Patients exposed to HIV, hepatitis at Massachusetts hospital

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A class action lawsuit against Mass General Brigham, Salem Hospital, and 10 unnamed employees has been filed after at least 450 patients were notified of their possible exposure to HIV and hepatitis.

The negligent administration of intravenous medications during endoscopy procedures performed between June 14, 2021, and April 19, 2023, at Salem Hospital, located about 20 miles northeast of Boston, has caused a “heightened risk of exposure to these harmful life-altering and life-threatening infections,” according to the lawsuit filed at Suffolk County Superior Court in Boston by Keches Law Group on behalf of plaintiff Melinda Cashman and others.

Although patients were notified in early November of their potential exposure, it could take months or even years to determine if infection has occurred. Attorneys for Ms. Cashman claim that the plaintiff “suffered and will continue to suffer severe emotional distress and anguish” as a result of the associated risks.

The lawyers argue that Ms. Cashman and others like her may “suffer permanent injuries,” along with “extreme anxiety and decreased quality of life.” They are seeking monetary damages to offset disruptions to relationships, increased medical bills, and any mental health therapy required.

Outreach to potentially affected patients began after the hospital was made aware, earlier this year, of an “isolated practice” that could have led to viral transmission, according to a statement from Mass General Brigham, but there is no evidence to date of any infections resulting from this incident. “We sincerely apologize to those who have been impacted and we remain committed to delivering high-quality, compassionate healthcare to our community.”

Hepatitis B and C are both treatable with antiviral mediations, and hepatitis C is curable in 95% of cases, according to the Centers for Disease Control and Prevention. HIV, although not curable, can be managed with antiretroviral therapy.

Mass General Brigham is working with the Massachusetts Department of Public Health, which will conduct an onsite investigation into quality-control practices. Affected patients can reach out to a clinician-staffed hotline with questions and receive free screening for the viruses, hospital officials report.
 

A version of this article appeared on Medscape.com.

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A class action lawsuit against Mass General Brigham, Salem Hospital, and 10 unnamed employees has been filed after at least 450 patients were notified of their possible exposure to HIV and hepatitis.

The negligent administration of intravenous medications during endoscopy procedures performed between June 14, 2021, and April 19, 2023, at Salem Hospital, located about 20 miles northeast of Boston, has caused a “heightened risk of exposure to these harmful life-altering and life-threatening infections,” according to the lawsuit filed at Suffolk County Superior Court in Boston by Keches Law Group on behalf of plaintiff Melinda Cashman and others.

Although patients were notified in early November of their potential exposure, it could take months or even years to determine if infection has occurred. Attorneys for Ms. Cashman claim that the plaintiff “suffered and will continue to suffer severe emotional distress and anguish” as a result of the associated risks.

The lawyers argue that Ms. Cashman and others like her may “suffer permanent injuries,” along with “extreme anxiety and decreased quality of life.” They are seeking monetary damages to offset disruptions to relationships, increased medical bills, and any mental health therapy required.

Outreach to potentially affected patients began after the hospital was made aware, earlier this year, of an “isolated practice” that could have led to viral transmission, according to a statement from Mass General Brigham, but there is no evidence to date of any infections resulting from this incident. “We sincerely apologize to those who have been impacted and we remain committed to delivering high-quality, compassionate healthcare to our community.”

Hepatitis B and C are both treatable with antiviral mediations, and hepatitis C is curable in 95% of cases, according to the Centers for Disease Control and Prevention. HIV, although not curable, can be managed with antiretroviral therapy.

Mass General Brigham is working with the Massachusetts Department of Public Health, which will conduct an onsite investigation into quality-control practices. Affected patients can reach out to a clinician-staffed hotline with questions and receive free screening for the viruses, hospital officials report.
 

A version of this article appeared on Medscape.com.

A class action lawsuit against Mass General Brigham, Salem Hospital, and 10 unnamed employees has been filed after at least 450 patients were notified of their possible exposure to HIV and hepatitis.

The negligent administration of intravenous medications during endoscopy procedures performed between June 14, 2021, and April 19, 2023, at Salem Hospital, located about 20 miles northeast of Boston, has caused a “heightened risk of exposure to these harmful life-altering and life-threatening infections,” according to the lawsuit filed at Suffolk County Superior Court in Boston by Keches Law Group on behalf of plaintiff Melinda Cashman and others.

Although patients were notified in early November of their potential exposure, it could take months or even years to determine if infection has occurred. Attorneys for Ms. Cashman claim that the plaintiff “suffered and will continue to suffer severe emotional distress and anguish” as a result of the associated risks.

The lawyers argue that Ms. Cashman and others like her may “suffer permanent injuries,” along with “extreme anxiety and decreased quality of life.” They are seeking monetary damages to offset disruptions to relationships, increased medical bills, and any mental health therapy required.

Outreach to potentially affected patients began after the hospital was made aware, earlier this year, of an “isolated practice” that could have led to viral transmission, according to a statement from Mass General Brigham, but there is no evidence to date of any infections resulting from this incident. “We sincerely apologize to those who have been impacted and we remain committed to delivering high-quality, compassionate healthcare to our community.”

Hepatitis B and C are both treatable with antiviral mediations, and hepatitis C is curable in 95% of cases, according to the Centers for Disease Control and Prevention. HIV, although not curable, can be managed with antiretroviral therapy.

Mass General Brigham is working with the Massachusetts Department of Public Health, which will conduct an onsite investigation into quality-control practices. Affected patients can reach out to a clinician-staffed hotline with questions and receive free screening for the viruses, hospital officials report.
 

A version of this article appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>A class action lawsuit against Mass General Brigham, Salem Hospital, and 10 unnamed employees has been filed after at least 450 patients were notified of their </metaDescription> <articlePDF/> <teaserImage/> <teaser>There is no evidence to date of any infections resulting from this incident.</teaser> <title>Patients Exposed to HIV, Hepatitis at Massachusetts Hospital</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>2</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>mdid</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>51892</term> <term>15</term> <term canonical="true">21</term> </publications> <sections> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">234</term> <term>38029</term> <term>318</term> <term>314</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Patients Exposed to HIV, Hepatitis at Massachusetts Hospital</title> <deck/> </itemMeta> <itemContent> <p><br/><br/><span class="tag metaDescription">A class action lawsuit against Mass General Brigham, Salem Hospital, and 10 unnamed employees has been filed after at least 450 patients were notified of their possible exposure to <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/211316-overview">HIV</a></span> and <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/775507-overview">hepatitis</a></span>.</span><br/><br/>The negligent administration of intravenous medications during endoscopy procedures performed between June 14, 2021, and April 19, 2023, at Salem Hospital, located about 20 miles northeast of Boston, has caused a “heightened risk of exposure to these harmful life-altering and life-threatening infections,” according to the <span class="Hyperlink"><a href="https://kecheslaw.com/wp-content/uploads/2023/11/Complaint-11.16.23-as-docketed.pdf">lawsuit</a></span> filed at Suffolk County Superior Court in Boston by Keches Law Group on behalf of plaintiff Melinda Cashman and others.<br/><br/>Although patients were notified in early November of their potential exposure, it could take months or even years to determine if infection has occurred. Attorneys for Ms. Cashman claim that the plaintiff “suffered and will continue to suffer severe emotional distress and anguish” as a result of the associated risks.<br/><br/>The lawyers argue that Ms. Cashman and others like her may “suffer permanent injuries,” along with “extreme anxiety and decreased quality of life.” They are seeking monetary damages to offset disruptions to relationships, increased medical bills, and any mental health therapy required.<br/><br/>Outreach to potentially affected patients began after the hospital was made aware, earlier this year, of an “isolated practice” that could have led to viral transmission, according to a statement from Mass General Brigham, but there is no evidence to date of any infections resulting from this incident. “We sincerely apologize to those who have been impacted and we remain committed to delivering high-quality, compassionate healthcare to our community.”<br/><br/><span class="Hyperlink"><a href="https://emedicine.medscape.com/article/177632-overview">Hepatitis B</a></span> and C are both treatable with antiviral mediations, and <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/177792-overview">hepatitis C</a></span> is curable in 95% of cases, according to the <span class="Hyperlink"><a href="https://www.cdc.gov/vitalsigns/hepc-treatment/index.html">Centers for Disease Control and Prevention.</a></span> HIV, although not curable, can be managed with antiretroviral therapy.<br/><br/>Mass General Brigham is working with the Massachusetts Department of Public Health, which will conduct an onsite investigation into quality-control practices. Affected patients can reach out to a clinician-staffed hotline with questions and receive free screening for the viruses, hospital officials report.<br/><br/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/998984">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Deprived of sleep, many turn to melatonin despite risks

Article Type
Changed
Tue, 06/07/2022 - 11:26

Can’t sleep? When slumber doesn’t come naturally, some are turning to melatonin, an over-the-counter sleep aid that often is mistaken for a supplement. This powerful hormone plays an important role in human biology, and specialists are questioning whether increasing levels could be doing more harm than good.

A new investigation launched by the American Academy of Sleep Medicine is looking into the safety of melatonin. And while the health advisory checking the evidence is underway, the academy is recommending that melatonin not be used for insomnia in adults or children.

But what is insomnia, and how is it different from a few bad nights of sleep? Insomnia disturbs sleep at least three times a week for more than 3 months, often causing people to feel tired during the day as well.

Production of melatonin (dubbed the “vampire hormone”) begins at night, when it starts getting dark outside. Melatonin release is scheduled by the small but mighty pineal gland at the back of the head. Melatonin signals to the body that it’s time to sleep. And as the sun rises and light shines, melatonin levels decline again to help the body wake.

Sometimes packaged in gummy bear fruit flavors, melatonin can have an alluring appeal to sleep-deprived parents looking for relief for themselves and their children.

Muhammad Adeel Rishi, MD, vice chair of the public safety committee for the American Academy of Sleep Medicine, said he has a doctor colleague who started taking melatonin to help him during the pandemic when he was having trouble falling asleep at night. His doctor friend started giving the hormone to his own children, who were also having sleep issues.

But Dr. Rishi said there are important reasons to not use melatonin for insomnia until more information is available.

Melatonin affects sleep, but this hormone also influences other functions in the body. “It has an impact on body temperature, blood sugar, and even the tone of blood vessels,” Dr. Rishi said.

And because melatonin is available over the counter in the United States, it hasn’t been approved as a medicine under the Food and Drug Administration. A previous study of melatonin products, for instance, flagged problems with inconsistent doses, which make it hard for people to know exactly how much they are getting and prompted calls for more FDA oversight.
 

Imprecise doses

While melatonin doses typically range from 1 to 5 milligrams, bottles examined have been off target with much more or less hormone in the product than listed on the label.

Researchers from the University of Guelph (Ont.), tested 30 commercially available formulas and found the melatonin content varied from the ingredients labeled on the bottles by more than 10%. In addition to melatonin, the researchers found other substances in the bottles too: In about a quarter of the products, they also identified serotonin.
 

Impurities

While melatonin plays a role in setting the body’s biological clock and the sleep and wake cycle, serotonin is also at work. Occurring naturally in our bodies, serotonin is involved in mood and helps with deep REM sleep. But adding serotonin in unknown amounts could be unhealthy.

Dr. Rishi said it can be dangerous to use a product as a medication when doses can be so off and there are unknown byproducts in it.

Serotonin can influence the heart, blood vessels, and brain, so it’s not something Dr. Rishi wants to see people taking without paying attention. People taking medication for mood disorders could be especially affected by the serotonin in their sleep aid, he warns.

For anyone taking melatonin, Dr. Rishi recommended they check the bottle to see whether they are using a product with a USP-verified check mark, which indicates that the product meets the standards of the U.S. Pharmacopeia Convention.

The risk of impurities is a good reason for kids to not be given the hormone, but another worry is whether melatonin interferes with puberty in children – which is also a question researchers at the Children’s Hospital of Eastern Ontario in Ottawa are asking.
 

Disrupting puberty

While short-term melatonin use is considered safe, the researchers reported, concerns that long-term use might delay children’s sexual maturation require more study. One theory is that nightly melatonin use might interrupt the decline of natural hormone levels and interfere with the start of puberty.

Researchers from the Children’s Hospital of Michigan in Detroit also reported an uptick in accidental ingestion of melatonin in children. Kids got their hands on melatonin and swallowed too many capsules more often than other pill-related mishaps during the pandemic.

Dr. Rishi said more research is needed to assess the safe use of melatonin in children. He points out that the hormone can treat circadian rhythm disorders in adults.

While specialists weigh the benefits and risks of melatonin use and where it is safest to try, Dr. Rishi said the hormone does have a role in medicine.

Melatonin will probably need to be regulated by the FDA as a medication – especially for children – Dr. Rishi pointed out. And what place, if any, it will have for managing chronic insomnia is “a big question mark.”

Results of the investigation by the American Academy of Sleep Medicine will be published on its sleepeducation.org website in a few months.

A version of this article first appeared on WebMD.com.

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Can’t sleep? When slumber doesn’t come naturally, some are turning to melatonin, an over-the-counter sleep aid that often is mistaken for a supplement. This powerful hormone plays an important role in human biology, and specialists are questioning whether increasing levels could be doing more harm than good.

A new investigation launched by the American Academy of Sleep Medicine is looking into the safety of melatonin. And while the health advisory checking the evidence is underway, the academy is recommending that melatonin not be used for insomnia in adults or children.

But what is insomnia, and how is it different from a few bad nights of sleep? Insomnia disturbs sleep at least three times a week for more than 3 months, often causing people to feel tired during the day as well.

Production of melatonin (dubbed the “vampire hormone”) begins at night, when it starts getting dark outside. Melatonin release is scheduled by the small but mighty pineal gland at the back of the head. Melatonin signals to the body that it’s time to sleep. And as the sun rises and light shines, melatonin levels decline again to help the body wake.

Sometimes packaged in gummy bear fruit flavors, melatonin can have an alluring appeal to sleep-deprived parents looking for relief for themselves and their children.

Muhammad Adeel Rishi, MD, vice chair of the public safety committee for the American Academy of Sleep Medicine, said he has a doctor colleague who started taking melatonin to help him during the pandemic when he was having trouble falling asleep at night. His doctor friend started giving the hormone to his own children, who were also having sleep issues.

But Dr. Rishi said there are important reasons to not use melatonin for insomnia until more information is available.

Melatonin affects sleep, but this hormone also influences other functions in the body. “It has an impact on body temperature, blood sugar, and even the tone of blood vessels,” Dr. Rishi said.

And because melatonin is available over the counter in the United States, it hasn’t been approved as a medicine under the Food and Drug Administration. A previous study of melatonin products, for instance, flagged problems with inconsistent doses, which make it hard for people to know exactly how much they are getting and prompted calls for more FDA oversight.
 

Imprecise doses

While melatonin doses typically range from 1 to 5 milligrams, bottles examined have been off target with much more or less hormone in the product than listed on the label.

Researchers from the University of Guelph (Ont.), tested 30 commercially available formulas and found the melatonin content varied from the ingredients labeled on the bottles by more than 10%. In addition to melatonin, the researchers found other substances in the bottles too: In about a quarter of the products, they also identified serotonin.
 

Impurities

While melatonin plays a role in setting the body’s biological clock and the sleep and wake cycle, serotonin is also at work. Occurring naturally in our bodies, serotonin is involved in mood and helps with deep REM sleep. But adding serotonin in unknown amounts could be unhealthy.

Dr. Rishi said it can be dangerous to use a product as a medication when doses can be so off and there are unknown byproducts in it.

Serotonin can influence the heart, blood vessels, and brain, so it’s not something Dr. Rishi wants to see people taking without paying attention. People taking medication for mood disorders could be especially affected by the serotonin in their sleep aid, he warns.

For anyone taking melatonin, Dr. Rishi recommended they check the bottle to see whether they are using a product with a USP-verified check mark, which indicates that the product meets the standards of the U.S. Pharmacopeia Convention.

The risk of impurities is a good reason for kids to not be given the hormone, but another worry is whether melatonin interferes with puberty in children – which is also a question researchers at the Children’s Hospital of Eastern Ontario in Ottawa are asking.
 

Disrupting puberty

While short-term melatonin use is considered safe, the researchers reported, concerns that long-term use might delay children’s sexual maturation require more study. One theory is that nightly melatonin use might interrupt the decline of natural hormone levels and interfere with the start of puberty.

Researchers from the Children’s Hospital of Michigan in Detroit also reported an uptick in accidental ingestion of melatonin in children. Kids got their hands on melatonin and swallowed too many capsules more often than other pill-related mishaps during the pandemic.

Dr. Rishi said more research is needed to assess the safe use of melatonin in children. He points out that the hormone can treat circadian rhythm disorders in adults.

While specialists weigh the benefits and risks of melatonin use and where it is safest to try, Dr. Rishi said the hormone does have a role in medicine.

Melatonin will probably need to be regulated by the FDA as a medication – especially for children – Dr. Rishi pointed out. And what place, if any, it will have for managing chronic insomnia is “a big question mark.”

Results of the investigation by the American Academy of Sleep Medicine will be published on its sleepeducation.org website in a few months.

A version of this article first appeared on WebMD.com.

Can’t sleep? When slumber doesn’t come naturally, some are turning to melatonin, an over-the-counter sleep aid that often is mistaken for a supplement. This powerful hormone plays an important role in human biology, and specialists are questioning whether increasing levels could be doing more harm than good.

A new investigation launched by the American Academy of Sleep Medicine is looking into the safety of melatonin. And while the health advisory checking the evidence is underway, the academy is recommending that melatonin not be used for insomnia in adults or children.

But what is insomnia, and how is it different from a few bad nights of sleep? Insomnia disturbs sleep at least three times a week for more than 3 months, often causing people to feel tired during the day as well.

Production of melatonin (dubbed the “vampire hormone”) begins at night, when it starts getting dark outside. Melatonin release is scheduled by the small but mighty pineal gland at the back of the head. Melatonin signals to the body that it’s time to sleep. And as the sun rises and light shines, melatonin levels decline again to help the body wake.

Sometimes packaged in gummy bear fruit flavors, melatonin can have an alluring appeal to sleep-deprived parents looking for relief for themselves and their children.

Muhammad Adeel Rishi, MD, vice chair of the public safety committee for the American Academy of Sleep Medicine, said he has a doctor colleague who started taking melatonin to help him during the pandemic when he was having trouble falling asleep at night. His doctor friend started giving the hormone to his own children, who were also having sleep issues.

But Dr. Rishi said there are important reasons to not use melatonin for insomnia until more information is available.

Melatonin affects sleep, but this hormone also influences other functions in the body. “It has an impact on body temperature, blood sugar, and even the tone of blood vessels,” Dr. Rishi said.

And because melatonin is available over the counter in the United States, it hasn’t been approved as a medicine under the Food and Drug Administration. A previous study of melatonin products, for instance, flagged problems with inconsistent doses, which make it hard for people to know exactly how much they are getting and prompted calls for more FDA oversight.
 

Imprecise doses

While melatonin doses typically range from 1 to 5 milligrams, bottles examined have been off target with much more or less hormone in the product than listed on the label.

Researchers from the University of Guelph (Ont.), tested 30 commercially available formulas and found the melatonin content varied from the ingredients labeled on the bottles by more than 10%. In addition to melatonin, the researchers found other substances in the bottles too: In about a quarter of the products, they also identified serotonin.
 

Impurities

While melatonin plays a role in setting the body’s biological clock and the sleep and wake cycle, serotonin is also at work. Occurring naturally in our bodies, serotonin is involved in mood and helps with deep REM sleep. But adding serotonin in unknown amounts could be unhealthy.

Dr. Rishi said it can be dangerous to use a product as a medication when doses can be so off and there are unknown byproducts in it.

Serotonin can influence the heart, blood vessels, and brain, so it’s not something Dr. Rishi wants to see people taking without paying attention. People taking medication for mood disorders could be especially affected by the serotonin in their sleep aid, he warns.

For anyone taking melatonin, Dr. Rishi recommended they check the bottle to see whether they are using a product with a USP-verified check mark, which indicates that the product meets the standards of the U.S. Pharmacopeia Convention.

The risk of impurities is a good reason for kids to not be given the hormone, but another worry is whether melatonin interferes with puberty in children – which is also a question researchers at the Children’s Hospital of Eastern Ontario in Ottawa are asking.
 

Disrupting puberty

While short-term melatonin use is considered safe, the researchers reported, concerns that long-term use might delay children’s sexual maturation require more study. One theory is that nightly melatonin use might interrupt the decline of natural hormone levels and interfere with the start of puberty.

Researchers from the Children’s Hospital of Michigan in Detroit also reported an uptick in accidental ingestion of melatonin in children. Kids got their hands on melatonin and swallowed too many capsules more often than other pill-related mishaps during the pandemic.

Dr. Rishi said more research is needed to assess the safe use of melatonin in children. He points out that the hormone can treat circadian rhythm disorders in adults.

While specialists weigh the benefits and risks of melatonin use and where it is safest to try, Dr. Rishi said the hormone does have a role in medicine.

Melatonin will probably need to be regulated by the FDA as a medication – especially for children – Dr. Rishi pointed out. And what place, if any, it will have for managing chronic insomnia is “a big question mark.”

Results of the investigation by the American Academy of Sleep Medicine will be published on its sleepeducation.org website in a few months.

A version of this article first appeared on WebMD.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>A new investigation launched by the American Academy of Sleep Medicine is looking into the safety of melatonin.</metaDescription> <articlePDF/> <teaserImage/> <teaser>Melatonin will probably need to be regulated by the FDA as a medication – especially for children – one expert points out.</teaser> <title>Deprived of sleep, many turn to melatonin despite risks</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>cpn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>nr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle>Neurology Reviews</journalTitle> <journalFullTitle>Neurology Reviews</journalFullTitle> <copyrightStatement>2018 Frontline Medical Communications Inc.,</copyrightStatement> </publicationData> </publications_g> <publications> <term>6</term> <term>15</term> <term>21</term> <term>9</term> <term canonical="true">22</term> </publications> <sections> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">296</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Deprived of sleep, many turn to melatonin despite risks</title> <deck/> </itemMeta> <itemContent> <p>Can’t sleep? When slumber doesn’t come naturally, some are <a href="https://jamanetwork.com/journals/jama/article-abstract/2788539">turning to melatonin</a>, an over-the-counter sleep aid that often is mistaken for a supplement. This powerful hormone plays an important role in human biology, and specialists are questioning whether increasing levels could be doing more harm than good.</p> <p><span class="tag metaDescription">A new investigation launched by the American Academy of Sleep Medicine is looking into the safety of melatonin.</span> And while the health advisory checking the evidence is underway, the academy is recommending that melatonin not be used for insomnia in adults or children.<br/><br/>But what is insomnia, and how is it different from a few bad nights of sleep? Insomnia disturbs sleep at least three times a week for more than 3 months, often causing people to feel tired during the day as well.<br/><br/>Production of melatonin (dubbed the “vampire hormone”) begins at night, when it starts getting dark outside. Melatonin release is scheduled by the small but mighty pineal gland at the back of the head. Melatonin signals to the body that it’s time to sleep. And as the sun rises and light shines, melatonin levels decline again to help the body wake.<br/><br/>Sometimes packaged in gummy bear fruit flavors, melatonin can have an alluring appeal to sleep-deprived parents looking for relief for themselves and their children.<br/><br/>Muhammad Adeel Rishi, MD, vice chair of the public safety committee for the American Academy of Sleep Medicine, said he has a doctor colleague who started taking melatonin to help him during the pandemic when he was having trouble falling asleep at night. His doctor friend started giving the hormone to his own children, who were also having sleep issues.<br/><br/>But Dr. Rishi said there are important reasons to not use melatonin for insomnia until more information is available.<br/><br/>Melatonin affects sleep, but this hormone also influences other functions in the body. “It has an impact on body temperature, blood sugar, and even the tone of blood vessels,” Dr. Rishi said.<br/><br/>And because melatonin is available over the counter in the United States, it hasn’t been approved as a medicine under the Food and Drug Administration. A previous <a href="https://jcsm.aasm.org/doi/pdf/10.5664/jcsm.6462">study of melatonin</a> products, for instance, flagged problems with inconsistent doses, which make it hard for people to know exactly how much they are getting and prompted calls for more FDA oversight.<br/><br/></p> <h2>Imprecise doses</h2> <p>While melatonin doses typically range from 1 to 5 milligrams, bottles examined have been off target with much more or less hormone in the product than listed on the label.</p> <p>Researchers from the University of Guelph (Ont.), tested 30 commercially available formulas and found the melatonin content varied from the ingredients labeled on the bottles by more than 10%. In addition to melatonin, the researchers found other substances in the bottles too: In about a quarter of the products, they also identified serotonin.<br/><br/></p> <h2>Impurities</h2> <p>While melatonin plays a role in setting the body’s biological clock and the sleep and wake cycle, serotonin is also at work. Occurring naturally in our bodies, serotonin is involved in mood and helps with deep REM sleep. But adding serotonin in unknown amounts could be unhealthy.</p> <p>Dr. Rishi said it can be dangerous to use a product as a medication when doses can be so off and there are unknown byproducts in it.<br/><br/>Serotonin can influence the heart, blood vessels, and brain, so it’s not something Dr. Rishi wants to see people taking without paying attention. People taking medication for mood disorders could be especially affected by the serotonin in their sleep aid, he warns.<br/><br/>For anyone taking melatonin, Dr. Rishi recommended they check the bottle to see whether they are using a product with a USP-verified check mark, which indicates that the product meets the standards of the U.S. Pharmacopeia Convention.<br/><br/>The risk of impurities is a good reason for kids to not be given the hormone, but another worry is whether melatonin interferes with puberty in children – which is also a question researchers at the Children’s Hospital of Eastern Ontario in Ottawa <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6362935/">are asking</a>.<br/><br/></p> <h2>Disrupting puberty</h2> <p>While short-term melatonin use is considered safe, the researchers reported, concerns that long-term use might delay children’s sexual maturation require more study. One theory is that nightly melatonin use might interrupt the decline of natural hormone levels and interfere with the start of puberty.</p> <p>Researchers from the Children’s Hospital of Michigan in Detroit also <a href="https://publications.aap.org/pediatrics/article/148/1/e2021051001/179723/COVID-19-and-Pediatric-Ingestions">reported an uptick</a> in accidental ingestion of melatonin in children. Kids got their hands on melatonin and swallowed too many capsules more often than other pill-related mishaps during the pandemic.<br/><br/>Dr. Rishi said more research is needed to assess the safe use of melatonin in children. He points out that the hormone can treat circadian rhythm disorders in adults.<br/><br/>While specialists weigh the benefits and risks of melatonin use and where it is safest to try, Dr. Rishi said the hormone does have a role in medicine.<br/><br/>Melatonin will probably need to be regulated by the FDA as a medication – especially for children – Dr. Rishi pointed out. And what place, if any, it will have for managing chronic insomnia is “a big question mark.”<br/><br/>Results of the investigation by the American Academy of Sleep Medicine will be published on its sleepeducation.org website in a few months.</p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.webmd.com/sleep-disorders/news/20220418/melatonin-risks-what-to-know">WebMD.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Fatal child poisonings linked to common cough and cold meds

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Fri, 10/29/2021 - 14:35

 

A number of fatal child poisonings have been linked to common cough and cold medications, according to a report.

The Pediatric Cough and Cold Safety Surveillance System, which tracks fatal child poisonings, has identified 40 such deaths in recent years and raised particular concern about medications containing diphenhydramine, a common antihistamine that can be sedating.

“There is little evidence that cough and cold medicines make children feel better or reduce their symptoms, but there is evidence they can suffer harm,” says Kevin Osterhoudt, MD, medical director of the Poison Control Center at the Children’s Hospital of Philadelphia.

In recent years, the FDA has advised labeling changes and recommended that cough and cold medications not be given to children younger than 2. Drugmakers also voluntarily relabeled these products to state “do not use in children under 4 years of age.”

Compared to older children or adults, young children have a different physiology when they breathe, so any product containing antihistamines can be a danger to little kids, Dr. Osterhoudt says.

But a recent survey shows about half of American parents gave their child cough and cold medication the last time they were ill, Dr. Osterhoudt says. And the findings suggest that cough and cold medications are in homes where children might find them.

Using the new evidence from the national surveillance system, investigators set up an expert panel to review the results. They found that most of the deaths were in children under the age of 2. The results were reported in the October issue of Pediatrics.

In seven instances, death followed the intentional use of medication to sedate the child, reports lead investigator Laurie Seidel Halmo, MD, from Children’s Hospital Colorado, Aurora.

“It’s not uncommon for parents to use sedatives like diphenhydramine to make their child sleepy for activities like air travel,” Dr. Osterhoudt says.

While antihistamines can be sedating, “an overdose of antihistamines like diphenhydramine can paradoxically become a stimulant,” having the opposite effect, he explains.

Adults and teens who take overdoses will sometimes become delirious, hallucinate, and have a racing heart.

But in young children, “if not careful with your dosing, you could actually give too much and create this stimulant activity,” Dr. Osterhoudt says.

In six other cases, the cough and cold medication was given to murder the child, the investigators reported.

The findings are “concerning,” especially with “more than one-half of nontherapeutic intent cases determined to be malicious in nature,” Michele Burns, MD, from Boston Children’s Hospital, and Madeline Renny, MD, from the Grossman School of Medicine in New York, wrote in a commentary with the report.

This important fatality review shows that despite safety efforts, young children remain at risk for death, they report.

The investigators point out that labeling changes do not seem to have protected vulnerable children, and they recommend that doctors educate parents and caregivers about the risk of cough and cold medications.

Dr. Halmo and her team also recommend that the medical community and child welfare advocates be on the lookout for medication use as a source of child abuse.

At home, preventing accidental ingestion could go along with other practices already ingrained in the minds of many, Dr. Osterhoudt says.

“We know to change the clocks in the spring and fall and make sure your smoke detector and carbon monoxide detector has fresh batteries, but maybe it’s also a good time to look at medicines in the house.”

In other words, after you change the clocks, it’s time to take inventory of medications around the house, and if they’re no longer in use, safely dispose of them.

The American Academy of Pediatrics offers guidelines on the safe home storage of medications to keep them out of reach of children and the use of protective caps on drugs.

A version of this article first appeared on WebMD.com.

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A number of fatal child poisonings have been linked to common cough and cold medications, according to a report.

The Pediatric Cough and Cold Safety Surveillance System, which tracks fatal child poisonings, has identified 40 such deaths in recent years and raised particular concern about medications containing diphenhydramine, a common antihistamine that can be sedating.

“There is little evidence that cough and cold medicines make children feel better or reduce their symptoms, but there is evidence they can suffer harm,” says Kevin Osterhoudt, MD, medical director of the Poison Control Center at the Children’s Hospital of Philadelphia.

In recent years, the FDA has advised labeling changes and recommended that cough and cold medications not be given to children younger than 2. Drugmakers also voluntarily relabeled these products to state “do not use in children under 4 years of age.”

Compared to older children or adults, young children have a different physiology when they breathe, so any product containing antihistamines can be a danger to little kids, Dr. Osterhoudt says.

But a recent survey shows about half of American parents gave their child cough and cold medication the last time they were ill, Dr. Osterhoudt says. And the findings suggest that cough and cold medications are in homes where children might find them.

Using the new evidence from the national surveillance system, investigators set up an expert panel to review the results. They found that most of the deaths were in children under the age of 2. The results were reported in the October issue of Pediatrics.

In seven instances, death followed the intentional use of medication to sedate the child, reports lead investigator Laurie Seidel Halmo, MD, from Children’s Hospital Colorado, Aurora.

“It’s not uncommon for parents to use sedatives like diphenhydramine to make their child sleepy for activities like air travel,” Dr. Osterhoudt says.

While antihistamines can be sedating, “an overdose of antihistamines like diphenhydramine can paradoxically become a stimulant,” having the opposite effect, he explains.

Adults and teens who take overdoses will sometimes become delirious, hallucinate, and have a racing heart.

But in young children, “if not careful with your dosing, you could actually give too much and create this stimulant activity,” Dr. Osterhoudt says.

In six other cases, the cough and cold medication was given to murder the child, the investigators reported.

The findings are “concerning,” especially with “more than one-half of nontherapeutic intent cases determined to be malicious in nature,” Michele Burns, MD, from Boston Children’s Hospital, and Madeline Renny, MD, from the Grossman School of Medicine in New York, wrote in a commentary with the report.

This important fatality review shows that despite safety efforts, young children remain at risk for death, they report.

The investigators point out that labeling changes do not seem to have protected vulnerable children, and they recommend that doctors educate parents and caregivers about the risk of cough and cold medications.

Dr. Halmo and her team also recommend that the medical community and child welfare advocates be on the lookout for medication use as a source of child abuse.

At home, preventing accidental ingestion could go along with other practices already ingrained in the minds of many, Dr. Osterhoudt says.

“We know to change the clocks in the spring and fall and make sure your smoke detector and carbon monoxide detector has fresh batteries, but maybe it’s also a good time to look at medicines in the house.”

In other words, after you change the clocks, it’s time to take inventory of medications around the house, and if they’re no longer in use, safely dispose of them.

The American Academy of Pediatrics offers guidelines on the safe home storage of medications to keep them out of reach of children and the use of protective caps on drugs.

A version of this article first appeared on WebMD.com.

 

A number of fatal child poisonings have been linked to common cough and cold medications, according to a report.

The Pediatric Cough and Cold Safety Surveillance System, which tracks fatal child poisonings, has identified 40 such deaths in recent years and raised particular concern about medications containing diphenhydramine, a common antihistamine that can be sedating.

“There is little evidence that cough and cold medicines make children feel better or reduce their symptoms, but there is evidence they can suffer harm,” says Kevin Osterhoudt, MD, medical director of the Poison Control Center at the Children’s Hospital of Philadelphia.

In recent years, the FDA has advised labeling changes and recommended that cough and cold medications not be given to children younger than 2. Drugmakers also voluntarily relabeled these products to state “do not use in children under 4 years of age.”

Compared to older children or adults, young children have a different physiology when they breathe, so any product containing antihistamines can be a danger to little kids, Dr. Osterhoudt says.

But a recent survey shows about half of American parents gave their child cough and cold medication the last time they were ill, Dr. Osterhoudt says. And the findings suggest that cough and cold medications are in homes where children might find them.

Using the new evidence from the national surveillance system, investigators set up an expert panel to review the results. They found that most of the deaths were in children under the age of 2. The results were reported in the October issue of Pediatrics.

In seven instances, death followed the intentional use of medication to sedate the child, reports lead investigator Laurie Seidel Halmo, MD, from Children’s Hospital Colorado, Aurora.

“It’s not uncommon for parents to use sedatives like diphenhydramine to make their child sleepy for activities like air travel,” Dr. Osterhoudt says.

While antihistamines can be sedating, “an overdose of antihistamines like diphenhydramine can paradoxically become a stimulant,” having the opposite effect, he explains.

Adults and teens who take overdoses will sometimes become delirious, hallucinate, and have a racing heart.

But in young children, “if not careful with your dosing, you could actually give too much and create this stimulant activity,” Dr. Osterhoudt says.

In six other cases, the cough and cold medication was given to murder the child, the investigators reported.

The findings are “concerning,” especially with “more than one-half of nontherapeutic intent cases determined to be malicious in nature,” Michele Burns, MD, from Boston Children’s Hospital, and Madeline Renny, MD, from the Grossman School of Medicine in New York, wrote in a commentary with the report.

This important fatality review shows that despite safety efforts, young children remain at risk for death, they report.

The investigators point out that labeling changes do not seem to have protected vulnerable children, and they recommend that doctors educate parents and caregivers about the risk of cough and cold medications.

Dr. Halmo and her team also recommend that the medical community and child welfare advocates be on the lookout for medication use as a source of child abuse.

At home, preventing accidental ingestion could go along with other practices already ingrained in the minds of many, Dr. Osterhoudt says.

“We know to change the clocks in the spring and fall and make sure your smoke detector and carbon monoxide detector has fresh batteries, but maybe it’s also a good time to look at medicines in the house.”

In other words, after you change the clocks, it’s time to take inventory of medications around the house, and if they’re no longer in use, safely dispose of them.

The American Academy of Pediatrics offers guidelines on the safe home storage of medications to keep them out of reach of children and the use of protective caps on drugs.

A version of this article first appeared on WebMD.com.

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