Pro Power Max have reportedly been found to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED). More informationFDA investigating rare brain infection in patient taking Gilenya (fingolimod)

FDA is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod). This is the first case of this disease, called progressive multifocal leukoencephalopathy or PML, reported following the administration of Gilenya to a patient who had not previously received Tysabri (natalizumab), an MS drug associated with a higher risk of PML. More information

Federal judge approves consent decree against Dakota Laboratories

Dakota Laboratories LLC and its president, Charles L. Voellinger, Sr., are prohibited from manufacturing and distributing drugs until they correct their ongoing violations of the drug manufacturing laws. The U.S. Food and Drug Administration entered into a consent decree of permanent injunction on Aug. 26, 2013 which enjoined the drug maker and distributor for repeated failure to comply with federal drug manufacturing requirements, known as Current Good Manufacturing Practices (cGMPs).  More information


 


Blue Shirt/ hand with finger pointing to rightComunicaciones de la FDA sobre la seguridad de los medicamentos en español

Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante 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 ingles y en 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

Medwatch 20th anniversary 

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

For more important safety information on human drug and devices or to report a serious problem, please visit MedWatch.






Product Short and DC



Empty Medicine Cabinet with Empty Medicine BottleFDA 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

 

Drug Shortages Resolved During the Past 2 Weeks:


 


  • Methoxsalen 1% Topical Lotion (Oxsoralen)

  • Sodium Benzoate

  • Sodium Phenylacetate (Ammonul) Injection

 


 


 


 


 


 


 




Blue Shirt/ hand with finger pointing to right

 






Product Approval Bar


No New Product Approvals.


 



Drugs@FDAFor information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.





Comments and Guidances







View current opportunities for comment on topics of interest for patients.


 


Announcements Bar



Demystifying FDAPublic Meeting: FDA Patient Network Annual Meeting – Demystifying FDA: An Exploration of Drug Development

Date: September 10, 2013

This meeting will serve as a forum for FDA’s patient stakeholders and the general public, including health professionals, academia, and industry to learn about regulatory issues related to drug development, analyze where in the process patient input may be most practical and most valuable, and explore practicable approaches to incorporating meaningful patient input that will represent broad patient perspectives in medical product development and regulatory decision-making. More information

Michelle McMurry HeathConsidering Women’s Needs in Developing Medical Devices: Here’s ‘HoW’, by Michelle McMurry-Heath, MD, Ph.D.

Women differ from men in anatomy, physiology, risk factors and disease symptoms. They are also likely to use more medical devices over the course of their lives than men do.That is why FDA is actively trying to learn more about how medical devices uniquely affect women, and how women can be better served by them.

This month we published a snapshot of how FDA is doing with such efforts. A congressionally-required report (Section 907 of the Food and Drug Administration Safety and Innovation Act) looked at the inclusion and analysis of women and other demographic subgroups in clinical studies supporting the approval of medical devices and other FDA-regulated medical products.


To read the rest of this blog, See FDA Voice Blog, August 30, 2013


 


 






New method could speed potency testing of influenza vaccines

Scientists at FDA have developed a method in their laboratory for quickly measuring the amount of hemagglutinin (HA) antigen in standards used for potency testing of seasonal and pandemic influenza vaccines.


Seasonal and pandemic influenza is a significant public health threat and vaccination is the cornerstone for the prevention of influenza and its related complications, which can be severe. A fast and more accurate alternative method to measure influenza vaccine antigen content would facilitate more rapid preparation of reference standards and support production and availability of seasonal as well as pandemic influenza vaccines. More information








Lynne YaoFDA takes step to encourage pediatric drug studies, by: Lynne Yao, M.D., Associate Director, Pediatric and Maternal Health Staff

We all know that children are not just small adults. Many changes occur in children as they grow and develop that can affect how a drug works. In fact, some drugs that work in adults may not work at all in children. There may be different safety concerns compared to when they are used by adults, or they may need to be given in a different dose. That’s why products that are used in children must be studied in children.Congress enacted two laws that will increase the study of drugs in children: The Best Pharmaceuticals for Children Act (BPCA) provides an incentive for drug companies to conduct FDA-requested pediatric studies by granting an additional six months of marketing exclusivity.

To read the rest of this blog, See FDA Voice Blog, August 26, 201


 






Ucoming Meetings Bar



Advisory Committee Meeting at FDA

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.


View a complete list of upcoming public meetings and workshops


 


 


 


Blue Shirt/ hand with finger pointing to rightPlease 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.





Consumer Update bar



Hyberbaric Oxygen TherapyHyperbaric Oxygen Therapy: Don’t Be Misled

No, hyperbaric oxygen therapy (HBOT) has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes. But do a quick search on the Internet, and you’ll see all kinds of claims for these and other diseases for which the device has not been cleared or approved by FDA. 

HBOT involves breathing oxygen in a pressurized chamber. The Food and Drug Administration (FDA) has cleared hyperbaric chambers for certain medical uses, such as treating decompression sickness suffered by divers.


 


HBOT has not, however, been proven to be the kind of universal treatment it has been touted to be on some Internet sites. FDA is concerned that some claims made by treatment centers using HBOT may give consumers a wrong impression that could ultimately endanger their health. To continue reading Consumer Updates article.






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


Artículos en Español

Estos artículos para los consumidores incluyen información sobre la Administración de Medicamentos y Alimentos (FDA, Food and Drug Administration) y consejos para llevar una vida saludable.
Artículos en Español







Food Safety BarMythbusters



Food SafetyCenter 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 Bar



CooperAnimal Drug Shortages

A drug shortage may involve either an actual or a potential shortage of a drug product. When drug shortages involve medically necessary veterinary products, it is FDA’s policy to help prevent or alleviate them. FDA works with drug manufacturers in the U.S. and, when necessary, other countries, to find ways to resolve shortages of medically necessary veterinary products. FDA does not have the authority to require a company to make any product, even if it is medically necessary. More information

Dog with GlassesAnimal 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 

 


CVM Pet Facts

The Center for Veterinary Medicine (CVM) issues medical and feeding fact sheets to keep your pets healthy and safe. More information






Resources



Janet WoodcockHave a question about what the Center for Drug Evaluation and Research (CDER) does? Ask Janet Woodcock, M.D., Director, CDER, FDA

FDA will select some of your questions to answer each month. Due to the volume of e-mails we receive, we won’t be able to answer each question in this format. We may edit your questions for brevity or clarity. More information 

 


To read questions and answers, see MailBag.


FDA On line ResourceFDA 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 informationEducational Videos
FDA Food Safety and Modernization Act: An FDA Primer
The Rulemaking Process: An FDA Primer
What is Regulatory Science
Taking Acetaminophen Safely

 


healthfinder.govhealthfinder.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 

Tobacco Products Resources for You

Federal resources to help you quit using tobacco products and to help you learn more about youth tobacco prevention, effective treatment for nicotine addiction, and tobacco research and statistics.
More information


 


 


 


 


 






Take me to the web site


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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Food & Drug Safety News for Patients (9-4-2013)