Month: December 2018

2018-12-21T07:01:00

(BPT) – Lab tests play a significant role in detecting, diagnosing and monitoring diseases. Clinical decisions are often guided by test results — results such as those that indicate whether a patient is having a heart attack or needs a medication adjustment, whether a patient is a candidate for surgery or chemotherapy, or results that determine whether a patient is healthy enough to return home from a hospital stay. Awaiting answers can scare and stress patients.

Producing test results quickly is increasingly challenging for laboratories. The aging baby boomer population sends more samples to the laboratory than previous generations; yet, the number of workers available to process samples is decreasing. There is a critical shortage of skilled laboratory workers to process such samples. Lab managers consequently have to find new ways to deliver patient results efficiently.

“Laboratories are facing major challenges: staffing shortages, budget constraints and consolidation with other laboratories as health systems grow — while the number of samples they’re expected to run is increasing rapidly,” said Andy Olen, senior vice president of Laboratory Diagnostics for North America at Siemens Healthineers. “The Atellica Solution was engineered with advancements never before seen in the clinical laboratory to address testing challenges with greater speed and efficiency to improve productivity so physicians can have their patients’ results faster.”

The Atellica Solution produces results for the most common tests run in the laboratory: pregnancy tests, blood glucose, electrolytes, hormones, lipids and many more. Laboratory staff now spends less time maintaining the analyzers thanks to built-in quality control features that are important for delivering accurate results.

This solution is a significant innovation for laboratories that frequently run emergency samples such as those used for cardiac emergencies. Laboratories will often dedicate staff and instruments to priority samples to expedite results. Staff can now process patient samples by priority order with technology that transports each sample individually so that emergency samples can cut to the front of the line. Dedicated equipment and staff to process emergency samples quickly is no longer necessary.

For some patients, the amount of blood that needs to be drawn to run a test is more important than the speed of their results. Cincinnati Children’s Hospital Medical Center, one of the oldest and most distinguished pediatric hospitals in the United States, became the first children’s hospital worldwide to install the Atellica Solution. As one of the nation’s most well-respected children’s hospitals, Cincinnati Children’s Hospital Medical Center must continue to look at ways that the laboratory can improve a patient’s experience. This solution will allow the hospital to complete its routine testing panels while using a smaller sample size.

Smaller sample sizes also are of significance to patients with compromised bone marrow function, such as cancer patients. Young red blood cells are released from bone marrow. Patients undergoing extended hospital stays sometimes have their blood drawn daily, which in many cases for these sick patients is more frequently than their bodies can replenish. Siemens Healthineers designed this solution with the patient in mind, incorporating technologies that produce sensitive and precise results from very small sample volumes.

Siemens Healthineers provides more than 10 billion diagnostic tests to labs globally each year and built the Atellica Solution to deliver what laboratories worldwide need to modernize their operations. Laboratories across the U.S. are resoundingly enthusiastic about implementing the state-of-the-art technology.

2018-12-21T07:01:00

(BPT) – While many parents and others shopping for young people know to look out for violence and sexual content in video games, they may not be aware of something else found in many popular games that is raising serious public health concerns.

Research shows that exposure to images of tobacco — its use still the leading cause of preventable death and disease in the U.S. — can influence young people to start smoking. In fact, 44 percent of adolescents who start smoking do so because of smoking images they see in movies. Tobacco use in video games is likely to promote youth smoking in similar ways and may even pose additional concerns since video games are more active and intense experiences. Some games even include storylines or elements where tobacco use benefits a player.

Despite the risk, tobacco content in video games is not a well-known issue. Here are some important things to be aware of so you can avoid games with tobacco content.

Many youth- and teen-rated games include tobacco.

Just because a game is rated appropriate for youth and teens does not mean it is free of tobacco imagery. While a methodical review of games on the U.S. market has yet to be conducted, it is clear from past research that tobacco use is frequently depicted in video games geared toward young people.

For example, between 1994 and 2011, 60 out of 78 large video game publishers included tobacco imagery in at least one, and often more, of their games rated appropriate for youth. A 2012 paper on the prevalence of tobacco in games found a significant increase in tobacco content in games rated for young adolescents since 2005.

More recently, Truth Initiative, the national public health organization behind the tobacco public education campaign truth, conducted a partial review of 2016 releases from top publishers and found more than a dozen video games with tobacco imagery, including at least five rated “Teen.”

Warnings and content descriptors are not always reliable.

Video game content descriptors often fail to mention tobacco use, making it difficult for parents to use them to monitor for tobacco imagery.

A 2015 survey by the University of California, San Francisco, confirmed tobacco content in 42 percent of the video games that participants reported playing; however, only 8 percent of these games had tobacco warnings from the Entertainment Software Rating Board, the gaming industry’s self-regulatory organization that rates video games and apps.

In its report, “Played: Smoking and Video Games,” Truth Initiative called on the ESRB to consistently identify and disclose if any game contains tobacco use or tobacco references. The organization is also urging game developers and publishers to stop including tobacco use and tobacco images in their games, particularly those marketed to or played by youth, regardless of their ESRB rating. Research suggests that pressure on movie producers has succeeded in decreasing tobacco imagery in youth-rated movies, and the same efforts should be used to influence game developers and publishers.

Even as national smoking rates have declined to record lows, smoking continues to be portrayed positively on screens. Glamorizing and re-normalizing smoking, and making it appear “cool,” could threaten the progress the U.S. has made in decreasing tobacco use, which kills 1,300 Americans every day.

For more on the topic of tobacco in video games, visit truthinitiative.org.

2018-12-20T08:01:02

In order to manage his type 2 diabetes and heart health, Matthew focuses on eating healthy foods, exercising regularly, and tracking his progress. He takes INVOKANA^® (canagliflozin) to lower his blood sugar, which is also approved by the US Food and Drug Administration to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes who have established CV disease. INVOKANA^® is the first and only oral diabetes treatment approved with this additional CV indication.

INVOKANA^® is a once-daily pill used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA^® can reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes who have established CV disease. In most clinical trials, the majority of people taking INVOKANA^® reached an A1C goal of less than 7%, which is recommended by the American Diabetes Association. INVOKANA^® is not for weight loss, but may help people lose weight—on average 2-3 percent. INVOKANA^® was also shown in clinical trials to reduce systolic blood pressure (on average 3-5 mmHg), though it is not indicated as a blood pressure medication. Results may vary by dose and when used alone or with certain other diabetes medications. INVOKANA^® may increase the risk of lower-limb amputations. The most common side effects of INVOKANA^® include genital yeast infections, urinary tract infection, and changes in urination. These specific adverse events were generally mild-to-moderate in intensity and infrequently led to discontinuation in clinical studies.

If you have type 2 diabetes, here are a few tips for living well with the condition and managing your cardiovascular risk:

• Learn about heart-healthy foods. These simple food swaps can help you create healthy meals and lower your risk of developing heart disease.
• Take the climb. Incorporate cardiovascular exercise into your daily routine — one great option is taking the stairs! Did you know you can do an entire workout on your staircase at home? These exercises will get your heart pumping. Before any strenuous physical activity, be sure to talk to your doctor.
• Ask your doctor about your cardiovascular risk. Your doctor can help you understand if you are at risk for a cardiovascular event, and what you can do to lower your risk while managing type 2 diabetes.

Visit INVOKANA.com to find more heart-healthy recipes and cardiovascular exercise ideas, as well as information on reducing your risk for major adverse cardiovascular events, important components in a type 2 diabetes management plan.

WHAT IS INVOKANA^®?

INVOKANA^® is a prescription medicine used:

• along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes
• to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes who have known cardiovascular disease. INVOKANA^® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA^® is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

INVOKANA^® can cause important side effects, including:

• Amputations. INVOKANA^® may increase your risk of lower-limb amputations. Amputations mainly involve removal of the toe or part of the foot; however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation, some on both sides of the body. You may be at a higher risk of lower-limb amputation if you: have a history of amputation, have heart disease or are at risk for heart disease, have had blocked or narrowed blood vessels (usually in leg), have damage to the nerves (neuropathy) in the leg, or have had diabetic foot ulcers or sores. Call your doctor right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Your doctor may decide to stop your INVOKANA^® for a while if you have any of these signs or symptoms. Talk to your doctor about proper foot care
• Dehydration. INVOKANA^® can cause some people to become dehydrated (the loss of too much body water), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk of dehydration if you have low blood pressure, take medicines to lower your blood pressure (including diuretics [water pills]), are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older
• Vaginal yeast infection. Women who take INVOKANA^® may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching
• Yeast infection of the penis (balanitis or balanoposthitis). Men who take INVOKANA^® may get a yeast infection of the skin around the penis. Symptoms include: redness, itching, or swelling of the penis; rash of the penis; foul-smelling discharge from the penis; or pain in the skin around penis

Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis.

Do not take INVOKANA^® if you:

• are allergic to canagliflozin or any of the ingredients in INVOKANA^®. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing
• have severe kidney problems or are on dialysis

Before you take INVOKANA^®, tell your doctor if you have a history of amputation; heart disease or are at risk for heart disease; blocked or narrowed blood vessels (usually in leg); damage to the nerves (neuropathy) of your leg; diabetic foot ulcers or sores; kidney problems; liver problems; history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; are going to have surgery; are eating less due to illness, surgery, or change in diet; pancreas problems; drink alcohol very often (or drink a lot of alcohol in short-term); ever had an allergic reaction to INVOKANA^®; or have other medical conditions.

Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. INVOKANA^® may harm your unborn baby. If you become pregnant while taking INVOKANA^®, tell your doctor right away. INVOKANA^® may pass into your breast milk and may harm your baby. Do not breastfeed while taking INVOKANA^®.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take diuretics (water pills), rifampin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir^®, Kaletra^® – used to treat HIV infection), or digoxin (Lanoxin^®– used to treat heart problems).

Possible Side Effects of INVOKANA^®

INVOKANA^® may cause serious side effects, including:

• Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 or type 2 diabetes, during treatment with INVOKANA^®. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with INVOKANA^® even if your blood sugar is less than 250 mg/dL. Stop taking INVOKANA^® and call your doctor right away if you get any of the following symptoms: nausea, vomiting, stomach-area pain, tiredness, or trouble breathing
• Kidney problems. Sudden kidney injury has happened to people taking INVOKANA^®. Talk to your doctor right away if you: 1) reduce the amount of food or liquid you drink, if you are sick, or cannot eat or 2) you start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long
• A high amount of potassium in your blood (hyperkalemia)
• Serious Urinary Tract Infections: may lead to hospitalization and have happened in people taking INVOKANA^®. Tell your doctor if you have signs or symptoms of a urinary tract infection such as: burning feeling while urinating, need to urinate often or right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Some people may also have high fever, back pain, nausea, or vomiting
• Low blood sugar (hypoglycemia). If you take INVOKANA^® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take INVOKANA^®

Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking, or feeling jittery.

• A rare but serious bacterial infection that destroys the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men who take INVOKANA^®. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries to remove affected tissues, and may lead to death. Seek medical attention immediately if you have fever or you are feeling very weak, tired, or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, or redness of the skin (erythema).

Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA^® and call your doctor right away or go to the nearest hospital emergency room.

Broken Bones (fractures): Bone fractures have been seen in patients taking INVOKANA^®. Talk to your doctor about factors that may increase your risk of bone fracture.

The most common side effects of INVOKANA^® include: vaginal yeast infections and yeast infections of the penis; changes in urination, including urgent need to urinate more often, in larger amounts, or at night.

Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.

Please click here for full Product Information, including Boxed Warning, and Medication Guide for INVOKANA^®.

Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.

Trademarks are those of their respective owners.

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2018-12-20T16:01:01

(BPT) – At the beginning of the school year in 2014, Laura Hall, a Spanish teacher from a town on Lake Champlain in Vermont, began experiencing an unrelenting cough that continued for months. After countless doctor visits and multiple false diagnoses — everything from allergies to influenza — Laura had lost nearly 20 pounds. Frustrated, tired and ill, but knowing something was terribly wrong, Laura took matters into her own hands and checked herself into the ER.

In the ER, Laura was finally diagnosed correctly with active tuberculosis, or TB. Without realizing it, she had been walking around with active TB for months, putting hundreds of students, colleagues, family and friends at risk of this airborne disease. According to Laura’s doctors, she most likely contracted TB while visiting family in Peru, though it is not clear how long the disease was living dormant in her body — meaning Laura may have been living with a latent TB infection (LTBI) for years, one that could have been treated long before it became active.

Many people consider TB a disease of the past, but it remains one of the most widespread, fatal infectious diseases worldwide, resulting in 1.3 million deaths a year. Approximately one-quarter of the world, including an estimated 13 million people in the U.S., are infected with LTBI, which has no symptoms and can progress to the highly contagious TB disease, particularly in those who are immunocompromised. Though only 10 percent of individuals infected with LTBI will go on to develop active TB, prevention of this life-threatening and contagious disease is essential. Given the silent symptoms of LTBI, people often aren’t diagnosed until it progresses to active disease.

Like most children who are born outside of the U.S., Laura was vaccinated for TB with the Bacillus Calmette–Guérin (BCG) vaccine as a child and was tested regularly throughout her career with the commonly used 100-year-old tuberculin skin test. However, the test never indicated Laura’s LTBI and she was never treated for it. If Laura had been accurately tested for LTBI, doctors may have been able to treat the infection before it progressed to the active, dangerous form of the disease.

“Most people do not understand the risk factors for TB progression, which is why latent TB infection often goes undiagnosed,” said Dr. Lee Reichman, founding executive director of Global Tuberculosis Institute at Rutgers University. “Those at a heightened risk should talk with their doctors about being tested with the more accurate blood test rather than the skin test.”

Laura’s active TB forced her to be quarantined at home for months. Laura’s isolation and resulting panic in the community led to her constantly questioning, “Why did this happen to me?”

“I couldn’t go out, see friends and was unable to teach for five months while I was being treated,” Laura said. “It was incredibly isolating. I remember the panic that developed at my school and local community when the Vermont Department of Health required that 500 students and co-workers be tested for TB after my diagnosis.”

The Department of Health found 19 children and two adults positive for LTBI using QuantiFERON^®-TB Gold, an advanced and accurate blood test for LTBI detection.

Today Laura does not want others to have the same experience, and she advocates for people to take control of their health by talking to their doctors about the risk factors of LTBI and about their testing options. By getting tested with a blood test, which yields results that are more accurate, objective and cost-effective than the older skin test, individuals who test positive for LTBI can begin treatment to stop the infection before it progresses to active disease.

If you or a family member think you may be living with latent TB, talk to your doctor about getting tested for latent TB — and request the accurate TB blood test.

The performance of the USA format of the QuantiFERON-TB Gold test has not been extensively evaluated with specimens from individuals younger than age 17 years, or in the immunocompromised population or in patients receiving immunosuppressive treatment or drugs.