Here are what the editors at HealthDay consider to be the most important developments in Pharmacy for November 2018. This roundup includes the latest research news from journal articles, as well as the FDA approvals and regulatory changes that are the most likely to affect clinical practice.
Teva Recalls Two Blood Pressure Medications
FRIDAY, Nov. 30, 2018 (HealthDay News) — All lots of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide combination blood pressure tablets have been recalled by Teva Pharmaceuticals due to higher-than-acceptable levels of a chemical that may cause cancer.
Care for Chronic Kidney Disease Varies Across VA Facilities
FRIDAY, Nov. 30, 2018 (HealthDay News) — For veterans with diabetes and concomitant chronic kidney disease (CKD), CKD care, including ordering laboratory tests and scheduling nephrology referrals, varies considerably by facility, according to a study published online Nov. 29 in the Clinical Journal of the American Society of Nephrology.
Abstract/Full Text (subscription or payment may be required)
Editorial (subscription or payment may be required)
Increase Seen in Amphetamine, Opioid Use in Pregnant Women
FRIDAY, Nov. 30, 2018 (HealthDay News) — The incidence of amphetamine and opioid use has increased among pregnant women, especially in rural counties, according to a study published online Nov. 29 in the American Journal of Public Health.
Abstract/Full Text (subscription or payment may be required)
Most Bills Enacted Into Law Limit Vaccine Exemptions
THURSDAY, Nov. 29, 2018 (HealthDay News) — Most proposed bills in state legislatures from 2011 to 2017 sought to expand access to immunization exemptions, but the majority of bills enacted into law limited exemptions, according to a study published online Nov. 29 in the American Journal of Public Health.
Abstract/Full Text (subscription or payment may be required)
FDA Approves Treatment for AML Patients With Gene Mutation
THURSDAY, Nov. 29, 2018 (HealthDay News) — Xospata (gilteritinib) tablets were approved today by the U.S. Food and Drug Administration for treatment of relapsed or refractory acute myeloid leukemia (AML) in adults with an FLT3 mutation, the agency announced in a news release. The FDA also granted expanded approval to the LeukoStrat CDx FLT3 Mutation Assay used to detect the FLT3 mutation in AML patients.
FDA Approves Firdapse for Rare Autoimmune Disorder
THURSDAY, Nov. 29, 2018 (HealthDay News) — Firdapse (amifampridine) tablets have been approved by the U.S. Food and Drug Administration for adults with Lambert-Eaton myasthenic syndrome (LEMS).
Certain SGLT2 Inhibitors, GLP-1 RAs for T2DM Also Cut CV Risk
THURSDAY, Nov. 29, 2018 (HealthDay News) — Certain sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists (GLP-1 RAs) demonstrate significant cardiovascular (CV) benefit and should be used for reducing CV risk in patients with type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD), according to a report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways published online Nov. 26 in the Journal of the American College of Cardiology.
FDA Approves First Biosimilar to Non-Hodgkin’s Lymphoma Drug
WEDNESDAY, Nov. 28, 2018 (HealthDay News) — Truxima (rituximab-abbs) has been approved by the U.S. Food and Drug Administration as the first biosimilar to the non-Hodgkin’s lymphoma drug Rituxan, the agency said today.
Lanadelumab Reduces Attack Rate in Hereditary Angioedema
WEDNESDAY, Nov. 28, 2018 (HealthDay News) — For patients with hereditary angioedema type I or II, lanadelumab, a fully human monoclonal antibody that selectively inhibits active plasma kallikrein, reduces the attack rate compared with placebo, according to a study published in the Nov. 27 issue of the Journal of the American Medical Association.
FDA: Kratom Products Have High Levels of Heavy Metals
WEDNESDAY, Nov. 28, 2018 (HealthDay News) — In addition to many other health risks, kratom products can have high levels of heavy metals, according to Scott Gottlieb, M.D., commissioner of the U.S. Food and Drug Administration.
Men Should Avoid ‘Rhino’ Sexual Enhancement Products, FDA Says
TUESDAY, Nov. 27, 2018 (HealthDay News) — The U.S. Food and Drug Administration is warning men that “Rhino” products promising better sex may pose serious health risks.
FDA Approves Vitrakvi for Cancers With Certain Genetic Trait
TUESDAY, Nov. 27, 2018 (HealthDay News) — Vitrakvi (larotrectinib) has been approved by the U.S. Food and Drug Administration to treat adult and pediatric patients whose cancers have a specific genetic feature.
FDA to Update Medical Device Approvals Process
TUESDAY, Nov. 27, 2018 (HealthDay News) — A major update of the United States’ system for approving medical devices was announced yesterday by the Food and Drug Administration.
CBS/AP News Article
More Information
Risks of Trazodone Similar to Those of Atypical Antipsychotics
TUESDAY, Nov. 27, 2018 (HealthDay News) — For older adults with dementia, trazodone is associated with a comparable risk for falls and fractures as that of atypical antipsychotics, according to a study published online Nov. 26 in CMAJ, the Journal of the Canadian Medical Association.
Abstract/Full Text
Editorial (subscription or payment may be required)
Food Assistance May Help Older Adults Adhere to Diabetes Meds
TUESDAY, Nov. 27, 2018 (HealthDay News) — Participation in the Supplemental Nutrition Assistance Program (SNAP) may reduce the number of low-income older adults with diabetes forgoing medications because of cost, according to a study published online Nov. 19 in JAMA Internal Medicine.
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Pregnancy-Associated Mortality Involving Opioids Up
TUESDAY, Nov. 27, 2018 (HealthDay News) — From 2007 to 2016, there was a sharp increase in pregnancy-associated mortality involving opioids, according to a research letter recently published in the American Journal of Obstetrics & Gynecology.
Recommended Therapies for Polycythemia Vera Underused
TUESDAY, Nov. 27, 2018 (HealthDay News) — Among older patients with polycythemia vera (PV), therapeutic phlebotomy and hydroxyurea (HU) are associated with improved overall survival and decreased risk for thrombosis but are underused, according to a study recently published in Blood Advances.
ACA Coverage Substantial, but Did Not Impact Labor Markets
MONDAY, Nov. 26, 2018 (HealthDay News) — Millions of workers gained insurance coverage under the Affordable Care Act (ACA) without adverse effects on labor markets, according to a report published by the Robert Wood Johnson Foundation and the Urban Institute.
Report: How Have Workers Fared Under the ACA?
FDA Approves New Treatment for Acute Myeloid Leukemia
MONDAY, Nov. 26, 2018 (HealthDay News) — The U.S. Food and Drug Administration recently announced the approval of Daurismo (glasdegib) tablets for use in combination with a low dose of the chemotherapy cytarabine to treat newly diagnosed acute myeloid leukemia (AML). The treatment is indicated for patients aged 75 years or older who have comorbidities that may prevent the use of intensive chemotherapy.
Newborns Infected With Ebola in Congo Outbreak
MONDAY, Nov. 26, 2018 (HealthDay News) — Ebola infections in newborns are being reported in the current outbreak of the deadly disease in Congo, the World Health Organization says.
AP News Article
More Information: CDC
Early Antibiotic Use May Be Tied to Higher Childhood Body Weight
MONDAY, Nov. 26, 2018 (HealthDay News) — Antibiotic use in children <24 months of age is associated with a slightly higher body weight at 5 years of age, according to a study published recently in Pediatrics.
Abstract/Full Text (subscription or payment may be required)
USPSTF Suggests Universal HIV Screening, PrEP for High-Risk Patients
TUESDAY, Nov. 20, 2018 (HealthDay News) — The U.S. Preventive Services Task Force (USPSTF) recommends HIV screening for individuals aged 15 to 65 years, including all pregnant women, and pre-exposure prophylaxis (PrEP) should be offered to those at high risk of HIV. These findings form the basis of two draft recommendation statements published online Nov. 20 by the USPSTF.
Draft Evidence Review – Adolescents/Adults
Draft Recommendation Statement – Adolescents/Adults
Comment on Recommendation Statement – Adolescents/Adults
Draft Evidence Review – Pregnancy
Draft Recommendation Statement – Pregnancy
Comment on Recommendation Statement – Pregnancy
Draft Evidence Review – PrEP
Draft Recommendation Statement – PrEP
Comment on Recommendation Statement – PrEP
Ocrelizumab May Help Preserve Hand, Arm Function in PPMS
MONDAY, Nov. 26, 2018 (HealthDay News) — For patients with primary progressive multiple sclerosis (PPMS), ocrelizumab reduces progression of upper-extremity (UE) impairment, according to an exploratory analysis published online Nov. 12 in the Multiple Sclerosis Journal.
Insulin Needed for T2DM Tx Set to Increase >20 Percent by 2030
MONDAY, Nov. 26, 2018 (HealthDay News) — From 2018 to 2030, the insulin required to treat type 2 diabetes is expected to increase more than 20 percent, according to a study published online Nov. 20 in The Lancet Diabetes & Endocrinology.
Abstract/Full Text (subscription or payment may be required)
Editorial (subscription or payment may be required)
Probiotics Show No Benefits for Pediatric Acute Gastroenteritis
MONDAY, Nov. 26, 2018 (HealthDay News) — For children with acute gastroenteritis, probiotics show no significant benefit versus placebo, according to two studies published in the Nov. 22 issue of the New England Journal of Medicine.
Abstract/Full Text – Schnadower (subscription or payment may be required)
Abstract/Full Text – Freedman (subscription or payment may be required)
Editorial (subscription or payment may be required)
ADT May Up Risk for Heart Failure in Prostate Cancer Patients
MONDAY, Nov. 26, 2018 (HealthDay News) — For patients with prostate cancer, androgen deprivation therapy is associated with an increased risk for heart failure, according to a study published online Nov. 7 in the Journal of Clinical Pharmacology.
Abstract/Full Text (subscription or payment may be required)
FDA Approves Drug to Treat Rare Immune Disease
WEDNESDAY, Nov. 21, 2018 (HealthDay News) — The U.S. Food and Drug Administration on Monday approved Gamifant (emapalumab-lzsg) for the treatment of primary hemophagocytic lymphohistiocytosis (HLH) in pediatric (as young as newborn) and adult patients who have refractory, recurrent, or progressive disease or intolerance with conventional HLH treatment.
FDA Warns Two Companies About Bogus Opioid Addiction Treatment
WEDNESDAY, Nov. 21, 2018 (HealthDay News) — Warning letters about products illegally marketed as treatments for opioid addiction, pain, and anxiety have been sent to two companies, the U.S. Food and Drug Administration said Tuesday.
FDA Approves Drug for Treatment of Travelers’ Diarrhea
WEDNESDAY, Nov. 21, 2018 (HealthDay News) — The U.S. Food and Drug Administration on Friday announced it has approved Aemcolo (rifamycin), an antibacterial drug indicated for treating adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli) without fever or blood in the stool.
Few Mandatory Pediatric Postmarketing Studies Completed
WEDNESDAY, Nov. 21, 2018 (HealthDay News) — During a median follow-up of 6.8 years, only 33.8 percent of mandatory pediatric postmarketing studies were completed, according to a study published online Nov. 19 in JAMA Pediatrics.
Abstract/Full Text (subscription or payment may be required)
Editorial (subscription or payment may be required)
Novel Scoring System Can Up Access to Biologics in Psoriasis
WEDNESDAY, Nov. 21, 2018 (HealthDay News) — A new scoring system that accounts for “not relevant” responses (NRRs) on the Dermatology Life Quality Index (DLQI) for patients with psoriasis is valid for avoiding bias and can improve access to biologics, according to a study published in the November issue of the British Journal of Dermatology.
Abstract/Full Text (subscription or payment may be required)
Editorial
Dementia Tied to Mortality in Older Adults With Down Syndrome
TUESDAY, Nov. 20, 2018 (HealthDay News) — Dementia is associated with mortality in most older adults with Down syndrome, according to a study published online Nov. 19 in JAMA Neurology.
Pain Management Telementoring May Cut Opioid Prescribing
TUESDAY, Nov. 20, 2018 (HealthDay News) — Military patients whose primary care clinicians participated in a telementoring program, including education on pain management best practices, have larger declines in opioid-related prescriptions than patients whose clinicians did not participate, according to a study published online Oct. 31 in the Journal of General Internal Medicine.
Even With Standing Orders, Naloxone Access Varies
MONDAY, Nov. 19, 2018 (HealthDay News) — There are great differences in access to naloxone even among states that have passed legislation to allow pharmacists to dispense the medication without a physician’s prescription, according to two research letters published in the Nov. 13 issue of the Journal of the American Medical Association.
Abstract/Full Text – Puzantian (subscription or payment may be required)
Abstract/Full Text – Evoy (subscription or payment may be required)
Editorial (subscription or payment may be required)
FDA Approves First-Line Tx for Peripheral T-Cell Lymphoma
MONDAY, Nov. 19, 2018 (HealthDay News) — The U.S. Food and Drug Administration on Friday expanded approval for the use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with specific types of peripheral T-cell lymphoma (PTCL).
Prevalence of Food Allergy 7.6 Percent in U.S. Children
MONDAY, Nov. 19, 2018 (HealthDay News) — The prevalence of food allergy (FA) is 7.6 percent among children in the United States, according to a study published online Nov. 19 in Pediatrics.
Patient Education Ups VTE Prophylaxis in Hospital Setting
MONDAY, Nov. 19, 2018 (HealthDay News) — A patient-centered education bundle intervention can reduce nonadministration of venous thromboembolism (VTE) prophylaxis, according to a study published online Nov. 16 in JAMA Network Open.
HIV Transmission Risk Small With Antiretroviral Compliance
Homicide, Suicide, and Overdose Leading Causes of Maternal Death 
Model Predicts Poor Outcomes Within 30 Days of a Before Medically Advised Discharge 
Fewer Than Half of Drug Overdose Survivors Go to the Hospital 
2000 to 2023 Saw Rise in Pediatric Exposure to Medications, Supplements 
2013 to 2024 Saw Decrease in Benzodiazepine Prescribing 
GLP-1 Receptor Agonists, SGLT-2is Slow Renal Function Decline in T2D With Albuminuria 
Polypharmacy of Prescription Medications Increased for U.S. Older Adults 
Low Hydroxychloroquine Intake, Blood Levels Linked to ASCVD Risk in Lupus 
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