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  • FDA Warning: Aspirin-Containing Antacid Medicines Can Cause Bleeding

    StomachDrugs containing an antacid and aspirin, and used to treat heartburn, sour stomach, acid indigestion, or upset stomach, can cause serious bleeding, FDA warns.

    Read the Drug Facts label to see if the product you’re using for these conditions has aspirin, especially if you have a risk factor for bleeding.

    The next time you reach for an over-the-counter (OTC) product to treat your upset stomach or heartburn, consider whether you should use one of the many antacids that don’t have aspirin.

    Why? Aspirin-containing medicines to treat heartburn, sour stomach, acid indigestion, or upset stomach can cause stomach or intestinal bleeding, especially in some people, warns the U.S. Food and Drug Administration (FDA).

    Cases of bleeding are rare. In 2009, FDA issued a warning about serious stomach bleeding risk with aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs). Despite that warning, when FDA reviewed its Adverse Event Reporting System database, it found eight new cases of serious bleeding caused by aspirin-containing antacid products since that 2009 warning. Some of those patients required a blood transfusion.

    Antacids Antacids (aka anti-acids) typically come in two forms - those that absorb or neutralize acids, and those that coat and protect against the acidic discomfort. First Aid Store offers both types of Antacid Remedies, with Pepto Bismol type pink bismuth, and Tums or Maalox type Antacid Tablets available in dispenser boxes and single dose packets. Antacids
    Antacids (aka anti-acids) typically come in two forms - those that absorb or neutralize acids, and those that coat and protect against the acidic discomfort. First Aid Store offers both types of Antacid Remedies, with Pepto Bismol type pink bismuth, and Tums or Maalox type Antacid Tablets available in dispenser boxes and single dose packets.

    “Take a close look at the Drug Facts label, and if the product has aspirin, consider choosing something else for your stomach symptoms,” says Karen Murry Mahoney, MD, Deputy Director of the Division of Nonprescription Drug Products at FDA. “Unless people read the Drug Facts label when they’re looking for stomach symptom relief, they might not even think about the possibility that a stomach medicine could contain aspirin.”

    Mahoney adds: “Today we’re focusing on bleeding risk specifically with antacid-aspirin products used to treat upset stomach or heartburn. We’re not telling people to stop taking aspirin altogether.”

    How will you know what OTC medicine to take to get relief from indigestion? Again, it’s important to read the Drug Facts label. It will tell you if the product contains aspirin, and it lists the risk factors for bleeding. If the medicine has aspirin, consider looking for something else. There are plenty of stomach medicines that don’t contain aspirin.

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  • Right to Try: aka Drugs or Death

    We've shared information about the FDA in the past, especially concerning Automated External Defibrillators'Antibacterial' SoapConsumer RecallsTruth in Advertising, and Consumer complaints. We've also discussed the FDA stance on Generic Drugs. Now we'll discuss some uglier aspects of the FDA... especially concerning terminally ill individuals and their "Right to Try" experimental and/or not-quite-approved-for-market drugs.

    Many States have passed local legislation to allow such terminal patients to do just that - try drugs not yet FDA approved. The concept is simple, really, constitutionally, the Federal agencies are not supposed to be able to supersede the sovereignty of the State (meaning the Feds can't trump a State Law). Morally, these laws make sense... these patients are dying, these drugs might help. If they don't help, or even hasten the end, is it really a big deal? Not when the patients themselves choose the risk, and not compared to the advancement and testing of these possible cures for others that will result from this human testing.

    The main issue is that the FDA says that it is illegal to administer drugs to a dying patent if they haven't passed their approval process - even if they are likely to help, and the alternative is certain death. Many individuals and lawmakers disagree. "Right to Try" laws are designed to let terminally ill patients try experimental therapies, treatments and drugs that have completed Phase 1 testing but have not been approved by the Food and Drug Administration (FDA) for market.

    According to Wikipedia, Colorado became the first state to pass a right-to-try law. As of February 2016, 24 states have enacted such laws: Alabama, Arizona, Arkansas, Colorado, Florida, Illinois, Indiana, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, North Carolina, North Dakota, Oklahoma, Oregon, South Dakota, Tennessee, Texas, Utah, Virginia, and Wyoming

    It really comes down to one's position on what our individual rights of choice are or are not.

    What does "Bringing a new Medication to Market" cost?

    FDAThe cost of getting a new drug through FDA approval can be prohibitive, running from "as low as" $7 million upwards of $500 million according to Fast Magazine.

    Average out-of-pocket cost for each phase of clinical trials:
    Phase I - $18.6 million
    Phase II - $28.8 million
    Phase III - $105.8 million

    How long to get a new drug approved and on the market for use?

    According to the FDA, it takes up to 14 years to bring a new drug to market, passing through several stages and milestones before the public gets their hands on it:

    FDA Approval process FDA Approval process

    And this, of course assumes it passes all the rigorous stages along the way.... which even the FDA will tell you is only about 5 of every 5,000 submitted!

    There are exceptions, of course, and accelerated programs, but again, we're talking about power and money to get this through.

    Here's a recap of the process from the FDA itself:

    FDADrug companies continuously analyze thousands of compounds, seeking ones of therapeutic value. During the six to seven years of preclinical testing, the manufacturer completes synthesis and purification of the drug and conducts limited animal testing. Of five thousand compounds tested, approximately five will appear promising enough to induce the company to file an Investigational New Drug Application (IND). If the IND is approved by the FDA and by an Institutional Review Board, the manufacturer may begin the first phase of development.

    The IND stage consists of three phases. In phase I, clinical trials using healthy individuals are conducted to determine the drug’s basic properties and safety profile in humans. Typically the drug remains in this stage for one to two years. In phase II, efficacy trials begin as the drug is administered to volunteers of the target population. At the end of phase II, the manufacturer meets with FDA officials to discuss the development process, continued human testing, any concerns the FDA may have, and the protocols for phase III, which is usually the most extensive and most expensive part of drug development. During the phases of the IND, the manufacturer can obtain accelerated development/review of the drug. Other accommodations for usage prior to approval include treatment IND and parallel tracking.

    Once phase III is complete, the manufacturer files an NDA. Review of the NDA typically lasts one to two years, bringing total drug development and approval (that is, the IND and NDA stages) to approximately nine years. During the NDA stage, the FDA consults advisory committees made of experts to obtain a broader range of advice on drug safety, effectiveness, and labeling. Once approved, the drug may be marketed with FDA regulated labeling. The FDA also gathers safety information as the drug is used and adverse events are reported, and it will occasionally request changes in a labeling or will submit press releases as new contraindications arise. If adverse events appear to be systematic and serious, the FDA may withdraw a product from the market.

    Over time there has been a clear tendency for FDA regulations and requirements to expand and multiply. In 1980, the typical drug underwent thirty clinical trials involving about fifteen hundred patients. By the mid-1990s, the typical drug had to undergo more than sixty clinical trials involving nearly five thousand patients.

    Public Agenda Online has some useful background information on medical and drug research in the form of easy-to-read charts.

    Why Drugs fail to get FDA Approval:

    While many drugs are not approved as there in no proof of efficacy, far more fail the test of time, paperwork, and money - basically, only the big pharmaceutical companies have the legions of paper pushers, scientists, lawyers, and moneybags to make it to the finish line.

    According to the National Institutes for Health, Some new drug applications fail because of inadequate drug performance and others are not approved because the information submitted to the US Food and Drug Administration (FDA) is unsatisfactory to make that determination. Resubmission of failed applications is costly, delaying marketing approval and the availability of new drugs to patients.

    The testing and stringent guidelines of the FDA are all well-intended and are in place to protect the consumer - but they can also keep life-saving drugs from reaching the market in a timely manner, if at all.

  • FDA on AEDs (Automated External Defibrillators)

    While Public Access Defibrillation (PAD) means thousands of AEDs on street corners for anyone to use in other countries, here in the USA, our government tends to "err on the side of caution". In other places, the approval for these critical lifesaving devices is streamlined to fast-track to market, while in the US regulatory agencies continue to impede production and supply.

    We're not saying thorough testing and engineering controls aren't essential, but rather governing agencies like the FDA should do more to assist in the process and lower the high cost- and time-barriers the impose. It is a very frustrated market where some agencies and legislation require AEDs in public (places such as gyms and restaurants) yet others are regularly slowing production or halting shipping altogether.

    Below is a press release from the FDA yesterday. Suddenly and "un-relatedly" at least two of the top five AED brands suddenly went on "backorder" and aren't shipping for a few weeks.


    The U.S. Food and Drug Administration announced today that it will strengthen its review of automated external defibrillators (AEDs) to help improve the quality and reliability of these devices.

    The FDA issued a final order that will require AED manufacturers to submit premarket approval applications (PMAs), which undergo a more rigorous review than what was required to market these devices in the past. The agency’s strengthened review will focus on the critical requirements needed to ensure the safety and reliability of AEDs and their necessary accessories, including batteries, pad electrodes, adapters and hardware keys for pediatric use.CPR-AED-BANNER

    “Automated external defibrillators save lives,” said William Maisel, M.D., M.P.H, deputy director for science, chief scientist and acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “These changes to the way these devices are reviewed will allow us to more closely monitor how they are designed and manufactured. This will go a long way towards correcting long-standing problems and ultimately improving the reliability of these devices.”

    Automated external defibrillators are portable, electronic medical devices that automatically sense potentially life-threatening cardiac arrhythmias and either automatically deliver or advise the user to deliver electrical stimulation to re-establish normal heart rhythms. They are often stored in public locations for use in an emergency and, while they can be lifesaving, there has been a history of malfunction issues.

    AEDs are EASY to use! AEDs are EASY to use!

    From January 2005 through September 2014, the FDA received approximately 72,000 medical device reports associated with the failure of these devices. Since 2005, manufacturers have conducted 111 recalls, affecting more than two million AEDs. The problems associated with many of these recalls and reports included design and manufacturing issues, such as inadequate control of components purchased from other suppliers.

    By requiring premarket approval for these devices, the FDA will receive important information about an AED manufacturer’s quality systems information. The FDA will also conduct inspections of manufacturers’ facilities prior to approval. After approval, manufacturers will be required to submit to the FDA any changes made to the devices that affect safety or effectiveness, and annual reports on device performance.

    Given the importance of these devices in emergency situations, AEDs currently on the market will remain available while manufacturers work to meet the new PMA requirements. The FDA does not intend to enforce the PMA requirement for AEDs until July 29, 2016, as long as manufacturers notify the FDA of their intent to file a PMA by April 29, 2015. The FDA does not intend to enforce the PMA requirement for currently marketed, necessary AED accessories until January 29, 2020.

    The Food and Drug Administration Safety and Innovation Act calls for the FDA to publish proposed and final orders to reclassify or call for PMAs for pre-amendments devices. The FDA’s Circulatory System Devices Panel recommended that AEDs remain Class III medical devices and require PMAs. The FDA originally issued a proposed order in March 2013 calling for PMAs to ensure the appropriate regulation of Class III pre-amendments devices.

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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    Also Read:

    Looking for an AED?

    Defibrillator - AED Grants for business, Groups and Individuals! AED Grants for business, Groups and Individuals!
    AEDGrant.com Public & Private Entities Grant for funding Automated External Defibrillators (AEDs).This program is designed to help institutions and individuals everywhere place these amazing life saving devices at an affordable price. You may even apply as an Individual for a Home AED!Generous participation and corporate backing have been secured by AEDGrant.com for this corporate sponsored AED Buy Down Grant Project .AEDGrant.com also offers training for CPR and AEDs.
    AEDGrant.com can help you donate an AED, receive funding for an AED Device, place defibrillators in your home or workplace, help public facilities obtain AED Grants for Automated External Defibrillators and discounts on AED Batteries and AED Cabinets. We work with AED Manufacturers such as Medtronic, Philips, Defibtech, Heartsine, and Zoll to provide state of the art AED machines like the the OnSite, FRx, LifePak, PAD, Lifeline, Samaritan, CPR Plus, LifePak 500 and more... let us know your Defibrillation of AED Training need, and we can help you find your AED answers. We even have resources for refurbished AEDs and AED Refurbishers.
  • FDA, CPR and SmartPhone Apps

    USA Today says that the FDA is slowing down the Nation's head long plunge toward techno-life and safety by stepping in and regulating First Aid, CPR, and other Health-related apps. It is true, these things can certainly slow progress, on the other hand, some things require a live, hands on approach, so a modicum of caution is appropriate - for instance the reference here to CPR... it is, indeed awesome that apps can now "coach" someone through CPR - others can leads rescuers to the nearest AED... these are good things. On the other hand, why isn't the FDA cracking down on the websites offering "CPR certification" online? You cannot learn CPR by clicking a mouse. Whether compression only/hands-only CPR or full CPR with rescue breathing - these things require real practice, with an Instructor and a manikin. Leave the helpful apps alone and clamp down on the scam site selling "certifications".

    Everyone needs to know CPR - and it is not expensive to learn. American CPR Training teaches group CPR & First Aid classes at your location from as low as $16.50 per Student for full 2 year Adult, Child & Infant CPR - anywhere in the USA!

    If you don't have a group of 4 or more, there is an awesome program to learn CPR at Home (including CPR Manikins!) /catalogsearch/result/?q=cpr+anytime

    The national group American CPR Training (www.AmericanCPR.com) is teaching their new easy C.A.R.E. CPR™ Their website says:
    American CPR Training™ ~ America's Favorite CPR, AED & First Aid Training™ is more than just the Leader in Safety Training throughout the US, Canada, & Mexico... American CPR Training is ½ the Time, ½ the Price, and TWICE the Fun!™

    image of CPR kit Infant CPR Anytime is an “all-in-one” learning kit that teaches the basic skills of Infant CPR, Infant choking relief and calling for help in approximately 20 minutes.
    Infant CPR Anytime allows users to learn these life-saving skills anywhere, either in the comfort of their own home or in large group settings.
    The kit teaches CPR using the AHA’s research-proven “practice-while-watching” technique, which allows
    users to watch an instructional DVD while practicing their skills on a personal manikin.
    Infant CPR Anytime is designed to be shared with close family members and friends to help extend lifesaving training to more people. Because more lives can be saved….
    The Infant CPR Anytime kit includes the following:
    · 1 bilingual (English/Spanish) Infant CPR Anytime DVD
    · 1 poly-bagged Mini Baby® CPR personal manikin
    · 1 bilingual (English/Spanish) Infant CPR Anytime skills reminder card
    · 1 Mini Baby replacement lung
    · Manikin wipes

    While the government certainly offers many of it's own apps ( See our article on 100+ free Phone Apps) for everything from finance and immigration to health and safety, USA Today thinks they are now sticking their nose in where it doesn't belong in regulating Smartphone apps...

    FDA's slow process hurts innovation: 

    Agency keeps us safe, but process could slow development of low-risk health technology.

    They've helped coaches perform CPR on breathless athletes. They remind pharmacists in sub-Saharan Africa to order more retroviral drugs for HIV patients, and their pocket-sized storage capacity dwarfs bulky filing cabinets. Smart phones have revolutionized the way we live and their capabilities appear restricted only by the limits of our imaginations.

    Technology has changed the way Nebraskans and Mainers stay in touch, do business, and feed the world. The best ideas have always come from a couple of guys working out of a garage, or a young woman with a breakout business model. That's the genius of America.

    As the gatekeeper for new health information technologies trying to enter the marketplace, the Food and Drug Administration is tasked with keeping Americans safe. The FDA's work is important, but its processes are often painstakingly slow and based on outdated assumptions. This halting regulatory pace, along with a lack of bureaucratic incentives to embrace disruptive technological change, has often held back progress.
    Continue reading

  • FDA Warns of Rare Acetaminophen Risk

    Acetaminophen can be a Rash Risk

    A warning about of a rare risk of three skin diseases will be added to the labels of prescription products containing acetaminophen, a widely used pain and fever relief medication. FDA is also working with the manufacturers of non-prescription products containing acetaminophen to add the warning to packages.

    If you are taking acetaminophen and develop a rash or other skin reaction, stop taking the product immediately and seek medical attention.

    FDA Warns of Rare Acetaminophen Risk - bottle

     

    FDA Warns of Rare Acetaminophen Risk - healthcare providerIf you've ever had a skin reaction when taking acetaminophen, don't take the drug again and discuss alternate pain relievers/fever reducers with your health care professional.

    Acetaminophen, a fever and pain reliever that is one of the most widely used medicines in the U.S., can cause rare but serious skin reactions, warns the Food and Drug Administration (FDA).

    Although rare, possible reactions to acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of skin. If you are taking acetaminophen and develop a rash or other skin reaction, stop taking the product immediately and seek medical attention right away.

    Used for decades by millions of people, acetaminophen is the generic name of a common active ingredient included in numerous prescription and non-prescription medicines. Tylenol is one brand name of the pain reliever sold over the counter, but acetaminophen is also available as a generic under various names. It is also used in combination with other medicines, including opioids for pain and medicines to treat colds, coughs, allergy, headaches and trouble sleeping.

    "This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications," says Sharon Hertz, M.D., deputy director of FDA's Division of Anesthesia, Analgesia and Addiction. "However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious, side effects, which are potentially fatal."

    Other drugs used to treat fever and pain, such as nonsteroidal anti-inflammatory drugs including ibuprofen and naproxen, already carry warnings about the risk of serious skin reactions. Advil and Motrin are among the common brand names that include ibuprofen as an active ingredient. Aleve and Midol Extended Relief are among the best-known brand names that include naproxen as an active ingredient.

    FDA is requiring that a warning about these skin reactions be added to the labels of all prescription medicines containing acetaminophen. FDA will work with manufacturers to get the warnings added to the labels of over-the-counter (OTC) medicines containing acetaminophen.

    On OTC medicines, the word "acetaminophen" appears on the front of the package and on the Drug Facts label's "active ingredients" section. On prescription medications, the label may spell out the ingredient or use a shortened version such as "APAP," "acet," "acetamin" or "acetaminoph."

    Ingredient Linked to Several Conditions

    Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) are the two most serious skin reactions linked in rare cases to acetaminophen. They usually require hospitalization and can cause death.

    Problems usually begin with flu-like symptoms followed by rash, blistering and extensive damage to the surfaces of the skin. Recovery can take weeks or months, and possible complications include scarring, changes in skin pigmentation, blindness and damage to internal organs.

    A third skin reaction, acute generalized exanthematous pustulosis (AGEP), usually resolves within two weeks of stopping the medication that caused the problem.

    A serious skin reaction can occur at any time, even if you've taken acetaminophen previously without a problem. There is currently no way of predicting who might be at higher risk.

    If you've ever had a skin reaction when taking acetaminophen, don't take the drug again and discuss alternate pain relievers/fever reducers with your health care professional.

    Evidence of Link

    Prior to deciding to add a warning about skin reactions to products containing acetaminophen, FDA reviewed medical literature and its own database, the FDA Adverse Event Reporting System (FAERS).

    A search of FAERS uncovered 107 cases from 1969 to 2012, resulting in 67 hospitalizations and 12 deaths. Most cases involved single-ingredient acetaminophen products; the cases were categorized as either probable or possible cases associated with acetaminophen.

    A small number of cases, just over two dozen, are documented in medical literature, with cases involving people of various ages.

    FDA has examined—and continues to examine—acetaminophen for safety issues, just as it does with all approved drugs. The warning comes two years after FDA took new steps to reduce the risk of liver injury from acetaminophen. In that case, FDA asked all makers of prescription products to limit acetaminophen to 325 milligrams per tablet or capsule. FDA also required all prescription acetaminophen products to include a Boxed Warning—FDA's strongest warning, used for calling attention to serious risks.

    The agency continues to consider the benefits of this medication to outweigh the risks.

    "FDA's actions should be viewed within the context of the millions who, over generations, have benefited from acetaminophen," says Hertz. "Nonetheless, given the severity of the risk, it is important for patients and health care providers to be aware of it."

    This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

    August 1, 2013

  • Brand Name Blindness - is a Drug the same without the name?

    Are you a sucker for the Brand Name? - It is just a name... a Rose by any other name... you get it... or Do You?

    2 Reasons Consumers Can't Help But Waste Money On Brand-Name Drugs

    When drug-maker Novartis yanked its blockbuster pain reliever, Excedrin, off shelves in 2012, people were so desperate to get their hands on the stuff that they shelled out hundreds of dollars to online resellers.

    It didn't matter that there were plenty of generic and store-brand varieties to fill the gap. Somehow, people had it in their heads that brand names were simply better.

    “The generic version at CVS isn’t quite the same,” an eBay user who sells Excedrin told the New York Post. “Like comparing a steak from T.G.I. Friday’s to Peter Luger’s.”

    But he's wrong. Not only are these other brands a better bargain than Excedrin––Walmart sells its 100-count Equate brand for $3 and Walgreens sells a version for about $9, according to Consumer Reports––but they contain the exact same ingredients. Federal law dictates as much, and the U.S. Food & Drug Administration is tasked with making sure stores comply. (see post Drugs – U.S. Food & Drug Administration (FDA) on Generic Drugs)

    ExcedrineFor some reason, however, even science isn't enough to convince consumers not to spend more for the same product. It's the kind of irrational behavior behavioral economics expert Dan Ariely analyzes in his book "Predictably Irrational."

    "The truth is that [name-brand drugs] run on the power of suggestion. They are effective because people believe in them," Ariely writes. "You see your doctor and you feel better. You pop a pill and you feel better. And if your doctor is a highly acclaimed specialist, or your prescripton is for a new wonder drug of some kind, you feel even better."

    There are two factors driving us to believe that the store brand version of Excedrin is somehow less powerful than the name brand stuff, he says.

    Belief. Just as patients believe a pill can work wonders because their friend or coworker raves about them, we're more likely to believe in a certain drug if it's widely known and trusted. "Even a doctor's enthusiasm for a particular treatment or procedure may predispose us toward a positive outcome," Ariely says. "Branding, packaging, and the reassurance of the caregiver can make us feel better."

    Conditioning. If you've been taking Excedrin or any type of drug for an extended period of time and find relief, you'll condition yourself to expect relief from that particular treatment. "The body builds up expectancy after repeated experiences and releases various chemicals to prepare us for the future," Ariely says. That expectation is difficult to remove or re-associate with another product.

    The only way to change your behavior is to adjust the way you think about pain relief, Ariely suggests.

    "Consumers who stop to reflect about the relationship between price and quality are far less likely to assume that a discounted drink is less effective...These results not only suggest a way to overcome the relationship between price and the placebo effect but also suggest that the effect of discounts is largely an unconscious reaction to lower prices."

     

    meds-and-tabs

     

    Read more: Business Insider
  • Drugs. FDA monitors truth in advertising

    FDA's Office of Prescription Drug Promotions (OPDP), monitors for truth and balance

    Keeping Drug Advertising Honest and Balanced Keeping Drug Advertising Honest and Balanced

    Drug companies spend $25 billion a year in the U.S. promoting prescription medications, including a growing amount spent on direct-to-consumer advertising. Thomas Abrams, director of FDA's Office of Prescription Drug Promotions (OPDP), discusses what his staff does to monitor for truth and balance.

    READ MORE ? Keeping Drug Advertising Honest and Balanced

     

    Continue reading

  • FDA is asking for Consumer complaints

    WANTED: Consumers to Report Problems

    FDAA new consumer-friendly form is now available for making reports to MedWatch, FDA's on-line system for collecting information about serious problems with drugs, medical devices and other FDA-regulated products.

    The less technical form is part of a larger effort to encourage consumers to submit quality reports. By reporting your experience or suspicion of a product problem to MedWatch, you could help identify an unknown risk and potentially spark a variety of actions—from changes to a warning label to removal of the product from the market.

    Read this Consumer Update to learn more about what FDA is doing to increase consumer participation in MedWatch

  • Picnic Food Safety: How Safe Is Your Picnic? FDA Free Webinar Tomorrow

    Picnics are a great way to enjoy the outdoors but did you know that warm weather increases opportunities for foodborne illness?

    picnic_basketThe Food and Drug Administration (FDA) will host a webinar "Picnic Food Safety," Thursday, May 30 at 1 PM ET. Nadine M. Shaw, of FDA's Center for Food Safety and Applied Nutrition, will share tips on how to ensure a safe picnic.

    Visit FDA Basics to learn how to join this webinar.


  • Keep Listeria Out of Your Kitchen

    Is your Kitchen ant Risk? Could your Family get sick?
    If you eat food contaminated with bacteria called Listeria, you could get so sick that you have to be hospitalized. And for certain vulnerable people, the illness could be fatal.

    Contaminated food can bring Listeria into the home. Unlike most bacteria, Listeria germs can grow and spread in the refrigerator. So if you unknowingly refrigerate Listeria-contaminated food, the germs not only multiply at the cool temperature, they could contaminate your refrigerator and spread to other foods there, increasing the likelihood that you and your family will become sick.

    Those most at risk for listeriosis—the illness caused by Listeria monocytogenes—include pregnant women, older adults and people with compromised immune systems and certain chronic medical conditions (such as HIV/AIDS, cancer, diabetes, kidney disease, and transplant patients). In pregnant women, listeriosis can cause miscarriage, stillbirth, and serious illness or death in newborn babies.

    What foods could be contaminated?

    Listeria has been linked to a variety of ready-to-eat foods, including deli meats, hot dogs, smoked seafood and store-prepared deli-salads. A draft study released May 10, 2013 by the Food and Drug Administration (FDA) and the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) evaluates the risk of listeriosis associated with foods prepared in retail delis. There are many steps that deli operators and processing establishments that supply food to delis can follow to reduce the risk of listeriosis.

    FDA and FSIS recommend that consumers at risk for developing listeriosis—including older adults, pregnant women and people with compromised immune systems—reheat hot dogs and lunch meats until steaming hot.

    At-risk consumers are also advised to avoid unpasteurized milk and soft cheeses (such as feta, brie, camembert, blue-veined cheeses, "queso blanco," "queso fresco" or Panela), unless they are made with pasteurized milk.

    And Listeria can sometimes be found in other foods. In 2011, a multi-state outbreak of listeriosis tied to contaminated cantaloupes caused illnesses and deaths.

    Donald Zink, Ph.D, senior science advisor at FDA's Center for Food Safety and Applied Nutrition, says FDA is aware of cases of foodborne illness caused by bacteria that can live in the kitchen and spread to foods that had not been contaminated.

    Consumers are advised to wash all fruits and vegetables under running water just before eating, cutting or cooking, even if you plan to peel the produce first. Scrub firm produce such as melons and cucumbers with a clean produce brush.

    To further protect yourself and your family from Listeria, follow these steps:

    Keep Refrigerated Foods Cold

    Chilling food properly is an important way of reducing risk of Listeria infection. Although Listeria can grow at refrigeration temperatures, it grows more slowly at refrigerator temperatures of 40 degrees F or less.

    • Keep your refrigerator at 40 degrees F or lower and the freezer at 0 degrees F or lower.
    • Wrap or cover foods with a sheet of plastic wrap or foil or put foods in plastic bags or clean covered containers before you place them in the refrigerator. Make certain foods do not leak juices onto other foods.
    • Place an appliance thermometer, such as a refrigerator thermometer, in the refrigerator, and check the temperature periodically.  Adjust the refrigerator temperature control, if necessary, to keep foods as cold as possible without causing them to freeze. Place a second thermometer in the freezer to check the temperature there.
    • Use precooked and ready-to-eat foods as soon as you can. The longer they are stored in the refrigerator, the more chance Listeria has to grow.

    "If you have leftovers in your refrigerator, it’s best to throw them out after three days, just to be sure,” says Zink. “It's better to be safe than sorry."

    Clean Refrigerator Regularly

    Listeria can contaminate other food through spills in the refrigerator.

    • Clean up all spills in your refrigerator right away—especially juices from hot dog and lunch meat packages, raw meat, and raw poultry. Consider using paper towels to avoid transferring germs from a cloth towel.
    • Clean the inside walls and shelves of your refrigerator with warm water and liquid soap, then rinse. As an added measure of caution, you can sanitize your refrigerator monthly using the same procedures described below for kitchen surfaces.

    Clean Hands and Kitchen Surfaces Often

    Listeria can spread from one surface to another.

    • Thoroughly wash food preparation surfaces with warm, soapy water. As an added precaution you should sanitize clean surfaces by using any of the kitchen surface sanitizer products available from grocery stores, being careful to follow label directions.

    You can make your own sanitizer by combining 1 teaspoon of unscented bleach to one 1 quart of water, flooding the surface and letting it stand for 10 minutes.  Then rinse with clean water.  Let surfaces air dry or pat them dry with fresh paper towels.  Bleach solutions get less effective with time, so discard unused portions daily.

    • Antimicrobial Wipes
      Safetec Personal Antimicrobial Wipes available bulk or boxed - Dispenser canister of SaniZide Plus Germicidal Wipes. Tough microbe killing substances such as Cholroxylenol (PCMX) and Ethyl Alcohol.
    • Germicidal Solutions
      Sanizide Plus environmental surface germicidal solution, available in spray bottles and gallon jugs. Proven effective against a wide variety of bacterial and viral pathogens.
    • Germicidal Wipes
      Personal Germicidal Wipes individually wrapped and in dispenser canisters - SaniZide Plus Germicidal Wipes - These pre-saturated hard surface wipes kill TB, MRSA, VRE, E Coli and more in 10 minutes and HIV-1 in 2 minutes.
    • A cutting board should be washed with warm, soapy water after each use. Nonporous acrylic, plastic, or glass boards can be washed in a dishwasher.

    • Dish cloths, towels and cloth grocery bags should be washed often in the hot cycle of your washing machine.
    • It’s also important, to wash hands with warm water and soap for at least 20 seconds before and after handling food.

    This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.Kitchen

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