April 2017 Issue of FYDI - For Your Drug Information
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Co-edited by:
Tiffany Gaspard and Erin Posey, 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
          Online Drug Information Requests

In this issue, read about current...
             FDA MedWatch and Other Safety Alerts
             News Items
             Drug Approvals
             New Guidelines

See our list of  Drug Information Services

FDA MedWatch and Other Safety Alerts...

Recall of StrataMR Adjustable Valves and Shunts by Medtronic
Medtronic calls for a voluntary recall of all unused units of StrataMR Adjustable Valves and Shunts. After implantation, the product may cause under-drainage of cerebrospinal fluid, which may cause serious side effects including death if left untreated.
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Recall of Sterile Compounded Products by Isomeric Pharmacy Solutions
Isomeric Pharmacy Solutions is recalling all lots of products due to a lack of sterility assurance. This was concluded after a recent inspection by the FDA though no adverse events have been reported as of yet.
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Field Corrective Action for Newport HT70 and HT70 Plus Ventilators by Medtronic
Newport HT70 and Newport HT70 Plus ventilators may spontaneously reset without warning during standard operation. The risk of reset will require close monitoring of the patient by a healthcare professional or caregiver and ready access to an alternate source of ventilation.
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Class 1 Recall - Prelude Short Sheath Introducer by Merit Medical Systems
Merit Medical Systems is recalling this product due to a mechanical defect that may cause the tip of the sheath to enter the bloodstream, possibly causing blood clots, perforation of arteries and veins, bleeding, or death.
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Voluntary Recall Issued for EpiPen and EpiPen Jr
Meridian Medical has voluntarily recalled 13 different lots of EpiPen and EpiPen Jr Auto Injectors due to the potential for defective devices.
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Recall Issued Due to Undeclared Ingredient
The U.S. FDA found LaBri’s Body Health Atomic by Envy Me to contain the undeclared ingredient sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons.
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Viberzi Warning for IBS-D Patients Without Gallbladder
The U.S. FDA has issued a warning for Viberzi (eluxadoline) regarding an increased risk of serious pancreatitis that may develop when the medication is used to treat irritable bowel syndrome with diarrhea (IBS-D) in patients without a gallbladder.
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Class I recall - SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps
Medtronic is recalling the SynchroMed Implantable Infusion Pumps due to a software problem that may cause unintended delivery of drugs to the patient’s spine during the priming bolus procedure, which may lead to potential serious adverse effects due to over or under dosing.
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FDA warning - Potential Contamination of SPS-1 Static Preservation Solution
Organ Recovery Systems is voluntarily removing two lots of SPS-1 Static Preservation Solution due to an odor discovered during an operation. Laboratory results from the SPS-1 confirmed contamination with Pantoea and Enterococcus (vancomycin-resistant) bacteria.
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Recall of Herbal and Dietary Supplements
Regeneca Worldwide, a division of VivaCeuticals, is recalling all of its herbal and dietary supplement products pursuant to a consent decree entered by the federal court for the central district of California. The recall includes, but is not limited to all lots of these products: RegeneSlim, RegenErect, RegeneArouse, RegeneBlend, RegeneBoost, RegeneBlast, and RegeneFit.
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Voluntary Recall of Dietary Supplement for Male Sexual Enhancement
A & H Focal Inc. is voluntarily recalling all lots from January 2014 to present that were marketed as dietary supplements for male sexual enhancement. The recall is due to these products containing undeclared drug ingredients, PDE-5 Inhibitors.
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News Items...

Study Suggests Diabetes May be More Deadly Than Previously Thought
A recent study suggests that diabetes may contribute to death more frequently than reported and could be the third leading cause of death in the U.S., as opposed to its current ranking at number seven.
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View Study
FDA Allows Marketing of 23andMe
23andMe is the first direct-to-consumer test that informs an individual of their genetic predisposition to 10 different conditions, including Parkinson's, Alzheimer’s, G6PD deficiency, etc.
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Vitamin D Deficiency May Be Associated with CVD Risk in Obese Children
Vitamin D Deficiency may have negative effects on some lipids markers. This may lead to an increase in cardiovascular disease (CVD) risk in overweight children and adolescents.
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Potential to Treat PTSD with Antibiotic
A specially designed trial led by British and Swiss researchers shows promise regarding the treatment of post-traumatic stress disorder (PTSD) with doxycycline.
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Flu Vaccines Save Children’s Lives According to CDC Study
The CDC studied influenza data from the 2010 flu season through the 2014 season and found that the flu vaccination reduced a child’s risk of influenza death by 51% in children with underlying health conditions and 65% in healthy children.
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View Study
Experimental Drug May Significantly Reduce Menopausal Hot Flashes
Researchers at Imperial College London found that women who have seven or more hot flashes a day may find a 73% reduction in the number and severity of hot flashes with a new experimental drug.
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Tdap Vaccination for Pregnant Women Significantly Reduces Risk for Infants
Infants born to Tdap vaccinated mothers saw a 91% reduction in the risk of contracting pertussis during their first two months of life, when babies cannot get their own pertussis vaccination.
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Zika Vaccine Enters Next Stage of Development
A randomized controlled trial, consisting of 2,400 uninfected adults and adolescents, will start in June to determine the effectiveness of the vaccine.
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View Study of Phase 1 Trial
Cancer Death Rates Continue to Decline
According to the latest Annual Report to the Nation on the Status of Cancer, death rates continued to decline (2010-2014) for majority of the most common types of cancers.
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Potential Breast Cancer Treatment with Diabetes Medication
A study published in the Journal of Experimental Medicine found that epalrestat inhibits cancer growth and metastasis in human basal-like triple negative breast cancer cells.
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UF Health Finds Connection Between Perforated Eardrums and Ear Drops
A study performed at University of Florida Health found a possible connection between common antibiotic ear drops and perforated ear drums.
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Heart Failure Drug Serelaxin Fails Trial
A prospective medication for heart failure, serelaxin, has reportedly failed the primary endpoint of reduced cardiovascular death over 180 days. The drug had previously been rejected in 2014.
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Data not released yet, but watch for it here.
Possible Link Between Septic Shock Death Rates and Drug Shortage
A study published in the Journal of American Medicine found a strong link between mortality rates among septic shock patients and the shortage of norepinephrine.
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Study Finds Pharmacist Involvement Reduces Readmissions
A study performed at USC found that pharmacists with an expanded role in patient care reduced high risk patient readmissions and reduced the cost of care.
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New Drug Combination Possible Answer to Treating Superbugs
Mcmaster University researchers found a new drug combination that shows promise as an effective treatment against resistant bacteria.
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Drug Approvals...

FDA Approves Two Drugs for Hepatitis C in Children
Sovaldi and Harvoni have been approved for children ages 12-17, which are the first Hepatitis C drugs to be approved for children. 
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FDA Approves New Drug for Multiple Sclerosis
The U.S. FDA approves Ocrevus (ocrelizumab) to treat the relapsing form and the primary progressive form of multiple sclerosis.
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FDA Approves New Drug for Eczema
The U.S. FDA approves Dupixent (dupilumab) injection to treat adults with moderate to severe atopic dermatitis. This drug is intended for those with eczema that is not controlled with topical agents.
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FDA Approves New Drug for Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancers
The U.S. FDA approves Zejula (niraparib) for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, whose tumors have completely or partially shrunk in response to platinum-based chemotherapy.
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FDA Approves New Drug for Rare Skin Cancer
The U.S. FDA approves Bavencio (avelumab) as the first treatment for Merkel Cell Carcinoma (MCC), a rare and aggressive form of skin cancer. 
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FDA Approves New Drug for Parkinson’s Disease
The U.S. FDA approves Xadago (safinamide) as an add-on treatment for patients with Parkinson’s disease who are taking levodopa/carbidopa and are experiencing treatment failure.
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FDA Approves New Drug for Nocturnal Polyuria
The U.S. FDA approves Noctiva, a nasal spray taken 30 minutes before bedtime to reduce the number of times a night a patient wakes up to urinate.
View Here


ACC - Guidelines for Nonvalvular AF, PAD Management
The American College of Cardiology has released new guidelines for anticoagulation of nonvalvular atrial fibrillation prior to undergoing a surgical procedure. The guidelines also discuss management of lower-extremity peripheral artery disease.
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AANEM - Consensus Statement for Vocal Cord Paralysis
The consensus statement provides recommendations from the American Association of Neuromuscular and Electrodiagnostic Medicine regarding when to utilize laryngeal electromyography in the diagnosis and treatment of vocal cord paralysis.
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Updated Guidelines for Heel Pain-Plantar Fasciitis
The American Physical Therapy Association, Inc., The Orthopaedic Section has revised their guidelines for the treatment of heel pain-plantar fasciitis.
View Here
CAP - New Reporting Guidelines for Hematologic Neoplasms
The College of American Pathologist Pathology and Laboratory Quality Center has released guidelines on the most appropriate way to complete bone marrow synoptic reporting for hematologic neoplasms.
View Here
IAPAC - Guidelines for Optimizing Continuum of Care of HIV Patients
The International Association of Providers of AIDS Care has released guidelines on how to eliminate discrimination and stereotyping of patients living with HIV/AIDS.
View Here
Systemic Review on Lipoprotein Biomarkers and Risk of Cardiovascular Disease
Laboratory Medicine Best Practices has released a review of evidence showing the connection between lipoprotein biomarkers and CV risk.
View Here
AHA - Updated Guidelines for Kawasaki Disease Management
The American Heart Association updated the guidelines for Kawasaki Disease diagnosis, treatment, and management after analyzing evidence-based data.
View Here
University of Louisiana at Monroe
School of Pharmacy

Drug Information Center


          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
Pharmacy and Therapeutics Committee Support
Pregnancy and Lactation
Product Compounding
Therapeutic Drug Monitoring
Therapeutic Uses/Drugs of Choice
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
          Online Drug Information Requests

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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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