Type 2 diabetes drug metformin recalled over contamination with possible carcinogen

Nostrum Laboratories Inc., based in Kansas City, Missouri, announced Monday that it is voluntarily recalling its metformin HCl extended release tablets, USP 750 mg, according to a recall posted by the US Drug & Food Administration.
Testing revealed levels of nitrosamine, or NDMA, above acceptable limits in the recalled tablets.
The chemical NDMA is considered a possible carcinogen by the US Environmental Protection Agency. It’s an organic chemical used to make liquid rocket fuel and it can be a byproduct of manufacturing, including pharmaceutical manufacturing. It’s also found in water and foods, including meats, dairy and vegetables.

NDMA has also been found in certain blood pressure drugs and antacid.

This is the latest in a series of metformin recalls linked to potentially cancer-causing contaminants in the drugs.

Nostrum said it has not received any reports of adverse events related to the recall. The company also said it was notifying its distributors and arranging for the return of the recalled product.

The impacted product is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. The affected Metformin HCl Extended Release Tablets, USP 750 mg lots are under NDC 29033-056-01, lot numbers MET200101 and MET200301 which expiration date 05/2022. It can be identified as an off-white oblong tablet debossed with “NM7.”

More than 34 million people in the US have diabetes — about 1 in 10 — with approximately 90 to 95% of them being diagnosed with type 2 diabetes, according to the US Centers for Disease Control and Prevention.

Source Article

Read more

Coronavirus updates: CDC says people who test positive for covid-19 can still vote in person

Here are the latest developments:

As the presidential election collides with a global pandemic, the CDC says that people who are sick with the coronavirus can still vote in person on Tuesday.

In newly-updated guidance published Sunday, the agency says that voters who have tested positive or may have been exposed to the coronavirus should follow the standard advice to wear a mask, stay at least six feet away from others and sanitize their hands before and after voting. “You should also let poll workers know that you are sick or in quarantine when you arrive at the polling location,” the CDC’s website states.

For tens of thousands of Americans, that may be the only option: People who received their test results in the past few days missed the cutoff to request an absentee ballot in most states, and getting an exemption typically requires surmounting arduous logistical hurdles, as The Post previously reported. But the prospect of casting a ballot alongside someone who’s sick is unlikely to defuse the tension surrounding mask-wearing at polling places — something that remains optional in multiple states.

While turnout numbers and exit polls consume much of the national attention, the steady rise of new infections across the country shows no sign of abating. The United States reported more than 86,000 new coronavirus cases on Monday, pushing the total count to nearly 9.3 million, according to data tracked by The Post. Twelve states — Arkansas, Iowa, Kentucky, Missouri, Montana, Nebraska, New Mexico, Ohio, Utah, West Virginia, Wisconsin and Wyoming — recorded record numbers of hospitalizations.

Rural areas are feeling the strain. In Utah, overwhelmed hospitals are repurposing pediatric beds for adult patients, and plan to soon start bringing in doctors who don’t typically work in hospitals, the Salt Lake Tribune reported.

“We’re asking people to do things that they trained for, maybe when they were a resident, but they haven’t done in three years,” Russell Vinik, chief medical operations officer at University of Utah Health, told the paper on Monday.

Jacqueline Dupree contributed to this report.

Source Article

Read more

Fred Hutch researchers uncover new genetic details of White House COVID-19 outbreak

Since it was revealed in early October, details about President Trump’s COVID-19 infection have been in short supply, including the likely source of his exposure and when he was tested.

a group of people standing in front of a building: Judge Amy Coney Barrett delivers remarks after President Donald Trump announces her nomination to the U.S. Supreme Court, Sept. 26, 2020, in the Rose Garden of the White House. The event is believed to be responsible for the spread of COVID-19 among some attendees. (Official White House Photo by Andrea Hanks, Public Domain )

© Provided by Geekwire
Judge Amy Coney Barrett delivers remarks after President Donald Trump announces her nomination to the U.S. Supreme Court, Sept. 26, 2020, in the Rose Garden of the White House. The event is believed to be responsible for the spread of COVID-19 among some attendees. (Official White House Photo by Andrea Hanks, Public Domain )

New research from the Fred Hutchinson Cancer Research Center in Seattle gives a glimpse into the spread of the disease among America’s first family and White House staff and guests.

Two journalists who directly interacted with White House officials at the end of September — but were not in each other’s company — contracted variations of the virus that were “highly genetically similar.” The genetic code from the SARS-CoV-2, the virus that causes COVID, that infected the journalists contained five unique mutations and were distinct from the genomes of more than 160,000 publicly available virus sequences.

The scientists said this particular lineage of the virus was first documented in the U.S. in April or May, but its exact spread from there was unclear.

Shortly after Trump was infected, Anthony S. Fauci — the nation’s top infectious-disease expert — said that the White House had been the site of a so-called super spreader event when it hosted a Rose Garden reception for Judge Amy Coney Barrett, now a member of the U.S. Supreme Court. Photos show that many in attendance did not wear masks. At least 50 COVID-19 cases have been connected to an outbreak associated with the White House, according to the researchers.

Trump Administration officials at the time of the outbreak made little effort to do contact tracing to potentially help contain the spread — a decision that drew criticism from some health experts.

When it comes to the source of the White House infections, “it’s sort of an unknowable question, where it entered the environment,” said White House deputy press secretary Brian Morgenstern, in a press conference on Oct. 7.

The Fred Hutch-led research calls that assertion into question. While it’s too late to use the information to limit spread from the initial event, genomic sequencing could provide additional insights into the path of transmission if more samples were tested. It could also help build a more complete picture of the outbreak’s spread by analyzing infections that occur weeks or months following the White House event.

chart: Researchers at the Fred Hutchinson Cancer Research Center have created a family tree for SARS-CoV-2, the virus that causes COVID-19, and identified the form associated with the White House outbreak. (Fred Hutch Image)

© Provided by Geekwire
Researchers at the Fred Hutchinson Cancer Research Center have created a family tree for SARS-CoV-2, the virus that causes COVID-19, and identified the form associated with the White House

Read more

How Many Americans Now on Special Diets?

Almost one in five adults in the U.S. said they ate a “special diet” from 2015 to 2018, National Health and Nutrition Examination Survey (NHANES) data showed.

Among adults ages 20 and older, 17.1% reported that they stuck to a special diet on any given day, according to Bryan Stierman, MD, MPH, of the National Center for Health Statistics (NCHS) in Hyattsville, Maryland, and colleagues.

This percentage is substantially bigger than in previous years: 14.3% of U.S. adults followed any special type of diet in 2007 to 2008.

“About one-half of U.S. adults have diet-related chronic diseases, such as cardiovascular disease, high blood pressure, or type 2 diabetes,” the researchers wrote. “Special diets are one way that many adults prevent, treat, and manage such diseases.”

The study, published as an NCHS Data Brief, also pinpointed a low-calorie or weight-loss oriented diet as the most popular choice of diet, used by nearly 10% of all adults. Next was a diabetic diet, followed by 2.3% of adults on any given day, followed by low-carbohydrate (2%) and low-fat or low-cholesterol diets (1.8%).

Stierman’s group drew upon data from the cross-sectional NHANES. Dietary information was obtained via 23-hour dietary recall interviews with trained interviewers. “Special diets” were considered to be an affirmative response to the question: “Are you currently on any kind of diet, either to lose weight or for some other health-related reason?”

There was some variance of diet popularity according to age group, but a weight loss or low-calorie diet was overwhelmingly the favorite across every age group, Stierman and co-authors reported.

Diabetic diets were nearly twice as popular among those age 60 and over, used by about 4.7% of these adults. A low-sodium diet was another of the most popular diets among this older group (3%). Overall, more adults in this age group used any type of special diet compared with any other age group.

Interestingly, a “weight gain” diet was followed by 0.7% of those between the ages of 20 and 39, but not by any of the other age groups.

By 2017-2018, the popularity of weight loss and low-carb diets had a significant gain in popularity compared with 2007-2008. On the other hand, low-fat and low-cholesterol diets dropped off significantly in popularity, possibly due to the recent rising trend for the ketogenic diet, the researchers speculated.

Adherence to special diets also varied according to sex and race. Specifically, women tended to diet more than men, with 19% of U.S. women reported being on a diet on any given day vs 15.1% of men. And more than 20% of women over the age of 40 adhered to a special diet, the data showed.

More so than any other race, white adults were more likely to adhere to a special diet, with about 18% of non-Hispanic white adults reporting sticking to a diet. About 16.4% of Hispanic adults stuck to a diet, while only 14.7% and 14.9% of Black and Asian adults, respectively, reported dieting.

When broken down by educational levels,

Read more

Birx warns Trump administration ‘aggressive action’ must be taken on COVID-19

Dr. Deborah Birx, coordinator of the White House Coronavirus Task Force, wrote in an internal report shared with White House officials on Monday that the Trump administration must take “much more aggressive action” in order to curb the spread of the coronavirus.

Birx warned that “cases are rapidly rising in nearly 30 percent of all USA counties, the highest number of county hotspots we have seen with this pandemic,” The Washington Post reports. In many areas, testing is “flat or declining” but the number of cases is increasing, Birx wrote, and the country is “entering the most concerning and most deadly phase of this pandemic … leading to increasing mortality. This is not about lockdowns — it hasn’t been about lockdowns since March or April. It’s about an aggressive balanced approach that is not being implemented.”

President Trump has been claiming the U.S. is “rounding the turn” on the virus, and in the report, Birx expressly contradicts Trump, warning against huge gatherings like his campaign rallies. One administration official told the Post that Birx has been sending “urgent” messages like this for weeks, and has been pleading with Trump staffers to “ask the American people to use masks, avoid gatherings, and socially distance, basically since it became apparent that we were heading into a third surge.”

Another administration official told the Post that Birx feels “like she’s being ignored,” especially since Trump has been persuaded by his new medical adviser, radiologist Scott Atlas, that herd immunity is the way to go. Birx has been challenging Atlas in meetings, the Post reports, and has spent the last few weeks traveling to virus hot spots and asking health officials to shutter restaurants and bars and make masks mandatory. Read more at The Washington Post.

More stories from theweek.com
COVID-19 keeps proving everyone wrong
Is this the year the New South turns blue?
Democrats’ first priority

Source Article

Read more

Silver Cross Puts New Visitor Restrictions In Place

NEW LENOX, IL — As coronavirus cases increase across the state, Silver Cross Hospital has updated its visitor policy. The hospital has seen increased COVID-related hospitalizations over the last few weeks, Director of Marketing and Community Relations Debra Robbins told Patch.

As of Monday morning, there are 75 total isolated patients at the hospital. 71 patients are positive for the coronavirus, while four are patients under investigation.

Robbins said one patient is on a ventilator.

“With the growing number of COVID cases in the region, to keep our patients and staff safe, we’ve also implemented visitor restrictions effective today, Nov. 2,” Robbins said.

The new changes are:

  • For emergency department, procedural care unit and obstetrics: 1 visitor is allowed, but it must be the same visitor throughout

  • Inpatients: No visitors allowed unless approved for special circumstances such as a pediatric patient, end-of-life situations, or patients with special needs.

  • Outpatients: No visitors allowed unless the patient needs additional support, such as a pediatric patient, or patients with special needs.

“Please remember to mask, wash your hands often, and practice social distancing,” Robbins said.

This article originally appeared on the New Lenox Patch

Source Article

Read more

Why this Covid-19 surge is worse than the others

The West Texas city of El Paso, which is seeing facilities hard-pressed to handle the fast-rising number of coronavirus cases, is preparing to open its civic center for additional beds and add a fourth mobile morgue.

a person in a blue blanket: HOUSTON, TX - OCTOBER 31: A medical staff member grabs a hand of a patient to reposition the bed in the COVID-19 intensive care unit (ICU) at the United Memorial Medical Center (UMMC) on October 31, 2020 in Houston, Texas. According to reports, Texas has reached over 916,000 cases, including over 18,000 deaths. (Photo by Go Nakamura/Getty Images)

© Go Nakamura/Getty Images
HOUSTON, TX – OCTOBER 31: A medical staff member grabs a hand of a patient to reposition the bed in the COVID-19 intensive care unit (ICU) at the United Memorial Medical Center (UMMC) on October 31, 2020 in Houston, Texas. According to reports, Texas has reached over 916,000 cases, including over 18,000 deaths. (Photo by Go Nakamura/Getty Images)

University Medical Center of El Paso’s spokesman Ryan Mielke told CNN their hospital has 222 patients with Covid-19.

“We set a record yesterday and beat it today,” Mielke said. “It is just a new peak every day.”

About 978 patients with the virus are hospitalized in El Paso — a city of 680,000 residents — and 273 of those are in intensive care, according to the city’s coronavirus dashboard.

The city is about to use its civic center for Covid-19 patients and will have 50 beds, Mielke said.

The hospital has already expanded its Covid-19 capacity by partnering with El Paso Children’s Hospital, which has dedicated a floor to non-Covid-19 overflow patients, and it has a mobile isolation tent outside the hospital accepting patients.

A fourth mobile morgue is on its way to the hard-hit city, which has reported 605 deaths.

Asked about the surging cases and the link to the need for a fourth mobile morgue, Mielke said, “Simple math will tell you a certain percentage of those will have negative outcomes.”

‘We are breaking records all over the place’

No one wants another shutdown. But Americans who don’t wear masks and ignore social distancing are fueling that possibility, doctors say.

“We are breaking records all over the place here. The rate of acceleration of this virus is just increasing,” emergency medicine physician Dr. Leana Wen said.

“We’re already seeing our hospitals at breaking point in some parts of the country. And that means it doesn’t just affect patients with coronavirus. It also means that elective surgeries are being put off for things like hip replacements, for cancer surgery or heart surgery in some cases,” she said.

“When we get to breaking point here, we might have no other choice but to implement these measures that no one wants, like shutdowns. And that’s why we all have to take action right now with targeted measures, like wearing masks, like restricting indoor gatherings — things we can do now to prevent that really horrible outcome because cases are raging out of control across the US.”

Nationwide, the pandemic has gone from bad to worse.

The US just set a record for the highest seven-day average of daily new cases: 81,336 as of Sunday. That’s the first time the number has ever topped 80,000, according to data from Johns Hopkins University.

And once again, increases in new cases are far exceeding new

Read more

Maradona Admitted To Hospital In Argentina

Argentine football great Diego Maradona was admitted to hospital Monday for medical checks, his personal doctor announced.

“It’s not a serious situation and we didn’t come for an emergency,” Leopoldo Luque told reporters outside the clinic in La Plata, south of Buenos Aires.

Though he gave no details of Maradona’s condition, Luque said his patient would undergo a series of medical check-ups.

“He’s an elderly patient with many pressures in his life. It’s a time when we must help him. It’s very difficult to be Maradona,” Luque said of the star, who celebrated his 60th birthday on Friday.

The doctor ruled out any link to the coronavirus pandemic, which is ravaging the South American country, much of it still under confinement.

Maradona, who has a history of drug and alcohol abuse and poor health, is considered at high risk of coronavirus complications should he be infected.

He has suffered two heart attacks in the past and contracted hepatitis.

Diego Maradona (pictured September 2020) was hospitalized in Argentina, but his doctor ruled out any link to the coronavirus Diego Maradona (pictured September 2020) was hospitalized in Argentina, but his doctor ruled out any link to the coronavirus Photo: Gimnasia y Esgrima La Plata / Eva PARDO

“Diego is fine, but he can be much better. I didn’t find him the way I wanted to see him. I had a previous talk with him, I told him: ‘Let’s go to a clinic to improve a little,’ and he said: ‘Well, let’s go,'” said Luque.

The former Argentina captain, who led his team to triumph in the 1986 World Cup, is currently coach of Argentine SuperLiga club Gimnasia.

Along with Brazil’s Pele, Maradona is widely regarded as the greatest player of all time.

He joined his players briefly at the club’s training ground on his birthday, but had obvious difficulty walking and had to be helped away by his assistants after staying only 30 minutes.

“It breaks my heart to see him like this,” one of his daughters, Giannina, tweeted the next day.

“I didn’t go to see him that day, but the day before he was very well,” his doctor told reporters outside the clinic in La Plata, where Gimnasia is based.

Maradona went into self-isolation last month after a bodyguard showed symptoms of the virus, though he later tested negative.

Source Article

Read more

How Parents Feel About Their Kids in COVID-19 Vaccine Trials

Katelyn Evans, 16, has never met Randy Kerr—and there’s no reason she should have. It was 66 years ago that Kerr, then 6, became briefly famous, receiving the first injection of Jonas Salk’s experimental polio vaccine during the massive field trial of hundreds of thousands of children in the spring of 1954. History notes that the vaccine worked, and the children who stepped forward to receive either the actual shot or a placebo were heroically dubbed the Polio Pioneers.

Evans is a pioneer of the modern age, one of an eventual group of 600 children in the 16-to-17 year-old age group (along with 2,000 more between 12 and 15) to volunteer to be part of a Phase 3 trial to test an experimental COVID-19 vaccine made by the multinational pharmaceutical giant Pfizer. The company had already enrolled 42,113 adult volunteers in its Phase 2 and 3 trials, but only recently did the U.S. Food and Drug Administration (FDA) give approval to include children. And Evans, a high school junior in Cincinnati, was among the earliest, receiving her first of two injections on Oct. 14, at Cincinnati Children’s Hospital.

“She was the youngest one to receive the vaccine at that point in time,” says her mother, Laurie Evans, an elementary school teacher. In the spring, the family saw a news report that Pfizer was looking for volunteers and Evans and both of her children signed up. “Katelyn was the only one who got the call,” Laurie says. “I know from the response we’ve gotten that there are some people out there who don’t think this is the smartest thing for us to have done. But I’m more afraid of COVID than the vaccine.”

With good reason. The 8.8 million Americans who have contracted the disease include about 800,000 children, with the American Academy of Pediatrics (AAP) reporting a 13% increase in total pediatric cases in just the first two weeks of October. Children with COVID-19 may typically fare better than adults who catch the virus, but they can still become severely ill: some 3.6% of total U.S. COVID-19 patients who have had to be hospitalized have been children, according to the AAP. That reality makes volunteering for the Pfizer field trial more than an act of public-service heroism; it is also a potential act of preventive medicine.

Certainly, that’s the way Sharat Chandra saw things. Sharat was already part of the Pfizer adult trial and when word first went around that children would soon be included too, he and his wife discussed the possibility of enrolling their 12-year-old son Abhinav, and then posed the question to him.

“I raised it to my son and we felt that it might be a good thing for him because if he got the vaccine, it could protect him from getting the virus himself,” Sharat says. “Because he was attending school in person, we felt that it would be good to minimize his risk for infection, if we can.”

Abhinav Chandra participating in Pfizer's COVID-19 vaccine trial.

Abhinav Chandra participating in Pfizer’s

Read more

Cases of Covid-19 in children on rise in the US, with highest 1-week spike yet

Soaring case counts around the country are impacting children at “unprecedented levels,” according to new numbers released Monday by the American Academy of Pediatrics and the Children’s Hospital Association, which are tracking data reported by state health departments.

a police car parked in a parking lot: An attendant talks to a person waiting in their car at a coronavirus testing site October 31 in El Paso, Texas.

© Cengiz Yar/Getty Images
An attendant talks to a person waiting in their car at a coronavirus testing site October 31 in El Paso, Texas.

There were 61,000 new cases in children during the last week of October, “which is larger than any previous week in the pandemic,” the AAP said in a statement. From the onset of the pandemic through October 29, more than 853,000 children have tested positive for Covid-19, the AAP said, including nearly 200,000 new cases during the month of October.

“This is a stark reminder of the impact this pandemic is having on everyone — including our children and adolescents,” said AAP President Dr. Sally Goza in the statement.

“This virus is highly contagious, and as we see spikes in many communities, children are more likely to be infected, too,” Goza said.

Yet these numbers are likely an undercount, the AAP said. Because symptoms in children are often mild and can look like common colds or viruses, many children go untested.

Symptoms in children

Typical symptoms of Covid-19 in both children and adults include a fever of 100 degrees Fahrenheit or higher, a dry cough, difficulty breathing, headaches, digestive issues, body aches and fatigue, runny nose, sore throat and sneezing.

Unusual symptoms can include “Covid toes” — a reddish tinge to toes and other extremities, a sudden loss of taste and smell and conjunctivitis, a highly contagious condition also known as pink eye.

However, early research has suggested children may not get fever, cough or shortness of breath as often as adults. Fever and cough was found in 56% and 54% of children in one study, compared to 71% and 80% of adults, according to the US Centers for Disease Control and Prevention. Shortness of breath was found in only 13% of pediatric patients, compared to 43% of adults. Sore throat, headache, muscle pain, fatigue and diarrhea were also less commonly reported in children.

While cases of severe illness due to Covid-19 appears to be rare among children, severe illness has been reported, most often in infants less than a year.

When children did need to be hospitalized, the CDC found, one in three needed to be treated in the intensive care unit — the same rate as for adults.

Long-term effects not known

Adolescents between the ages of 12 and 17, according to an early October report by the CDC, were about twice as likely to test positive for Covid-19 than kids between 5 and 11 years old.

More severe cases of Covid-19 were most likely to be found in children with underlying health conditions, the CDC said, with chronic lung disease, including asthma, the most commonly reported condition (55%). While in smaller percentages, children with disability (9%), immune disorders (7%), diabetes (6%), psychological conditions

Read more