Antares: FDA Approves Xyosted™ (Testosterone Enanthate) Injection for Testosterone Replacement Therapy in Adult Males

The FDA has approved XYOSTED™ (testosterone enanthate) injection and is the first FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot® auto injector.  XYOSTED™ is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Read More →

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Paratek: FDA Approves SEYSARA™ (Sarecycline) for the Treatment of Moderate to Severe Acne

FDA has approved SEYSARA™ (sarecycline) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. SEYSARA (sarecycline) is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate to severe acne in the community setting. Read More →

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AHA: Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association

AHA – new statement includes recommendations for the diagnosis and treatment of resistant hypertension (elevated BP despite concurrent use of 3 antihypertensive drug classes). Recommendations include confirming adherence, excluding white-coat effect, evaluating lifestyle issues, detecting drug interactions, screening for secondary HTN, and using specific drug classes (long-acting thiazide-like diuretic, mineralocorticoid receptor antagonist, others with complementary mechanisms of action). Read More →

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OIG: Treatment Planning and Medication Monitoring Were Lacking for Children in Foster Care Receiving Psychotropic Medication

OIG – a new report from the Office of Inspector General showed that 34% of children in foster care who were treated with psychotropic medications did not receive treatment planning or medication monitoring as required. Up to 80% of children enter foster care with significant mental health needs and psychotropic medications may be effective, however, they can have serious side effects that require treatment planning mechanisms and effective medication monitoring. Read More →

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NC DHHS migrates the NC Controlled Substances Reporting System (CSRS) to a new software platform on September 19th

NC DHHS - migrated the NC Controlled Substances Reporting System (CSRS) to a new software platform on September 19th. Your existing CSRS account has automatically been transferred into the new software system, but you will need to reset your password. If you have any questions or concerns, please contact support directly at 855-962-4767. Read More →

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FDA approves the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

FDA – approved the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals. This expanded REMS now applies to immediate-release (IR) opioid analgesics in addition to extended-release and long-acting (ER/LA) opioids, which have been subject to REMS since 2012. The FDA also approved the new “Opioid Analgesic REMS Education Blueprint for Health Care Providers (HCP) Involved in the Treatment and Monitoring of Patients with Pain” that outlines the core HCP-facing educational messages for the Opioid Analgesic REMS. Read More →

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Teva Announces U.S. Approval of AJOVY™ (fremanezumab-vfrm) Injection, the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Preventive Treatment of Migraine in Adults

Teva - approved AJOVY (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults. AJOVY, a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor, is the first and only anti-CGRP treatment for the prevention of migraine with quarterly (675 mg) and monthly (225 mg) dosing options. Read More →

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JAMA: Receipt of Timely Addiction Treatment and Association of Early Medication Treatment With Retention in Care Among Youths With Opioid Use Disorder

JAMA –Just 1 of 21 adolescents younger than 18 years and 1 of 4 young adults aged 18 to 22 years received medication for opioid use disorder within 3 months of diagnosis. Youths who received MAT were much less likely to discontinue care (buprenorphine 42% less likely, naltrexone 46% less likely, methadone 68% less likely) compared with youths who received behavioral treatment only. Strategies to address the underuse of evidence-based medications for youths with OUD are urgently needed. Read More →

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PLOS: Fixed-dose combination antihypertensive medications, adherence, and clinical outcomes: A population-based retrospective cohort study

Among older adults initiating combination antihypertensive treatment, single-pill fixed-dose combination therapy was associated with a significantly lower risk of composite clinical outcomes (death or hospitalization for acute MI, HF, or stroke), which may be related to better medication adherence. The proportion of total follow-up days covered with medications was significantly greater in the single-pill fixed-dose combination group (70%) versus the multi-pill group (42%). Read More →

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CDC: Opportunities to Prevent Overdose Deaths Involving Prescription and Illicit Opioids, 11 States, July 2016–June 2017

CDC - During July 2016–June 2017, among 11,884 opioid overdose deaths, bystanders were reportedly present in approximately 40% of cases; however, naloxone was rarely administered by a layperson (in approximately 4% of deaths involving only illicit opioids and 0.8% of prescription opioid–only deaths). These data suggest prevention efforts should prioritize naloxone distribution to persons misusing opioids or using high dosage prescription opioids and to their family members and friends. Read More →

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FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence

FDA - approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence. This action provides a new dosage strength (16 milligrams/4 milligrams) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths. The introduction of new treatment options has the potential to broaden access for patients. Read More →

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BMJ: 2018 update of the EULAR recommendations for the management of hand osteoarthritis

EULAR releases 2018 update for recommendations for the management of hand osteoarthritis including those related to the role of pharmacologic treatments. Topical treatments are preferred over systemic treatments with topical NSAIDs as first-line, oral analgesics particularly NSAIDs can be considered for symptom relief for a limited duration, chrondroitin sulfate may be used for symptom relief, intraarticular glucocorticoids are not generally recommended, and conventional/biological DMARDs are discouraged. Read More →

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GARFIELD-AF registry confirms that NOACs are superior to VKAs in reducing 2-year mortality in higher risk patients with AF

GARFIELD-AF registry confirms that NOACs are superior to VKAs in reducing 2-year mortality in higher risk patients with AF (19% fewer deaths). In addition, patients who receive an anticoagulant (AC) plus add-on antiplatelet therapy (AP) for stroke prevention have a significantly worse prognosis than patients on AC alone. Lastly, patients receiving non-recommended low-dose NOAC, all-cause mortality increased by 51%. Read More →

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BMJ: Statins for primary prevention of cardiovascular events and mortality in old and very old adults with and without type 2 diabetes: retrospective cohort study

BMJ - In participants older than 74 years without type 2 diabetes, statin treatment was not associated with a reduction in atherosclerotic CVD or in all-cause mortality. In the presence of diabetes, statin use was statistically significantly associated with reductions in the incidence of atherosclerotic CVD and in all-cause mortality, however, this effect decreased after age 85 years. Read More →

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CNBC: Walgreens to offer Auvi-Q as EpiPen shortage challenges parents

Walgreens will stock the Auvi-Q as an EpiPen shortage has left some pharmacies unable to fill prescriptions. Eligible patients with commercial insurance, even those with high deductible plans or whose insurers don't cover the Auvi-Q, can obtain it at no cost. People without insurance whose household income is less than $100,000 can get the Auvi-Q for free through an assistance program. Read More →

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AAP: Recommendations for Prevention and Control of Influenza in Children, 2018–2019

AAP released updated recommendations for influenza prevention/control in children for 2018-19 including annual flu vaccination for patients 6 months and older, inactivated flu vaccine is the primary choice, all children with egg allergy can receive flu vaccine without additional precautions, and although timely initiation of antiviral treatment within 48 hours of symptom onset is best, therapy should still be considered beyond 48 hours in children with severe disease or those at high risk of complications. Read More →

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