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 September 2016 Issue of FYDI - For Your Drug Information
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Co-edited by:
Ryan Byrd and Tiffany Mayer, 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 Issued for Roadrunner UniGlide Hydrophilic Wire Guides by Cook Medical
The recall is on all lot numbers of the wire guides that may contain glass particles in the coating. If contaminated lots are used, the effects could be life threatening.
View Here
 
Voluntary Recall on Hy-Optic, OptiVet, and Optimend
Kinetic Technologies and Kinetic Vet have announced a voluntary recall on the following eye drops due to deficiencies in sterility.
View Here
 
FDA Warns of Software Defect in Sciex Mass Spectrometer
The FDA has been informed by Sciex that their mass spectrometer devices can produce incorrect results under certain conditions due to a defect in their software.
View Here
 
Changes to Drug Safety Labeling Database
The Center for Drug Evaluation and Research’s Office of Communications has created a new database to increase the efficiency in which it provides changes needed for drug labeling.
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Vascu-Guard Peripheral Vascular Patch by Baxter International May Increase Bleeding and Hematoma Risk
Baxter International has alerted the FDA to a number of adverse events in which the Vascu-Guard patch was used, raising concerns that the patch is not working as intended in patients undergoing a carotid endarterectomy.
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FDA Requires Boxed Warning for Benzodiazepines, Opioid Pain and Cough Medicines
The FDA has issued a need for a boxed warning on the above medications due to an increased risk of serious injury and death when used together. 
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DHZC-2 Tablets Recalled by Ton Shen
The DHZC-2 tablet made by Tom Shen may contain higher than normal levels of lead. All lot numbers have been recalled and distribution has ceased until September 1st, 2016.
View Here
 
Recall on Lamotrigine 200 mg Orally Disintegrating Tablets
Impax Laboratories, Inc has announced a voluntary recall on one lot of lamotrigine 200mg orally disintegrating tablets due to a mislabeling on the blister packs.
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Low Infusion Rates from Programmable Syringe Pumps Deliver Inconsistent Flow
The FDA is reporting that pumps programmed to deliver less than 5 mL of fluid an hour are not delivering a constant flow, resulting in suboptimal therapy.
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Voluntary Recall of Eyesaline Eyewash by Honeywell
Honeywell is recalling one lot of an eyewash solution due to the risk of contamination by Klebsiella pneumoniae.
View Here
 
Voluntary Recall on Oxacillin by Sagent Pharmaceuticals, Inc.
A nationwide recall on one lot of Oxacillin is being implemented due to a complaint of iron oxide particulate matter existing in a vial.
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Voluntary Recall on Cetylev Effervescent Tablets by Arbor Pharmaceuticals
Three lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, are being recalled for inadequate seals on blister packs. This could lead to possible sub-therapeutic doses along with possible microbial exposure.
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Recall on System 83 Plus Automated Endoscope Reprocessors (AERs) by Custom Ultrasonics
The FDA has issued an urgent recall on System 83 Plus AERs due to the risk of infection and death caused by inadequate reprocessing of duodenoscopes by these devices.  An alternative method for reprocessing duodenoscopes should be adopted.
View Here
 
Addition to Sage Products National Recall of Comfort Shield Barrier Cream Cloths
Sage Products is adding the Lot # 55781 to the list of products under a voluntary recall.  This lot and the previous ones recalled on August 1st of 2016 may be contaminated with Burkholderia cepacia.
View Here
 
Recall Issued for PharmaTech Liquid Products
Several drug and dietary liquid products recalled due to contamination with Burkholderia cepacia. If consumed, could cause life-threatening infections.
View Here
 
Voluntary Recall on 0.25% Bupivacaine Hydrochloride
Particulate matter located in a single vial initiates recall on one lot of 0.25% bupivacaine hydrochloride.
View Here

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News Items...


FDA Allows for Marketing of New Clot Retrieval Devices
Two Trevo clot retrieval devices have received approval as an initial therapy for strokes related to blood clot when used in combination with a tissue plasminogen activator.
View Here
 
FDA Rules that OTC Antibacterial Soaps Should No Longer Be Marketed
The FDA has found that antibacterial soaps sold over the counter are not more effective or safer than plain soaps in preventing the spread of germs.
View Here
 
Guidance for Preventing Influenza in Pediatric Patients
The Committee on Infectious Diseases has issued a set of guiding principles for preventing influenza for the current flu season, 2016-2017.
View Here
 
Kratom Expected to be a Schedule 1
DEA has the intention to place the Kratom plant as a schedule 1 narcotic due to its opioid-like effect. 
View Here
 
Invasive Coronary Strategies Associated with Better Survival Rates After NSTEMI
A large study involving 247 hospitals has demonstrated that the relative mortality rates of patients who had suffered an NSTEMI decreased greatly after undergoing invasive coronary surgery compared to those only on medications.
View Here
 
Genetic Data on Antibiotic Resistant Salmonella Infection Released by CDC.
A whole genome sequence on Salmonella bacteria was released by the CDC in the National Antimicrobial Resistance Monitoring System (NARMS) annual report.
View Here
 
FDA Advises Testing for Zika Virus in Donated Blood
With Zika virus outbreaks occurring, the FDA is advising all donated blood and blood components to be tested for Zika Virus.
View Here
 
Low BMI Linked to a Reduced Risk for Eight More Types of Cancer
The International Agency for Research on Cancer has linked a high BMI to an increase in the risk for cancer of the stomach, liver, gall bladder, pancreatic, ovarian, thyroid, meningioma, and multiple myeloma.
View Here
 
CDC Asking HealthCare Providers to Think Sepsis
The CDC has found 80% of sepsis cases to have begun outside of the hospital and is asking healthcare providers to think of sepsis in patients with chronic disease states that require frequent medical treatments.
View Here
 
New Findings on Damages to the Brain by Zika Virus in Infants
A report published by the journal, Radiology, has found new evidence of brain abnormalities in infected Zika virus infants other than microcephaly.
View Here
 
Breast Density and Cancer Risk Can Guide Frequency of Mammograms
An increase in benefits was seen in annual screening of women with above average breast density and breast cancer risk than through normal biannual mammograms.
View Here
 
FDA Allows for Marketing of Computerize Cognitive Tests to Help Assess Cognitive Skills after Head Injury.
The FDA has allowed marketing for two new devices, ImPACT and ImPACT Pediatric, to help assess cognitive function skills after a head injury or concussion.
View Here
 
Omega-3 Injections Reduce Brain Damage in Mouse Model
Colombia University has demonstrated that a fat emulsion injected into neonatal mice that had been subject to hypoxic ischemic brain injury reduced the damage to their brain tissue.
View Here
 
Updates to Limiting Radiation Doses in Patients Receiving 3D Conformational Radiation Therapy
The American Society for Radiation Oncology has updated an article stressing the need to measure the upper limit of radiation used in 3D conformational radiation therapy, and they list the appropriate methods to do so.
View Here
 
FDA Approves Expanded Indication for Two Transcatheter Heart Valves.
The FDA has approved expanding the indications for Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at an intermediate risk for death or complications associated with open-heart surgery.
View Here
 
FDA Asks for More Data on AndexXa
The FDA has delayed the approval of andexanet alfa, and it is asking Portola Pharmaceuticals for more data on the efficacy and manufacturing of their reversal agent for factor Xa inhibitors.
 View Here
 
Genetically Modified Mosquitos Approved For Use
FDA has stated that using genetically modified mosquitos in Florida poses no significant environmental risk. However, there are still local and state hurdles to be overcome.
View Here

Drug Approvals...


Erelzi, a Biosimilar to Enbrel, Approved
The FDA has approved a biosimilar for Enbrel for multiple inflammatory diseases, like rheumatoid arthritis.
View Here
 
Tamiflu Generic Approved
Natco Pharma received FDA approval for oseltamivir phosphate the first generic for Tamiflu, a popular treatment for the flu (Influenza A and B). 
View Here

 

Guidelines...


Updated WHO Guidelines for STI Treatment
WHO has updated their guidelines involved in the treatment of gonorrhea, syphilis, and chlamydia in response to the development of antibiotic resistance.
View Here
 
Updated AHRQ Guidelines to Prevent Venous Thrombosis
AHRQ has released a new, updated set of guidelines for the prevention of venous thrombosis in the hospital setting.
View Here
 
Update to NICE Guidelines for Stable Angina Management
The NICE guidelines have been updated with new information in regards to the safety concerns of using ivabradine and nicorandil.
View Here
 
Preventing Obesity and Eating Disorders in Adolescents
The American Academy of Pediatrics has released a guidance on preventing teenage obesity and eating disorders.
View Here
 
Heavy Menstrual Bleeding Guidelines Updated
NICE guidelines has updated guidelines on heavy menstrual bleeding with new evidence on drug treatments for women with large fibroids.
View Here
 
Update to Guidelines for Evaluation and Management of Infants with Congenital Zika Virus Infection
The CDC has modified the interim guidelines for the care of infants with a possible Zika virus infection.
View Here
 
Ovarian Cancer Guidelines
The American Society of Clinical Oncology and the Society of Gynecologic Oncology have issued new guidelines on treating ovarian cancer.
View Here
 
New Guidelines for Infantile Wheezing
The American Thoracic Society has issued guidelines for evaluating infants with recurrent or persistent wheezing.
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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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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