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FDA Warns Dollar Store About Tainted OTC Drugs

Nov. 15, 2019 — Dollar Tree has been sent a warning letter for selling over-the-counter (OTC) drugs made by foreign companies with serious, multiple violations of federal manufacturing laws, the U.S. Food and Drug Administration says.

The drugs include Dollar Tree’s Assured Brand OTC drugs and other drug products sold by Dollar Tree Co., which operates stores under the Dollar Tree and Family Dollar names.

The contract manufacturers used by Dollar Tree to make the OTC drugs have received warning letters from the FDA for violations such as not testing raw materials or finished drugs for pathogens and quality.

In its warning letter to Dollar Tree, the FDA outlines a number of corrective actions the company needs to take, including a system to ensure that they do not import impure drugs.

Dollar Tree said that it is cooperating with the FDA and plans to meet with the agency, CNN reported.

“We are committed to our customers’ safety and have very robust and rigorous testing programs in place to ensure our third-party manufacturers’ products are safe,” Randy Guiler, vice president of investor relations at Dollar Tree, said in a company statement.

“Each of the items referenced in the report are topical, and not ingestible, products. As always, we are cooperating with the U.S. Food and Drug Administration [FDA]. We plan to meet with the FDA in the near future and expect that our plans will satisfy their requirements in all regards,” the statement said, CNN reported.

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Climate Change Will Hurt Kids Most, Report Warns

THURSDAY, Nov. 14, 2019 — Children will face more food shortages and infections if climate change continues unchecked, researchers from the World Health Organization and 34 other institutions warn.

Climate change is already harming children’s health. And they’re at risk for lifelong health threats unless the world meets Paris Agreement targets to limit warming to well below 2 degrees Celsius, the scientists reported in the Nov. 14 issue of The Lancet.

“This year, the accelerating impacts of climate change have become clearer than ever,” said Hugh Montgomery, co-chair of The Lancet Countdown on Health and Climate Change.

“The highest recorded temperatures in Western Europe and wildfires in Siberia, Queensland and California triggered asthma, respiratory infections and heat stroke. Sea levels are now rising at an ever-concerning rate. Our children recognize this climate emergency and demand action to protect them. We must listen, and respond,” Montgomery said in a journal news release.

Montgomery is director of University College London’s Institute for Human Health and Performance, in the United Kingdom.

The health impact of climate change needs to be at the top of the agenda at the UN Climate Conference (COP25) next month in Madrid, the scientists urged.

Without action, children born today will live in a world that’s an average of more than 4 degrees Celsius warmer by age 71, posing a risk to their health at every stage of their lives, the report stated.

These children will face rising food prices and increased risk of malnutrition, according to the scientists. They noted there have been declines in average global yield potential of maize (?4%), winter wheat (?6%), soybean (?3%) and rice (?4%) over the past 30 years.

Children will also be at high risk from the climate change-related rise in infectious diseases. Last year was “the second most climatically suitable year on record” for the spread of bacteria that cause many cases of diarrhea and wound infection cases worldwide, the researchers noted.

Also, as kids born today progress through their teens, the health harms of air pollution will worsen. And as they move into adulthood, extreme weather events, such as heatwaves and wildfires, will intensify.

Meeting the Paris Agreement target to limit warming to well below 2 degrees Celsius could allow a child born today to grow up in a world that reaches net-zero emissions by age 31 and to provide a healthier future for coming generations, according to the report.

The journal’s Countdown on Health and Climate Change is a yearly analysis of what action to meet the Paris Agreement targets — or inaction — means for human health. The project is a collaboration among 120 experts from 35 institutions.

According to Dr. Nick Watts, executive director of The Lancet Countdown, “Children are particularly vulnerable to the health risks of a changing climate. Their bodies and immune systems are still developing, leaving them more susceptible to disease and environmental pollutants. The damage done in early childhood is persistent and pervasive, with health consequences lasting for a lifetime.”

Watts said, “Without immediate action from all countries to cut greenhouse gas emissions, gains in well-being and life expectancy will be compromised, and climate change will come to define the health of an entire generation.”

More information

The World Health Organization has more on climate change and health.

© 2019 HealthDay. All rights reserved.

Posted: November 2019

Drugs.com – Daily MedNews

FDA Warns of Problems for Some Taking Hep C Drugs

By Robert Preidt        
       HealthDay Reporter

THURSDAY, Aug. 29, 2019 (HealthDay News) — Taking the hepatitis C drugs Mavyret, Zepatier or Vosevi can trigger rare cases of severe liver problems or liver failure in patients who already have moderate-to-severe liver impairment, the U.S. Food and Drug Administration warned Wednesday.

The agency has identified 63 cases of worsening liver function, some resulting in liver failure or death, among patients taking the drugs.

While the medicines are safe and effective in patients with no or mild liver impairment, the same cannot be said for those with moderate-to-severe liver impairment, the FDA said.

“Hepatitis C virus remains a significant public health issue, but effective therapeutic options have helped patients to receive important curative treatments,” said Dr. Debra Birnkrant, director of the FDA’s Division of Antiviral Products at the Center for Drug Evaluation and Research.

Chronic hepatitis C, or HCV, is a viral disease that causes inflammation of the liver that can lead to serious liver problems if left untreated. Hepatitis C medicines reduce the amount of HCV in the body by preventing it from multiplying and eventually curing a patient of HCV,” Birnkrant explained in an agency news release.

Health care providers should continue to prescribe Mavyret, Zepatier or Vosevi as indicated, but should not give these medicines to patients with signs and symptoms of worsening liver function, the agency advised.

Dr. David Bernstein, chief of hepatology at Northwell Health in Manhasset, N.Y., noted that these medications “are safe and effective when properly prescribed.”

Bernstein said that “most hepatitis C patients do not have impaired liver function, so these therapies should be safe.”

And he added that other hepatitis drugs such as Harvoni and Epclusa are safe for patients with impaired liver function because they do not contain the agent that can threaten liver function.

Patients should not stop taking these medicines without first talking to a health care professional, and those with liver disease should talk with a health care professional about the benefits and risks of the medicines, the FDA said.

In many of the 63 cases, liver failure occurred in patients who should not have been prescribed these medicines, according to the FDA news release.

In some cases, patients had no cirrhosis (liver scarring) or cirrhosis with mild liver impairment, but did have indications of advanced liver disease or risk factors for liver impairment. In most of the patients, symptoms improved after they stopped taking the potent medicines.

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Sources

SOURCES: David Bernstein, M.D., chief, hepatology, Northwell Health, Manhasset, N.Y.; U.S. Food and Drug Administration, news release, Aug. 28, 2019

Copyright © 2013-2018 HealthDay. All rights reserved.

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CDC Warns Again of Salmonella From Pet Hedgehogs

FRIDAY, May 31, 2019 — Ten more cases of salmonella linked to pet hedgehogs have been reported in the United States, bringing the total to 27, according to the U.S. Centers for Disease Control and Prevention.

The latest cases were reported in six states: California, Indiana, Kansas, Michigan, Oregon and Tennessee.

Forty-two percent of those sickened are kids 12 years and younger, and two people have been hospitalized, the CDC said. No deaths have been reported in the outbreak that began Oct. 22, 2018.

The patients bought hedgehogs from various sources, including pet stores, breeders or online, the CDC noted.

“This investigation is ongoing, and CDC will provide updates when more information becomes available,” the agency said in a news release.

Even if hedgehogs look healthy and clean, they can have salmonella in their droppings, and it’s easily spread to their bodies and throughout their living areas, the CDC warned.

Most people infected with salmonella develop diarrhea, fever and stomach cramps 12 to 72 hours after exposure. They’re typically ill for four to seven days, and most recover without treatment.

It’s important to protect yourself when keeping pet hedgehogs, the CDC advises.

“Always wash hands thoroughly with soap and water right after touching, feeding, or caring for a hedgehog or cleaning its habitat,” the CDC said. Adults should supervise young children as they wash up.

And you should never kiss or snuggle a hedgehog because this can spread salmonella to your face and mouth, and make you sick. Don’t let hedgehogs roam freely in kitchens or other areas where food is prepared or stored.

When possible, clean hedgehog habitats, toys and supplies outside your home.

More information

The U.S. Centers for Disease Control and Prevention has more on salmonella.

© 2019 HealthDay. All rights reserved.

Posted: May 2019

Drugs.com – Daily MedNews

Pet Hedgehogs Still Spreading Salmonella, CDC Warns

FRIDAY, March 29, 2019 — They’re tiny, furry and cute, but hedgehogs as pets can bring salmonella dangers, U.S. health officials warned on Friday.

There have been 17 cases of the serious gastrointestinal infection across 11 states — all linked to contact with hedgehogs, according to the U.S. Centers for Disease Control and Prevention.

“Hedgehogs can carry salmonella germs in their droppings while appearing healthy and clean,” the CDC warned in a statement. “Germs can easily spread to their bodies and anything in the area where they live.”

Salmonella is no joke, the agency added.

“Most people infected with salmonella develop diarrhea, fever and stomach cramps 12 to 72 hours after being exposed to the bacteria,” the CDC said, and although most will recover, “the illness usually lasts four to seven days.”

Since the last update on hedgehog-linked salmonella cases, which was issued in late January, six new cases have been identified, bringing the total to 17. Two of the cases were so severe as to require hospitalization, although no deaths have been reported.

Of the 14 cases with information available to the CDC, six cases involved children under the age of 13.

That’s why the agency stressed that people — adults and kids alike — shouldn’t “kiss or snuggle hedgehogs, because this can spread salmonella germs to your face and mouth, and make you sick.”

And if you do handle a hedgehog, or clean out its cage, “always wash hands thoroughly with soap and water right after,” the agency said. “Adults should supervise handwashing for young children.”

States so far affected by the outbreak are Colorado, Iowa, Maine, Minnesota, Mississippi, Missouri, Nebraska, Texas, Virginia, Washington and Wyoming.

The CDC said that no one supplier of pet hedgehogs has yet been identified as the source of the outbreak, and families affected got their pets from various sources, including online. New cases have been ongoing since October 2018.

In other tips, the CDC suggested that people with children under 5, or families with seniors or people who have weakened immune systems shouldn’t get a pet hedgehog, due to the salmonella danger.

And, certainly, don’t let your hedgehog “roam freely in areas where food is prepared or stored, such as kitchens,” the CDC said. It’s also probably best to clean the animal’s habitat and toys outside, away from the interior of the home, when possible.

More information

There’s more on salmonella at foodsafety.gov.

© 2019 HealthDay. All rights reserved.

Posted: March 2019

Drugs.com – Daily MedNews

You May Be Prediabetic and Don’t Know It, CDC Warns