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 March 2017 Issue of FYDI - For Your Drug Information
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Co-edited by:
Laney Ebersole and Mason Westmoreland, 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 current...
             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 Edex
Endo Pharmaceuticals Inc. is recalling one lot of Edex injection (alprostadil) 10mcg due to a defect in the crimp caps used in the manufacturing. This could potentially compromise the product’s sterility and lead to adverse events.
View Here
 
Recall of “Latex Free” Products
Advanced Pharma, Inc. (Avella Specialty Pharmacy in Houston) is voluntarily recalling all unexpired injectable products labeled “latex free” because these products may contain some forms of latex.
View Here
 
Voluntary Recall of XtraHRD Natural Male Enhancement Capsules
Organic Herbal Supply, Inc. is conducting a voluntary nationwide recall of all XtraHRD Natural Male Enhancement capsules. FDA analysis has found the product to contain Tadalafil.
View Here
 
Class I Recall - Comprehensive Reverse Shoulder
Zimmer Biomet is recalling the Comprehensive Reverse Shoulder due to higher rates of fractures than listed in their labeling.
View Here
 
Recall of Human Chorionic Gonadotropin
Synergy Rx Pharmacy is recalling all lots of Human Chorionic Gonadotropin (HCG) due to sterility issues.
View Here
 
Class I Recall - Alaris Syringe Pump Module
CareFusion is recalling Alaris Syringe Pump due to a faulty Air-In-Line (AIL) sensor causing a false alarm; which is stopping the infusion to the patient.
View Here
 
Recall of Ibuprofen Lysine Injection
Exela Pharma Sciences is voluntarily recalling one lot of Ibuprofen Lysine Injection due to the presence of particulate matter in some vials.
View Here
 
Recall of Well Balance Xanthium & Siler Combo Dietary Supplement
Kingsway Trading Inc. is recalling two batches of Well Balance Xanthium & Siler Combo Dietary Supplement due to the presence of Ephedra Herba; which is banned by the FDA.
View Here
 
Drug Safety Communication - Chlorhexidine Gluconate
The FDA is warning that there have been rare but serious allergic reactions reported with antiseptic products containing chlorhexidine gluconate.
View Here

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News Items...


Youth With Type 2 Diabetes at Higher Risk for Complications Than Type 1 Counterparts
Teens and young adults with type 2 diabetes develop kidney, nerve, and eye diseases more often than their peers with type 1 diabetes in the years shortly after diagnosis. The results are the latest findings of the SEARCH for Diabetes in Youth study.
View Here
 
Significant Rise in Colorectal Cancer in Young to Middle-aged Adults
Epidemiological study finds a steady increase in the incidence of colorectal cancer in adults since the early 1980s, with an annual increase of as much as 2.4% in the 20-29 year age group. Incidence among adults over 55 have declined in the same time period.
View Here
 
Experimental Gene Therapy for Aggressive Non-Hodgkin Lymphoma Shows Promise
Novel therapy involves removal and in vitro modification of patient T cells with specially engineered chimeric antigen receptors (CARs) before they are reintroduced to patient’s circulation. More than one-third of patients reported disease free at 6 months post-treatment.
View Here
 
New Cases of Avian Flu
There has been two recent cases of avian influenza A (H7N9) virus infections reported in China and one in Taiwan. These infections have been linked to the exposure of poultry; the WHO advises people traveling to these countries to be aware and avoid areas with poultry.
View Here
 
FDA Clears Test to Help Manage Antibiotic Treatment
The U.S. FDA cleared the expanded use of the Vidas Brahms PCT Assay. This test helps health care providers to determine if antibiotic treatment should be initiated or stopped in patients with lower respiratory tract infections and stopped in patients with sepsis.
View Here
 
Vaccine for Respiratory Syncytial Virus (RSV) Enters Phase I Clinical Trials
The National Institute of Allergy and Infectious Diseases (NIAID) has launched a Phase 1 clinical trial of an investigational vaccine against respiratory syncytial virus (RSV).
View Here
 
Clinical Trial: Liraglutide Versus Placebo in the Reduction of Type 2 Diabetes Mellitus
This study investigated prediabetic patients for a total of three years and showed there was a significant increase in weight loss and the time to onset of diabetes with liraglutide versus the placebo.
View Article Here
 
Risk of Autism Linked to Herpes Infection While Pregnant
Pregnant women who have the herpes infection are found to be twice as likely to give birth to a child that will be diagnosed with autism; the risk is not due to direct infection to the virus.
View Article Here
 
Estrogen Therapy Shows Efficacy in Reducing Periodontal Disease Among Postmenopausal Women
A study published by the North American Menopause Society found the rate of occurrence of severe periodontitis was 44% lower in a postmenopausal osteoporosis-treatment group receiving systemic estrogen (alone or with progestin) for a minimum of six months, versus control.
View Here
 
NIH Investigates Novel Vaccine Against Broad Range of Mosquito-borne Diseases
The National Institute of Allergy and Infectious Diseases (NIAID) has launched a Phase 1 clinical trial of an investigational vaccine intended to provide broad protection against a range of mosquito-transmitted diseases. The investigational vaccine, called AGS-v, is designed to trigger an immune response to mosquito saliva rather than to any specific virus or parasite carried by mosquitoes.
View Here
 
Testosterone Improves Bone Density, Increases Coronary Plaque in Older Men
Results from the Testosterone Trials (T Trials) suggests that one year of testosterone therapy in older men led to improved bone density and corrected anemia, but also increased volume of coronary artery plaque. Treatment had no effect on memory or other cognitive function.
View Here
 
The Risk of Overdose in Children May be Higher in Mothers Prescribed Opioids
A study has shown if mothers are prescribed opioids then their young children are at an increased risk for overdose. Healthcare providers and parents should take all measures to reduce this; such as smaller quantities prescribed, proper medication storage and proper disposal.
View Here
 
Secukinumab Demonstrated Improvement in TNF-Inhibitor Non-Responders
The study showed that secukinumab (Cosentyx) improves the signs and symptoms and reduces the disease activity in patients with rheumatoid arthritis who did not respond to TNF-inhibitors. Abatacept (Orencia) had higher number of improvements compared to secukinumab.
View Article Here
 
CDC Releases Morbidity and Mortality Report for this Seasons Influenza Activity
CDC released an update of the morbidity and mortality report regarding the influenza activity during October 2,2016 - February 4,2017.The influenza vaccine was found to be 48% effective in all age groups.
View Here
 
Clinical Trial: Baricitinib in Rheumatoid Arthritis
The study showed that baricitinib was associated with significant clinical improvements in patients who had an inadequate response to methotrexate compared to placebo and adalimumab.
View Article Here
 
Scientists May be Able to Predict One’s Risk of Developing COPD
The University of Leicester has conducted the world’s largest study looking at genetic codes which may more accurately “predict” one’s chances of developing COPD based on genes and smoking status.
View Here
 
Addition of Antiandrogen Therapy Following Prostatectomy Improves Outcomes
In a long-term follow up study, prostatectomy patients who had been treated with bicalutamide in addition to radiation showed significantly increased survival over patients receiving radiation therapy alone.
View Here
 
PCSK9 Inhibitor Shows Benefits in First Outcomes Trial
Amgen has announced that Repatha (evolocumab) has met both of its primary endpoints in the FOURIER trial, reinforcing its efficacy in LDL reduction among patients already on statin therapy.
View Here
 
Treatment with Bezlotoxumab Significantly Reduces Reinfection Rate with C. difficile
Data from the MODIFY trials suggest a significant improvement in sustained cure rates among patients receiving antibiotic treatment for primary or recurrent C. difficile infection. Addition of actoxumab, however, did not improve efficacy.
View Here

Drug Approvals...


FDA Approves New Drug for House Dust Mite Allergies
The U.S. FDA has approved Odactra, a once-daily sublingual tablet designed to reduce the frequency and severity of nasal and eye allergy symptoms due to dust mite allergies.
View Here
 
FDA Approves New Drug for Carcinoid Syndrome Diarrhea
The U.S. FDA has approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of carcinoid syndrome diarrhea in adults that SSA therapy alone was insufficient.
View Here
 
FDA Approves New Combination Drug for Type 2 Diabetes
The U.S. FDA has approved Qtern, a fixed-dose combination of dapagliflozin and saxagliptin, for the treatment of type-2 diabetes in adults who have inadequate control with dapagliflozin alone, or who are already treated with dapagliflozin and saxagliptin.
View Here
 
FDA Extends Approval of Spiriva Respimat to Children
The U.S. FDA has extended approval of Spiriva Respimat to include children 6 years and older, from the previous September 2015 approval of 12 years and older.
View Here
 
FDA Approves New Drug for Psoriasis
The U.S. FDA has approved Siliq (brodalumab) injection to treat adults with moderate-to-severe plaque psoriasis.
View Here
 
FDA Approves New Drug for Duchenne Muscular Dystrophy
The U.S. FDA has approved Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years and older with Duchenne muscular dystrophy (DMD).
View Here
 
FDA Approves New Drug for Hyperparathyroidism Secondary to CKD
The U.S. FDA has approved Parsabiv (etelcalcetide) to treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis
View Here
 

Guidelines...


Updated Guideline on the Diagnosis and Management of Diabetic Retinopathy
The American Diabetes Association has updated its guideline on diagnosing and managing diabetic retinopathy in Diabetes Care.
View Here
 
WHO Releases New Guideline on Hepatitis B and C Testing
The World Health Organization has issued its first guideline on Hepatitis B and C testing. Recommendations include the use of rapid diagnostic tests for hard-to-reach populations, and suggestions on logistical concerns for increased laboratory workload.
View Here
 
ACIP Releases New Adult Vaccine Schedule
Recommendations from the Advisory Committee on Immunization Practices (ACIP) include avoidance of live attenuated influenza vaccine due to low efficacy, and updated conditions for HepB, meningococcal, and HPV vaccines in select groups.
View Here
 
AACE/ACE Release New Guideline on Dyslipidemia and Atherosclerosis
Recommendations from the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) include the lowering of LDL goals in select groups, updated screening recommendations, and guidance on special issues for children, adolescents, and patients with diabetes.
View Here
 
Updated Guideline on the Management of Earwax
The American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) have released an updated guideline on the management of earwax impaction.
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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