Environment Friday: Water

Water may reshape energy industry | CSM

Demand for fresh water could exceed supply by an estimated 40 percent by 2030, pushing up prices for the water-intensive energy industry. Soaring water prices would help wind, solar, and natural gas, but hurt coal and nuclear plants.

Water Protection Gets Shortchanged in Proposed Fracking Rules | NatGeo

By Monika Freyman, water program manager at Ceres

Proposed standards that the U.S. Department of Interior announced last week for hydraulic fracturing (aka fracking) on federal and Indian lands are hugely important, especially in the arid West where water is gold. Unfortunately, water protection gets short shrift in the rules that, once finalized, will apply to 750 million acres of public lands (see map below).

U.S. Groundwater Consumption Accelerating | ENS

RESTON, Virginia, May 23, 2013 (ENS) -- Aquifers across the United States are being drawn down at an increasing pace, finds a new study released today by the U.S. Geological Survey.

Programs To Reduce Ag's Water Use Must Be Strengthened, Not Cut | EWG

THURSDAY, MAY 23, 2013
Since it was first authorized in the 1996 farm bill, USDA's Environmental Quality Incentives Program has grown into the single most important federal program that helps farmers and ranchers protect farmland and the environment as they grow America's food.

Fracking accident leaks benzene into Colorado stream | Grist

More than two months after the spill was discovered, neighbors of the plant are wondering why the energy company is being put in charge of the cleanup -- and why the state has failed to issue any fines.

Policymakers Issue Flurry of Misleading Statements on Climate Science | UCS

Scientists have gone to great pains to differentiate between extreme weather than can or cannot be definitively linked to climate change. Yet, public and policymaker confusion about these connections abounds.

Why Undocumented Immigrants Should Have Access To Taxpayer-Funded Health Care | ThinkProgress

Why Undocumented Immigrants Should Have Access To Taxpayer-Funded Health Care | ThinkProgress

As Congress debates comprehensive immigration reform, members of both parties have insisted on barring undocumented immigrants who achieve provisional legal status from receiving Medicaid coverage or Obamacare subsidies (a provision that was already part of the health law). But preventing these immigrants from gaining basic health benefits is actually a fiscally irresponsible model that will only raise health care spending and contribute to a sicker U.S. population.

A powerful argument irrefutable to everything but demagoguery.

Health Thursday: Contrary edition

Twitter Chat on Borderline Personality Disorder | NIMH NIMH teams up with Dr. Perry D. Hoffman from the National Education Alliance for Borderline Personality Disorder for a chat about this topic in recognition of Borderline Personality Disorder Awareness Month in May. Please join us on May 31, 2013 from 1 to 2 p.m. ET on Twitter. Please use the hash tag #NIMHchats to follow the chat. Tweet us your questions @NIMHgov. Read more...

Many mental health professionals find it challenging to diagnose the disorder and even find fault with its names.

Yeah, me too.



Hormone replacement therapy: clarity at last! | Machines Like Us

The British Menopause Society and Women's Health Concern have today released updated guidelines on Hormone Replacement Therapy (HRT) to provide clarity around the role of HRT, the benefits and the risks.

I'm not objective on this topic. Menopause was a huge relief to me and I experienced no symptoms. That + two sisters (OS and YS) with cancer after HRT = the only clarity I'm buying is to run screaming in the other direction. ES used a non-steroid supplement to good effect.



New Recommendations for Management of High Blood Glucose in Hospitalized Patients | ScienceDaily

High blood glucose is associated with poor outcomes in hospitalized patients, and use of intensive insulin therapy (IIT) to control hyperglycemia is a common practice in hospitals. But the recent evidence does not show a consistent benefit and even shows harms associated with the use of IIT, according to the American College of Physicians' (ACP) Clinical Guidelines Committee in a new evidence-based paper published today online in the American Journal of Medical Quality.

The harm in this case is that glucose levels can fall too low and probably too rapidly with intensive glucose management.



Peering at bright screens after dark could harm health, doctor claims | The Guardian

Watching TV or using computers, tablets or smartphones after dark may cause sleep loss and resultant health problems, a leading doctor has warned.

"Doctor claims" seems overly dismissive considering the evidence. An informative read on an important topic (she said as she wrote on her computer screen in front of the TV before bed).



5 Health Benefits of Masturbation | Men's Health

"Masturbation is part of a healthy sex life," says Gloria Brame, Ph.D., a clinical sexologist. "It's totally safe and harmless. It's healthier than brushing your teeth every day."

No argument there.

Wednesday Whimsy

At Despair.com



F*cking Hilarious | Amanda Kessler [There Are Two Sides] | Pinterest

Content advisory. It was very healing :-).

Before I try to find something whimsical

Still struggling a bit with the aftereffects of the antibiotics. Rising out of the depression but gave thought to having an anxiety episode while suspended in the chair at the podiatrist's office. Didn't sleep last night because of an 8 AM meeting. I'd worked late and it was important that I be there. Those folks, all of whom volunteered to learn and provide support for their colleagues, and one of whom attended the meeting at 11 PM his time, uplift me. Collaboration is not a vibrant part of the culture of this workplace. Proactivity is a faint memory in all enterprises so it makes me happy that these people stepped up.

I kept nodding off while watching TV with ES. She yelled at me, despite the fact that she does it all the time. She might have missed a dose of her happy medication or she's stressed out because both her children are home from college. She tends to confuse me with them. I usually tell her directly not to yell at me but I was too annoyed this time.

Off to find something silly.

Technology Tuesday

Oklahoma Students Design Drones That Can Fly Into Tornadoes | PopSci

The remotely piloted vehicles could one day replace storm chasers, who risk their lives to capture valuable data about tornadoes

3 Robots That Want To Save Your Life | PopSci

Meet the machines that might rescue you after a future disaster.

How It's Made Season 11 | The Science Channel [Videos]

I watched them all except cremation urns (really?). The ones I liked:

Frozen Pancakes -- Strangely soothing
Paper Towels -- Interesting and gross at the same time
Spring Rider -- That sand mold thing is pretty cool
Rubber Gloves -- Sort of disturbing
Paper Umbrellas -- Reminded me of my youth in Asia
Soap Sculptures -- Frivolous and fun
Perogies -- What? I was hungry....



Moth eyes inspire more efficient thin-film solar cells | TreeHugger

Researchers at North Carolina State University are looking to biomimicry to solve one of thin-film solar technology's biggest problems: light reflection between films that causes light to be lost before it can be harnessed for energy production. They found their solution in the eyes of moths.

Watch out for the picture if insects creep you out.



Scientists Ponder 'Epoch' of Damage to Global Water System | VOA

Scientists say a new geologic epoch has begun whereby humans are causing major damage to global water systems. They warn of a planetary transformation comparable to the retreat of the glaciers more than 11,000 years ago. Scientists are meeting in Bonn, Germany this week (5/21-24) to discuss what can be done about it.

Drowning In Devices? Your Next Gadget May Dissolve When You're Done | LiveScience

Waste not thy future gadgets. That may soon become the 11th Commandment.

Short video starts when you open the page.



Sweet Confusion | ScienceNews

Does high fructose corn syrup deserve such a bad rap?

The article explains the ways that fructose is worse than sugar and then rushes to conclude that it gets a bad rap. Still, it's informative and worth being the one article you'll read on the subject.

Marvelous Monday

Nepal Photos | NatGeo


Dancers Among Us: Amazing Pictures of Dancers Brightening Mundane Situations | Thumbpress

New York photographer Jordan Matter's "Dancers Among Us" project features performers from the Paul Taylor Dance Company performing guerrilla dance moves in iconic Manhattan locations. Some of them are amusing, while others are simply beautiful.

Taming schizophrenia, Diabetes clinical trial | NIH

Taming suspect gene reverses schizophrenia-like abnormalities in mice 05/22/2013 05:02 PM EDT Scientists have reversed behavioral and brain abnormalities in adult mice that resemble some features of schizophrenia by restoring normal expression to a suspect gene that is over-expressed in humans with the illness. Targeting expression of the gene Neuregulin1, which makes a protein important for brain development, may hold promise for treating at least some patients with the brain disorder, say researchers funded by the National Institutes of Health. NIH funds studies to improve type 2 and prediabetes treatment 05/22/2013 09:16 AM EDT The National Institutes of Health is looking for volunteers to take part in one of three clinical trials to improve and preserve the production of insulin in people with prediabetes or recently diagnosed type 2 diabetes. The project is called the Restoring Insulin Secretion study (RISE).

NIH Research Matters -- Congenital heart disease genomics

From NIH Research Matters: Clues to Congenital Heart Disease A large-scale genomic analysis found that non-inherited mutations in hundreds of genes together account for about 1 in 10 cases of severe congenital heart defects, the most common type of birth defect. Editor's Picks from past issues: Hormone May Help Treat Diabetes Gene Linked to Migraine and Sleep Disorder Red Meat-Heart Disease Link Involves Gut Microbes Gut Microbes Affect Weight After Gastric Bypass Killing Cancer With Radioactive Bacteria NIH Research Matters is on Facebook! Join us at www.facebook.com/ResearchMatters, and write on our wall. NIH Research Matters is also available as an RSS News Feed. Point your RSS reader to http://www.nih.gov/researchmatters/feed.xml (to learn more about RSS, visit http://www.nih.gov/news/rss.htm).

U.S. Food & Drug Administration (FDA) Weekly Digest Bulletin

I remove tracking, duplicate alerts, and some items targeted only to healthcare professionals. To subscribe to the full edition, go to Get Email Updates at the FDA site.  You can see previous posts on this site in the FDA Bulletins thread.

Additional Lots Added: Voluntary Nationwide Recall of 21 Lots of Piperacillin and Tazobactam for Injection, USP 40.5 Grams Due to Possibility of Precipitation / Crystallization in IV Bag or IV Line Upon Reconstitution

05/10/2013 10:09 PM EDT

May 10, 2013 -- Weston, Florida: Apotex Corp. announced today that it is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary nationwide recall of 21 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams, NDC number 60505-0773-00 to the hospital / healthcare provider /user level. The impacted lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams may show precipitation / crystallization in IV bag or IV line after reconstitution.

In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Sterile Compounded Products Due to a Lack of Sterility Assurance Distributed Within its Local Market Area

05/10/2013 04:00 PM EDT

The Compounding Shop, LLC is conducting a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The recall is being initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Hannaford Supermarkets Issues Allergy Alert for Two Bakery Cookie Products That May Contain Undeclared Nuts

05/10/2013 04:49 PM EDT

Hannaford Supermarkets is recalling two products sold in the bakery section because they may contain nuts that are not listed on the product packaging label. Individuals who have an allergy or severe sensitivity to any nuts may run the risk of serious or life-threatening allergic reaction should they consume these items.

Smart & Final Expands Recall to Include Additional Production Dates; Allergy Alert - Undeclared Wheat, Milk and Eggs in La Romanella Tri-Color Cheese Tortellini

05/10/2013 04:48 PM EDT

Smart & Final of Los Angeles, Calif., which previously announced a recall of certain production dates of 2.5 lb - La Romanella Tri-Color Cheese Tortellini, is expanding its recall to include additional production dates due to undeclared wheat, eggs and milk. People who have an allergy or severe sensitivity to wheat, eggs and/or milk run the risk of serious or life-threatening allergic reaction if they consume these products.

Food Defense -- What's Your Plan?

By Ted Elkin and Julia Guenther in FDA's Center for Food Safety and Applied Nutrition

While food safety—preventing unintentional contamination from sources likely to be found in the food chain—is a priority for FDA, so is food defense—protecting our food from intentional contamination by saboteurs, terrorists or other criminals. 

Recently, we released a new tool that will help the owners and operators of food facilities develop customized food defense plans to minimize the risk of intentional contamination. It's a software program called the Food Defense Plan Builder and it's designed to be easy to use.  … Continue reading

May 2013 www.fda.gov/womens Message from the Director As we celebrate National Women's Health Week, I encourage you to look to FDA for women's health resources. FDA is an active partner in helping you to understand, diagnose and treat the health problems that affect women. Whether we are approving new products, inspecting manufacturers, drafting safety alerts, conducting research, or educating consumers, the dedicated professionals at FDA strive each day to protect and promote the health of women and their families. To learn more about these efforts, check out the resources and activities highlighted in this update. Also, visit the FDA for Women website for links to other helpful tips, and safety information.   Marsha Henderson, M.C.R.P. Director FDA Office of Women's Health Women's Health highlights Resources for Pregnant Women and New Moms FDA has new resources to help pregnant women and new mothers make good choices about the medicines, foods and other products that are safe for them and their babies. These resources include: A new video, "Resources for You and Your Baby," developed in collaboration with text4baby An improved FDA Pregnancy page at (www.fda.gov/pregnancy) A new consumer update "Pregnancy: A Time for Special Caution" OWH Pregnancy Exposure Registries Website Buttons, which you can embed on your website to connect your patients to over 50 registries Free medication safety fact sheets, post cards and brochures, available for bulk order Help start a dialogue by sharing these resources with your networks. New Graphic on Mammography Myths Knowing the truth about mammography could help save a woman's life.  OWH released a new infographic to help women separate fact from fiction and better understand the procedure. The graphic highlights mammography myths, facts, and information to know prior to a mammogram. View the graphic and share with your networks. Get more information on mammograms. News from FDA New FDA Patient Website FDA recently launched the Patient Network website, which helps people find reliable information about medical products and their approvals, clinical trials and other treatment options. The website also includes links to FDA public meetings and information on how to become a FDA Patient Representative. Visit the new FDA Patient Network. Research OWH Awards 2013 Research Grants OWH recently awarded grants for 11 new women's health research projects by FDA scientists. The projects will address mechanical causes of hip implant failures in women, MRI safety testing of breast tissue expanders, among other issues. OWH funds scientific research that can be used to facilitate regulatory decision-making and advance the understanding of sex differences. View the full list of OWH research projects. Read publications from previous OWH-funded projects. New Report Examines Safety of PCI A recent article in the American Heart Journal summarizes the key safety issues related to percutaneous coronary intervention (PCI) which is used to treat narrowed arteries in the heart. Women have higher rates of bleeding than men after PCI, and female sex independently predicts bleeding and death after PCI. Leaders from OWH, other government agencies, academia, professional societies, and industry met to examine approaches for improving the overall safety of PCI. The meetings called TransRadial Education and Therapeutics (TREAT) resulted in the SAFE-PCI for Women trial which will compare the efficacy and feasibility of two approaches to PCI in women. Read more about the SAFE-PCI for Women Trial. Article Citation: Hess CN et al., TransRadial Education And Therapeutics (TREAT): Shifting the balance of safety and efficacy of antithrombotic agents in percutaneous coronary intervention: A report from the Cardiac Safety Research Consortium. Am Heart J. 2013 Mar; 165(3):344-353 Exhibits and Presentations Check out an OWH exhibit booth or presentation at one of these conferences to learn more about OWH programs, research, and free educational resources. American Academy of Physician Assistants, May 28-29 -- Washington, DC American College Health Association, May 28-Jun 1 -- Boston, MA YWCA, Jun 5-8 -- Washington, DC American Academy of Nurse Practitioners, Jun 20-22 -- Las Vegas, NV American Library Association, Jun 28-Jul 1 -- Chicago, IL American Association of Colleges of Pharmacy, Jul 13-17 -- Chicago, IL National Council of La Raza, Jul 20-23 -- New Orleans, LA National Black Nurses Association, Aug 1-3 -- New Orleans, LA Please share this update with your network, members, constituents, and community FDA Office of Women's Health 10903 New Hampshire Avenue WO32 - Room 2333 Silver Spring, MD 20993*0002 301-796-9440

FDA is announcing a Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research
Date:
June 14, 2013

Time:
9:30 a.m. to 5:30 p.m

Location:
FDA White Oak Campus
10903 New Hampshire Ave.
Building 31, Room 1503A (Great Room)
Silver Spring, MD 20993
On June 14, 2013, as part of the Patient-Focused Drug Development initiative intended to enhance patient input, FDA will be hosting a public meeting on human immunodeficiency virus (HIV) Patient-Focused Drug Development and HIV Cure Research. FDA is interested in obtaining patient input on the impact of HIV on daily life and currently available therapies to treat the condition (topic 1), and patients' views on issues related to HIV cure research (topic 2).

FDA's Role in Regulating Safety of GE Foods

05/14/2013 09:00 AM EDT

Genetically engineered (GE) foods, also known as biotech foods and referred to by some as food from genetically modified organisms (GMOs), have been in our food supply for about 20 years. Genetic engineering refers to certain methods that scientists use to introduce new traits or characteristics to an organism. For example, plants may be genetically engineered to produce characteristics that enhance the growth or nutritional value of food crops.

Using a science-based approach, FDA regulates foods and ingredients made from genetically engineered plants to help ensure that they are safe to eat.

Read this Consumer Update to learn more.

Submit Nominations to the Advisory Committee on Minority Health

The Office of Minority Health (OMH) is seeking nominations for qualified candidates to be considered for appointment as voting members of the Advisory Committee on Minority Health. The Committee provides advice to the Deputy Assistant Secretary for Minority Health, with a focus on improving the health of racial and ethnic minority populations and the development of goals and program activities. The nominations must be received by OMH by Friday, May 31 at 5 pm ET.

View the Federal Register Notice | Learn more about the Advisory Committee on Minority Health

Track Our Success as We Implement New Law

By: Leslie Kux and Malcolm Bertoni

As we continue to implement the exciting new tools provided by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), we are inviting interested members of the public to use the … Continue reading

Stay Safe in the Summer Sun

05/15/2013 11:30 AM EDT

As summer approaches, FDA has taken steps on multiple fronts to protect consumers from the skin damage that can be caused by too much exposure to the sun.

This is the first summer in which FDA's new rules governing sunscreen labeling are in effect. These rules include allowing only products proven to protect against both UVB and UVA ultraviolet rays to bear the label "broad spectrum." And FDA is supporting "Don't Fry Day" on May 24, 2013, a skin-safety awareness campaign that takes place every year on the Friday before Memorial Day.

Read this Consumer Update to learn more about how to keep yourself and your family safe while enjoying the summer sun.

Volume 3 | Number 10 | May 15, 2013 Comunicaciones 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 Voluntary Recall: 21 Lots of Piperacillin and Tazobactam for Injection Due to Possibility of Precipitation/Crystallization in IV Bag or IV Line Upon Reconstitution Apotex Corp. announced that it is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary nationwide recall of 21 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams, NDC number 60505-0773-00 to the hospital / healthcare provider /user level. The impacted lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams may show precipitation / crystallization in IV bag or IV line after reconstitution. Hospira has stated that administration of precipitated Piperacillin / Tazobactam in an IV bag or IV line may result in local reactions such as phlebitis, renal impairment, end-organ embolism and ischemia, and/or vasculitis (because the precipitate was visible, its particles may be large enough to cause these adverse events). In addition, the precipitation of the drug may not allow delivering a needed therapeutic dose of piperacillin and tazobactam, thus resulting in inadequate treatment of the targeted infection. This could result in adverse health consequences that could range from transient and minor impairment or complaints to permanent impairment of a body function or permanent damage to a body structure. Hospira has not received any reports of adverse events related to this recall. More information Hospira Inc., GemStar Infusion System - Damage from Battery Leakage The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required. Power can be lost when the pump loses contact with the batteries, or when components on the Middle Printed Wire Assembly (PWA) fail, or when the Middle PWA does not receive appropriate signals from elsewhere in the pump. Loss of contact can be due to a mechanical disconnect at either the positive or negative battery terminal. Inappropriate or missing input signals can be due to contamination, corrosion damage, electronic defects or keypad problems disrupting turn on/turn off signals. More information For more important safety information on human drug and devices or to report a serious problem, please visit MedWatch. 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 quality/manufacturing and quality problems, delays, and discontinuations. When quality/manufacturing issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, the 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 Voluntarily Reported by Manufacturers During the Past 2 Weeks: Desmopressin Acetate Injection (DDAVP) Fluphenazine Hydrochloride Injection Lomustine Capsules Drugs to be Discontinued Announced During Past 2 Weeks: Asacol (mesalamine) Delayed-Release Tablets 400 mg Chloroquine 250 mg (2790-06-0115) and 500 mg (7010-09-0115) Tablets Demeclocycline 150 mg (NDC: 2111-01-0115) and 300 mg (NDC: 2122-14-0115) Tablets Terbutaline 2.5 mg (NDC: 2611-01-0115) and 5 mg (NDC: 2622-01-0115) Tablets More information about drug shortages, drug shortages resolved, and drugs to be discontinued. Information about blood and biologic shortages, resolved shortages, and discontinuations FDA approves new drug for advanced prostate cancer FDA approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone. Prostate cancer forms in a gland in the male reproductive system found below the bladder and in front of the rectum. The male sex hormone testosterone stimulates the prostate tumors to grow. According to the National Cancer Institute, an estimated 238,590 men will be diagnosed with prostate cancer and 29,720 will die from the disease in 2013. Xofigo is being approved more than three months ahead of the product's prescription drug user fee goal date of Aug. 14, 2013, the date the agency was scheduled to complete review of the drug application. The FDA reviewed Xofigo under the agency's priority review program, which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. More information FDA approves first companion diagnostic to detect gene mutation associated with non-small cell lung cancers (NSCLC) and expands use for Tarceva (erlotinib) as a first-line treatment for patients with metastatic NSCLC FDA approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of NSCLCs. The test is being approved with an expanded use for Tarceva as a first-line treatment for patients with NSCLC that has spread to other parts of the body (metastasized) and who have certain mutations in the EGFR gene. Lung cancer is the leading cause of cancer-related death among men and women. According to the National Cancer Institute, there will be an estimated 228,190 new cases of lung cancer this year, and 159,480 deaths. About 85 percent of lung cancers are NSCLC, making it the most common type of lung cancer. More information FDA approves Nymalize—first nimpdipine oral solution for use in certain brain hemorrhage patients FDA approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was available only as a liquid-filled gel capsule. Subarachnoid hemorrhage is serious, life threatening bleeding that occurs in the subarachnoid space -- the area between the brain and the thin tissues that cover the brain. Nimodipine is a medication given in a critical care setting to treat neurologic complications from subarachnoid hemorrhage. More information FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease FDA approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations. More information Perclose ProGlide Suture-Mediated Closure System (ProGlide AMC) - P960043/S080 FDA approved Perclose ProGlide Suture-Mediated Closure (ProGlide SMC) System, which is designed to deliver a single monofilament polypropylene suture to close a femoral artery (a major artery in the thigh) puncture site following diagnostic or interventional catheterization procedures. The Perclose ProGlide SMC System is used to deliver a suture to close the femoral artery site. It is composed of a plunger, handle, guide, and sheath. The ProGlide SMC System tracks over a standard four-tenths (0.4) of an inch (or smaller) guidewire. More information For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed. FDA warns consumers about potential health risk with Juices Incorporated juice products FDA is warning consumers not to consume any juice products or other beverages from Juices Incorporated (aka Juices International and Juices Enterprises) of Brooklyn, N.Y. The company's carrot and beet juice products have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause botulism, a serious and potentially fatal foodborne illness. Consumers are warned not to consume these products even if they do not look or smell spoiled. More information Salmonella, Feeder Rodents, and Pet Reptiles and Amphibians -- Tips You Should Know to Prevent Infection You may be one of the many Americans who own a pet reptile or amphibian. Reptiles—corn snakes, iguanas, and red-eared sliders, and amphibians, frogs and toads, to name a few—are unique creatures and can make for interesting pets. But pet reptiles and amphibians carry some risks to their owners, such as the potential for Salmonella infection. Both the reptiles and amphibians themselves, as well as the feeder rodents fed to some reptiles or amphibians can be sources of Salmonella infection for people. What are feeder rodents? What are the symptoms of salmoneliosis in people? Answers to these questions and more. 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 CVM Pet Facts The Center for Veterinary Medicine (CVM) issues medical and feeding fact sheets to keep your pets healthy and safe. More information

FDA MedWatch -
05/15/2013
The MedWatch April 2013 Safety Labeling Changes posting includes 48 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.
 The "Summary Page" provides a listing of drug names and safety labeling sections revised:
 http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm348021.htm
The following drugs had modifications to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections:
Actonel (Risedronate Sodium) 
Actonel with Calcium (Risedronate Sodium with Calcium Carbonate)
Actemra (Tocilizumab) 
Ambien (Zolpidem Tartrate)
Ambien CR (Zolpidem Tartrate) 
Amrix (Cyclobenzaprine Hydrochloride)  
Atacand (Candesartan Cilexetil)
Atacand HCT (Candesartan Cilexetil/Hydrodchlorothiazide)
Atelvia (Risedronate Sodium) 
Atripla (Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate)    
Binosto (Alendronate Sodium) 
Boniva (Ibandronate Sodium)
Coartem (Artemether/Lumefantrine)  
Cogentin (Benztropine Mesylate) 
Didronel (Itidronate Disodium)
Dificid (Fidaxomicin)
Edluar (Zolpidem Tartrate)   
Emtriva (Emtricitabine) 
Flexeril (Cyclobenzaprine Hydrochloride)
Fosamax (Alendronate Sodium)
Fosamax Plus D (Alendronate Sodium/Cholecalciferol)        
Incivek (Telaprevir)
Jalyn (Dutasteride and Tamsulosin Hydrochloride)    
Juxtapid (Lomitapide)   
Nulojix (Belatacept)   
Pradaxa (Dabigatran Etexilate Mesylate)
Qualaquin (Quinine Sulfate)     
Rebif (Interferon Beta-1a)
Samsca (Tolvaptan)
Seroquel (Quetiapine Fumarate)     
Seroquel XR (Quetiapine fumarate)    
Simponi (Golimumab)    
Supprelin LA (Histrelin Acetate)
Victozo (Liraglutide [rDNA orgin])
Viread (Tenofovir Disoprixil Fumarate)

Symbios Medical Products Issues Nationwide Recall of GOPump and GOBlock Kits

05/16/2013 03:49 PM EDT

May 10, 2013 - Symbios Medical Products initiated a voluntary recall of all GoPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control components assembled prior to July 2012. These products have been found to potentially cause excessively high flow rates, which presents a risk of patient toxicity and serious injury (e.g., seizure, dysrhythmia, death) due to the rapid influx of medication particularly in patients with low body mass or advanced age.

Rural King Recalls Deer Corn Because of Possible Health Risk

05/17/2013 09:41 AM EDT

Rural King Distributing of Mattoon, IL is recalling 205 tons of Deer Corn, because it has the potential to be contaminated with aflatoxin. Aflatoxin is a naturally occurring mold by-product.

Tropical Valley Foods Issues Allergy Alert on Undeclared Milk and Walnuts in Next by Nature Dark Chocolate Bananas

05/17/2013 11:54 AM EDT

Tropical Valley Foods Inc. of Plattsburgh, NY, is recalling next by Nature DARK CHOCOLATE BANANAS, 3 oz. bags, due to undeclared milk and walnuts. People who have an allergy to milk and/or walnuts run the risk of serious or life-threatening allergic reaction if they consume this product.

Science Is the Foundation of Food Safety at FDA

By: Michael R. Taylor, J.D.

Science is the foundation of everything we do at FDA to keep your food safe. The Food Safety Modernization Act that President Obama signed into law in 2011 emphasizes prevention of foodborne illnesses. Margaret Hamburg, … Continue reading

Compounded Prescription Therapies By Pentec Health Inc.: Recall - Lack Of Sterility Assurance

AUDIENCE: Pharmacy, Patient, Health Professional
ISSUE: Pentec Health, Inc. initiated a limited, voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of its laminar flow hoods used in compounding. Pentec Health has received no reports of injury or illness associated with any of the prescriptions subject to this recall. However, because patients are at increased risk of infection in the event a sterile product is compromised, the pharmacy is recalling any unused product whose beyond-use date has not passed.
BACKGROUND: These renal therapies were supplied to renal dialysis centers and directly to patients. Pentec Health is directly notifying each dialysis center and in-home dialysis patient of the recall. Prescriptions for a total of 163 patients are included in the scope of this recall. The recall covers renal therapies that were compounded in this hood on or before May 2, 2013. Sterility tests associated with the compounding hood involved, as well as testing of finished products made in the hood, have shown sterility.
RECOMMENDATION: Consumers or health care providers with questions regarding this recall may contact Pentec Health by phone at 800-223-4376, prompt 7, or e-mail at recall@pentechealth.com, Monday through Friday, between 9:00 am and 8:00 pm EDT. Patients who have received any prescriptions prepared by Pentec Health and have concerns should contact their health care provider.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MeDWatch safety alert, including a link to the Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm352939.htm

All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance

AUDIENCE: Pharmacy, Patient, Health Professional
ISSUE: FDA is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA is basing this expanded alert on a recent inspection of the NuVision Dallas facility, during which FDA investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of the company's sterile drug products. The agency is not aware of any additional adverse event reports associated with other sterile products from NuVision.
BACKGROUND: In April 2013, NuVision recalled Methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA inspection. The FDA received adverse event reports of fever, flu-like symptoms, and soreness at the injection site associated with the Methylcobalamin injection product that was previously recalled.
RECOMMENDATION: For all sterile products from NuVision, the FDA recommends that health care providers and other health care professionals, including hospital staff, immediately check their medical supplies for NuVision sterile products, quarantine those products, and not administer them to patients. Patients who were administered any sterile drug products produced and distributed by NuVision and who have concerns should contact their health care provider.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety
Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm352949.htm

DSM-5 and RDoC: Shared Interests | NIMH

DSM-5 and RDoC: Shared Interests

The National Institute of Mental Health (NIMH) and the American Psychiatric Association (APA) have a shared interest in ensuring that patients and health providers have the best available tools and information today to identify and treat mental health issues, while we continue to invest in improving and advancing mental disorder diagnostics for the future.

Read NIMH and APA's joint statement on the DSM-5 and RDoC

I would title this something else. Think politics, hurt feelings, and ego massage.