Thursday, June 06, 2019

Woman's 'brain tumor' turns out to be a parasite, a tapeworm growing in her head



Magnetic resonance image in a person with neurocysticercosis showing many cysts within the brain. Cysticercosis is a tissue infection caused by the young form of the pork tapeworm. ... A specific form called neurocysticercosis, which affects the brain, can cause neurological symptoms.

A parasite in the brain sounds like the plot of a horror movie, but it’s a preventable infection from a pork tapeworm known as neurocysticercosis — a leading cause of adult onset epilepsy worldwide, according to the Centers for Disease Control and Prevention.
A New York woman began having terrible nightmares, hallucinations, and insomnia, and then she started to drop things. She was making strange phone calls she didn’t remember and forgetting where she was. Visits to urgent care did not reveal the cause, and an MRI was eventually done; it revealed a lesion adjacent to an area of the brain controlling speech. Doctors thought she had a malignant tumor and scheduled surgery.
It did not turn out to be a tumor, instead a cyst holding a baby tapeworm.
“Sure enough, a baby tapeworm came out of that lesion, This is one case where the parasite was the preferable diagnosis. “She had a single parasite in her head that we were able to take out. We were very happy; it was one of those rare situations where you see a parasite and you’re like, wow this is great!” ” said Dr. Jonathan Rasouli, the chief neurosurgery resident at the Icahn School of Medicine at Mount Sinai in New York City and another surgical team member.

This kind of parasitic infection, cysticercosis, is relatively rare in the United States and was not considered when the doctors were making their original diagnosis; it doesn’t happen like many food borne illnesses that are caused by bacterial pathogens, and is not caused by eating under cooked pork.
Instead, a person first has to have an intestinal tapeworm, which sheds eggs that end up in their feces. The eggs - larval cysts - can infect tissues, like muscles or the brain. So if feces from a person with a tapeworm contaminates food that gets eaten, then cysticercosis - the parasitic tissue infection - develops. Therefore the disease is far likelier to happen to members of a household in which someone is carrying a tapeworm than to members of households without a tapeworm case. Under cooked pork can, however, cause a tapeworm if larval cysts are in the meat.

Tapeworm and cysticercosis happen to people around the world. Rates are highest in areas with poor sanitation practices and pigs that range freely. While it’s more common in Asia, Africa, and Latin America, it can also happen in North America when people don’t use good hand washing practices. Hand washing can prevent these type of parasites as well as diseases like Flu.
Please share, print and follow these hand washing poster series for children, educate early.
The Centers for Disease Control and Prevention (CDC) has targeted cysticercosis for “public health action” and considers it a neglected parasitic infection. They want to improve diagnostics and increase awareness of the illness, among other goals.

Tuesday, June 04, 2019

Medtec China 2019 will be held at Shanghai World Expo Exhibition and Convention Center September 25–27

Medtec China 2018 Match Making zone

The 15th Exhibition of Medical Device Design & Manufacturing in China (Medtec China 2019) will take place from September 25-27, 2019, at Shanghai World EXPO Exhibition & Convention Center, and the co-located conference — MDiT Forum and Regulation Summit 2019 will be also held at the same time, providing valuable learning opportunities for industry insiders and propelling the development of the medical device industry. The focus of the MDiT Forum and Regulation Summit 2019 remains on Regulation, Quality and Technology and renowned speakers will be invited to present compelling topics to attendees.
 
Press Release;
 
SHANGHAI, June 4, 2019 /PRNewswire/ -- Medtec China 2019 will be held at Shanghai World Expo Exhibition and Convention Center September 25–27. This exhibition has continued its upward momentum trend -- the overall scale of the event is up by 21%, and the area of exhibition booths commercially available has increased by 25%. To date, sales activities in terms of booth selling have proceeded favorably and are approaching the end as there are only a few booths available now. It is predicted that Medtec China 2019 will bring together about 450+ premium brand suppliers from 23countries around the world, and 25,000 professional visitors. To participate in China' premier medical design and manufacturing exhibition, please click here to get free access.

 Over the past five years, China's medical device industry has continued to grow at a 15% compound growth rate, and over the next 10 years the growth rate is expected to remain above 10% annually. Meanwhile the government of China also released some policies to encourage the rapid development of the medical device industry. To satisfy increasing demands and propose development and innovation of the industry, Medtec China will expand to two halls for the first time in 2020 and continue to provide the Chinese medical device industry with raw materials for product development, manufacturing and registration, precision parts and components, manufacturing equipment, processing technology, contract customization, testing and certification, policies and regulations, design, and market consulting, among other services.

Intelligence Match Making service connects precise business

For this year's show the organizers decided to cooperate with the leading global intelligence match making system supplier Jublia again to provide a series of high quality business match making services which will start one month before the show. The aim of reusing this upgraded system is to provide more valuable service to exhibitors so that they could reach more buyers easily, and also to help visitors to find qualified suppliers efficiently.

This productive service will be provided to 450 suppliers throughout the world, including 50+ new exhibitors who will gain access to hundreds of buyers and be able to make precise business appointments. Medtec China 2019 has enhanced the Business Matching service to realize a better user experience for the intelligent meeting system and the onsite service follow-up plan. Accompanied by an activity contingency plan, based on the user's different product needs, the system intelligently screens exhibitors and professional visitors in order to provide a professional and efficient business invitation platform for both parties, which ensures a high exhibitors and visitors' participation rate of return.

Onsite conferences focus on hot spots and technology trends

The MDiT Forum and Regulation Summit 2019 focusing on Regulation, Quality and Technology will discuss the marketing authorization holder system (MAH), reform of the medical device clinical trial management system, regulation of medical devices upon launch on the market, FDA factory inspection, IIMD new materials, and 3D printing technology. Speakers from the government, research institutions, renowned hospitals, and international medical device manufacturing companies will be invited. To discover more conference topics please click here and register to enjoy the early bird price. The activities will gather 900+ industry experts, engineers, QA/QC practitioners, and managers, affording the audience a perfect opportunity for gain more practical information.

Don't miss the chance to join China's premier MedTech Design and Manufacturing Exhibition, Click here to complete the visitor pre-registration right away. For more information, please visit: www.medtecchina.com
To exhibit, visit or for media cooperation, please contact:
Carina Li
Tel.: +86 10 5730 6163
E-Mail: carina.li@ubm.com
Medtec China Organization Committee

SOURCE Medtec China

Monday, June 03, 2019

FDA is warning women of childbearing age about vinpocetine supplement. Vinpocetine may cause a miscarriage or harm fetal development.


Vinpocetine is a man-made chemical resembling a substance found in the periwinkle plant Vinca minor. People use it as medicine. Vinpocetine production requires considerable laboratory work, stretching the Dietary Supplement Health and Education Act (DSHEA) definition of a dietary supplement.
Also Known as AY-27255, Cavinton, Eburnamenine-14-carboxylic acid, Ethyl Apovincaminate, Ethylapovincaminoate, Ethyl Ester, RGH-4405, TCV-3b, Vinpocetin, Vinpocetina, Vinpocétine. As well as Vinca minor extract, lesser periwinkle extract, or common periwinkle extract.

FDA Release; 


Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine



For Immediate Release:
June 03, 2019
Statement From:
Principal Deputy Commissioner - Office of the Commissioner
Amy Abernethy MD PhD.
Deputy Commissioner for Food Policy and Response - Food and Drug Administration
Frank Yiannas
Today, the U.S. Food and Drug Administration is warning consumers about safety concerns regarding an ingredient called vinpocetine that is found in dietary supplements, specifically concerns about the use of this ingredient by women of childbearing age. According to data reviewed by the FDA, including a recent report by the National Institute of Health’s (NIH) National Toxicology Program (NTP), consumption of vinpocetine is associated with adverse reproductive effects – in other words, vinpocetine may cause a miscarriage or harm fetal development.
These findings are particularly concerning since products containing vinpocetine are widely available for use by women of childbearing age. That’s why today we’re advising pregnant women and women who could become pregnant not to take vinpocetine. We are also advising firms marketing dietary supplements containing vinpocetine to evaluate their product labeling to ensure that it provides safety warnings against use by pregnant women and women who could become pregnant.
Vinpocetine is a synthetically produced compound that is used in some products marketed as dietary supplements, either by itself or combined with other ingredients. Vinpocetine may be referred to on product labels as Vinca minor extract, lesser periwinkle extract, or common periwinkle extract. Dietary supplements containing vinpocetine are often marketed for uses that include enhanced memory, focus, or mental acuity; increased energy; and weight loss. Scientists who have studied the effects of vinpocetine on pregnant animals concluded that vinpocetine decreased fetal weight and increased the chances of a miscarriage. The blood levels of vinpocetine measured in the pregnant animals were similar to those reported in people after taking a single dose of vinpocetine, indicating that pregnant women may experience adverse effects from vinpocetine similar to those seen in the pregnant animals. 
In some countries outside of the U.S., vinpocetine is regulated as a prescription drug. When products like vinpocetine are sold as dietary supplements in the U.S., they have not been reviewed by the FDA under the safety and effectiveness standards that apply to drug products. This means that the FDA has not reviewed each vinpocetine product, or its labeling, before those products become available to consumers.
In the 1990s, the FDA received several premarket safety submissions (known as new dietary ingredient notifications) for vinpocetine as an ingredient in dietary supplements. In 2016, we requested comment from stakeholders as part of an administrative proceeding to evaluate whether vinpocetine is legal for sale as a dietary supplement. With the results in NTP’s report, it was important to issue today’s warning because the availability of dietary supplement products containing vinpocetine has grown and the labels of vinpocetine products often have no warnings about the dangers of miscarriage and harm to fetal development. For the same reasons, the FDA will expedite completion of the administrative proceeding that we began in September 2016. 
The dietary supplement market is a growing industry, with sales multiplying ten-fold over the past 25 years and more than half of all Americans taking at least one dietary supplement on a regular basis. This expansion is one reason why earlier this year, the FDA announced new efforts to strengthen the regulation of dietary supplements by modernizing our regulatory framework.
Today’s safety warning is just one of many steps the FDA is taking to adapt to the realities of the evolving dietary supplement industry. Protecting the public from unsafe dietary supplements remains a top priority for the FDA. We’ve also created a public-private partnership, the Botanical Safety Consortium, to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. In April, we introduced a new tool, the Dietary Supplement Ingredient Advisory List, to more quickly alert the public when we become aware of ingredients that appear to be unlawfully marketed in dietary supplements. And finally, just last month, we held a public meeting with our stakeholders to discuss responsible innovation in the dietary supplements industry.
These efforts, along with today’s announcement regarding vinpocetine, underscore how the FDA will continue to preserve access to safe, well-manufactured, and accurately labeled dietary supplements, while we protect the American public from potentially unsafe or otherwise unlawful products.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
###

Inquiries

Media:
 Lindsay Haake
 301-796-3007
Consumer:
 888-INFO-FDA

Donna Olson and Robert Olson, Wins $325 Million Mesothelioma Verdict Against Johnson & Johnson for Asbestos in Baby Powder

A jury in the New York City on Friday has awarded a $325 million verdict against Jonson & Jonson over claims of asbestos in its talc caused plaintiff Donna Olson to develop mesothelioma.

After a 4-month trial, jurors ordered the company to pay $300 million in punitive damages, $20 million for Olson’s past and future pain, plus $5 million to her husband for loss of consortium. This is so far the largest award against J&J in it's talc litigation. Last summer, jurors in St. Louis handed over a $4.69 billion decision against the company after a trial that combined the claims of 22 women. J&J said it would appeal. Before that, a California plaintiff scored a $417 million verdict, but J&J won its appeal in that case.

In addition to the talc litigation, J&J also faces the Oklahoma opioid trial and is the only remaining defendant after Teva and Purdue settled for a total of $355 million. In opening remarks last week, Oklahoma attorney general Mike Hunter accused Johnson & Johnson of a “deceitful, multibillion-dollar brainwashing campaign.” J&J denied wrongdoing and argues it marketed opioid painkillers responsibly.
More about the New York City Case

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