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FDA: NSAID painkillers can raise risk for pregnancy complications

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If you’re pregnant and you think popping nonsteroidal anti-inflammatory drugs, or NSAIDs, for your aches and pains is safe, think again.

The U.S. Food and Drug Administration warned on Thursday that taking these widely used painkillers — which include Advil, Motrin, Aleve and Celebrex — at 20 weeks or later in a pregnancy could raise the risk of complications.

Specifically, taking the medications can cause rare but serious kidney problems in the unborn baby that can lead to low levels of amniotic fluid, increasing the potential for pregnancy complications.

After about 20 weeks of pregnancy, the fetus’s kidneys begin producing most of the amniotic fluid, so kidney problems can cause low levels of this protective fluid. Low levels of amniotic fluid usually resolve if a pregnant woman stops taking an NSAID, according to the FDA.

The agency said it has ordered that NSAID labeling warns women and their health care providers about this risk.

NSAIDs are prescription and over-the-counter, or OTC, drugs that include ibuprofen, naproxen, diclofenac and celecoxib, which are taken to treat pain and fever. Aspirin is also an NSAID, but the new labeling rules don’t apply to the use of low-dose aspirin.

“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Dr. Patrizia Cavazzoni, acting director of FDA’s Center for Drug Evaluation and Research, said in an agency news release.

One ob-gyn noted that over-the-counter NSAIDs may pose the greatest danger to pregnant women.

“Many female patients use ibuprofen regularly for headaches and menstrual cramps,” said Dr. Jennifer Wu, from Lenox Hill Hospital in New York City. “It is very important that these patients realize that ibuprofen and other NSAIDs pose a unique danger to pregnant patients.

“The majority of patients get these medications over the counter and may even be using them at the prescription-strength level,” Wu added. “While many prescription drugs come with the oversight of the pharmacist and a warning label, the over-the-counter medications lack all this. Patients also often assume that over-the-counter necessarily means safe.”

The FDA’s warning comes after a review of medical literature and cases reported to the agency about low amniotic fluid levels or kidney problems in unborn babies associated with NSAID use during pregnancy.

For prescription NSAIDs, the new FDA warning recommends limiting use between about 20 weeks to 30 weeks of pregnancy. A warning to avoid taking NSAIDs after about 30 weeks of pregnancy was already included in prescribing information due to a risk of heart problems in unborn babies.

If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest possible dose and shortest possible length of time, the FDA said.

Makers of OTC NSAIDs intended for adults will also make similar updates to their labeling, according to the agency.

More information

The U.S. Food and Drug Administration has more on NSAIDs.

Copyright 2020 HealthDay. All rights reserved.



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‘Green prescriptions’ could cancel mental health benefits for some

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So-called “green prescriptions” may end up being counterproductive for people with mental health conditions, researchers say.

Spending time in nature is believed to benefit mental health, so some doctors are beginning to “prescribe” outdoor time for their patients.

That led researchers to investigate whether being in nature helps actually does help people with issues such as anxiety and depression. They collected data from more than 18,000 people in 18 countries.

The takeaway: Time in nature does provide several benefits for people with mental health conditions, but only if they choose on their own to visit green spaces.

While being advised to spend time outdoors can encourage such activity, it can also undermine the potential emotional benefits, according to the authors of the study published this month in the journal Scientific Reports.

The researchers said they were surprised to find that people with depression were spending time in nature as often as folks with no mental health issues, and that people with anxiety were doing so much more often.

While in nature, those with depression and anxiety tended to feel happy and reported low anxiety. But those benefits appeared to be undermined when the visits were done at others’ urging, the investigators found.

The more external pressure people with depression and anxiety felt to visit nature, the less motivated they were to do so and the more anxious they felt.

“These findings are consistent with wider research that suggests that urban natural environments provide spaces for people to relax and recover from stress,” said study leader Michelle Tester-Jones, a postdoctoral research associate at the University of Exeter in the United Kingdom.

But the findings also show that health care practitioners and loved ones should be sensitive about recommending time in nature for people who have mental health issues.

“It could be helpful to encourage them to spend more time in places that people already enjoy visiting, so they feel comfortable and can make the most of the experience,” Tester-Jones said in a university news release.

More information

For more on the benefits of green spaces, go to the National Recreation and Park Association.

Copyright 2020 HealthDay. All rights reserved.



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Study: Nearly half of ‘essential workers’ in U.S. at risk for severe COVID-19

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Nov. 9 (UPI) — Nearly half of those classified as “essential workers” in the United States are at increased risk for severe COVID-19, according to an analysis published Monday by JAMA Internal Medicine.

This means that more than 74 million workers and those with whom they live could be at risk for serious illness, based on disease risk guidelines developed by the U.S. Centers for Disease Control and Prevention, the researchers said.

“Many parts of the country face high and rising infection rates, [and] we should not think about work exposure and health risks in isolation, given that workers and persons at increased risk often live in the same households,” study co-author Thomas M. Selden told UPI.

“Insofar as we can reduce the prevalence of COVID-19 in our communities, we can reduce the extent to which policymakers have to choose between the economy and keeping the population safe,” said Selden, an economist with the U.S. Department of Health and Human Services’ Agency for Healthcare Research and Quality.

Since the COVID-19 pandemic spread to the United States in March, states and cities across the country have instituted lockdown measures designed to limit the spread of the disease.

Many of these measures entailed closing schools and non-essential businesses, with only banks, grocery stores, pharmacies and other businesses deemed to provide vital services allowed to stay open.

For this study, Selden and his colleagues analyzed data on the U.S. workforce to examine how many people were in essential jobs, how often they were able to work at home, their risk for severe COVID-19 and the potential health risks for their household members.

Of the more than 157 million workers across the country, 72% are in jobs deemed essential — based on U.S. Department of Homeland Security criteria — and more than three-fourths of all essential workers are unable to work at home, Selden said.

Essential workers include those in the medical and healthcare, telecommunications, information technology systems, defense, food and agriculture, transportation and logistics and energy, water and wastewater industries, as well as those in law enforcement and public works, the DHS criteria stipulates.

The study notes that up to 60% of these workers have underlying health issues, placing them at increased risk for severe COVID-19 if they get infected, as defined by U.S. Centers for Disease Control and Prevention guidelines.

Those with diabetes, heart disease, high blood pressure and chronic respiratory conditions like asthma are considered to be at high risk for serious illness, the CDC says.

Based on these findings, between roughly 57 million and 74 million adults working in on-site essential jobs — and their families — are at increased risk for serious illness, Selden and his colleagues estimated.

“Policymakers face important decisions about how to balance the economic benefits of keeping workers employed and the public health benefits of protecting those with increased risk of severe COVID-19,” Selden said.

“These issues arise in the context of decisions to close segments of the economy and decisions about how to distribute vaccines, which will initially be available only with limited supply, [and] become all the more difficult when the prevalence of infection rises in parts of the country,” he said.



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Study: Hydroxychloroquine no better than placebo for hospitalized COVID-19 patients

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Nov. 9 (UPI) — COVID-19 patients treated with hydroxychloroquine showed no signs of significant improvement in “clinical status” compared with those given a placebo, a study published Monday by JAMA found.

Patients given a five-day course of the drug were scored as “category six” based on the World Health Organization’s seven-category COVID Ordinal Outcomes Scale, the same as those given a placebo, the researchers said.

Also, 28 days after they started treatment, 10.4% of those treated with hydroxychloroquine died, just slightly lower than the 10.6% fatality rate in the placebo group.

“The results show that hydroxychloroquine did not help patients recover from COVID-19,” study co-author Dr. Wesley H. Self told UPI.

“In the study, patients treated with hydroxychloroquine and those treated with a placebo had nearly identical outcomes, [so] I do not foresee any role for hydroxychloroquine in acutely ill patients hospitalized with COVID-19,” said Self, an infectious disease specialist at Vanderbilt University Medical Center.

Hydroxychloroquine is an immunosuppressive and anti-parasitic drug that is used to treat malaria.

Early in the COVID-19 pandemic, it was touted by President Donald Trump and others as a potential treatment for the virus, despite the lack of any scientific data supporting its use.

Given its effectiveness helping those sickened with malaria — a mosquito-borne infection — to recover, “there was a strong rationale for why hydroxychloroquine may have been beneficial for patients with COVID-19,” according to Self.

However, in July, the U.S. Food and Drug Administration warned against the drug’s use in the treatment of those infected with the new coronavirus, due to potentially serious heart-related side effects.

For this study, Self and his colleagues treated 433 COVID-19 patients at 34 hospitals across the United States with either the drug or a placebo for a period of five days.

Patients assigned to the hydroxychloroquine group received 400 milligrams of the drug in pill form twice a day for the first two doses and then 200 mg. in pill form twice a day for the next eight doses, for a total of 10 doses over the five days.

All of the patients were then assessed based on the WHO’s COVID Ordinal Outcomes Scale, which categorizes those infected according to disease severity.

Most of the patients in both the hydroxycholorquine group and the placebo group were in “category six,” meaning they were hospitalized and receiving extracorporeal membrane oxygenation or invasive mechanical ventilation to maintain their breathing, the researchers said.

“Our results, especially when combined from other studies conducted in the United Kingdom and Brazil, are good evidence that hydroxychloroquine does not provide benefit for patients hospitalized with COVID-19,” Self said.



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