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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.<\/p>\n
Teva Recalls Two Blood Pressure Medications<\/font><\/p>\n 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.<\/p>\n More Information<\/a><\/p>\n Care for Chronic Kidney Disease Varies Across VA Facilities<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n Editorial (subscription or payment may be required)<\/a><\/p>\n Increase Seen in Amphetamine, Opioid Use in Pregnant Women<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n Most Bills Enacted Into Law Limit Vaccine Exemptions<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n FDA Approves Treatment for AML Patients With Gene Mutation<\/font><\/p>\n 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<\/i> mutation, the agency announced in a news release. The FDA also granted expanded approval to the LeukoStrat CDx FLT3<\/i> Mutation Assay used to detect the FLT3<\/i> mutation in AML patients.<\/p>\n More Information<\/a><\/p>\n FDA Approves Firdapse for Rare Autoimmune Disorder<\/font><\/p>\n 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).<\/p>\n More Information<\/a><\/p>\n Certain SGLT2 Inhibitors, GLP-1 RAs for T2DM Also Cut CV Risk<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text<\/a><\/p>\n FDA Approves First Biosimilar to Non-Hodgkin’s Lymphoma Drug<\/font><\/p>\n 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.<\/p>\n More Information<\/a><\/p>\n Lanadelumab Reduces Attack Rate in Hereditary Angioedema<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text<\/a><\/p>\n FDA: Kratom Products Have High Levels of Heavy Metals<\/font><\/p>\n 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.<\/p>\n More Information<\/a><\/p>\n Men Should Avoid ‘Rhino’ Sexual Enhancement Products, FDA Says<\/font><\/p>\n 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.<\/p>\n More Information<\/a><\/p>\n FDA Approves Vitrakvi for Cancers With Certain Genetic Trait<\/font><\/p>\n 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.<\/p>\n More information<\/a><\/p>\n FDA to Update Medical Device Approvals Process<\/font><\/p>\n 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.<\/p>\n CBS\/AP News<\/i> Article<\/a><\/p>\n More Information<\/a><\/p>\n Risks of Trazodone Similar to Those of Atypical Antipsychotics<\/font><\/p>\n 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<\/i>, the Journal of the Canadian Medical Association.<\/p>\n Abstract\/Full Text<\/a><\/p>\n Editorial (subscription or payment may be required)<\/a><\/p>\n Food Assistance May Help Older Adults Adhere to Diabetes Meds<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n Pregnancy-Associated Mortality Involving Opioids Up<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text<\/a><\/p>\n Recommended Therapies for Polycythemia Vera Underused<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text<\/a><\/p>\n ACA Coverage Substantial, but Did Not Impact Labor Markets<\/font><\/p>\n 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.<\/p>\n Report: How Have Workers Fared Under the ACA?<\/a><\/p>\n FDA Approves New Treatment for Acute Myeloid Leukemia<\/font><\/p>\n 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.<\/p>\n More Information<\/a><\/p>\n Newborns Infected With Ebola in Congo Outbreak<\/font><\/p>\n 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.<\/p>\n AP News<\/i> Article<\/a><\/p>\n More Information: CDC<\/a><\/p>\n Early Antibiotic Use May Be Tied to Higher Childhood Body Weight<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n USPSTF Suggests Universal HIV Screening, PrEP for High-Risk Patients<\/font><\/p>\n 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.<\/p>\n Draft Evidence Review – Adolescents\/Adults<\/a><\/p>\n Draft Recommendation Statement – Adolescents\/Adults<\/a><\/p>\n Comment on Recommendation Statement – Adolescents\/Adults<\/a><\/p>\n Draft Evidence Review – Pregnancy<\/a><\/p>\n Draft Recommendation Statement – Pregnancy<\/a><\/p>\n Comment on Recommendation Statement – Pregnancy<\/a><\/p>\n Draft Evidence Review – PrEP<\/a><\/p>\n Draft Recommendation Statement – PrEP<\/a><\/p>\n Comment on Recommendation Statement – PrEP<\/a><\/p>\n Ocrelizumab May Help Preserve Hand, Arm Function in PPMS<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text<\/a><\/p>\n Insulin Needed for T2DM Tx Set to Increase >20 Percent by 2030<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n Editorial (subscription or payment may be required)<\/a><\/p>\n Probiotics Show No Benefits for Pediatric Acute Gastroenteritis<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text – Schnadower (subscription or payment may be required)<\/a><\/p>\n Abstract\/Full Text – Freedman (subscription or payment may be required)<\/a><\/p>\n Editorial (subscription or payment may be required)<\/a><\/p>\n ADT May Up Risk for Heart Failure in Prostate Cancer Patients<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n FDA Approves Drug to Treat Rare Immune Disease<\/font><\/p>\n 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.<\/p>\n More Information<\/a><\/p>\n FDA Warns Two Companies About Bogus Opioid Addiction Treatment<\/font><\/p>\n 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.<\/p>\n More Information<\/a><\/p>\n FDA Approves Drug for Treatment of Travelers’ Diarrhea<\/font><\/p>\n 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<\/i> (E. coli<\/i>) without fever or blood in the stool.<\/p>\n More Information<\/a><\/p>\n Few Mandatory Pediatric Postmarketing Studies Completed<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n Editorial (subscription or payment may be required)<\/a><\/p>\n Novel Scoring System Can Up Access to Biologics in Psoriasis<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n Editorial<\/a><\/p>\n Dementia Tied to Mortality in Older Adults With Down Syndrome<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text<\/a><\/p>\n Editorial<\/a><\/p>\n Pain Management Telementoring May Cut Opioid Prescribing<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text<\/a><\/p>\n Even With Standing Orders, Naloxone Access Varies<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text – Puzantian (subscription or payment may be required)<\/a><\/p>\n Abstract\/Full Text – Evoy (subscription or payment may be required)<\/a><\/p>\n Editorial (subscription or payment may be required)<\/a><\/p>\n FDA Approves First-Line Tx for Peripheral T-Cell Lymphoma<\/font><\/p>\n 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).<\/p>\n More Information<\/a><\/p>\n Prevalence of Food Allergy 7.6 Percent in U.S. Children<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text<\/a><\/p>\n Patient Education Ups VTE Prophylaxis in Hospital Setting<\/font><\/p>\n 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<\/i>.<\/p>\n Abstract\/Full Text<\/a><\/p>\n HIV Transmission Risk Small With Antiretroviral Compliance<\/font><\/p>\n MONDAY, Nov. 19, 2018 (HealthDay News) — The risk for sexual transmission of HIV is negligible when an HIV-positive sex partner adheres to antiretroviral therapy and maintains viral suppression, according to research published in the November issue of CMAJ<\/i>, the journal of the Canadian Medical Association.<\/p>\n Abstract\/Full Text<\/a><\/p>\n Opioid Misuse Varies With Sexual Orientation<\/font><\/p>\n MONDAY, Nov. 19, 2018 (HealthDay News) — Opioid misuse varies with sexual orientation, with increased misuse among female bisexuals, according to a study published online Nov. 19 in the American Journal of Preventive Medicine<\/i>.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n MS Relapse Drops During Pregnancy but Rises After<\/font><\/p>\n MONDAY, Nov. 19, 2018 (HealthDay News) — Rates of multiple sclerosis (MS) relapse decrease during pregnancy but increase postpartum, according to a study published online Oct. 23 in Neurology<\/i>.<\/p>\n Abstract\/Full Text<\/a><\/p>\n Editorial (subscription or payment may be required)<\/a><\/p>\n Onset of Musculoskeletal Adverse Events Varies Between Statins<\/font><\/p>\n MONDAY, Nov. 19, 2018 (HealthDay News) — The onset of musculoskeletal adverse events (MAEs) during statin monotherapy is significantly faster with use of atorvastatin and rosuvastatin versus simvastatin, according to a study published online Nov. 7 in Pharmacology Research & Perspectives<\/i>.<\/p>\n Abstract\/Full Text<\/a><\/p>\n Epinephrine Personal Autoinjectors Cost-Effective at $24<\/font><\/p>\n FRIDAY, Nov. 16, 2018 (HealthDay News) — In a simulation of children with peanut allergy, epinephrine personal autoinjectors are cost-effective at $24, according to a study published online Nov. 16 in JAMA Network Open<\/i>.<\/p>\n Abstract\/Full Text<\/a><\/p>\n Higher Risk for Amputation, DKA With SGLT2 Inhibitors for T2DM<\/font><\/p>\n FRIDAY, Nov. 16, 2018 (HealthDay News) — Use of sodium glucose cotransporter 2 (SGLT2) inhibitors is associated with an increased risk for lower-limb amputation and diabetic ketoacidosis compared with use of glucagon-like peptide 1 (GLP1) receptor agonists, according to a study published online Nov. 14 in The BMJ<\/i>.<\/p>\n Abstract\/Full Text<\/a><\/p>\n CDC: 8.8 Percent Uninsured in U.S. in First Half of 2018<\/font><\/p>\n FRIDAY, Nov. 16, 2018 (HealthDay News) — In the first six months of 2018, 8.8 percent of U.S. individuals of all ages were uninsured, which was not significantly different from 2017, according to a report published Nov. 15 by the U.S. Centers for Disease Control and Prevention National Center for Health Statistics.<\/p>\n Abstract\/Full Text<\/a><\/p>\n Name-Brand Medications Driving Spike in U.S. Drug Spending<\/font><\/p>\n THURSDAY, Nov. 15, 2018 (HealthDay News) — Rising drug spending in the United States is being fueled by expensive name-brand prescription medicines, a new study shows.<\/p>\n NBC News<\/i> Article<\/a><\/p>\n Blue Cross Blue Shield Report<\/a><\/p>\n CDC: Many Americans May Have Prediabetes and Not Know It<\/font><\/p>\n THURSDAY, Nov. 15, 2018 (HealthDay News) — More than one-third of Americans have prediabetes, but 90 percent of them do not know they have it, medical experts say.<\/p>\n Do I Have Prediabetes<\/a><\/p>\n More Information<\/a><\/p>\n Pharmacist-Led Effort Cuts Inappropriate Rx in Older Adults<\/font><\/p>\n WEDNESDAY, Nov. 14, 2018 (HealthDay News) — A pharmacist-led intervention has the potential to reduce prescriptions for inappropriate medication in older adults, according to a study published in the Nov. 13 issue of the Journal of the American Medical Association<\/i>.<\/p>\n Abstract\/Full Text<\/a><\/p>\n Editorial (subscription or payment may be required)<\/a><\/p>\n Changes in Risk Indicators of MetS Severity Tied to T2DM Risk<\/font><\/p>\n WEDNESDAY, Nov. 14, 2018 (HealthDay News) — For patients with prediabetes who are randomly assigned to interventions, changes in risk indicators of metabolic syndrome (MetS) severity are associated with the risk for type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD), according to a study published in the November issue of Diabetes Care<\/i>.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n Consensus Statement Issued on Management of Foot, Ankle Gout<\/font><\/p>\n WEDNESDAY, Nov. 14, 2018 (HealthDay News) — The American College of Foot and Ankle Surgeons and the American Association of Nurse Practitioners-Orthopedics Specialty Practice Group have issued a new joint clinical consensus statement on the etiology, diagnosis, and treatment of gouty arthritis of the foot and ankle; the consensus statement was published in the November-December issue of the Journal of Foot & Ankle Surgery<\/i>.<\/p>\n Abstract\/Full Text<\/a><\/p>\n One-Third of Peds Medication Errors Due to Usability Issues<\/font><\/p>\n TUESDAY, Nov. 13, 2018 (HealthDay News) — More than one-third of pediatric patient safety reports in 2012 to 2017 that were related to electronic health record (EHR) use were attributed to usability issues, according to a study published in the November issue of Health Affairs<\/i>.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n Denosumab Promising for TDT-Induced Osteoporosis Treatment<\/font><\/p>\n TUESDAY, Nov. 13, 2018 (HealthDay News) — Denosumab (DNM), a fully human monoclonal antibody against the receptor activator of nuclear factor kappa-B ligand (RANKL), may be beneficial for managing transfusion-dependent thalassemia (TDT)-induced osteoporosis, according to a study published online Oct. 31 in Blood Advances<\/i>.<\/p>\n Abstract\/Full Text<\/a><\/p>\n Ebola Outbreak Worst in Congo’s History<\/font><\/p>\n