August 3, 2017 – The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.
Mavyret is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. Standard treatment length was previously 12 weeks or more. Continue reading
Cadmium exposure and endometrial cancer risk: A large midwestern U.S. population-based case-control study.
Estrogen-mimicking chemicals, such as cadmium, may be associated with increased susceptibility to hormone-dependent cancers, though supporting data are sparse, particularly for endometrial cancer. The Health and Environmental Exposure Research (HEER) study worked with the Arkansas Central Cancer Registry, Iowa Cancer Registry and Missouri Cancer Registry to obtain names of women diagnosed with endometrial cancer who were willing to be contacted for participation in our case control study. Continue reading
August 3, 2017 – The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD.
cGVHD is a life-threatening condition that can occur in patients after they receive a stem cell transplant from blood or bone marrow, called hematopoietic stem cell transplantation (HSCT), to treat certain blood or bone marrow cancers. cGVHD occurs when cells from the stem cell transplant attack healthy cells in a patient’s tissues. Symptoms of cGVHD can occur in the skin, eyes, mouth, gut, liver and lungs. The condition is estimated to occur in 30-70 percent of all patients who receive HSCT. Continue reading
Protecting American Families: Comprehensive Approach to Nicotine and Tobacco
Remarks by Scott Gottlieb, M.D. / Commissioner of Food and Drug Administration
July 28, 2017 / White Oak, MD
Tobacco use remains the leading cause of preventable disease and death in the United States. But much has changed in the landscape of tobacco product regulation and FDA’s ability to address this public health crisis.
For one, FDA has significant new regulatory authorities. When I last served, FDA lacked the authority to regulate tobacco products as traditionally marketed. Since that time, our statute has been amended to include an entire chapter of new authorities. And FDA has stood up a new Center for Tobacco Products that already has a number of important accomplishments. Continue reading
Pneumonia or sepsis in adults associated with increased risk of cardiovascular disease.
Sophia Antipolis, 2 August 2017: Pneumonia or sepsis in adults that results in hospital admission is associated with a six-fold increased risk of cardiovascular disease in the first year, according to research published today in the European Journal of Preventive Cardiology.(1) Cardiovascular risk was more than doubled in years two and three after the infection and persisted for at least five years. Continue reading
One hospital’s journey to improve the patient experience.
By Ashleigh Anderson, BSN, RN, PCCN, and Amanda Swedhin, BSN, RN, CMSRN
Despite the availability of evidence-based pain-management guidelines, pain remains prevalent among hospitalized patients and is often underreported, underassessed, and under-treated. (See Efforts to address pain management.)
- In an effort to improve the state of pain management, nurses in the acute care setting of one hospital developed a plan to supplement traditional pharmacologic treatments with nonpharmacologic interventions.
- A Comfort Menu and Comfort Cart provides patients with nonpharmacologic pain and comfort interventions.
The secret is finding balance and working collaboratively.
By Timothy P. Luckett, CRNFA
The perioperative nurse who leaves the hospital to take a position in an Ambulatory Surgery Center (ASC) must be prepared for a bit of a bumpy ride as he or she faces new tasks and responsibilities. The good news is that the ride will smooth out and may even become one of the most rewarding of your career.
Working as a nurse in an ambulatory surgery center (ASC) requires the ability to take on multiple responsibilities.
Success as an RN in an ASC requires knowing when and how to delegate, understanding finances, staying organized, and building relationships with the administration.
On July 20, the U.S. Food and Drug Administration (FDA) cleared Embrace Neonatal MRI System, the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units. Read more
Risk factors for melanoma in patients who have undergone kidney transplant include being older, white, and male, according to a study in JAMA Dermatology. Read more
Obese patients who undergo bariatric surgery are more like to achieve a body mass index (BMI) of less than 30 one year after surgery if they have a BMI of less than 40 before surgery, according to a study published by JAMA Surgery. Read more
On July 18, the U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir. Vosevi is the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other drugs for HCV that inhibit a protein called NS5A. Continue reading
Decades before people with Alzheimer’s disease develop memory loss and confusion, their brains become dotted with plaques made of a sticky protein – called amyloid beta – that is thought to contribute to the disease and its progression. Continue reading
Competing interests: Anick Bérard is a consultant for plaintiffs in litigations involving antidepressants and birth defects. Flory Tsobo Muanda and Odile Sheehy report no conflicts of interest. Continue reading