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FDA Drug Safety Communication: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease
The U.S. Food and Drug Administration (FDA) is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. Our recommendation is based on our review of the results of a 10-year follow-up study1 of patients with coronary heart disease from a large clinical trial2 that first observed this safety issue. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 22, 2018 Category: Drugs & Pharmacology Source Type: news

Seggiano USA, Inc. Issues Allergy Alert on Undeclared Tree Nuts
Seggiano USA, Inc. of Cheyenne, WY is voluntarily recalling Tuscan Kale Pesto mislabeled with Artichoke& Garlic labels because the labels do not declare tree nuts (cashews). Individuals who have allergies to tree nuts run the risk of a serious life-threatening allergic reaction if they consume the Tuscan Kale Pesto product. No incidents have been reported to date in connection with this issue. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 22, 2018 Category: Food Science Source Type: news

Snyder ’s Lance Announces Voluntary Recall of a Limited Amount of 6.5 oz Emerald® Glazed Walnuts Due to Potential Presence of Undeclared Peanuts, Almonds, Cashews and Pecans
Emerald ® Nuts is initiating a voluntary recall for a limited amount of its 6.5oz Glazed Walnuts product, distributed nationwide, due to the potential presence of undeclared peanuts, almonds, cashews and pecans in the product. People who have an allergy or severe sensitivity to peanuts run the risk of ser ious or life-threatening allergic reaction if they consume this product (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 22, 2018 Category: Food Science Source Type: news

FDA plans 2018 update for global UDI database
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration will soon implement updates to its Global Unique Device Identification Database, or GUDID, based on feedback and requests from medical device manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. The post FDA plans 2018 update for global UDI database appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 22, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

Nigeria:NAFDAC Cautions Media Against Illegal Advertisement of Pharmaceutical Products
[Guardian] The National Agency for Food and Drug Administration and Control (NAFDAC) has cautioned the media over the advertisement of pharmaceutical products without confirmation from the agency. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - February 22, 2018 Category: African Health Source Type: news

Market of Choice Issues Allergy Alert on Undeclared Egg in Sezam Kale Salad
Market of Choice of Eugene, Oregon is recalling Sezam Kale Salad because it may contain undeclared EGG. People who have an allergy or severe sensitivity to Egg run the risk of serious or life-threatening allergic reaction if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 22, 2018 Category: Food Science Source Type: news

Allergy Alert Issued by Sunneen Health Foods for Undeclared Pecan in Vegan Buffalo Chicken Bites
Sunneen Health Foods is voluntarily recalling mislabeled Whole Foods Market Vegan Buffalo Chicken Bites sold at 13 Whole Foods Market stores in New York and New Jersey because the products contained tree nut (pecan) allergens that were not listed on the product label. The issue was discovered at the distribution center. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 22, 2018 Category: Food Science Source Type: news

FDA Comment Request: Foodborne Illness Risk Factors
The Food and Drug Administration (FDA) is providing an opportunity for public comment on the " Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types. " The submission deadline is April 9, 2018. (Source: PHPartners.org)
Source: PHPartners.org - February 21, 2018 Category: International Medicine & Public Health Source Type: news

U.S. FDA says recalls, destroys certain kratom-containing dietary products
(Reuters) - The U.S. Food and Drug Administration on Wednesday said it recalled and destroyed a large volume of kratom-containing dietary supplements made by a company in Missouri. (Source: Reuters: Health)
Source: Reuters: Health - February 21, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioid
(Source: Food and Drug Administration)
Source: Food and Drug Administration - February 21, 2018 Category: American Health Source Type: news

Constitutional attorney Jonathan Emord calls for FEDERAL investigation into link between psych drugs and school shootings
(Natural News) A top-rated lawyer who has beaten the Food and Drug Administration more times in court than any other attorney is calling on the Trump administration to launch a probe into possible links between commonly-prescribed psychiatric drugs and the epidemic of school shootings. “The financial interests of the psychiatric industry is to feed this... (Source: NaturalNews.com)
Source: NaturalNews.com - February 21, 2018 Category: Consumer Health News Source Type: news

FDA Cracks Down on Kratom Products
WEDNESDAY, Feb. 21, 2018 -- A number of kratom-containing dietary supplements are being recalled and destroyed by the manufacturer, the U.S. Food and Drug Administration announced Wednesday. Kratom -- a plant that grows in Asia -- poses serious... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - February 21, 2018 Category: General Medicine Source Type: news

FDA Drug Safety Communication: FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety ―emphasizing that accidental exposure to used patches can cause death
The U.S. Food and Drug Administration (FDA) is requiring color changes to the writing on Duragesic (fentanyl) pain patches so they can be seen more easily. This is part of an effort to prevent accidental exposure to the patches, which can cause serious harm and death in children, pets, and others.   (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 21, 2018 Category: Drugs & Pharmacology Source Type: news

Kratom Is Linked to a Salmonella Outbreak Across 20 States, CDC Says
Kratom, a controversial herbal supplement used for pain relief, is likely behind a salmonella outbreak that has affected 20 states, according to the Centers for Disease Control and Prevention (CDC). Mitragyna speciosa, commonly called kratom, is often billed as a safer alternative to conventional painkillers. But the supplement made headlines a few weeks ago, when Food and Drug Administration (FDA) officials said that kratom contains the same addictive, potentially dangerous chemicals found in opioids, and submitted a review to that effect to the Drug Enforcement Administration (DEA). The bad news about kratom continues wi...
Source: TIME: Health - February 20, 2018 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized healthytime onetime public health Source Type: news

Siemens receives FDA nod for GoKnee3D
Siemens Healthineers has received U.S. Food and Drug Administration (FDA) clearance...Read more on AuntMinnie.comRelated Reading: Siemens to sell Symbia Intevo Bold SPECT/CT in Canada Lower revenue plagues Siemens Healthineers' Q1 numbers Siemens teams up with Florida Hospital Siemens Healthineers plans cost cuts to prepare for IPO Report: Siemens targets health IPO for March (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - February 20, 2018 Category: Radiology Source Type: news

CDC warns about salmonella infections traced to kratom
The Centers for Disease Control and Prevention, the Food and Drug Administration and several states are investigating an outbreak of salmonella illness linked to kratom, an unregulated herbal supplement that is sometimes used for pain, anxiety and opioid-withdrawal symptoms, the CDC said Tuesday. The agency, which urged consumers to not use kratom in any form because […]Related:Here’s what you should know about the flu season this yearThis season’s flu vaccine is only 36 percent effective, but experts say you should still get itNine organizations sue Trump administration for ending grants to teen pr...
Source: Washington Post: To Your Health - February 20, 2018 Category: Consumer Health News Source Type: news

Preventive Treatment For Peanut Allergies Succeeds In Study
The first treatment to help prevent serious allergic reactions to peanuts may be on the way. A company said Tuesday that its daily capsules of peanut flour helped children tolerate nuts in a major study. Millions of children have peanut allergies, and some may have life-threatening reactions if accidentally exposed to them. Doctors have been testing daily doses of peanut flour, contained in a capsule and sprinkled over food, as a way to prevent that. California-based Aimmune (AIM-yoon) Therapeutics said 67 percent of kids who had its treatment were able to tolerate the equivalent of roughly two peanuts at the end of the st...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - February 20, 2018 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health Local News Local TV Peanut Allergies Source Type: news

Health Tip: Comparing Soap and Other Body Cleansers
-- Traditional soaps are made by combining fats or oils with an alkali, such as lye. Most body cleansers, however, are actually synthetic detergent products, the U.S. Food and Drug Administration says. There are very few pure soaps on the market... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - February 19, 2018 Category: General Medicine Source Type: news

U.S. FDA approves AstraZeneca's immunotherapy for lung cancer
(Reuters) - The U.S. Food and Drug Administration on Friday granted approval for expanded use of AstraZeneca Plc's, immunotherapy drug, Imfinzi, to treat non-small cell lung cancer whose tumors can't be surgically removed. (Source: Reuters: Health)
Source: Reuters: Health - February 16, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing
FDA approves drug to reduce the risk of stage III non-small cell lung cancer progressing (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 16, 2018 Category: American Health Source Type: news

FDA clears blood test to assist concussion evaluation
The U.S. Food and Drug Administration (FDA) has approved a blood test that...Read more on AuntMinnie.comRelated Reading: MR spectroscopy finds lingering concussion effects Kids with concussion usually normal on CT, MRI (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - February 16, 2018 Category: Radiology Source Type: news

FDA Approves First Treatment for Nonmetastatic CRPC
The US Food and Drug Administration (FDA) has approved the oral agent apalutamide (Erleada) for the treatment of nonmetastatic castration-resistant prostate cancer. The oral androgen-receptor inhibitor is the first FDA-approved treatment for patients with nonmetastatic castration-resistant disease and the first to be approved based on the endpoint of metastasis-free survival. (Source: CancerNetwork)
Source: CancerNetwork - February 16, 2018 Category: Cancer & Oncology Authors: Leah Lawrence Tags: Editorial Men ' s Health Prostate Cancer Source Type: news

Photocure Announces U.S. FDA Approval of New Indication for Blue Light Cystoscopy with Cysview(R)
OSLO, Norway, Feb. 16, 2018 -- (Healthcare Sales & Marketing Network) -- Photocure ASA (OSE: PHO), announced today that the U.S. Food and Drug Administration (FDA) approved its supplemental new drug application (sNDA) to extend the indication for Blue Lig... Devices, Oncology, FDA Photocure, KARL STORZ, Blue Light Cystoscopy, Cysview, bladder cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 16, 2018 Category: Pharmaceuticals Source Type: news

Shares of Apricus tank after FDA declines to OK erectile dysfunction cream
(Reuters) - The U.S. Food and Drug Administration on Friday declined to approve Apricus Biosciences Inc's Vitaros, a cream to treat erectile dysfunction, for the second time in a decade, sending the company's shares down more than 70 percent before the opening bell. (Source: Reuters: Health)
Source: Reuters: Health - February 16, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Apricus says FDA declines to approve erectile dysfunction cream
(Reuters) - The U.S. Food and Drug Administration on Friday declined to approve Apricus Biosciences Inc's Vitaros, a cream treatment for erectile dysfunction, for the second time in a decade. (Source: Reuters: Health)
Source: Reuters: Health - February 16, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

TIP 63: Medications for Opioid Use Disorders - Full Document (Including Executive Summary and Parts 1-5)
This Treatment Improvement Protocol (TIP) reviews the use of the three Food and Drug Administration (FDA)-approved medications used to treat opioid use disorder (OUD)-methadone, naltrexone, and buprenorphine-and the other strategies and services needed to support recovery for people with OUD. (Source: HSR Information Central)
Source: HSR Information Central - February 16, 2018 Category: International Medicine & Public Health Source Type: news

FDA Expands Approval of Imfinzi (durvalumab) to Reduce the Risk of Non-Small Cell Lung Cancer Progressing
February 16, 2018 -- The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA budget requests include clinical software, natural language processing, real-time device data
Food and Drug Administration Commissioner Dr. Scott Gottlieb released the agency ’s budget requests for fiscal 2018 Tuesday, outlining digital health plans for the year. (Source: mobihealthnews)
Source: mobihealthnews - February 15, 2018 Category: Information Technology Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D. on the efficacy of the 2017-2018 influenza vaccine
FDA provides update on flu vaccines during this severe flu season (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 15, 2018 Category: American Health Source Type: news

New biopolymer liquid bandage has received FDA approval
(Natural News) A liquid skin bandage has been approved for licensing and sale by the U.S. Food and Drug Administration (FDA). Known as ElaSkin, the biopolymer liquid bandage is the first commercial product by the biomaterials and medical device start-up, Aleo BME. ElaSkin possesses a variety of characteristics that help make it a “best-in class technology,”... (Source: NaturalNews.com)
Source: NaturalNews.com - February 15, 2018 Category: Consumer Health News Source Type: news

New blood test can help diagnose traumatic brain injuries
Green light by the Food and Drug Administration ​ "is a big deal because then it opens the door and accelerates technology" (Source: Health News: CBSNews.com)
Source: Health News: CBSNews.com - February 15, 2018 Category: Consumer Health News Source Type: news

Recall Expansion Smokehouse Pet Products Inc. Recalls All Lots Of “Beefy Munchies” Sold Nationwide Because Of Possible < em > Salmonella < /em > Contamination
Smokehouse Pet Products, Inc. of Sun Valley, CA is recalling all sizes and package types of dog treats labeled as “Beefy Munchies,” because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the produc ts or any surfaces exposed to these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 15, 2018 Category: Food Science Source Type: news

Recall Expansion Smokehouse Pet Products Inc. Recalls All Lots Of “ Beefy Munchies ” Sold Nationwide Because Of Possible < em > Salmonella < /em > Contamination
Smokehouse Pet Products, Inc. of Sun Valley, CA is recalling all sizes and package types of dog treats labeled as “ Beefy Munchies, ” because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 15, 2018 Category: Food Science Source Type: news

How TransEnterix plans to double the number of procedures its surgical robot can treat
With U.S. Food and Drug Administration clearance for its Senhance surgical robot secured in October, TransEnterix is evaluating more opportunities moving forward. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - February 15, 2018 Category: American Health Authors: Jennifer Henderson Source Type: news

FDA expands use window for stroke treatment device
The U.S. Food and Drug Administration (FDA) has expanded the treatment window...Read more on AuntMinnie.comRelated Reading: FDA clears Viz.AI's stroke detection software Study finds gadolinium leaks into eyes of stroke patients Perfusion imaging expands window for stroke treatment FDA clears 2 clot retrieval devices for stroke Interventionalists: Proceed with caution for mechanical blood clot removal (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - February 15, 2018 Category: Radiology Source Type: news

Concussions Can Be Detected With New Blood Test Approved by F.D.A.
The test may be able to quickly identify people with suspected brain injuries that could be widely used by the Pentagon and in sports. (Source: NYT Health)
Source: NYT Health - February 15, 2018 Category: Consumer Health News Authors: SHEILA KAPLAN and KEN BELSON Tags: Concussions Tests (Medical) Brain Traumatic Brain Injury United States Defense and Military Forces Sports Injuries Defense Department Food and Drug Administration Source Type: news

FDA Approves First Blood Test to Help Diagnose Brain Injuries
(CHICAGO) — The first blood test to help doctors diagnose traumatic brain injuries has won U.S. government approval. The move means Banyan Biomarkers can commercialize its test, giving the company an early lead in the biotech industry’s race to find a way to diagnose concussions. The test doesn’t detect concussions and the approval won’t immediately change how patients with suspected concussions or other brain trauma are treated. But Wednesday’s green light by the Food and Drug Administration “is a big deal because then it opens the door and accelerates technology,” said Michael Mc...
Source: TIME: Health - February 15, 2018 Category: Consumer Health News Authors: Lindsey Tanner / AP Tags: Uncategorized APH healthytime medicine onetime Source Type: news

FDA clears Arterys Oncology AI suite
The U.S. Food and Drug Administration (FDA) has cleared imaging software developer...Read more on AuntMinnie.comRelated Reading: Arterys unveils Mica software at RSNA 2017 Arterys nets $30M in financing Arterys receives SIIM award for cloud project FDA OK's Arterys cardiac software Arterys nets FDA OK for 4D software (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - February 15, 2018 Category: Radiology Source Type: news

FDA expands treatment window for use of clot retrieval devices in certain stroke patients
FDA expands treatment window for use of clot retrieval devices in certain stroke patient (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 15, 2018 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D. on advancing the development of novel treatments for neurological conditions; part of broader effort on modernizing FDA ’s new drug review programs
FDA ’s 5 guidance documents provide details for drug development for neurological conditions such as ALS and Alzheimer’s disease (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 15, 2018 Category: American Health Source Type: news

Is an Anti-Aging Pill on the Horizon?
Anti-aging products from skin creams to chemical peels are part of a $250 billion industry, but scientists have yet to discover a longevity elixir that stands up to medical scrutiny. A group of researchers believe they’re getting closer, however, thanks to a compound called nicotinamide adenine dinucleotide, or NAD+ for short. “NAD+ is the closest we’ve gotten to a fountain of youth,” says David Sinclair, co-director of the Paul F. Glenn Center for the Biology of Aging at Harvard Medical School. “It’s one of the most important molecules for life to exist, and without it, you’re dea...
Source: TIME: Health - February 15, 2018 Category: Consumer Health News Authors: Alexandra Sifferlin Tags: Uncategorized anti-aging healthytime Longevity Source Type: news

Your Tax Dollars Fund Research on Hundreds of New Meds
THURSDAY, Feb. 15, 2018 -- The U.S. National Institutes of Health spent more than $100 billion on research that led to 210 new medicines gaining U.S. Food and Drug Administration approval over six years, a new study shows. Nearly $64 billion of... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - February 15, 2018 Category: General Medicine Source Type: news

F.D.A. Approves First Blood Test to Detect Concussions
The test may be able to quickly identify people with suspected brain injuries that could be widely used by the Pentagon and in sports. (Source: NYT Health)
Source: NYT Health - February 15, 2018 Category: Consumer Health News Authors: SHEILA KAPLAN and KEN BELSON Tags: Concussions Tests (Medical) Brain Traumatic Brain Injury United States Defense and Military Forces Sports Injuries Defense Department Food and Drug Administration Source Type: news

FDA approves first blood test that can help diagnose a concussion
The Food and Drug Administration on Wednesday approved a first-ever blood test to detect the telltale signs of serious brain injury, bringing to fruition a long quest to make the diagnosis of concussions simpler and more precise.After deliberations that took less than six months, theFDA approved... (Source: Los Angeles Times - Science)
Source: Los Angeles Times - Science - February 15, 2018 Category: Science Authors: Melissa Healy Source Type: news

First Blood Test to Detect Concussions Is Approved
The device may be able to quickly identify people with suspected brain injuries that could be widely used by the Pentagon and in sports. (Source: NYT Health)
Source: NYT Health - February 14, 2018 Category: Consumer Health News Authors: SHEILA KAPLAN and KEN BELSON Tags: Concussions Tests (Medical) Brain Traumatic Brain Injury United States Defense and Military Forces Sports Injuries Defense Department Food and Drug Administration Source Type: news

FDA approves first blood test for concussion
The US Food and Drug Administration has, for the first time, approved a blood test to help detect concussion in adults. (Source: CNN.com - Health)
Source: CNN.com - Health - February 14, 2018 Category: Consumer Health News Source Type: news

Amgen Announces FDA Advisory Committee Meeting To Review Potential New Use Of BLINCYTO ® (blinatumomab)
First-Ever Application to be Submitted for an MRD Positive Indication THOUSAND OAKS, Calif., Feb. 14, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the BLINCYTO® (blinatumomab) supplemental Biologics License Application (sBLA) for the treatment of patients with minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (ALL) at a meeting on March 7, 2018. MRD refers to the presence of a small amount of detectible cancer cells that remain in the patien...
Source: Amgen News Release - February 14, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

FDA Approves Erleada (apalutamide) for Non-Metastatic Castration-Resistant Prostate Cancer
February 14, 2018 -- The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 14, 2018 Category: Drugs & Pharmacology Source Type: news

FDA approves J & J prostate cancer treatment
(Reuters) - The U.S. Food and Drug Administration on Wednesday approved Johnson& Johnson's Erleada treatment for use with prostate cancer patients whose cancer has not spread but continues to grow despite hormone therapy. (Source: Reuters: Health)
Source: Reuters: Health - February 14, 2018 Category: Consumer Health News Tags: healthNews Source Type: news