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Posts for: February, 2017

By contactus@priority-pediatrics.com
February 20, 2017
Category: Teething
Tags: homeopathy   Teething   Poisoning  

FDA Investigates Infant Deaths Related to Homeopathic Remedies
From the Jounal of the American Medical Association · February 8, 2017 

Amanda Camp for Doximity

Last August, an infant was rushed from her home to a hospital after seizing for about 25 minutes. Unresponsive, she began to turn blue while gasping for air. At the hospital, she was diagnosed with status epilepticus—a prolonged seizure. The child had no known medical problems or allergies but had recently been given homeopathic teething tablets for the first time. The pills—whose active ingredient is a poisonous plant called belladonna—were the only medication she had taken in the days leading up to the event.

Fortunately, the infant survived, but on September 1, her father filed a MedWatch adverse event report with the US Food and Drug Administration (FDA). That report, obtained by JAMA through a Freedom of Information Act request, described the life-threatening scenario.

“As a member of the Law Enforcement community,” the child’s father wrote in the report, “I believe that this product should be inspected to make sure that it is safe for human consumption especially for children.”

The report triggered an FDA investigation, which found more than 400 reports of adverse events in infants and children associated with homeopathic teething products filed over the past 6 years. The events included additional seizures, as well as tremor, fever, shortness of breath, lethargy and sleepiness, constipation, vomiting, agitation, and irritability.

Most alarming, however, 10 of the reported events were deaths.

On September 30, the FDA issued a warning to consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The agency recommended that consumers stop using the products.

The same day as the warning, CVS Pharmacy voluntarily removedall brands of homeopathic teething products from its online and retail stores. This included its store brand product, which was cited in the adverse event report that triggered the FDA investigation. Less than 2 weeks later, Hyland’s, a popular purveyor of homeopathic teething remedies, discontinued its line in the United States. The action prevented new Hyland’s teething products from entering the market but did not address products already on store shelves.

In late November, Raritan Pharmaceuticals issued a voluntary recall of 3 homeopathic teething and ear relief products for infants and children—including the CVS tablets—after the FDA investigation found varying levels of belladonna in the products and recommended the recall.

“The FDA is concerned about inconsistent amounts of belladonna, a potentially toxic ingredient if present in sufficient quantities, in homeopathic products,” FDA press officer Lyndsay Meyer said in an email after the recall was announced.

Then, in January of this year, the FDA announced that its laboratory analysis had found elevated belladonna levels in certain homeopathic teething tablets that “far exceeded” the amount stated on the label.

Although the announcement did not specify the brand of tablets with high levels of belladonna, it stated that the agency had asked Standard Homeopathic Company, the makers of Hyland’s homeopathic teething remedies, to recall its teething pills, which would remove them from stores and online retailers.

At press time, the company had not agreed to the request, according to the FDA. The agency does not have authority to force the recall, and it would not comment on possible compliance and enforcement actions.

The FDA investigation of homeopathic teething products is ongoing. According to Meyer, the agency is analyzing the products to determine whether they caused the adverse events. Other factors, such as underlying health conditions, sometimes explain these complications, she said.

The adverse events reports—along with growing consumer popularity—have health experts and agencies taking new notice of homeopathy, a 2-centuries-old complementary and alternative medicine system that has flown largely below the regulatory radar.

“I think there are some really substantial safety concerns, as illustrated by this warning from the FDA,” said Josephine P. Briggs, MD, director of the National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH). “We are concerned about the regulatory issues and concerned about public safety.”

According to the American Institute of Homeopathy, the botanical, mineral, and animal-sourced ingredients in homeopathic medicines are selected based on the principle “let likes cure likes,” the idea that a substance that triggers symptoms in a healthy person can cure a sick person who has similar symptoms.

Homeopathic teething remedies, for example, may contain belladonna, also known as deadly nightshade. According to D. Craig Hopp, PhD, program director for natural products research at NCCIH, the primary agent in belladonna is atropine, which can cause redness of the skin and dryness of the mouth and throat, as well as fever, delirium, and hallucinations.

Despite such ingredients, homeopathy should, in theory, be safe. The remedies are formulated based on the principle of “the minimum dose”—the idea that the lower the dose of the medication, the more effective it will be if prepared properly. Classic homeopathic remedies are repeatedly diluted to the point where “you end up with almost no detectable molecules in the final solution,” Briggs explained. The remedies are vigorously agitated at each stage and, according to homeopathic practitioners, the final shaken and diluted solution retains a “memory” of the original substance that exerts its effects with minimal adverse effects.

The principle of the minimum dose should at least imbue safety from adverse events, if not effectiveness. “[I]n general, the theory would suggest that homeopathic remedies are unlikely to be harmful,” said Erica Sibinga, MD, associate professor of pediatrics at the Johns Hopkins School of Medicine and chair of the American Academy of Pediatrics Section on Integrative Medicine.

But problems have arisen with homeopathic remedies that may not have been properly diluted. Hyland’s Teething Tablets were recalled in 2010, after an FDA warning following reports of serious adverse events. That time, the FDA’s laboratory analysis found that the product contained inconsistent amounts of belladonna, and the adverse events reports were consistent with belladonna toxicity. The investigation also uncovered substandard manufacturing of the teething tablets. The product recall was voluntary, however, and Standard Homeopathic Company, the makers of Hyland’s teething tablets, introduced a reformulated version in 2011.

According to Meyer, since 2009, the FDA has issued nearly 40 consumer warning letters for homeopathic products for a variety of reasons. That year, it advised consumers to stop using 3 over-the-counter (OTC) zinc-containing Zicam cold remedies marketed as homeopathic after more than 130 reports of loss of smell associated with their use. In 2014, consumers were warned that Pleo Homeopathic products for colds, yeast infections, pain, and other conditions could contain penicillin or its derivatives, which could cause life-threatening allergic reactions. And in 2015, the FDA warned against the use of OTC asthma products labeled as homeopathic.

“The folks in the [homeopathic] industry are always quick to point out that if you compare the adverse event rate for homeopathic products or other dietary supplements with the fact that there are tens of thousands of deaths from opioid overdoses every year, in comparison, they’re actually quite safe,” Hopp said.

In fact, a systematic review and meta-analysis of randomized controlled trials published in 2016 found that a similar proportion of patients experienced adverse effects after being randomized to homeopathic treatments compared with those who were randomized to receive placebos and conventional medicine.

“The difference is that people use these products with the assumption that they’re safe,” Hopp said of homeopathic remedies, adding that consumers are more aware of known risks with pharmaceutical products.

The use of homeopathic medicine is still relatively uncommon in the United States, but the modality is growing in popularity, making safety concerns increasingly salient. The prevalence of homeopathy use among US adults during the previous year increased from 1.8% in 2007 to 2.1% in 2012—a 15% increase—according to an analysis of National Health Interview Survey data. Between the late 1980s and 2007, the US homeopathic drug market expanded from a multimillion dollar market to a multibillion dollar industry, with consumers paying $2.9 billion out of pocket.

Federal regulators are starting to respond. In November, the Federal Trade Commission (FTC) announced a new enforcement policy statement on marketing claims for nonprescription homeopathic drugs. The agency ruled that OTC homeopathic drug marketing must effectively communicate that evidence for health claims is lacking. Marketing messages for homeopathic products that fail to effectively convey that lack of scientific substantiation to consumers will be in violation of FTC policy.

The FDA has also taken notice. The website of the nonprofit National Center for Homeopathy states that the “safe” and “gentle” remedies are FDA regulated. Technically, the FDA does regulate homeopathic medicines as drugs under the Federal Food, Drug, and Cosmetic Act, but it has chosen to assert its authority only so far.

Importantly, although the agency does step in when safety concerns arise with an existing product, it does not require premarket testing for safety or efficacy for OTC or prescription homeopathic medicines. According to the FDA Compliance Policy Guide for homeopathic drugs, issued in 1988, as long as the active ingredients are listed in the Homeopathic Pharmacopoeia of the United States, the official compendium of homeopathic standards, the remedy can be marketed without agency preapproval.

In 2015, the FDA held a public hearing to obtain information from stakeholders about the current use of homeopathic products and the agency’s regulatory framework for them. According to Meyer, the FDA is gathering information about whether to adjust the current enforcement policies to reflect the dramatic increase in the homeopathic product marketplace. “[W]e have received more than 9000 comments to the docket about homeopathy, which can take considerable time to weigh and consider,” she said.

Despite its many adherents, including some in the medical profession, there’s a lack of credible research showing that homeopathy works.

“Although there are some positive studies, the conclusion of… evidence-based reviews has been that they were not necessarily the highest quality studies,” Briggs said. “Most of the studies that have been done by the modern standards of evidence-based-medicine have been negative,” offering little evidence to support them as effective.

A 2007 systematic review in Mayo Clinic Proceedings found the evidence from clinical trials was not convincing enough to recommend homeopathy as prevention or treatment for any condition in children or adolescents, for example. And a 2015 evidence-based review by the Australian government that Briggs called “rigorous” concluded that “there are no health conditions for which there is reliable evidence that homeopathy is effective.”

Studying highly diluted homeopathic remedies poses inherent challenges. Homeopathy has a “plausibility problem,” Hopp said: “It goes against all of the established and known principles of pharmacology.”

He noted that designing a rigorous placebo-controlled trial to test a homeopathic remedy is fraught with methodological issues. “You can’t distinguish the quote-unquote active homeopathic preparation from a placebo preparation,” he said. “In effect, they’re both water.”

Researchers at McMaster University in Hamilton, Ontario, Canada, are launching a controversial clinical trial of homeopathic “vaccines”—known as “nosodes”—for diphtheria, pertussis, tetanus, measles, and mumps. Although the investigators have predictednegative results, which could influence regulation, critics of the study say that conducting it legitimizes quackery.

New NIH-supported research on homeopathy is unlikely to be forthcoming in the near future. According to Briggs, NCCIH has received few grant applications to study homeopathic interventions, and the institute is currently not supporting any studies on homeopathic medicine.

That could change, however, if a research proposal focused on measurable aspects of the homeopathic care paradigm, such as how the amount of time homeopathic practitioners spend with patients relates to health outcomes.

“I’m not sure everything that’s embedded in homeopathic practice is always negative,” Briggs said.

Sibinga noted that the increased use of homeopathy, even in the absence of scientific evidence, shows that patients want attention paid toward their symptoms, “even if we don’t have typical allopathic treatments for them.”

She added, “Some of the homeopathic remedies are aimed at common symptoms, like teething and colic or muscle aches, and perhaps it suggests that physicians can listen to those concerns more attentively.”

Note: The print version excludes source references. Please go online to jama.com.


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By contactus@priority-pediatrics.com
February 06, 2017
Category: Uncategorized
Tags: Untagged

What Parents Should Know About Teen Depression

By Raychelle Cassada Lohmann | Contributor Feb. 1, 2017, at 6:00 a.m.

Look for these signs and be proactive in addressing the mood disorder.

What Parents Should Know About Teen Depression

(iStockPhoto)

Parents shouldn't just dismiss possible signs of depression, such as teens being extremely argumentative and withdrawing from family and friends, as normal adolescent behavior. (ISTOCKPHOTO)

Are you the parent of a depressed teen? If so, you're not alone.

According to the Substance Abuse and Mental Health Services Administration, in 2015 an estimated 3 million teens in America between the ages of 12 and 17 experienced at least one major depressive episode in the past 12 months; that’s 12.5 percent of the U.S. adolescent population. An MDE is experiencing symptoms of depression, such as loss of interest in usual activities, lack of energy and hopelessness, accompanied by depressed mood for a period of two weeks or more. According to a study published in the journal Pediatrics, the prevalence of adolescents who reported they had an MDE in the previous year jumped from 8.7 percent in 2005 to 11.5 percent in 2014 – a 37 percent increase. Sadly, adolescent depression continues to rise.

However, despite the increase in adolescent depression, there hasn’t been a proportionate increase in mental health treatment. These teens are not receiving the professional services they need to help them cope and relieve their symptoms. Teen depression goes beyond sadness and can often manifest in anger, moodiness and isolation. Whether your teen is being moody or suffering from clinical depression can be difficult to determine, since depression can be easily mistaken for typical teen behavior.

It’s easy to dismiss adolescent behavior as a snarky attitude or being disrespectful, but perhaps there’s more to the story. What if behind the defiance, your teen is miserable, can’t remember the last time she felt happy, or worse yet, questioned whether she’d be better off dead? With these troublesome and dismal thoughts looming, your teen may know that something is wrong but not know how to talk with you about how she feels. Though it may be difficult to distinguish from teen angst, adolescent depression is real, it’s painful and it can take an emotional, mental and physical toll. The only way you can combat teen depression is to take a proactive approach.

[See: Am I Just Sad – or Actually Depressed?]

How Do Adolescents Experience Depression?

To begin to understand depression, you have to know what it is and how to differentiate it from normal teen behavior. Depression can be described as the persistent feeling of deep sadness. Most of us have felt depressed at some point in our lives. Usually these feelings come and go, but sometimes they linger for days, weeks or even months.

Depressed adults and teens may experience similar symptoms. However, those symptoms may manifest in different ways, making it hard to separate normal adolescent behavior from the behavioral changes associated with depression. For example, depressed teens may show signs of anxiety, refuse to go to school, stop talking with friends, become extremely argumentative and stay awake most of the night, but sleep all day. Many teens who aren’t depressed may exhibit some these behaviors at one time or another. The difference between typical behavior and depression is the duration, frequency and intensity as well as the implications it has on personal, social and academic functioning. Unlike adult depression, teen depression may go unnoticed and get brushed off as rebellious adolescent behavior.

How Do I know If My Teen Is Depressed?

There are some tell-tale indicators of depression. The following are some common signs and symptoms of adolescent depression:

If you feel your teen is suffering from depression, please seek professional help immediately. Untreated depression is serious and can, in some instances, put an adolescent at risk for suicide.

[See: 9 Things to Do or Say When a Loved One Talks About Taking Their Life.]

How Can I Help My Teen Manage Depression?

If your teen is depressed, here are five things you can do right now to help him or her cope:

1. Stop and listen. Don't worry about what to say; be understanding and encouraging and let your teen know that you’re right there every step of the way. Set aside some face-to-face time each day to speak with your teen. Make sure there are no distractions during your time together, such as a vibrating cell phone or having to take dinner out of the oven. Your teen needs your unpided attention. There is nothing that can be more healing than the power of your presence.

2. Stay the course. Separate depression from your teen, and don’t let the illness push you away. Even if your teen refuses to talk, there is comfort in just sitting on the sofa together and watching Netflix. Small steps can lead to great strides.

3. Do something together. Go for a walk, play a game of one-on-one basketball or take up a new hobby, such as cooking or woodworking. Slowly reintroduce your teen to fun social activities. Keep in mind that depression may lead your teen to disengage, but with time, your teen may come around to doing the things he or she once found enjoyable.

4. Go there. Don’t steer clear of difficult topics, such as suicide or drugs. Too often parents avoid the tough conversations; but these are the exchanges that can have the most positive impact. For example, if you find your teen self-medicating with pot, discuss how marijuana is a depressant and can intensify depression. Likewise, ask your teen about thoughts of self-harm or suicide. Don’t worry about planting a seed, if the thought is there, you aren’t reinforcing it by saying it out loud. By bringing up the difficult topics, you make it clear that any subject can be discussed – and that can be comforting to a depressed teen.

5. Get help. Take your teen to see a mental health professional and stick with the treatment plan. Depression doesn’t develop overnight, and it won’t go away overnight either. Work closely with your child’s doctor and therapist, and sign a release for both to communicate with one another. These professionals will form your teen’s treatment team.

[See: How to Find the Best Mental Health Professional for You.]

With modern advancements in medication and therapy, depression can be effectively treated in 70 to 90 percent of cases. So, your teen doesn’t have to suffer in silence. There is hope, there is treatment, and there are brighter days ahead.


By contactus@priority-pediatrics.com
February 04, 2017
Category: Bullying

Bullying Can Also Hurt Kids’ Academic Performance

Bullying Can Also Hurt Kids' Academic Performance

New research finds that chronic bullying is related to lower academic achievement, a dislike of school, and low confidence by students in their own academic abilities.

Investigators tracked hundreds of children from kindergarten through high school and found that nearly a quarter of kids in the study experienced bullying.

 

While pop culture often depicts more frequent bullying in high school, the study found that bullying was more severe and frequent in elementary school and tended to taper off for most students as they got older.

However, 24 percent of the children in the study suffered chronic bullying throughout their school years, which was consistently related to lower academic achievement and less engagement in school, said lead researcher Gary Ladd, Ph.D., a psychology professor at Arizona State University.

“It’s extremely disturbing how many children felt bullied at school,” Ladd said. “For teachers and parents, it’s important to know that victimization tends to decline as kids get older, but some children never stop suffering from bullying during their school years.”

Most studies on bullying have tracked children for relatively short periods of time and focused on psychological effects, such as anxiety or depression. This is the first long-term study to track children for more than a decade from kindergarten through high school and analyze connections between bullying and academic achievement, Ladd said.

The research, which appears online in the Journal of Educational Psychology, was part of the Pathways Project, a larger longitudinal study of children’s social, psychological and academic adjustment in school.

The study, which began with 383 kindergarteners (190 boys, 193 girls) from public schools in Illinois, found several different trajectories for children related to bullying.

 

Children who suffered chronic levels of bullying during their school years (24 percent of sample) had lower academic achievement, a greater dislike of school and less confidence in their academic abilities.

Children who had experienced moderate bullying that increased later in their school years (18 percent) had findings similar to kids who were chronically bullied.

However, children who suffered decreasing bullying (26 percent) showed fewer academic effects that were similar to youngsters who had experienced little or no bullying (32 percent), which revealed that some children could recover from bullying if it decreased. Boys were significantly more likely to suffer chronic or increasing bullying than girls.

“Some kids are able to escape victimization, and it looks like their school engagement and achievement does tend to recover,” Ladd said. “That’s a very hopeful message.”

The researchers faced the difficult challenge of tracking children for more than a decade, from kindergarten through high school, as some families moved across the United States. The study began in school districts in Illinois, but the children were living in 24 states by the fifth year of the study.

“People moved and we had to track them down all over the country,” Ladd said. “We put people in cars or on planes to see these kids.”

The comprehensive study included annual surveys administered by researchers to the children, teacher evaluations, and standardized reading and math test scores.

Children described their own experiences about bullying in questions that asked whether they had been hit, picked on or verbally abused by other kids. Some children may be more sensitive to bullying, with one child who is shoved thinking it is bullying while another might think it is just playful, but parents and teachers shouldn’t dismiss what may seem like minor bullying, Ladd said.

“Frequently, kids who are being victimized or abused by other kids don’t want to talk about it,” he said. “I worry most about sensitive kids who are not being taken seriously and who suffer in silence. They are being told that boys will be boys and girls will be girls and that this is just part of growing up.”

The children from the study were followed into early adulthood, although researchers lost track of approximately one-quarter of the youngsters during the lengthy study. Approximately 77 percent of the children in the study were white, 18 percent were African-American, and four percent were Hispanic, biracial or had other backgrounds.

Almost one-quarter of the children came from families with low annual incomes ($0- $20,000), 37 percent had low to middle incomes ($20,001-$50,000), and 39 percent had middle to high incomes (more than $50,000).

Schools should have anti-bullying programs, and parents should ask their children if they are being bullied or excluded at school, Ladd said.

In the early years of the study, school administrators sometimes claimed there weren’t any bullies or victims in their schools, but the researchers stopped hearing that view as bullying has received more attention nationwide, Ladd said.

“There has been a lot of consciousness raising and stories of children being bullied and committing suicide, and that has raised public concern,” he said.

“But more needs to be done to ensure that children aren’t bullied, especially for kids who suffer in silence from chronic bullying throughout their school years.”

Source: American Psychological Association/EurekAlert


By contactus@priority-pediatrics.com
February 04, 2017
Category: Depression

Study Finds Physically Active Kids Less Depressed

Study Finds Physically Active Kids Less Depressed

Children who regularly engage in moderate to vigorous physical activity — the type that leaves them sweaty and out of breath — are less likely to develop depression, according to a new study by researchers at the Norwegian University of Science and Technology (NTNU) and NTNU Social Research.

“Being active, getting sweaty and roughhousing offer more than just physical health benefits. They also protect against depression,” said first author Tonje Zahl, a Ph.D. candidate at NTNU.

 

Although previous studies have found a link between physical activity and a lower risk for depression in adults and young people, the same effect has not been studied in children until now.

For the new study, published in the journal Pediatrics, the researchers followed hundreds of children over four years to see if they could find a correlation between physical activity and symptoms of depression.

They examined just under 800 children when they were six years old, and conducted follow-up examinations with about 700 of them when they were eight and ten years old. Physical activity was gauged with accelerometers, which served as a type of advanced pedometer, and parents were asked about their children’s mental health.

The findings showed that physically active six- and eight-year-olds showed fewer depressive symptoms when they were examined two years later, suggesting that physical activity may protect against the development of depression.

“This is important to know, because it may suggest that physical activity can be used to prevent and treat depression already in childhood,” said Dr. Silje Steinsbekk, associate professor in NTNU’s Department of Psychology. “We also studied whether children who have symptoms of depression are less physically active over time, but didn’t find that to be the case.”

Steinsbekk emphasizes that these results should now be tested in randomized studies where researchers can increase children’s physical activity and then examine any potential link to lowered depression.

 

Previous findings in adolescents and adults have shown that sedentary lifestyles — like watching television and computer gaming — are associated with depression, but the NTNU children’s study found no correlation between depression and a sedentary lifestyle. Furthermore, depressive symptoms did not lead to greater inactivity.

The takeaway message to parents and health professionals is to be proactive in facilitating physical activity among children, which means allowing and encouraging children to get a little sweaty and breathless.

According to the findings, limiting children’s TV or iPad screen time is not enough — go for a bike ride or engage in outdoor play. Children need actual increased physical activity to reap the mental health benefits.


By contactus@priority-pediatrics.com
February 04, 2017
Category: LGTBQ
Tags: teens   LGTBQ   Youth   Surveys   Gay   Rainbow  

 

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