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 October 2016 Issue of FYDI - For Your Drug Information
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Co-edited by:
Sydney Cary and Hang Luong, 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

 *NEW* Zika Virus Resources

See our list of  Drug Information Services

FDA MedWatch and Other Safety Alerts...


Class I Recall on Leonhard Lang Defibrillation Electrode Due to Connector Compatibility Issue
Leonhard Lang is recalling Skintact DF29N defibrillation electrode due to incompatible connection issue with Welch Allyn AED model 10. Users may not be able to connect the electrodes to the defibrillator, which could lead to a delay in delivering of shock to revive patients in cardiac arrest.
View Here
 
Safety Communication - Stӧckert 3T Heater-Cooler System by LivaNova Reports Mycobacterium Chimaera Infections
The use of Stӧckert 3T Heater-Cooler System are associated with Mycobacterium chimaera infections in patients who have undergone cardiothoracic surgeries in the U.S. Recommendations to minimize patient risk and exposure are provided here.
View Here

FDA Safety Communication- Battery Life May Fail Earlier Than Expected in Defibrillators Created by St. Jude Medical
Batteries in the implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) have run out within 24 hours of patients receiving Elective Replacement Indicator (ERI) alert. St. Jude Medical has initiated a recall and correction on affected devices.
View Here  
 
Recall of I.V. Flush Syringes Due to Potential Link to Burkholderia Cepacia Blood Stream Infections
Nurse Assist is recalling all unexpired lots of I.V. flush syringes distributed between 02/16/16 to 09/30/16 due to possible risk of Burkholderia Cepacia bloodstream infections.
View Here  
 
Recall of Twin-Pass Dual Access Catheters
Vascular Solutions is recalling all Twin-Pass Dual Access catheters with Model Numbers 5200, 5210, and 5230 due to remaining of excess manufacturing material at the tip of the catheter, or within the distal portion of the rapid exchange lumen. This excess material may separate from the catheter during use, which could possibly cause embolism.
View Here
 
Risk of Hepatitis B Reactivating from Direct-Acting Antivirals for Hepatitis C Treatment
The FDA is warning about the risk of HBV reactivation to patients who were treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus.
View Here  
 
Recall of 50 mm 0.2 Micron Filters by Baxter Due to Possibly Missing Filter Support Membrane
Baxter International Inc. is voluntarily recalling all 50mm 0.2 micron filters with the expiration date of 6/27/2016 - 6/27/2019 due to the potential of missing filter support membrane that could result in particulate matter in compounded solutions.
View Here  
 
Class I Recall on Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II 
DePuy Synthes is recalling Small Battery Drive I and II adaptors and light adaptors due to its potential risk of producing extreme internal pressure that may cause the device to explode.
View Here
 
Recall on Hyoscamine Sulfate by Virtus Pharmaceuticals
Virtus pharmaceuticals has issued a voluntary recall on seven batches of hyoscamine sulfate due to the possible subtherapeutic and supratherapeutic doses.
View Here
 
Nationwide Recall of Sterile Products Due to Concern of Lack of Sterility Assurance
Wells Pharmacy Network (WPN) is voluntarily recalling all human and veterinary sterile products that were prepared between February 22, 2016 to September 14, 2016.
View Here
 
Recall on GlucaGen Hypokit
Novo Nordisk, Inc. is recalling six batches of their glucagon injection kits due to claims that some of the kits may have detached needles on the syringes inside of the kits.
View Here
 
Recall on Family Care Eye Wash
United Exchange Corp is voluntarily recalling certain lots of Family Care Eye Wash 4 oz bottles due to possible microbial contamination.
View Here
 
FDA Does Not Recommend Use of Ovarian Cancer Screening Tests
The FDA does not endorse the use of ovarian cancer screening tests due to their lack of reliability in detecting early stage ovarian cancer.
View Here
 
Recall on Eye Wash/Eye Irrigating Solutions by Major Pharmaceuticals and Rugby Laboratories
United Exchange Corp, a primary source vendor, has issued a voluntary recall on Eye Irrigating Solution by Rugby and Eye Wash by Major due to possible microbial contamination.
View Here

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News Items...


Kratom Postponed to Become Schedule I
Drug Enforcement Administration has withdrawn its notice of intent to categorize kratom as a Schedule I medication.
View Here
 
Influenza Essentials for October 2016
There are three essential influenza studies to focus on for the month of October. New recommendations for influenza vaccine in children, vaccination opportunities in pediatric tertiary care, and maternal H1N1 vaccination not linked to birth defects.
View Here
 
FDA Approves New Dose for Zubsolv to Treat Opioid Dependence
Zubsolv is a buprenorphine formulation that is now available in a new low dose of 0.7mg/0.18mg. This new strength offers a 50% lower dose than any other buprenophrine/naloxone product in the US.
View Here
 
Study Suggests Fungus May Cause Crohn’s Disease
Recent studies show that fungus in the gut may be the key factor in developing Crohn’s disease. Researchers found that people with Crohn’s disease are more likely to have two types of bacteria, E.coli and Serratia marcescens, and one fungus, Candida Tropicalis, compared to those without the disease.
View Here
 
Does Gender Matter on Statin Adherence?
Recent findings show that women are less likely to adhere to statins compared to men. Potential reasons for this gender difference in use of statins can be linked to provider level, psychosocial, and medication intolerance factors.
View Here
 
FDA Approves Three New Indications for Ilaris
The FDA has approved Ilaris (canakinumab) for three new indications for adult and pediatric patients with rare and serious auto-inflammatory diseases such as tumor necrosis factor receptor associated periodic syndrome (TRAPS), Hyperimmunoglobulin D syndrome(HIDS)/ Mevalonate Kinase Deficiency(MKD), and Familial Mediterranean Fever (FMF).
View Here 
 
FDA Approves Inflatable Device for Treatment of Eustachian Tube Dysfunction
The FDA has approved the marketing of the Aera Eustachian Tube Balloon Dilation System in treating eustachian tube dysfunction.
View Here
 
New Zoster Recombinant Vaccine Shows Efficacy in Older Patients
GlaxoSmithKline has released a results of their trial involving their new recombinant herpes zoster vaccine (HZ/su) indicating that it works well in elderly patients 70 years of age or older.
View Here
 
Missing Link Found in Septic Shock
Scientists at VIB Nucleomics Core and Ghent University have found a new mechanism of blood-brain communication in peripheral inflammation through the release of extracellular vesicles by the choroid plexus epithelium.
View Here
 
CDC Findings on Zika Patient with No Known Risk Factors in Utah
The CDC has released their initial findings on a patient who may have contracted the disease through close contact to a patient with a high viral load.
View Here

VisuMax Femtosecond Laser Approved to Treat Nearsightedness
The FDA has approved the VisuMax Femtosecond Laser for small incision lenticule extraction (SMILE) to reduce or eliminate nearsightedness in certain patients 22 years or older.
View Here
 
FDA Panel Votes to Remove Black Box Warning on Chantix
An FDA panel has voted to remove the black box warning for the psychological effects caused by Chantix.
View Here
 
Possible New Target in Cancer Therapy, Kinase Suppressor of Ras
Researchers at Mt. Sinai School of Medicine have developed a small molecule that may be useful in preventing the Ras-mitogen activated protein kinase pathway by stabilizing the Kinase Suppressor of Ras.
View Here
 
Adalimumab Found Effective in Patients with Active Noninfectious Uveitis
Researchers from Duke University have released their trial data on using adalimumab in active noninfectious uveitis. Their results demonstrated that adalimumab was effective in patients with noninfectious uveitis, but they had more adverse effects than the placebo.
View Here
 
Vitamin D Supplementation May Reduce Asthma Attacks
A new Cochrane Review has found evidence that oral Vitamin D supplements, when taken daily, may help reduce the risks of severe asthma attacks.
View Here

Drug Approvals...


FDA Approves Automated Insulin Device
First automated insulin delivery device has been approved for type 1 diabetics. Medtronic’s MiniMed 670G hybrid closed looped system is programed to automatically monitor glucose and administer appropriate basal insulin dose.
View Here
 
Biosimilar to Humira Approved by FDA
Amjevita (adalimumab-atto) has been approved as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.
View Here  
 
Exondys 51 Approved for Duchenne Muscular Dystrophy
The FDA has granted accelerated approval for the first drug, Exondys 51(eteplirsen) injection, to treat patients with Duchenne muscular dystrophy.
View Here
 
FDA Approved Yosprala (A Combination of Aspirin and Omeprazole) for Secondary Cardiovascular Prevention
The FDA has approved Yosprala, a combination of aspirin and omeprazole for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events, and are also at risk of developing aspirin associated gastric ulcers.
View Here

 

Guidelines...


Guideline Update for Meningococcal B Vaccine
The two recent outbreaks of meningococcal disease on college campuses from springs 2013 and 2014 has driven the CDC to make new recommendations on marketed meningococcal vaccines.
View Here
 
Updated Guidelines to Postmastectomy Radiotherapy
The American Society of Clinical Oncology has updated their guidelines on treating a patient with radiation postmastectomy.
View Here
 
NICE Guidance for the Mental Health Problems Associated with Learning Disorders
NICE has released a set of guiding principles for preventing, assessing, and managing mental health issues in patients with learning disorders.
View Here
 
 
 

Zika Virus Resources...


Update of the Characterization of Zika Congenital Syndrome
After an international meeting, the PAHO/WHO has updated its characterization of Zika Congenital Syndrome.
View Here
 
Zika Virus Infection Resource
UpToDate has opened Zika virus information to the public and will continually update as new information is released.
View Here
 
Breastfeeding in the Context of Zika
The World Health Organization has published interim guidance on this matter.
View Here
 
WHO Zika Virus Pregnancy Management Guidance
The World Health Organization has provided interim guidance for pregnancy management in light of the Zika virus.
View Here
 
NPR Special Series: Zika Virus
NPR has a special series on the Zika virus, which contains podcasts and article links discussing affected locations, symptoms, funding, and more.
View Here
 
Zika Virus Disease Information for Pediatric Health Care Providers
The CDC has released updated guidelines for health care providers caring for infants and children with Zika virus disease, and recommendations for evaluating and testing potentially infected infants.
View Here
 
Interim Guidance for Protecting Workers from Occupational Exposure to Zika Virus
This interim guidance provides employers and workers with information and guidance on preventing occupational exposure to the Zika virus.
View Here
 
Interim Guidelines for Prevention of Sexual Transmission of Zika
The CDC has released recommendations for preventing the spread of Zika virus through sexual contact for men and their sexual partners who live or have traveled to areas where Zika virus is active.
View Here
 
MAC-ELISA Diagnostic Tool for Zika Virus
The FDA approved the CDC’s Emergency Use Authorization (EUA) for a Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) to diagnose Zika virus infection.
View Here
 
Guidelines for Documenting and Controlling Guillain Barre’ in Zika Patients
World Health Organization released guidelines for the management of Guillain Barre’, and mentions using the Brighton criteria to identify this syndrome in patients.
View Here
 
Guidelines for Decreasing Risk of Zika Transmission Through Blood
The FDA issued recommendations on preventing Zika virus transmission through donated blood in the United States.
View Here
 
Interim Guidelines for Providers Caring for Pregnant Women and Woman of Reproductive Age
The CDC released guidelines for providers caring for pregnant women and women of reproductive age who possibly could have been exposed to the Zika virus.
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!

Visit us at...
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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