Widely used diabetes drug can cause flesh-eating genital infection

Agencies
August 31, 2018

The U.S. Food and Drug Administration is warning doctors and patients that some widely used diabetes drugs may, in some rare cases, cause a flesh-eating bacterial infection of the genitals. The condition, known as Fournier’s gangrene, developed in a dozen patients shortly after they began taking the medicines between March 2013 and May 2018, the FDA said. The seven men and five women were all hospitalized and underwent surgery for the condition. One patient died.

More cases may be uncovered once the risk is better understood, the agency said in a statement. The drugs covered by the warning include Johnson & Johnson’s Invokana, AstraZeneca Plc’s Farxiga and Eli Lilly & Co.’s Jardiance. Known as SGLT2 inhibitors, they were approved in 2013, 2013 and 2016, respectively. The drugs help the body lower blood-sugar levels via the kidneys, and excess sugar is excreted in a patient’s urine. Urinary tract infections are a known side effect.

In comparison, the FDA found only six cases of the condition, all in men, in a review of all other diabetes drug classes for the past three decades. The drugs are expected to generate as much as $7.1 billion in sales by 2020, according to Bloomberg Intelligence. The FDA estimates about 1.7 million patients got a prescription for one of the medicines from a retail pharmacy in 2017, underscoring how rare the condition is.

All of the drugs in the class except Merck & Co.’s Steglujan, the most recently approved, have been linked to the condition. The manufacturers must add information about the risk to the prescribing information and medicine guides given to patients. AstraZeneca said it is working with the agency on updating the label and noted that it hadn’t seen any cases of the condition during the development of Farxiga. Officials at the other companies didn’t immediately return phone calls and emails requesting comment.

Diabetics using the drugs should seek immediate medical attention if they develop tenderness, redness or swelling of the genitals, and if they have even a slight fever of 100.4 degrees Fahrenheit, the agency said. The symptoms can worsen quickly, so it’s important to get help immediately, the drug agency said.

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Agencies
July 15,2020

The first COVID-19 vaccine tested in the US revved up people's immune systems just the way scientists had hoped, researchers reported Tuesday -- as the shots are poised to begin key final testing.

No matter how you slice this, this is good news, Dr. Anthony Fauci, the U.S. government's top infectious disease expert, told The Associated Press.

The experimental vaccine, developed by Fauci's colleagues at the National Institutes of Health and Moderna Inc., will start its most important step around July 27: A 30,000-person study to prove if the shots really are strong enough to protect against the coronavirus.

But Tuesday, researchers reported anxiously awaited findings from the first 45 volunteers who rolled up their sleeves back in March. Sure enough, the vaccine provided a hoped-for immune boost.

Those early volunteers developed what are called neutralizing antibodies in their bloodstream -- molecules key to blocking infection -- at levels comparable to those found in people who survived COVID-19, the research team reported in the New England Journal of Medicine.

This is an essential building block that is needed to move forward with the trials that could actually determine whether the vaccine does protect against infection, said Dr. Lisa Jackson of the Kaiser Permanente Washington Research Institute in Seattle, who led the study.

There's no guarantee but the government hopes to have results around the end of the year -- record-setting speed for developing a vaccine.

The vaccine requires two doses, a month apart.

There were no serious side effects. But more than half the study participants reported flu-like reactions to the shots that aren't uncommon with other vaccines -- fatigue, headache, chills, fever and pain at the injection site. For three participants given the highest dose, those reactions were more severe; that dose isn't being pursued.

Some of those reactions are similar to coronavirus symptoms but they're temporary, lasting about a day and occur right after vaccination, researchers noted.

Small price to pay for protection against COVID, said Dr. William Schaffner of Vanderbilt University Medical Center, a vaccine expert who wasn't involved with the study.

He called the early results a good first step, and is optimistic that final testing could deliver answers about whether it's really safe and effective by the beginning of next year.

It would be wonderful. But that assumes everything's working right on schedule, Schaffner cautioned.

Moderna's share price jumped nearly 15 percent in trading after US markets closed. Shares of the company, based in Cambridge, Massachusetts, have nearly quadrupled this year.

Tuesday's results only included younger adults. The first-step testing later was expanded to include dozens of older adults, the age group most at risk from COVID-19.

Those results aren't public yet but regulators are evaluating them. Fauci said final testing will include older adults, as well as people with chronic health conditions that make them more vulnerable to the virus and Black and Latino populations likewise affected.

Nearly two dozen possible COVID-19 vaccines are in various stages of testing around the world. Candidates from China and Britain's Oxford University also are entering final testing stages.

The 30,000-person study will mark the world's largest study of a potential COVID-19 vaccine so far. And the NIH-developed shot isn't the only one set for such massive U.S. testing, crucial to spot rare side effects. The government plans similar large studies of the Oxford candidate and another by Johnson & Johnson; separately, Pfizer Inc. is planning its own huge study.

Already, people can start signing up to volunteer for the different studies.

People think this is a race for one winner. Me, I'm cheering every one of them on, said Fauci, who directs NIH's National Institute of Allergy and Infectious Diseases.

We need multiple vaccines. We need vaccines for the world, not only for our own country. Around the world, governments are investing in stockpiles of hundreds of millions of doses of the different candidates, in hopes of speedily starting inoculations if any are proven to work.

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News Network
February 4,2020

Toronto, Feb 4: People who text while walking face a higher risk of an accident than those listening to music or talking on the phone, a study has found.

The study, published in the journal Injury Prevention, found that smartphone texting is linked to compromised pedestrian safety, with higher rates of 'near misses', and failure to look left and right before crossing a road.

Researchers from the University of Calgary in Canada call for a more thorough approach to exploring the impact of distracted pedestrian behaviours on crash risk.

Worldwide, around 270,000 pedestrians die every year, accounting for around a fifth of all road traffic deaths, according to the researchers.

'Pedestrian distraction' has become a recognised safety issue as more and more people use their smartphones or hand held devices while walking on the pavement and crossing roads, they said.

The researchers looked for published evidence to gauge the potential impact on road safety of hand-held or hands-free device activities.

This included talking on the phone, text messaging, browsing and listening to music.

From among 33 relevant studies, they pooled the data from 14 -- involving 872 people -- and systematically reviewed the data from another eight.

The analysis showed that listening to music wasn't associated with any heightened risk of potentially harmful pedestrian behaviours.

Talking on the phone was associated with a small increase in the time taken to start crossing the road, and slightly more missed opportunities to cross the road safely.

The researchers found that text messaging emerged as the potentially most harmful behaviour.

It was associated with significantly lower rates of looking left and right before or while crossing the road, and with moderately increased rates of collisions, and close calls with other pedestrians or vehicles, they said.

Texting also affected the time taken to cross a road, and missed opportunities to cross safely, but to a lesser extent, according to the researchers.

The review of the eight observational studies revealed that the percentage of pedestrians who were distracted ranged from 12 to 45 per cent, they said.

It also found behaviours were influenced by several factors, including gender, time of day, solo or group crossing, and walking speed.

The researchers acknowledge "a variety of study quality issues" which limit the generalisability of the findings.

"Given the ubiquity of smartphones, social media, apps, digital video and streaming music, which has infiltrated most aspects of daily life, distracted walking and street cross will be a road safety issue for the foreseeable future," the researchers noted.

"And as signage and public awareness campaigns don't seem to alter pedestrian behaviour, establishing the relationship between distracted walking behaviour and crash risk is an essential research need," they said.

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Agencies
January 4,2020

Washington D.C., Jan 3: A new study has found out that diet significantly affects the mental health and well being of an individual.

The study was published in the journal European Neuropsychopharmacology.

"We have found that there is increasing evidence of a link between a poor diet and the worsening of mood disorders, including anxiety and depression. However, many common beliefs about the health effects of certain foods are not supported by solid evidence," said the lead researcher, Professor Suzanne Dickson.

According to the researchers, the link between diet and mental health can be firmly established in certain cases like that of the ability of a ketogenic diet being helpful for children with epilepsy and the impact of vitamin B12 deficiency on poor memory, depression and fatigue.

"With individual conditions, we often found very mixed evidence. With ADHD for example, we can see an increase in the quantity of refined sugar in the diet seems to increase ADHD and hyperactivity, whereas eating more fresh fruit and vegetables seems to protect against these conditions," said Dickson

But there are comparatively few studies, and many of them don't last long enough to show long-term effects," added Dickson.

The study further concludes that some food items can be associated with treatment and the betterment of certain mental health conditions.

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