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 February 2015 Issue of FYDI - For Your Drug Information
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Co-edited by:
Pharm.D. Candidates: Regan Lecombe & Chris Maxwell
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


Learn more about our Drug Information Services

FDA MedWatch and Other Safety Alerts...


One Lot of 0.9% Sodium Chloride Injection Recalled by Hospira
Hospira has recalled one lot of 250 ml 0.9% Sodium Chloride Injection, USP, due to particulate matter being found in one of the units.
View Here

FDA Warns- Do Not Inject Patients With IV Solutions From Wallcur of San Diego
The FDA has become aware that simulated IV products (i.e. Practi IV Solution Bags) intended for training purpose only have been administered to patients at health care facilities, resulting in serious adverse events.
View Here
 
Virazole Powder For Solution Voluntarily Recalled Due to Microbial Contamination
Valeant Pharmaceuticals North America recalled one lot of Virazole (ribavirin powder for solution), 100 ml, 6g vial, 4-pack due to microbial contamination.
View Here
 
Mitoxantrone Voluntarily Recalled by Hospira
Hospira voluntarily recalled 10 lots of human and veterinary Mitoxantrone due to subpotency and impurity levels.
View Here
 
New Warning Added to Geodon (Ziprasidone) Drug Label
An FDA review of patients associated Geodon use with a rare but serious condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
View Here

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News Items...


Researchers Create Insulin-Producing Cells
Researchers at the University of Iowa have created insulin-producing cells that responded to glucose and corrected blood-sugar levels when transplanted into diabetic mice.
View Here
 
Compound Found in Beer Could Benefit Patients with Neurodegenerative Disorders
Researchers have discovered that xanthohumol, a compound found in hops, could protect neuronal cells and potentially help slow the development of neurodegenerative disorders such as Alzheimer’s and Parkinson’s disease.
View Here
 
First Mobile Medical App System for Continuous Glucose Monitoring Approved by FDA
The FDA has approved the use of mobile medical apps for the monitoring and sharing of glucose levels taken from a continuous glucose monitor.
View Here
 
Study Suggests Glyburide is Inferior Choice for Gestational Diabetes Treatment
Glyburide has been found through meta-analysis of fifteen randomized studies to be less efficacious at treating gestational diabetes as compared to metformin and insulin, and its use in this population is discouraged.
View Here
View Article
 
New Ebola Vaccine Sent to Africa for Clinical Trial
GlaxoSmithKline has sent an Ebola vaccine and a placebo to Liberia to begin the first large-scale trial testing its efficacy against the virus due to begin at the end of January.
View Here
 
Drug Candidate Shows Promise in Treatment of Acute Radiation Syndrome
A recent study showed a significant increase in the survival of mice exposed to radiation when treated with a compound called DBIBB.
View Here
 
CDC Determines This Year’s Flu Vaccine to be 23% Effective
The 2014-2015 influenza vaccine was found to be 23% effective at preventing flu virus infection in an analysis conducted by the CDC.
View Here
View Report
 
New Insulin Pump Approved by FDA
The FDA has approved Tandem Diabetes t:flex insulin pump, a new insulin pump which contains a larger-capacity reservoir which holds up to 480 units of insulin.
View Here
 
Breast and Pancreatic Cancer Drug Could Be Effective in Bile Duct Cancers
A new study demonstrates nab-paclitaxel could be highly effective against currently treatment limited bile duct cancers.
View Here
 
Six Week Drug Trial Achieves High Hepatitis C Cure Rate
A recent drug trial utilizing a combination of three direct-acting oral drugs for six weeks demonstrated no detectable HCV level in 38 of 40 patients when tested 12 weeks after completion of therapy.
View Here
 
Scientists Could Be Closing In On Universal Flu Vaccine
A possible universal flu vaccine developed by scientists at Mount Sinai Health System set to enter clinical trials later this year.
View Here
 
Study Suggests Depo-Provera May be Linked With a Higher Risk of Contracting HIV
A study at the University of California, Berkeley suggests Depo-Provera is linked with an increased risk of contracting HIV compared to other, non-hormonal forms of birth control.
View Here
 
Experimental Drug Effective in Reversing Effects of Xarelto
In a late-stage study, an experimental drug (andexanet alfa) was able to immediately reverse the anticoagulation effects of Xarelto.
View Here
 
New Antibiotic Discovered
Northeastern University researchers discover a new antibiotic, teixobactin, which eliminates pathogens without encountering any resistance.
View Here
 
E-Cigarette Policy Statement Issued by Cancer Organizations
The American Association for Cancer Research and the American Society of Clinical Oncology has released a policy statement on electronic nicotine delivery systems.
View Policy
 
FDA Transitioning to Full-Scale Sentinel System
Five years after the launch of the Mini-Sentinel program, the FDA is transitioning to the full Sentinel System, a program that will allow the FDA to more actively gather safety information on drugs.
View Here
View Sentinel Initiative Website
 
FDA Finalizes Changes to Pregnancy and Lactation Labeling
The ruling replaces the product letter categories with labeling subsections that provide details on the use of the product and goes into effect on June 30th.
View Here
 
Antibiotic Alternative Shows Early Effectiveness Against MRSA
Staphefekt, a drug that combines two bits of a viral enzyme called endolysin, has shown early success in a small-scale trial of patients with methicillin-resistant Staphylococcus aureus (MRSA) infections.
View Here
 

Drug Approvals...


New Drug Approved for Breast Cancer Treatment in Postmenopausal Women
The FDA has approved Ibrance (palbociclib) to treat advanced breast cancer in postmenopausal women.
View Here
 
FDA Approves New Combo Drug for Type 2 Diabetes
The first pill combining an SGLT2 inhibitor (empagliflozin) and a DPP-4 inhibitor (linagliptin) has been approved by the FDA and will be marketed under the name, Glyxambi.
View Here
 
FDA Approves New Indication for Vyvanse
An additional indication for binge-eating disorder (BED) has been added to the list of approved uses for Vyvanse by the FDA.
View Here
 
Waldenstrom’s Macroglobulinemia Gets First FDA Approved Treatment
Imbruvica (ibrutinib) received a new FDA indication for the treatment of patients with Waldenstrom’s macroglobulinemia, a rare form of non-Hodgkin lymphoma.
View Here
 
First Generic Esomeprazole Approved by FDA
The FDA has approved the first generic version of Nexium, esomeprazole magnesium delayed-release capsules, in 20 and 40 milligram dosage strengths for use in the U.S.
View Here
 
Natpara Hormonal Injection Approved by FDA
The FDA has approved Natpara for the treatment of patients with hypoparathyroidism who suffer from hypocalcemia.
View Here
 
FDA Approves Cosentyx
Cosentyx has been approved for the treatment of patients with moderate-to-severe plaque psoriasis by the FDA.
View Here
 
Anti-clotting Drug Savaysa Approved by FDA
Savaysa (edoxaban) has been approved for treatment of systemic embolism in atrial fibrillation patients, as well as for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who are being treated with parenteral anti-clotting drugs for 5 to 10 days.
View Here
 
Saxenda Approved for Weight Management by FDA
Saxenda (liragultide injection), a GLP-1 receptor agonist, has been approved by the FDA for use in chronic weight management in overweight or obese adults.
View Here
 
Rapivab Approved by FDA for Flu Infection
The FDA has approved Rapivab (peramivir), a neuraminidase inhibitor, for treatment of influenza infection as a single IV dose.
View Here
 
Opdivo Gains FDA Approval for Melanoma
Opdivo, (nivolumab), a PD-1 protein inhibitor, has been approved for the treatment of melanoma that is unresectable or metastatic and is resistant to other drugs.
View Here
 
Antibacterial Drug Zerbaxa Approved by FDA
The FDA has approved new combination antibacterial drug, Zerbaxa (ceftolazone/tazobactam), for the treatment of complicated intra-abdominal and urinary tract infections in adults.  
View Here
 
Viekira Pak Approved for Hepatitis C Treatment
The FDA has approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) for the treatment of hepatitis C genotype 1.
View Here
 
Lynparza Approved for Advanced Ovarian Cancer Treatment
Lynparza (olaparib), ovarian cancer treatment drug for use in women with defective BRCA genes, has been approved by the FDA.
View Here
 
Xtoro Approved For Swimmer’s Ear
Xtoro (finafloxacin otic suspension) has been approved by the FDA to treat acute otitis externa.
View Here

Cyramza Approved for New Indication
The FDA has approved Cyramza for the treatment of metastatic non-small cell lung cancer (NSCLC).
View Here
 
Gardasil 9 Approved by FDA
The FDA has approved Gardasil 9 for the prevention of nine different types of Human Papillomavirus (HPV), adding type 31, 33, 45, 52 and 58 to the original Gardasil’s type 6, 11, 16 and 18 coverage.
View Here
 

Guidelines...


Adult Immunization Schedule for 2015 Released
A new 2015 adult immunization schedule has been released by the CDC’s Advisory Committee on Immunization Practices (ACIP).
View Guideline
 
Guideline Released for Allergic Rhinitis Treatment
The American Academy of Otolaryngology- Head and Neck Surgery Foundation has released guidelines addressing the treatment of allergic rhinitis in patients age 2 and older.
View Guideline
 
Updated Diabetes Guidelines Released by ADA
The American Diabetes Association (ADA) has released an updated version of diabetes diagnosis and management guidelines.
View Guideline
 
Guidelines Released for Management of Obesity Through Pharmacological Intervention
The Endocrine Society has released guidelines mapping out the management of obesity through proper use of pharmacologic therapies.
View Guideline
 
New Recommendations for HIV Prevention
Updated recommendations consolidate existing recommendations as well as address areas that were absent from the last update.
View Guideline
 
Paget Disease Management Guidelines Released
New Paget Disease guidelines have been published by the Endocrine Society regarding the management and treatment of the disease.
View Guideline
 
New IBS Drug Treatment Guideline Released
The American Gastroenterological Association has released new guidelines regarding the pharmacological management of irritable bowel syndrome (IBS).
View Guideline
 
Guidelines for Cutaneous Wart Management Released
The British Association of Dermatologists has released guidelines for cutaneous wart management.
View Guideline
 
Opioid Overdose Management Guidelines Released
New guidelines regarding the management of opioid overdose in the community setting have been released by the World Health Organization.
View Guideline
 
Non-ST Segment Elevation Acute Coronary Syndrome Treatment Guideline Update Released
The American Heart Association and American College of Cardiology have released updated guidelines addressing the management and treatment of acute coronary syndrome without ST segment elevation.
View Guideline
 
New Pediatric Bronchiolitis Guidelines Released
The American Academy of Pediatrics has released new guidelines for the treatment of bronchiolitis in children 1 to 23 months of age.
View Guideline
 
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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