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 August 2016 Issue of FYDI - For Your Drug Information
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Co-edited by:
Lauren Blackwell and Brian Miller, 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...


Amikacin Sulfate Injection Recall
Teva is voluntarily recalling seven lots of Amikacin Sulfate Injection due to particulate matter.
View Here
 
FDA Revises Fluoroquinolone Boxed Warnings Due to Disabling Side Effects
Serious adverse effects have caused the FDA to make changes to the warnings of fluoroquinolone systemic agents.
View Here.
 
Talon Compounding Pharmacy Recall
Talon Compounding Pharmacy has recalled lots of HCG and sermorelin due to sterility concerns.
View Here
 
Liquid Docusate Sodium Recall
PharmaTech LLC is recalling lots of Diocto Liquid due to contamination with Burkholderia cepacia.
View Here
 
Dream Body Weight Loss Recall
Several Dream Body weight loss products are being recalled at the consumer level for containing sibutramine.
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HeartWare Ventricular Assist Device (HVAD) Batteries Recall
HeartWare Inc. is recalling batteries because they may lose power prematurely due to faulty cells.
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Kidney Injury Warnings for Canagliflozin and Dapagliflozin
The FDA has strengthened warnings about the risk of kidney injury for these type 2 diabetes medications.
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Zecuity Migraine Patch and the Risk of Burns or Scars
Health care professionals should discontinue prescribing Zecuity, and patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine.
View Here
 
Various Products by Nature Made Recall
Pharmavite is recalling specific lots of Nature Made products due to possible contamination.
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Step 2 60 Gold by The Body Shot Bar Recall
The Body Shot Bar is voluntarily recalling lots of Step 2 60 gold capsules due to the fact that they have tested positive for sibutramine.
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High Doses of Loperamide and Heart Problems
The FDA is warning that taking higher than recommended doses of loperamide can cause serious heart problems that can potentially lead to death.
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Risk of Bleeding with OTC Antacid Products Containing Aspirin  
The FDA is warning consumers about the risk of bleeding when using over-the-cournter aspirin-containing antacid products.
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News Items...


The CDC has Issued Guidance on Travel to a Miami Neighborhood
A Miami neighborhood has been identified as having the Zika virus spread by mosquitos. Thus, the CDC has issued guidance on travel to that area for women that are pregnant or who are considering becoming pregnant and their partners.
View Here
 
The CDC Awards Millions to Help Battle Zika
The CDC will begin awarding a total of nearly $60 million to states and territories to help fight the Zika virus.
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Metastatic Prostate Cancer on the Rise in the U.S
According to a recent study, starting in 2007 metastatic prostate cancer has been on the rise.
View Here
 
Florida Investigating Possible Mosquito to Human Case of Zika
Officials are investigating a Zika case in Miami-Dade County.
View Here
 
Female-to-Male Zika Transmission Reported
The first case of female-to-male sexual transmission of Zika was reported in New York City after a female contracted the virus and spread it to her partner.
View Here
 
Gonorrhea Growing Resistant
According to the CDC, Neisseria gonorrhoeae seems to be growing more resistant to antibiotics such as, azithromycin and ceftriaxone.
View Here
 
AHA Provides List of Drugs that Could Lead to Heart Failure
The American Heart Association has set forth a list of drugs that may cause or exacerbate heart failure so that providers can improve quality of care.
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Repatha Approved for Single Monthly Injection for Lowering Cholesterol
A device that can deliver a single monthly injection of the PCSK9 drug evolocumab, instead of the three consecutive injections, has now been approved by the FDA.
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HPV Associated Cancers Increased from 2008-2012
Human Papillomavirus (HPV) associated cancers increased from 10.8 per 100,000 persons during 2004–2008 to 11.7 per 100,000 persons during 2008–2012.
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FDA Approves Differin for OTC Treatment of Acne
Differin has been approved for over-the-counter use making it the first retinoid to be available as such.
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Abnormal Pap Tests Reduced with HPV Vaccination
According to Canadian researchers, young women who do not get the recommended three doses of human papillomavirus (HPV) vaccine have more abnormal Pap tests than women who receive the three doses.
View Here
 
ACIP Recommends Against the LAIV (Nasal Spray) Flu Vaccine
The ACIP has voted that the LAIV or “nasal spray” flu vaccine should not be used in the 2016-2017 flu season based on its low level of effectiveness from 2013-2016. This recommendation must still be reviewed and approved by the CDC to become policy.
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AspireAssist Device Approved for Obese Patients
The FDA approved a new treatment device for obese patients that drains a portion of the stomach contents after meals and decreases calorie absorption.
View Here

Drug Approvals...


New GLP-1 Medication Approved for Type 2 Diabetes
The FDA approved Adlyxin, lixisenatide, to help control blood sugar levels in patients with type 2 diabetes.
View Here
 
FDA Approves First Medication in a New Class of Drugs For Dry Eyes
Xiidra (lifitegrast ophthalmic solution), is the first lymphocyte function-associated antigen 1 (LFA-1), approved for dry eye disease.
View Here
 
FDA Approves First Absorbable Stent to Treat Coronary Artery Disease
Absorb GT1 BVS releases the drug everolimus and is gradually absorbed by the body in approximately three years to limit the growth of scar tissue.
View Here
 
FDA Approves Epclusa for Chronic HCV
Epclusa is a combination product of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, a hepatitis C virus NS5A inhibitor approved for specific HCV genotypes.
View Here
 
FDA Approves Vaccine for Cholera
The FDA has approved Vaxchora for the prevention of cholera for those traveling.
View Here
 

Guidelines...


Management of Acute Diarrheal Infection in Adults
An evidence-based approach to diagnosis, prevention, and treatment of acute diarrhea infection in both US-based and travel settings.
View Here
 
Hospital-Acquired and Ventilator-Associated Pneumonia Guidelines
The Infectious Disease Society of America and the American Thoracic Society released 2016 clinical practice guidelines for HAP and VAP for healthcare providers based on systemic literature reviews.
View Here
 
Antibiotic Stewardship Playbook
In an effort to enhance antibiotic stewardship initiatives, this playbook was developed by the CDC, in collaboration with the National Quality Forum, Hospital Corporation of America and many professional societies.
View Here
 
CDC Guidelines for Chronic Pain
Provides guidance for primary care providers who are prescribing opioids for non-cancer related pain.
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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