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 May 2016 Issue of FYDI - For Your Drug Information
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Co-edited by:
Alexie Soileau and Walker Taylor, 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...


Drug Safety Communication: Fluconazole (Diflucan)
FDA is evaluating a study that suggests that oral fluconazole may cause increased risk of miscarriage.
View Here
 
Fresenius Kabi Recalls Sensorcaine-MPF (bupivacaine HCl)
A voluntary recall of a single lot (Lot Number 6111504; Product Code 470237) of Sensorcaine®-MPF (bupivacaine HCl) Injection was issued due to presence of particulate matter.
View Here
 
Medtronic Recalls Battery Pack Used in Patient Monitors
Medtronic issued a voluntary recall for the battery pack used in its Covidien Oridion labeled Capnostream 20 and Capnostream 20p Patient Monitors due to a defect that may increase the risk of thermal damage in the battery pack.
View Here
 
FDA Advises Against Use of Sterile Drug Products from Pharmakon Pharmaceuticals, Inc
Due to a lack of sterility assurance and other quality issues, the FDA is advising healthcare professionals not to use sterile drug products produced by Pharmakon Pharmaceuticals Inc., in Noblesville, Indiana.
View Here
 
MedWatch March 2016 Safety Labeling Changes
This post includes 35 products with safety labeling changes to the contraindications, warnings, precautions, and adverse reactions sections.
View Here
 
Hospiria Recalls 50% Magnesium Sulfate Injection
Due to presence of particulate matter, Hospira, Inc. is voluntarily recalling one lot of 50% Magnesium Sulfate Injection, USP, 10 g/20 mL (0.5 g/ml), 20 mL Single-dose vials, Lot 50-343-DK, Expiration 01FEB2017, NDC 0409-2168-02.
View Here
 
Class I Recall on Focus Diagnostics Laboratory Examination Kits
Focus Diagnostics is recalling Simplexa Herpes Simplex Virus 1 & 2 Direct and Simplexa Group A Strep Direct kits due to inaccurate test results.
View Here
 
Class I Recall on Continuous Glucose Monitoring Systems
Dexcom Inc. is recalling G4 Platinum and G5 Mobile continuous glucose monitoring system receivers due to failure of the audible alarm to activate when high or low glucose levels are detected.
View Here
 
Boston Scientific Issues Voluntary Recall for Fetch 2 Aspiration Catheter
This thrombectomy catheter, labeled as a Bayer product, is being recalled due to complaints of shaft breakage.
View Here
 
FDA Recalls Guardian II Hemostasis Valves by Vascular Solutions, Inc.
Two specific lots (8210 and 8211) of Guardian II Hemostasis Valves by Vascular Solutions, Inc. have been recalled, due to an increased risk of air leakage that may lead to an air embolism.
View Here
 
Revised Warnings for Metformin-Containing Drugs
FDA is requiring label changes to metformin-containing drugs to include specific dosing recommendations for the newly expanded use in patients with mild kidney impairment and some with moderate kidney impairment.
View Here
 
Invisiblu International LLC Recalls Dietary Supplement LGD-Xtreme
One lot of Continuum Labs LGD-Xtreme was found to contain an investigational drug, LGD-4033 Ligandrol, that is not approved for use.
View Here
 
FDA Safety Update: Heart Failure Warning Added to Saxagliptin and Alogliptin
Type 2 diabetes drugs that contain the dipeptidyl peptidase-4 inhibitors (DPP-IV) saxagliptin and alogliptin will come with a new warning cautioning about the potential risk for heart failure. 
View Here
 
Lack of Sterility Assurance for Drug Products by Medaus Pharmacy
The FDA has released an alert to health professionals advise against the use of drug products that are produced and distributed by Medaus Pharmacy due to lack of sterility.
View Here
 
B. Braun Medical Recalls 5% Dextrose Injection USP in PAB Container
Compromised integrity in one lot of the 5% Dextrose injection USP 100/150 mL container can lead to leakage of the solution and potential microbial growth.
View Here
 
FDA Warns Consumers About Risk of Lead Poisoning with Best Bentonite Clay by Best Bentonite
FDA has determined that the Best Bentonite product contains elevated lead levels and may have potential lead poisoning risk.
View Here
 
Mislabeling Recall on NOW Health Group Dietary Supplements
NOW Health Group has recalled six of its dietary supplements due to a printing error on the label. People with an allergy or severe sensitivity to soy risk serious or life-threatening allergic reaction upon consumption of these products.
View Here
 
Drug Safety Communication: New Safety Warnings Added to Prescription Opioid Medications
The FDA has released new safety warnings regarding safety issues with opioid pain medications including serotonin syndrome, adrenal insufficiency, and androgen deficiency.
View Here
 
Hospira Recalls Sodium Bicarbonate Injection due to Particulate Matter
Hospira has released a recall of their sodium bicarb injection stating administration of this product may form localized inflammation, allergic reaction, granuloma formation, microembolic effects, or delayed therapy.
View Here
 
Verathon Releases Class I Recall of GlideScope Titanium Single-use Video Laryngoscope due to Potential Video Feed Disruption
Verathon has released a class one recall of this device due to a video feed issue which may lead to delayed tracheal tube insertion, intubation failure, hypoxemia, end organ damage, or death.
View Here
 
FDA Statement: Potential Risk of Loose Safety Seals in Eye Drops
The FDA has received six adverse events reports associated with safety seals on eye drop bottles. The FDA has released a statement to warn the public about tamper evident seals or safety rings that are below the bottle cap may fall into the eye when using this product.
View Here


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News Items...


FDA Advisory Panel Splits on Second DMD Drug Exondys 51 (eteplirsen)
FDA advisory panel voted 8-5 that a new Duchenne muscular dystrophy (DMD) agent failed to meet the minimum standards for accelerated approval on April 25, 2016 due to a lack of “substantial evidence from adequate and well-controlled studies”.
View Here
 
Elevated Psychiatric Risk Not Observed with Varenicline and Bupropion
EAGLES study reports no significant increase in neuropsychiatric adverse events caused by varenicline or bupropion relative to nicotine patch or placebo.
View Here
 
Rotavirus Vaccine Reduces ER Visits for Acute Gastroenteritis
This study demonstrated that there was a 10.3% reduction in emergency department visits for acute gastroenteritis among children younger than 5 years who received the rotavirus vaccine.
View Here
 
Should Metformin Still Be First-Line Diabetes Therapy?
This meta-analysis supports current clinical guidelines with the use of metformin as first-line diabetic therapy over newer agents.
View Here
 
Teen BMI Tied to Increased Risk for Cardiovascular Death in Midlife
Higher body mass index (BMI) in late adolescence, even within normal range, is associated with increased cardiovascular mortality in midlife. 
View Here
 
The Overdose Antidote: Should Naloxone Be Introduced as a Standard of Care for Take-home Use?
Take-home naloxone programs reduce opioid overdose mortality and have a low rate of adverse events.
View Here
 
Smoking May Be Hazardous to Job Prospects
A one-year observational study compared the likelihood of unemployed smokers versus nonsmokers attaining reemployment to determine if smoking can cause or effect unemployment.
View Here
 
Surgery Beats Medical Treatment in Reducing Fracture Risk in Primary Hyperparathyroidism
Parathyroidectomy is associated with reduced fracture risk compared with observation in patients with primary hyperparathyroidism.
View Here
 
Alcohol Consumption Decreases Lactate Clearance in Acutely Injured Patients
In a large group of acutely injured patients, a dose-dependent decrease in lactate clearance was seen in those with elevated blood alcohol content (BAC); this relationship will cause a falsely elevated lactate reading or prolong lactate clearance and should be taken into account when evaluating patients with positive BAC.
View Here
 
FDA Proposes End to Powdered Gloves
FDA has announced a proposal to ban use of powdered gloves in the U.S. due to the powder’s potential to become aerosolized and contribute to complications such as airway allergic reactions, surgical adhesions, and wound inflammation.
View Here  
 
Case-Control Study shows PCV13 Vaccine to be Highly Effective in U.S. Children
The 13-valent pneumococcal conjugate vaccine demonstrated to be 86 percent effective against pneumococcal disease in children aged 2 to 59 months.
View Here
 
Abrupt Smoking Cessation Leads to Higher Quit Rates
A controlled trial suggested that when smokers quit immediately, as compared to tapering, abstinence from smoking lasted longer.
View Here
 
High HDL Levels May Cause Problems
Studies have reported that high levels of HDL cholesterol may not be such a good thing; it may be linked to increased risk for coronary heart disease.
View Here
 
Fluticasone Plus Salmeterol Compared with Fluticasone Alone in Asthma Patients
According to a randomized, double blind trial, patients taking fluticasone plus salmeterol had a lower number of serious asthma exacerbations than those taking fluticasone alone.
View Here
 
Consuming Allergenic Foods Earlier in Life May Lead to Lower Allergy Risk
Two different studies have suggested testing children for allergenic foods early in life to help develop tolerance of food allergy.
View Here

 

Drug Approvals...


FDA Approves First BCL-2 Targeting Drug
The FDA has approved AbbVie's B-cell lymphoma (BCL)-2 inhibitor venetoclax (Venclexta) for patients with previously treated chronic lymphocytic leukemia (CLL) associated with 17-p deletion.
View Here
 
FDA Approves 2nd Biosimilar Inflectra (infliximab-dyyb) for Multiple Indications.
The FDA has approved Inflectra (infliximab-dyyb) for Crohn’s disease, ulcerative colitis, and rheumatoid arthritis.
View Here
 
New HIV Drug Gets Approval
The FDA has approved a new treatment for HIV-1 infection, Descovy (emtriciabine 200 mg and tenofovir alafenamide 25 mg, F/TAF).
View Here
 
FDA Approves Defitelio (defibrotide sodium) for Rare Liver Condition
Recent approval by the FDA, Defitelio (defibrotide sodium) is a first-in-class treatment for a rare, life-threatening liver condition in patients who have received a stem cell transplant from blood or bone marrow.
View Here
 
New Severe Asthma Medication Approved
Reslizumab (Cinqair) has been approved by the FDA as a maintenance treatment for severe asthma in patients who are uncontrolled on other medications.
View Here
 
Taltz (ixekizumab) Approved for Psoriasis
The FDA has recently approved a new treatment option, Taltz (ixekizumab), for patients with moderate to severe plaque psoriasis.
View Here
 
Generic Nasonex Approved by FDA
Mometasone furoate monohydrate, generic for Nasonex nasal spray, has been approved for use by the FDA.
View Here
 
FDA Approves Inhalation Anthrax Treatment
Anthim (obiltoxaximab) injection has been approved by the FDA for treatment of inhalational anthrax to be used in combination with antibacterial drugs, or to prevent inhalation anthrax.
View Here
 
Xalkori (crizotinib) Gets Approved Indication for Non-Small Cell Lung Cancer
The FDA expands indication of Xalkori to treat non-small cell lung cancer in patients with a ROS-1 gene mutation.
View Here
 
FDA Approves Idelvion for Patients with Hemophilia B
The FDA approved the first Coagulation Factor IX Albumin Fusion Protein for use in children and adults with Hemophilia B.
View Here

 

Guidelines...


New Evidence-Based Guidelines for Diabetic Foot Management
A multidisciplinary panel released new evidence-based, clinical-practice guidelines on diabetic foot management.
View Here
 
Update on Candidiasis Guidelines
The Infectious Disease Society of America (IDSA) recently updated the 2009 clinical practice guideline for the management of candidiasis, a major cause of morbidity and mortality in the healthcare environment.
View Here
 
Caring for Head and Neck Cancer Patients
Guidelines have been released by the American Cancer Society to guide treatment of caring for patients that have survived from head and neck cancer.
View Here
 
Smallpox Vaccine Recommendations
The CDC has released new recommendations for the vaccinia virus smallpox vaccine for healthcare workers and laboratory workers at risk.
View Here
 
New Guidelines for Prescribing Opioids
The CDC has released new guidelines for opioid prescribing outside of cancer and palliative care treatment.
View Here
 
Carpal Tunnel Syndrome Guidelines
The American Academy of Orthopaedic Surgeons released guidelines to manage Carpal Tunnel Syndrome.
View Here
 

Zika Virus Resources...


NPR Special Series: Zika Virus
NPR has a special series on Zika Virus, which contains podcasts and article links discussing affected locations, symptoms, funding, and more.
View Here
 
Zika Virus Disease: A CDC Update 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 evaluating and testing infants with possible virus.
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
 
New Brain Disorder Identified in Zika-Infected Patients
The development of acute disseminated encephalomyelitis (ADEM) may be associated with the Zika Virus according to a small study done in Brazil.
View Here
 
White House Shifts Ebola Funds to Fight Zika
The Obama administration has redirected $589 million to fight the Zika outbreak, including shifting $510 million from Ebola funds.
View Here
 
**NEW** MAC-ELISA Diagnostic Tool for Zika Virus
The FDA approves 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
 
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
 
Zika Virus Infection Resource
UpToDate has opened Zika virus information freely to the public and will update as new information is released.
View Here
 
Guillain Barre’ Syndrome Linked to Zika Virus
Zika virus may be linked to Guillain Barre’ Syndrome (GBS); a case-control study suggested that Zika infection with GBS was more likely than a control without GBS.
View Here
 
Guidelines for Breastfeeding with Zika Virus
The World Health Organization published breastfeeding guidelines for women with Zika virus who have recently given birth.
View Here
 
Guidelines for Documenting and Controlling Guillain Barre’ in Zika Patients
The World Health Organization has 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
 
Guidelines for Prevention of Sexual Transmission of Zika Virus
The CDC has released temporary recommendations for preventing the spread of Zika virus through sexual contact for men who live or have traveled to areas where Zika virus is active.
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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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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