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Abuse of unapproved anxiety drug phenibut on the rise

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A growing number of Americans may be having serious reactions after taking phenibut — an unapproved anxiety drug sold in some dietary supplements.

That’s the finding of a new study looking at calls to U.S. poison control centers. The numbers are not huge: Between 2009 and 2019, there were 1,320 calls related to phenibut.

But there was a sharp rise beginning in 2015, researchers found — going from a handful of calls each year to between 300 and 400 in 2018 and 2019.

More worrisome, the effects were sometimes life-threatening or fatal, said researcher Janessa Graves, an associate professor at Washington State University.

Overall, 80 people fell into comas and three died. Often, they had taken other substances as well. But even in cases where phenibut was used alone, 10% resulted in serious effects — including one death.

“This is reason for concern,” Graves said. “[Phenibut] is easily accessible, and it may be becoming more popular.”

The findings were published Sept. 4 in the U.S. Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

Originally developed in the Soviet Union in the 1960s, phenibut was given to cosmonauts, with the aim of combating anxiety and insomnia. It has never been an approved drug in the United States, but it is present in some dietary supplements marketed for enhancing mood and brain power.

The U.S. Food and Drug Administration has ruled phenibut is not a dietary ingredient and cannot be listed as such in dietary supplements. But phenibut supplements are widely available online, Graves noted.

There have also been reports of people abusing the drug for euphoric effects. A recent study of Minnesota poison centers found that in nearly half of calls related to phenibut, the person had used it with “abuse as the reason.”

The drug is similar to a brain chemical called GABA, which has a calming effect on the central nervous system. That can also cause side effects like sedation, reduced levels of consciousness and depressed breathing.

Previous research has uncovered signs that phenibut use is trending upward in the United States, Graves said. So her team tried to get a bigger picture, by analyzing a national database on calls to poison control centers.

From 2009 to 2014, they found there was a small number of calls each year related to “phenygam” or 4-amino-3-phenylbutyric acid — alternative names for phenibut.

Starting in 2015, poison control centers were able to use the term “phenibut.” After that, there was a steady, steep rise in calls related to the drug.

It’s not clear how much of that could be related to rising popularity, Graves said.

Based on internet search trends, public interest in phenibut has remained fairly stable in the past several years, said Pat Aussem, of the nonprofit Partnership to End Addiction.

“That said,” she added, “the sharp rise in calls to poison control centers is concerning, and may be attributable to people searching for and using anti-anxiety supplements without knowing their safety profiles.”

Consumers should not assume that dietary supplements are “safe,” stressed Aussem, who was not involved in the study.

She said phenibut would be particularly dangerous in combination with other substances that depress the central nervous system — including alcohol, opioids or benzodiazepines, like Xanax or Ativan.

In this study, 40% of adults and 30% of people under age 18 had used phenibut with other substances.

The findings highlight a bigger issue, according to Dr. Peter Lurie, president of the Center for Science in the Public Interest, a consumer advocacy group.

In the United States, dietary supplements are largely unregulated, Lurie said, and the FDA has limited resources to take action against companies that put unapproved drugs into supplements — or make unproven health claims.

The CSPI recently urged the FDA to take stronger steps against manufacturers and stores that sell supplements with an unapproved antidepressant called tianeptine.

The FDA has sent warning letters to a number of U.S. companies that market tianeptine or phenibut supplements. But the products are still readily available.

One of the concerns, Lurie said, is that consumers will be lured away from therapies — medication or not — that are proven to help anxiety and depression.

Graves and Aussem made the same point.

“In this age of COVID-19,” Aussem said, “many people are trying to cope with anxiety and may wish to find a ‘natural’ product to alleviate their symptoms.”

But, she said, “talking to a health care provider about their concerns is the safest approach.”

More information

The U.S. Food and Drug Administration has more on dietary supplements.

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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