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Published: Tuesday, October 04, 2016 @ 11:17 AM
Updated: Tuesday, October 04, 2016 @ 11:17 AM
The U.S. Food and Drug Administration last week warned parents against using homeopathic teething tablets and gels as regulators investigate reports of infants and children suffering seizures and other health issues after taking the natural remedies.
The FDA zeroed in on tablets and gels distributed by CVS Pharmacy and Hyland's Homeopathy in a warning released Friday, although regulators noted that other retailers might sell the products or similar ones in stores nationwide and online.
The tablets and gels are unnecessary to get children through teething, Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a news release.
"We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives," she said.
Regulators warned parents to be particularly careful if children suffer from seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation, all signs of belladonna toxicity, after taking the teething remedies.
The warning comes six years after the FDA warned parents against using Hyland's Teething Tablets. Regulators said a laboratory analysis found that the tablets used an inconsistent amount of belladonna, a substance that can be toxic in large doses.
Belladonna, also known as deadly nightshade, is not uncommon in homeopathic remedies and is used by Hyland's to combat redness, inflammation and general discomfort.
In a statement, Hyland's described the FDA warning as a "surprise" and said the company is "confident that Hyland's Baby Teething Tablets remain safe."
The company is cooperating with the FDA investigation, although it said it had yet to learn of any of the data supporting the FDA's warning.
The company's teething tablets are sold over the counter and are tested for excessive belladonna content and contaminants, Hyland's said.
"A 10-pound child would have to accidentally ingest, all at the same time, more than a dozen bottles of 135 Baby Teething Tablets before experiencing even dry mouth from the product," the company said in a statement.
"Additionally, the body clears belladonna alkaloids from any single dose in a matter of hours," making it unlikely that the substance would build in a person's system, the company said.
The company also worried about "rumors" that cause "fear and worry" about belladonna.
"This new FDA statement increases the confusion," the company said. "The safety and effectiveness of Hyland's natural homeopathic medicines is our top priority. That's why we work with regulators to ensure that our products meet the highest standards."
However, the FDA said the tablets and gels have not been evaluated or approved for either safety or efficacy by the government agency. Regulators said they were unaware "of any proven health benefit of the products."
Published: Friday, February 23, 2018 @ 10:58 PM
— The Food and Drug Administration on Wednesday approved a breakthrough blood test that can help detect concussions in adults.
It can be administered as soon as 15 minutes after the injury, but results take a few hours to produce.
According to the Atlanta-based Centers for Disease Control and Prevention, traumatic brain injury is a “serious public health problem in the United States.” In 2013 alone, there were about 2.8 million visits to emergency rooms for traumatic brain injury-related conditions. Of these, nearly 50,000 people died.
TBI is typically caused by a blow or bump to the head, or a by a head injury that disrupts the brain’s normal functioning. It can range from mild to severe. About 75 percent of TBIs that occur each year are assessed as mild TBIs or concussions.
Most patients with traumatic brain injury undergo a neurological exam, followed by a CT scan.
For their research, the FDA evaluated data on 1,947 individual blood samples from adults with suspected mild TBI or concussion and reviewed the product’s performance by comparing blood test results with CT scan results.
They found the blood test was 97.5 percent as effective in detecting concussion and 99.6 perfect as effective in ruling out the injury.
The test also costs as little as one-tenth as much as a CT scan.
"A blood test that accurately, reliably and consistently detects the presence of brain proteins that appear in the blood after a brain injury is a major advance," Dr. David Dodick, a fellow of the American Academy of Neurology who specializes in sports medicine and neurology, told CNN. Dodick was not involved in the study.
One of the challenges of diagnosing concussions is that the injury’s symptoms can occur at various times. For some, they appear instantly. Others may not experience symptoms for hours or even days.
Symptoms also vary from person to person. Some may experience light or noise sensitivity, or may lose balance.
“This is something that has been a long time coming,” Col. Dallas Hack, who was director of the Army’s Combat Casualty Care Research Program from 2008 to 2014 and is now retired, told the New York Times.
“The concept originally was that we would have something that medical personnel in the field would be able to use to assess whether somebody who had received a head injury needed a higher level of care,” Hack said.
A new blood test could within a few hours rule out concussion — or guide doctors to perform a full brain scan. https://t.co/VdCqvVdl9I— STAT (@statnews) February 21, 2018
But Dodick told CNN that researchers still need to better understand when brains have fully healed from trauma and how the protein biomarkers may actually affect prognosis. Additionally, it’s unclear whether or not the new test can determine subconcussive blows, hits to the head that don’t always cause symptoms but do cause brain injury.
Subconcussive or repeat blows are believed to lead to the neurodegenerative disease chronic traumatic encephalopathy, or CTE. Over time, that damage may lead to personality changes, mood disorders and other behavioral issues.
"These occur much more often than actual concussions, especially in certain collision and contact sports,” Dodick told CNN.
Published: Friday, February 23, 2018 @ 11:14 PM
— Over the years, much has been speculated about President Donald Trump’s hair, but he’s never admitted to having a reason for choosing his particular hairstyle other than the fact that it’s the way he “likes it.” However, on Friday, that all changed when he finally admitted to having a bald spot — and trying to hide it.
“Oh, I try like hell to hide the bald spot, folks. I work at it,” he told the crowd at the Conservative Political Action Conference in Oxon Hill, Maryland. “It doesn’t look bad. Hey, we are hanging in, we are hanging in, we are hanging in there. Right? Together, we are hanging in.”
Trump’s honest take on his hair came after a video of him boarding Air Force One at Andrews Air Force Base on Feb. 2 revealed a bald spot on the back of his head when his signature mane was whipped by the gusty wind.
Trump’s hair has been a topic of conversation for years, and he has often talked about it himself. In a much-maligned interview on “The Tonight Show with Jimmy Fallon,” the late-night host was allowed to mess up then-candidate Trump’s hair to prove that it was real.
Trump has also made it clear multiple times that he doesn’t wear a wig or a “rug” as he’s called it. “As everybody knows, but the haters and losers refuse to acknowledge, I do not wear a ‘wig.’ My hair may not be perfect, but it’s mine,” he once wrote on Twitter.
“I do not wear a rug. My hair is 100 percent mine. No animals have been harmed in the creation of my hairstyle,” the former businessman quipped in his book, “Trump: How to Get Rich.”
Published: Friday, February 23, 2018 @ 7:38 PM
SEATTLE — A couple strolled through downtown Seattle’s iconic, bustling Pike Place Market food stands on a clear winter Saturday when their dog started running through the booths.
"We noticed a puppy who looked very similar in age and appearance to [our dog] Maui, and once they saw each other they got really excited and started playing together," owner Kaitlyn Hawkins told KIRO 7. "After chatting with the other owners we realized that the dogs are siblings."
The 11-month-old dogs rolled around, embracing each other in their coincidental reunion.
Maui and her sister Juniper were adopted from Russia. They were flow to Seattle-Tacoma International Airport last May as puppies.
The two dogs recognizing each other nearly a year later has made them an internet sensation. With more than 15 million visitors exploring the historic district annually, people find the encounter quite remarkable.
A worker at the Pike Place Market captured the moment in a video, and nearly 3 million people have watched it on Facebook.
"I witnessed the coolest thing," the Facebook post said. "They even had identifying tattoos that confirmed it. This joyful reunion went on for over a half an hour, in fact they were still at it when I left the market."
Published: Saturday, February 24, 2018 @ 4:11 AM
In the wake of the recent mass shooting at a Florida high school, President Donald Trump on Saturday signaled again that he wants changes in background checks for those people who are buying firearms, as he emphasized his call for Congress to make a series of reforms to gun-related laws, also urging state and local officials to do more to toughen security at their schools.
“Congress is in a mood to finally do something on this issue – I hope!,” the President tweeted.
White House officials said Mr. Trump would again press his call for action on issues of school safety in coming days as he meets with the nation’s Governors, many of whom will be in Washington, D.C. for their yearly legislative conference.
But the question remains – what will the Congress do? Or what can Congress do?
1. Some details still murky on what the President wants to do. While the President has a ready list of items on which he is asking for action in the Congress, the exact details will determine how the Congress reacts. For example, Mr. Trump has repeatedly said he wants ‘comprehensive background checks with an emphasis on mental health’ – how that is structured is an extremely important point. While it may sound completely logical that someone who has mental issues should not be able to buy weapons, those details are not easily fleshed out. While he has talked repeatedly about background checks, the President has never addressed the issue of private gun sales – what is sometimes referred to as the ‘gun show loophole’ – which is something members in both parties have talked about dealing with for several years. At a Friday news conference with the Prime Minister of Australia, here’s how the President set out what he wants accomplished:
2. The push for the “Fix NICS” bill. Even before the Florida school shooting, there was a bipartisan effort to make some changes to ensure that more information is funneled into the background check system for gun buyers, whether it’s on mental health, or military charges which would disqualify someone who wants to buy a firearm. The House already passed the “Fix NICS” bill – but it was combined with another measure that approved a national “Concealed Carry” effort, which would allow anyone with a legal permit to carry a concealed weapon to do that in any state – even if that state has different laws and regulations governing such conduct. While that combination was approved by the House, it seems doomed in the Senate, and it is one reason that some lawmakers are now pressing for action on just the “Fix NICS” plan, which the President has endorsed.
3. How much would the Congress really do under Trump’s plans? This is a question that’s up for debate. Think of the President’s call for certain teachers or administrators to carry concealed weapons at schools – that seems more of a state and local matter than something which would be legislated by the Congress. Increasing security measures at schools – the Congress could deliver aid, but the idea of approving new spending is not exactly a popular item with some Republicans right now in the House and Senate. Changing the age of purchase for certain weapons like an AR-15 might sound attractive to some, but that is guaranteed to be controversial as well in Congress – especially when states might be able to take that same step on their own. The “gun violence restraining order” is another idea that’s popped up as a way to keep the mentally ill from access to firearms – but is that better done by state legislatures instead of the Congress?
4. There has been some movement in Congress – but not much. Yes, we have examples of members of Congress who have changed their position on certain gun issues, but by no means has there been an upheaval on Capitol Hill in the wake of the Florida school shooting, just like there was no major change after past school shootings. Yes, the President has talked to House and Senate leaders about the gun issue – but don’t expect gun legislation to be on the floor next week or anything. Here is one GOP lawmaker who said he wants to revisit that ban – but that’s just one.