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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.
FRIDAY, Nov. 30, 2018 -- 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.
FRIDAY, Nov. 30, 2018 -- 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.
FRIDAY, Nov. 30, 2018 -- 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.
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THURSDAY, Nov. 29, 2018 -- 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.
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THURSDAY, Nov. 29, 2018 -- 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.
THURSDAY, Nov. 29, 2018 -- Firdapse (amifampridine) tablets have been approved by the U.S. Food and Drug Administration for adults with Lambert-Eaton myasthenic syndrome (LEMS).
THURSDAY, Nov. 29, 2018 -- 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.
WEDNESDAY, Nov. 28, 2018 -- 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.
WEDNESDAY, Nov. 28, 2018 -- 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.
WEDNESDAY, Nov. 28, 2018 -- 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.
TUESDAY, Nov. 27, 2018 -- The U.S. Food and Drug Administration is warning men that "Rhino" products promising better sex may pose serious health risks.
TUESDAY, Nov. 27, 2018 -- 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.
TUESDAY, Nov. 27, 2018 -- A major update of the United States' system for approving medical devices was announced yesterday by the Food and Drug Administration.
TUESDAY, Nov. 27, 2018 -- 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.
TUESDAY, Nov. 27, 2018 -- 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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TUESDAY, Nov. 27, 2018 -- 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.
TUESDAY, Nov. 27, 2018 -- 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.
MONDAY, Nov. 26, 2018 -- 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?
MONDAY, Nov. 26, 2018 -- 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.
MONDAY, Nov. 26, 2018 -- Ebola infections in newborns are being reported in the current outbreak of the deadly disease in Congo, the World Health Organization says.
MONDAY, Nov. 26, 2018 -- 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.
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TUESDAY, Nov. 20, 2018 -- 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.
MONDAY, Nov. 26, 2018 -- 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.
MONDAY, Nov. 26, 2018 -- 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.
MONDAY, Nov. 26, 2018 -- 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.
MONDAY, Nov. 26, 2018 -- 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.
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WEDNESDAY, Nov. 21, 2018 -- 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.
WEDNESDAY, Nov. 21, 2018 -- 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.
WEDNESDAY, Nov. 21, 2018 -- 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.
WEDNESDAY, Nov. 21, 2018 -- 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.
WEDNESDAY, Nov. 21, 2018 -- 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.
TUESDAY, Nov. 20, 2018 -- Dementia is associated with mortality in most older adults with Down syndrome, according to a study published online Nov. 19 in JAMA Neurology.
TUESDAY, Nov. 20, 2018 -- 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.
MONDAY, Nov. 19, 2018 -- 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.
MONDAY, Nov. 19, 2018 -- 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).
MONDAY, Nov. 19, 2018 -- 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.
MONDAY, Nov. 19, 2018 -- 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.
MONDAY, Nov. 19, 2018 -- 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, the journal of the Canadian Medical Association.
MONDAY, Nov. 19, 2018 -- 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.
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MONDAY, Nov. 19, 2018 -- Rates of multiple sclerosis (MS) relapse decrease during pregnancy but increase postpartum, according to a study published online Oct. 23 in Neurology.
MONDAY, Nov. 19, 2018 -- 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.
FRIDAY, Nov. 16, 2018 -- 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.
FRIDAY, Nov. 16, 2018 -- 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.
FRIDAY, Nov. 16, 2018 -- 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.
THURSDAY, Nov. 15, 2018 -- Rising drug spending in the United States is being fueled by expensive name-brand prescription medicines, a new study shows.
THURSDAY, Nov. 15, 2018 -- More than one-third of Americans have prediabetes, but 90 percent of them do not know they have it, medical experts say.
WEDNESDAY, Nov. 14, 2018 -- 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.
WEDNESDAY, Nov. 14, 2018 -- 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.
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WEDNESDAY, Nov. 14, 2018 -- 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.
TUESDAY, Nov. 13, 2018 -- 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.
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TUESDAY, Nov. 13, 2018 -- 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.
TUESDAY, Nov. 13, 2018 -- The current Ebola outbreak in Congo is the worst in the country's recorded history, the health ministry says.
TUESDAY, Nov. 13, 2018 -- The antiviral agent fluoxetine is well tolerated but is not effective for patients with proven or presumptive enterovirus D68-associated acute flaccid myelitis (AFM), according to a study published online Nov. 9 in Neurology.
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FRIDAY, Nov. 9, 2018 -- A fast, single-use fingerstick test for infection with the Ebola virus has been approved by the U.S. Food and Drug Administration.
FRIDAY, Nov. 9, 2018 -- When used perioperatively in elective abdominal aortic aneurysm repair, curcumin has no beneficial effect, according to a study published in the Oct. 29 issue of CMAJ, the journal of the Canadian Medical Association.
THURSDAY, Nov. 8, 2018 -- A new version of an over-the-counter asthma inhaler that was taken off the market in 2011 has been approved by the U.S. Food and Drug Administration.
THURSDAY, Nov. 8, 2018 -- A birth control coverage opt-out for employers was finalized by the Trump administration on Wednesday.
THURSDAY, Nov. 8, 2018 -- Oral zoliflodacin, which inhibits DNA biosynthesis, seems effective for urogenital and rectal gonococcal infections but is less effective for pharyngeal infections, according to a study published in the Nov. 8 issue of the New England Journal of Medicine.
THURSDAY, Nov. 8, 2018 -- The quantity of opioids prescribed after surgery is associated with patient-reported opioid consumption, according to a study published online Nov. 7 in JAMA Surgery.
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THURSDAY, Nov. 8, 2018 -- For premenopausal women with stage I to IIIA estrogen receptor-negative, progesterone receptor-negative breast cancer, goserelin plus chemotherapy is associated with an increased likelihood of becoming pregnant without an increased risk for adverse effects, according to a study published online Oct. 29 in the Journal of the National Cancer Institute.
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WEDNESDAY, Nov. 7, 2018 -- Hundreds of thousands more low-income Americans could get health insurance after voters in three Republican-leaning states approved Medicaid expansion in the midterm elections.
WEDNESDAY, Nov. 7, 2018 -- For patients with multiple myeloma in whom treatment with lenalidomide and a proteasome inhibitor has failed, progression-free survival is longer in those receiving the immunostimulatory monoclonal antibody elotuzumab in addition to pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone, according to a study published in the Nov. 8 issue of the New England Journal of Medicine.
WEDNESDAY, Nov. 7, 2018 -- First-year nonadherence and discontinuation are high among older adults prescribed statins, according to a study published online Nov. 7 in the British Journal of Clinical Pharmacology.
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WEDNESDAY, Nov. 7, 2018 -- A polygenic risk score (PRS) for schizophrenia can predict 12-week posttreatment symptom scores among patients with first-episode psychosis, according to a study published online Nov. 5 in the American Journal of Psychiatry.
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WEDNESDAY, Nov. 7, 2018 -- Community-onset urinary tract infection (UTI) due to extended-spectrum cephalosporin-resistant (ESC-R) Enterobacteriaceae (EB) is significantly associated with clinical failure, according to a study published online Oct. 30 in Infection Control & Hospital Epidemiology.
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TUESDAY, Nov. 6, 2018 -- It may not be possible to bring the Ebola outbreak in Congo under control, and the deadly disease may become entrenched in the northeastern part of the country, U.S. Centers for Disease Control and Prevention Director Robert Redfield says.
TUESDAY, Nov. 6, 2018 -- Following the 2007 American Heart Association (AHA) update of recommendations for antibiotic prophylaxis (AP) to prevent infective endocarditis (IE), there has been a decrease in AP and an increase in IE incidence for high-risk individuals, according to a study published online Nov. 5 in the Journal of the American College of Cardiology. The research was published to coincide with the annual meeting of the American Heart Association, held from Nov. 10 to 12 in Chicago.
TUESDAY, Nov. 6, 2018 -- Stratifying tuberculosis (TB) patients by disease severity may enable shorter treatment regimens, according to a study published online Nov. 5 in Nature Medicine.
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TUESDAY, Nov. 6, 2018 -- An adjunctive buprenorphine/samidorphan (BUP/SAM) combination seems beneficial for patients with major depressive disorder (MDD) with inadequate response to antidepressant therapy (ADT), according to a study published online Oct. 29 in Molecular Psychiatry.
MONDAY, Nov. 5, 2018 -- A majority of internists still report financial ties to industry, according to a study published online Oct. 5 in the Journal of General Internal Medicine.
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MONDAY, Nov. 5, 2018 -- Prenatal exposure to most medications affecting neurotransmitter systems is not associated with estimates of autism spectrum disorder (ASD) risk, according to a study published online Oct. 31 in JAMA Psychiatry.
FRIDAY, Nov. 2, 2018 -- Ruling against the recommendation of one of its chief experts, the U.S. Food and Drug Administration today approved an extremely potent new opioid painkiller, Dsuvia.
FRIDAY, Nov. 2, 2018 -- The number of opioid overdose deaths in the United States reached a new record last year with 72,000 deaths, which works out to about 200 a day, according to a Drug Enforcement Administration report released today. The report comes just over a week after U.S. health secretary Alex Azar said overdose deaths have started to level off.
FRIDAY, Nov. 2, 2018 -- The federal government website where Americans can sign up for health insurance under the Affordable Care Act is up and running, officials said yesterday.
FRIDAY, Nov. 2, 2018 -- Although progress has been made in increasing human papillomavirus (HPV) vaccination, coverage is still too low to achieve full cancer prevention potential, according to a report from the President's Cancer Panel published Nov. 1.
THURSDAY, Nov. 1, 2018 -- The first cannabis-based medication approved by the U.S. Food and Drug Administration is now available by prescription nationwide.
THURSDAY, Nov. 1, 2018 -- Another hypertension drug is being recalled due to contamination that could pose a cancer risk, the U.S. Food and Drug Administration says.
THURSDAY, Nov. 1, 2018 -- New guidelines have been released for the treatment of primary cutaneous melanoma, according to a report from the American Academy of Dermatology published online Nov. 1 in the Journal of the American Academy of Dermatology.
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THURSDAY, Nov. 1, 2018 -- There is a high prevalence of financial conflicts of interest among authors of clinical practice guidelines (CPGs) related to high-revenue medications and in gastroenterology, according to two research letters published online Oct. 29 in JAMA Internal Medicine.
THURSDAY, Nov. 1, 2018 -- The American Academy of Pediatrics, American College of Emergency Physicians, and Emergency Nurses Association have released updated guidelines for emergency care of injured and critically ill children. The guidelines were published in a policy statement in the November issue of Pediatrics.
Posted: December 2018