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Month: June 2018

LL’s Magnetic Clay Inc Issues Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling certain lots of Prescript-Assist, a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, dairy, casein, eggs, & peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.
Prescript-Assist dietary supplement was distributed nationwide, including through online sales on the LL’s Magnetic Clay website and brick & mortar retailers.  The Prescript-Assist product is available through distributors other than LL’s Magnetic Clay that purchased the product from the same source.
The impacted lots include Lots 1356300 (exp. 01/2019), 1405700 (exp. 03/2019), 17A128 (exp. 03/2021), & W00103 (exp. 06/2019). The lot numbers can be found printed either on the bottom of the bottle or on the label.  The white bottles contain capsules in quantities of either 60 or 90 capsules per bottle. A representative label is included below.
No illnesses regarding these products have been reported to date.
The recall was initiated after potential cGMP failures in the supply chain were identified by LL’s Magnetic Clay.
Consumers who have purchased Prescript Assist from LL’s Magnetic Clay are urged to discontinue use & return it to LL’s Magnetic Clay for a full refund. Consumers with questions may contact the company M-F, 9am-5pm at 1-800-257-3315.
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Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk & Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Pinnacle Foods Inc. is voluntarily recalling a limited quantity of Wish Bone House Italian Salad Dressing 15 oz. with the health and safety of our consumers as our top priority. The recall was initiated after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk and egg, known allergens not declared on the bottle. People who have an allergy or severe sensitivity to milk or egg may run the risk of a serious or life-threatening allergic reaction if they consume this product. If you are not allergic to milk or egg, this product is safe to eat. No illnesses have been reported to date. The Food & Drug Administration has been made aware of this recall.
No illnesses have been reported to date, but the company is taking this action as part of its commitment to the health & safety of its customer.
The product was produced on March 19, 2018. In total, 7,768 cases of Wish-Bone House Italian Salad Dressing in 15 oz. bottles, distributed nationwide, are involved in the recall. The “Best If Used By” date can be found on the neck label of the bottle. No other Wish-Bone products are included in this recall. Specific details of the product being recalled are outlined below.
All affected distributors & retail customers, as well as the Food Allergy & Anaphylaxis Network (FAAN), are being notified & the affected product is being removed from store shelves.
The recalled items can be identified by a “Best If Used…

Therapy Reduces Risk in Suicidal Youth

Preventing suicide has proven to be a difficult public health challenge. The suicide rate has climbed in recent years across age groups. In adolescents, suicide is the second leading cause of death. For every young person who dies by suicide, many more have suicidal thoughts, attempt suicide, or deliberately injure themselves without intending suicide.
To date, there have not been any research-validated treatments for preventing suicide among youth. & research has found that it’s hard to get adolescents with suicidal thoughts to start and stay with existing treatments.
Researchers at the University of Washington, Seattle Children’s Research Institute, and collaborators at the Los Angeles Biomedical Research Institute at Harbor- University of California, Los Angeles (UCLA) Medical Center, and the David Geffen School of Medicine at UCLA are addressing the treatment void for adolescents. A recent clinical trial of a psychotherapy called dialectical behavior therapy (DBT)—which has been shown to be effective in reducing suicide-related behavior in adults—showed that DBT can also reduce suicide attempts and suicidal behavior in adolescents.
“We have a real need for more evidence-based interventions to help suicidal youth,” said Jane Pearson, Ph.D., chair of the Suicide Research Consortium in NIMH’s Division of Services and Intervention Research. “This study is significant because it reinforces previous DBT studies with adolescents. DBT shows clear promise for helping at-risk youth develop skills that will set them on a “life preserving” path.”  
For this study, Elizabeth McCauley, Ph.D., & colleagues enrolled youth ages 12-18 who were at risk for suicide. The adolescents entering the study…

NCBI Hackathons Hit 25 & Celebrate with Bacon, Disco, and More

Let us explain.

MR BACOn: Mendelian Randomization with Biomarker Associations for Causality with Outcomes

You don’t have to have grown up in the ’70s to have danced disco and eaten bacon regularly, but to have developed DrugDisco, a high throughput automated drug discovery pipeline, or created MR BACOn, otherwise known as a Mendelian Randomization analysis of Biomarker Associations for Causality with Outcomes, you must have participated in an NCBI hackathon.
Creative titles, collaboration, & the courage to try new strategies—all while being transparent—are hallmarks of hackathons…NCBI style.
Since their debut on the NIH campus in January 2015, NCBI has been involved in 25 hackathons.
NCBI hackathons surpass expectations
Hackathons are events for computational biologists, computer programmers, & other professionals to collaborate on software projects. Typically, the events fill three days. Unlike other hackathons in which teams compete to come up with a winning solution to a problem, NCBI-style hackathons are collaborative. Each team tackles a different problem, and teams often help each other & share expertise.
The growth, interest, and results of the NCBI hackathons have surpassed expectations, according to Ben Busby, the center’s genomics outreach coordinator & hackathon organizer.
No two are alike

DrugDisco, a product of an NCBI hackathon, makes trial-and-error drug discovery a thing of the past by using a rational & structure-based approach.

NCBI’s hackathons have been held at academic institutions throughout the United States, as well as on the NIH campus in Bethesda.
Each group is different. An all-woman team tackled metadata collection & harmonization, a challenging topic because metadata on biomedical projects is often variable,…

NLM Technical Bulletin, NLM Technical Bulletin – May – June 2018 Issue Complete

Content not copyrighted; freely reproducible.Trademarks
Copyright Privacy Accessibility NLM Customer Support Viewers & PlayersU.S. National Library of Medicine 8600 Rockville Pike, Bethesda, MD 20894National Institutes of Health NIH…Turning Discovery into HealthU.S. Department of Health and Human Services Freedom of Information Act Last updated: 28 June 2018 …

The Facts on Tampons—and How to Use Them Safely

Tampons—shown within an applicator on the left & outside of an applicator on the right—are regulated by the U.S. Food & Drug Administration as medical devices.

 Subscribe: FDA Consumer Health Information
If you use tampons during your period (also called a “menstrual cycle”), it’s important to know the basics for how to use them safely. Consider this important information from the U.S. Food & Drug Administration—and please share it with friends & loved ones who may use these products.
What are tampons—and what are they made of?
You may be surprised to know that the FDA regulates tampons as medical devices. Tampons are inserted into the vagina to absorb menstrual flow when people have their periods. They are cylindrical in shape and made of cotton, rayon, or a blend of the two. Tampons are either designed to be inserted using a plastic or cardboard applicator or to be directly inserted, without an applicator.
What should you know about different types of tampons? & are tampons safe?
Tampons are available in “organic” & standard varieties. Tampons are also available in “scented” & “unscented” options. But before any tampons can be sold, they must go through FDA review to determine whether they are substantially equivalent to, including as safe and effective as, a legally marketed tampon.
As part of this FDA review, manufacturers submit, among other information, the results of testing to evaluate the safety of the materials used to make tampons & applicators (if present); tampons’ absorbency, strength, & integrity; & whether tampons enhance the growth of…

NLM Technical Bulletin, May-Jun 2018, NCBI Labs Project Update: PubMed Journals Discontinued

NCBI Labs Project Update: PubMed Journals Discontinued. NLM Tech Bull. 2018 May-Jun;(422):b12.
2018 June 27 [posted]
On June 15, 2018, PubMed Journals, an NCBI Labs project, was discontinued.
PubMed Journals was launched in September 2016 as part of NCBI Labs, a product incubator for delivering new features & capabilities to NCBI end users. PubMed Journals helped people follow the latest biomedical literature by making it simple to find & follow journals, browse new articles, and included a Journal News Feed to track new arrivals, news links, trending articles & important article updates.
We appreciate the feedback provided by our users that helped to make PubMed Journals a productive test of new ideas. In the time the experiment ran, nearly 20,000 people followed 10,453 distinct journals & each customer followed three journals on average. Though PubMed Journals will no longer exist as a separate entity, we hope to add its features into future NCBI products.
More information about NCBI Labs is available from the NCBI Insights blog. …

Genetics Home Reference: spastic paraplegia type 49

Spastic paraplegia type 49 is part of a group of genetic disorders known as hereditary spastic paraplegias. These disorders are characterized by progressive muscle stiffness (spasticity) & the development of paralysis of the lower limbs (paraplegia). Hereditary spastic paraplegias are divided into two types: pure & complex. The pure types involve only the lower limbs, whereas the complex types also involve the upper limbs (to a lesser degree) & other problems with the nervous system. Spastic paraplegia type 49 is a complex hereditary spastic paraplegia.
Spastic paraplegia type 49 often begins with weak muscle tone (hypotonia) that starts in infancy. During childhood, spasticity & paraplegia develop & gradually worsen, causing difficulty walking & frequent falls. In addition, affected individuals have moderate to severe intellectual disability & distinctive physical features, including short stature; chubbiness; an unusually small head size (); a wide, short skull (); a short, ; & . Some people with spastic paraplegia type 49 develop seizures.
Problems with autonomic nerve cells (autonomic ), which control involuntary body functions such as heart rate, digestion, and breathing, result in several features of spastic paraplegia type 49. Affected individuals have difficulty feeding beginning in infancy. They experience a backflow of stomach acids into the esophagus (called or GERD), causing vomiting. GERD can also lead to recurrent bacterial lung infections called aspiration pneumonia, which can be life-threatening. In addition, people with spastic paraplegia type 49 have problems regulating their breathing, resulting in pauses in breathing (apnea), initially while sleeping but eventually also while awake….

Genetics Home Reference: alopecia areata

The causes of alopecia areata are complex & not well understood. A combination of factors likely underlies the disorder, including changes in many genes that function in the hair & skin & in the immune system.
Alopecia areata is one of a large group of immune system diseases classified as autoimmune disorders. Normally, the immune system protects the body from foreign invaders, such as bacteria & viruses, by recognizing & attacking these invaders and clearing them from the body. In autoimmune disorders, the immune system malfunctions and attacks the body’s own tissues instead. For reasons that are unclear, in alopecia areata the immune system targets , stopping hair growth. However, the condition does not permanently damage the follicles, which is why hair may later regrow.
Many of the genes that have been associated with alopecia areata participate in the body’s immune response. These include several genes belonging to a gene family called the . The HLA complex helps the immune system distinguish the body’s own proteins from proteins made by foreign invaders. Each HLA gene has many different variations, allowing each person’s immune system to react to a wide range of foreign proteins. Certain variations in HLA genes likely contribute to the inappropriate immune response targeting hair follicles that leads to alopecia areata. Immune system genes outside the HLA complex, such as several genes involved in inflammation, have also been associated with alopecia areata.
Some of the genetic variations associated with alopecia areata have been identified in people with other autoimmune disorders, which…

Two Diabetes Medications Don't Slow Progression of Type 2 Diabetes in Youth

News Release
Monday, June 25, 2018 NIH-funded study adds to growing evidence that condition is more aggressive in youth. In youth with impaired glucose tolerance or recent-onset type 2 diabetes, neither initial treatment with long-acting insulin followed by the drug metformin, nor metformin alone preserved the body’s ability to make insulin, according to results published online June 25 in Diabetes Care. The publication is concurrent to a presentation of the results at the American Diabetes Association Scientific Sessions in Orlando, Florida.
The results come from a study of 91 youth ages 10-19, part of the larger Restoring Insulin Secretion (RISE) study. To determine if early, aggressive treatment would improve outcomes, participants at four study sites were randomly assigned to one of two treatment groups. The first received three months of glargine — a long-acting insulin — followed by nine months of metformin. The second received only metformin for 12 months. Participants were then monitored for three more months after treatment ended. RISE was funded primarily by the National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) of the National Institutes of Health.
The RISE Pediatric Medication Study found that beta cell function — key to the body’s ability to make & release insulin — declined in both groups during treatment & worsened after treatment ended. An earlier NIH-funded study also found that type 2 diabetes progresses more rapidly in youth than previously reported in adults despite comparable treatment.
“Only two drugs are currently approved for youth with type 2 diabetes, & we were…

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