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 August 2017 Issue of FYDI - For Your Drug Information
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Co-edited by:
Ashley Guilbeau and Kendrick Hunter, Pharm.D. Candidates
Gregory W. Smith, Pharm.D., Director, Drug Information Services
Greetings from the Drug Information Center at the University of Louisiana at Monroe School of Pharmacy

We hope you find this newsletter service helpful in staying well-informed. We continue to provide drug information services to healthcare professionals as a courtesy, so take a few moments to 
learn more about our Drug Information Services. 

Please contact us for assistance with your drug information needs by any of the following: 
          Phone 318.342.5501
          Email: druginfo@ulm.edu 
          Online Drug Information Requests

In this issue, read about...
             FDA MedWatch and Other Safety Alerts
             News Items
             Drug Approvals
             New Guidelines


See our list of  Drug Information Services

 
FDA MedWatch and Other Safety Alerts...


Recall of Normal Saline Injection
ICU Medical, Inc. is conducting a voluntary recall of one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to the presence of particulate matter.

View Here 

Recall of Man of Steel 1 and 2
Man of Steel is conducting a voluntary recall to the retail level of Man of Steel 1 and Man of Steel 2 due to the presence of sildenafil.
View Here

Recall of La Bri's Body Health Atomic and Xplode Capsules
EZ Weight Loss TX is conducting a voluntary recall to the consumer level of La Bri's Body Health Atomic and Xplode capsules due to the presence of sibutramine, an appetite suppressant.
View Here
 
Recall of Sterile Drug Products
Cantrell Drug Company is conducting a voluntary recall to the hospital and user level of all unexpired sterile drug products due to lack of sterility.
View Here
 
Recall of Super Panther 7K Capsules
Ultra Shop Supplement is conducting a voluntary recall to the consumer level of Super Panther 7K Capsules due to the presence of tadalafil and sildenafil.
View Here

Recall of Sten Z and M1 Alpha Capsules
Andropharm is conducting a voluntary recall to the consumer level for the dietary supplements Sten Z and M1 Alpha Capsules due to the presence of anabolic steroid derivatives.
View Here

Recall of Novopen Echo Insulin Delivery Device
Novo Nordisk is conducting a recall of insulin cartridge holders used in batches of Novopen Echo devices due to the possibility of cracking or breaking when exposed to certain chemicals.
View Here

Recall of Potassium Phosphate and Succinylcholine Chloride
PharMEDium Services is conducting a voluntary recall for specific lots of potassium phosphate and succinylcholine chloride secondary to a recall by Hospira due to suspected lack of sterility. These PharMEDium products were compounded using certain Hospira products.
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Recall of Succinylcholine Chloride Syringe
Fagron Sterile Services is conducting a voluntary recall to the hospital/clinic level of  three lots of succinylcholine chloride 20mg/mL 5mL syringes. These syringes were originally manufactured by Hospira Inc., which has recently issued a recall due to bacterial growth during a routine simulation of manufacturing processes.
View Here 
 
Recall of Succinylcholine Chloride and Potassium Phosphate
Advanced Pharma, Inc. d/b/a Avella of Houston is conducting a voluntary recall of specific lots of potassium phosphate and succinylcholine chloride products originally manufactured by Hospira Inc. These products were repackaged or compounded using recalled products from Hospira. A recall has been issued by Hospira due to lack of sterility.
View Here
 
Recall of Clindamycin Injection ADD-Vantage Vials
Alvogen is conducting a voluntary recall to the hospital/retail level of seven lots of Clindamycin Injection USP ADD-Vantage Vials due to a result of a routine simulation of manufacturing processes that demonstrated bacterial growth.
View Here
 
Recall of Sodium Bicarbonate, Succinylcholine Chloride, and Potassium Phosphate Injections
Hospira, Inc. is conducting a voluntary recall to the hospital/retail level of 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials. This recall is a result of a routine simulation of manufacturing processes that demonstrated bacterial growth.
View Here

Recall of Nitroglycerin 5% Dextrose, USP
Advanced Pharma, Inc. d/b/a Avella of Houston is conducting a voluntary recall to the hospital level of unexpired lots of compounded nitroglycerin injection products produced at the Houston location due to sub potency test results. These products include the 100 mcg per mL and 200 mcg per mL strengths available in 5 mL, 10 mL, and 20 mL sterile single dose syringes. 
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Recall of Paliperidone Extended Release 3 mg Tablets
Teva Pharmaceuticals USA, Inc. is conducting a voluntary recall to the consumer level of one lot of 90 count bottles of paliperidone extended release 3 mg tablets (lot 1160682A) due to failed dissolution tests.
View Here
 
Recall of Phillips Topical Products
Phillips Company is conducting a voluntary recall for certain topical products to the retail level for concerns related to manufacturing practices. These products include Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneen, StaphWash, StringMed, NoPain and LidoMed.
View Here
 
Recall of Eliquis (apixaban) 5 mg
Bristol-Myers Squibb Company is conducting a voluntary recall to the retail level for one lot (#HN0063) of Eliquis 5 mg tablet due to a bottle containing 2.5 mg Eliquis tablets.
View Here

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News Items...


Increasing Rates of Drug-Resistant HIV
The World Health Organization warns about the emerging resistance to common HIV drugs, such as efavirenz and nevirapine.
View Here

Dementia Prevention and Nine Modifiable Risk Factors
Dementia may be prevented or delayed by focusing on nine modifiable risk factors, which include education through the age of 11–12 years, midlife hypertension and obesity, hearing loss, depression later in life, diabetes, physical inactivity, smoking, and social isolation.
View Here
View Study

The Facts about Expired Drugs
Toxicologist Lee Cantrell tested a box of thirty to forty year old prescription drugs forgotten in a back closet of a retail pharmacy to answer one of the age old questions about the efficacy of expired medications.
View Here

Growing Incidence of Diabetes and Prediabetes According to CDC Report
The Centers for Disease Control and Prevention releases a National Diabetes Statistics Report, which revealed that more than 30.3 and 84.1 million Americans have diabetes and prediabetes, respectively.
View Here

Potential Alzheimer's Medications in the Pipeline
The Alzheimer’s community can expect to see new medications on the market within the next five years. Currently, there are 27 drugs in phase three clinical trials and 8 medications in phase two clinical trials.
View Here

Effects of Recent Codeine Warnings
Label changes to codeine and tramadol include recommendations against use in breastfeeding women and a contraindication for children less than 12 years of age. These label changes have prompted some institutions to change their prescribing methods.
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New Draft of BCRA Unfavorable to Patients with Pre-Existing Conditions
Legislature released a new draft of the Better Care Reconciliation Act (BCRA), which included an amendment that allows insurance companies to charge higher premiums based on medical conditions.
View Here

Idarucizumab is Safe and Effective
The safety and efficacy of Praxbind (Idarucizumab) as a reversal agent for dabigatran has been demonstrated by a recent study published in the New England Journal of Medicine.  
View Here 
View Study

Preeclampsia Rates on the Rise
High blood pressure and protein in the urine during pregnancy is both a threat to the mother and baby. Rates of preeclampsia continue to rise and exert an economic burden.
View Here

Meningitis Vaccine May Offer Protection Against Gonorrhea
New Zealand researchers find that a meningitis vaccine (MeNZB vaccine) prevented the STI gonorrhea in one third of patients receiving the vaccine.
View Here
View Study

Increasing Medication Mistakes in U.S.
A new study using U.S. National Poison Data System records found that medication errors have doubled since the year 2000. Since this study only included errors reported to poison control centers, this is an underestimation of true medication mistakes.
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Heat Strokes May Be Deadly in Older Adults
People aged 65 and older are especially susceptible to heat stroke. According to the Centers for Disease ControI, 40% of heat-related deaths occurred in people 65 and older between 1999 and 2003.
View Here
 
Drug Competition Action Plan Being Implemented by the FDA
In an effort to promote lower costs of medications to patients, the FDA published a list of drugs off patent and without generics. The FDA also put into place a plan to speed up the review of generic drug applications.
View Here

Death by Opioids
Experts estimate that within the next decade approximately half a million Americans could possibly die due to opioid overdoses.
View Here

Zika-Carrying Mosquitoes More Widespread in U.S.
The Centers for Disease Control Prevention collected mosquitoes from the south United States and reported that the prevalence of counties with Zika-containing mosquitos has risen by 21%. Insect repellents with the active ingredient DEET is the most effective way to prevent mosquito bites.
View Here

Antibiotics with Probiotics in Hospital Reduces Risk of C. Difficile
When giving antibiotics to hospitalized adult patients, the concurrent use of probiotics reduces the relative risk of Clostridium difficile infection by more than 50% as reported by one study.
View Here
View Study
 


Drug Approvals...


FDA Approves New Drug for Hepatitis C
The U.S. FDA approves Vosevi (sofosbuvir/ velpatasvir/ voxilaprevir) for the treatment of chronic hepatitis C virus genotypes 1-6  in adult patients without cirrhosis or with mild cirrhosis.
View Here

FDA Approves New Treatment to Reduce the Risk of Breast Cancer Return
The U.S. FDA approves Nerlynx (neratinib) for patients with early-stage, HER2-positive breast cancer. Nerlynx is indicated for the extended adjuvant treatment of adult patients who have been previously treated with a trastuzumab containing regimen.
View Here

FDA Approves New Drug for Psoriasis
The U.S. FDA approves the biologic Tremfya (guselkumab) to treat moderate to severe plaque psoriasis in adult patients.
View Here

FDA Approves New Treatment for Sickle Cell Disease
The U.S. FDA approves Endari (L-glutamine oral powder) for reduction of severe complications associated with sickle cell disease in patients aged five years and older.
View Here

FDA Approves New Treatment for Hair Loss During Chemotherapy
The U.S. FDA approves the expanded use of the DigniCap Cooling System to reduce hair loss during chemotherapy. The cooling cap is indicated for use in patients with solid tumors.
View Here  

FDA Approves New Drug for VTE Prophylaxis in Adults
The U.S. FDA approves Bevyxxa (betrixaban) for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.
View Here

FDA Approves New Drug for Hereditary Angioedema
The U.S. FDA approves Haegarda (human, C1 esterase inhibitor) to aid in the prevention of hereditary angioedema (HAE) attacks in adolescent and adult patients. With proper training, the subcutaneous administration of this new treatment allows for easy self-injection at home.
View Here

FDA Approves New Fluoroquinolone Antibiotic
The U.S. FDA approves  Baxdela (delafloxacin) to treat acute bacterial skin infections.
View Here

FDA Approves New Biologic for Hemophilia B
The U.S. FDA approves Rebinyn (recombinant, glycopegylated coagulation factor IX)  injection for on-demand treatment and control of bleeding episodes as well as perioperative management of bleeding in children and adults.
View Here

FDA Approves First Generic of Strattera for ADHD
The U.S. FDA approves the first generics of Strattera (atomoxetine) to treat attention deficit/hyperactivity disorder in adult and pediatric patients.Apotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited will be marketing these generics.
View Here

FDA Approves First Cancer Treatment for Solid Tumors with a Specific Genetic Marker
The U.S. FDA approves a new indication for Keytruda (pembrolizumab) to treat patients with unresectable or metastatic solid tumors containing the microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) biomarkers, regardless of tumor location origin.
View Here

FDA Approves First Drug for Giant Cell Arteritis
The U.S. FDA approves a new indication of the subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis.
View Here

FDA Approves New Drug for Rheumatoid Arthritis
The U.S. FDA approves Kevzara (sarilumab) injection to treat rheumatoid arthritis in patients with moderate to severe disease after failure of at least one other DMARD.
View Here 

FDA Expands Approved Use of Kalydeco for Additional Mutations of Cystic Fibrosis
The U.S. FDA approves the expanded use of Kalydeco (ivacaftor) to cover 33 gene mutations (previously 10) in the treatment of cystic fibrosis.
View Here

FDA Approves New Drug for ALS
The U.S. FDA approves Radicava (edaravone) intravenous infusion to treat amyotrophic lateral sclerosis (ALS).
View Here

FDA Approves New Agent for Locally Advanced or Metastatic Urothelial Carcinoma
The U.S. FDA approves Imfinzi (durvalumab) for the treatment of locally advanced or metastatic urothelial carcinoma. This medication is indicated for patients who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
View Here

FDA Approves New Drug for Postmenopausal Women with Osteoporosis
The U.S. FDA approves Tymlos (abaloparatide) to treat osteoporosis in postmenopausal women at high risk of fractures.
View Here
 
FDA Approves New Drug for ALK-Positive Non–Small Cell Lung Cancer
The U.S. FDA approves Alunbrig (brigatinib) to treat metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in patients who have progressed on or are intolerant to crizotinib.
View Here

FDA Approves New Drug for Acute Myeloid Leukemia
The U.S. FDA approves Rydapt (midostaurin) for adult patients newly diagnosed with acute myeloid leukemia and FLT3 genetic mutation. This drug is approved for use in combination with chemotherapy. Rydapt is a kinase inhibitor used to inhibit cell growth.
View Here
 
FDA Approves First Drug for a Form of Batten Disease
The U.S. FDA approves Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. Brineura slows the loss of ambulation in pediatric patients ages 3 years and up with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2) or tripeptidyl peptidase-1 (TPP1) deficiency.
View Here

FDA Approves Expanded Use of Stivarga for Liver Cancer
The U.S. FDA approves the expanded use of Stivarga (regorafinib) for patients previously treated with sorafenib in the treatment of hepatocellular carcinoma.
View Here

FDA Approves First Drug for Tardive Dyskinesia
The U.S. FDA approves Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia.
View Here
 


Guidelines...


New Guideline for Perioperative Management of Total Hip or Knee Arthroplasty
American College of Rheumatology and the American Association of Hip and Knee Surgeons releases a new guideline for the perioperative management of antirheumatic drug therapy for adults with rheumatoid arthritis (RA), spondyloarthritis (SpA) including ankylosing spondylitis and psoriatic arthritis, juvenile idiopathic arthritis (JIA), or systemic lupus erythematosus (SLE) undergoing elective total hip (THA) or total knee arthroplasty (TKA).
View Here
 
Updated Guideline for the Management of Valvular Heart Disease
The American College of Cardiology and American Heart Association releases an update to the 2014 guidelines for the management of valvular heart disease.
View Here
 
Primary Dysmenorrhea Consensus Guideline
The Society of Obstetricians and Gynecologists of Canada (SOGC) releases a revision and update of No. 169, December 2005 guidelines of Primary Dysmenorrhea.
View Here

Updated Guidelines on Managing Glucocorticoid-Induced Osteoporosis
The American College of Rheumatology releases updated guidance on managing glucocorticoid-induced osteoporosis in adults and children.
View Here
 
Updated Colorectal Cancer Screening Recommendations
The U.S. Multi-Society Task Force on Colorectal Cancer (MSTF) releases updated colorectal cancer screening recommendations.
View Here

ACP Releases New Guideline on the Management of Osteoporosis
The American College of Physicians releases an updated guideline that includes six key recommendations to help in the therapy selection for treatment of low bone density and osteoporosis to reduce the risk of fracture in older men and women.
View Here

Empyema Guidelines Released
The American Association for Thoracic Surgery releases new guidelines for managing empyema.
View Here
View Abstract

Urologic Groups Offer New Prostate Cancer Management Guideline
The American Urological Association, the American Society for Radiation Oncology, and the Society of Urologic Oncology releases new guidelines for managing localized prostate cancer.
View Here

Guideline Recommends Against Arthroscopy for Most Cases of Degenerative Knee Disease
An international expert panel releases a recommendation against the use of arthroscopy in nearly all patients with degenerative knee disease.
View Here

New Guidelines for Diagnosing Recent Zika Virus Infection in Pregnant Women
The Centers for Disease Control and Prevention releases new recommendations for testing asymptomatic pregnant women who live or travel in areas with reported Zika virus transmission.
View Here

Guidelines for the Prevention of Surgical-Site Infection (SSI)
Healthcare Infection Control Practices Advisory Committee (HICPAC) releases updated evidence-based recommendations for the prevention of SSI.
View Here

Updated ACCF/AHA Heart Failure Management Guideline
Heart Failure Society of America (HFSA) has partnered with the American College of Cardiology (ACC), and American Heart Association (AHA) to deliver updated guidelines on the management of heart failure.
View Here

New Guidelines on Sudden Unexpected Death in Epilepsy
The American Academy of Neurology and the American Epilepsy Society releases guidelines that help determine the incidence rates of SUDEP in diverse epilepsy populations.
View Abstract
View Here
 
CDC Updates Guidelines to Prevent Pandemic Influenza
The Centers for Disease Control and Prevention releases guidelines to replace the 2007 Interim Pre-pandemic Planning Guidance.
View Here
 
University of Louisiana at Monroe
School of Pharmacy

Drug Information Center

         318-342-5501
          druginfo@ulm.edu
          Online Drug Information Requests

The Louisiana Drug Information Center (DIC) is located on the first floor of the School of Pharmacy in the Bienville Building of the University of Louisiana at Monroe.
As a courtesy to healthcare professionals, we provide drug information services pertaining to the following areas:

Adverse Drug Events
Availability of Products
Complimentary and Alternative Medicine
Clinical Kinetics
Drug Dosage and Scheduling
Drug Identification
Drug Interactions
Drug Regulations/Laws
Drug Use Evaluation Support
Institutional Review Board Support
Investigational/Foreign Drugs
IV Compatibility
Laboratory Interpretation
Pharmacoeconomics
Pharmacy and Therapeutics Committee Support
Pregnancy and Lactation
Product Compounding
Therapeutic Drug Monitoring
Therapeutic Uses/Drugs of Choice
Toxicology
Travel/Health Information


The DIC provides information services to the healthcare professionals of the State of Louisiana. Additionally, this service is available to Medicaid providers through support from the Louisiana Medicaid Pharmacy Benefits Management Program.

Please contact us for assistance with your drug information needs by any of the following:
          Phone:  318-342-5501
          Email: druginfo@ulm.edu
          Online Drug Information Requests

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Thank you for reading the FYDI newsletter!

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University of Louisiana at Monroe School of Pharmacy
Drug Information Center
View previous issues of the FYDI newsletter.
Please send your comments and suggestions to 
druginfo@ulm.edu.

Disclaimer: No information source can replace clinical judgment applied to a specific case. Some of the drug therapy we write about will be outside the labeled indications for specific products. References will be provided when possible. Consult these references, product labeling, and/or give us a call if we can help with specific cases. This newsletter is supported by the University of Louisiana at Monroe School of Pharmacy and is not intended for commercial promotion.


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