Copy
 April 2018 Issue of FYDI - For Your Drug Information
View this email in your browser
Co-edited by:
Hannah Carpenter and Michael Tran, Pharm.D. Candidates
Gregory W. Smith, Pharm.D., Director, Drug Information Services
Greetings from the Drug Information Center at the University of Louisiana Monroe College of Pharmacy

We hope this newsletter service helps you stay well-informed. Please 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

National Drug Takeback Day is April 28, 2018

In this issue, read about...
             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...


Voluntary Recall of Euphoric Capsules and Bottles by Epic Products
Epic Products is issuing a voluntary recall on Euphoric capsules packaged in 1 count blister cards, 3 count bottles, and 12 count bottles after an FDA analysis found samples to be tainted with undeclared sildenafil and tadalafil.
View Here
 
FDA Recommends Firmware Update to Reduce Premature Battery Depletion
The FDA recently approved a firmware update to reduce the risk of potential patient harm from premature battery depletion as well as potential cybersecurity vulnerabilities to be fixed in the device.
View Here
 
Voluntary Recall of Injectable Drug Vials by Coastal Meds
Coastal Meds is issuing a voluntary recall on their sterile non-expired products due to visible particles.
View Here
 
Voluntary Recall of Rhino 69 Extreme 50000 Capsules by AMA Wholesale Inc
AMA Wholesale Inc. is issuing a voluntary recall due to undeclared tadalafil found in analysis. Consumers and distributors/retailers should immediately stop the consumption and the release of the product.
View Here
 
Voluntary Recall of Specific Sterile Injectable Products by Premier Pharmacy Labs
Premier Pharmacy Labs is issuing a voluntary recall due to microbial contamination detection during routine testing. Healthcare facilities with these products should discontinue use and return them to the company per recall notification.
View Here
 
Voluntary Recall of Maeng Da Red Kratom Bottles by Club 13
Club 13 is issuing a voluntary recall on Maeng Da Red Kratom Bottles due to possible contamination of Salmonella.
View Here
 
Mandatory Recall on All Triangle PharmaNatural Products
The FDA issues mandatory recall on all products by Triangle Pharmanaturals due to the risk of Salmonella.
View Here
 
Nutrizone Recalls Various Lots of Multiple Dietary Supplements
Nutrizone, LLC of Houston, Texas is recalling 4 different dietary supplements due to possible Salmonella contamination.
View Here
 
Voluntary Recall of Pasta De Lassar Andromaco Skin Protectant
MarcasUSA and Industria Farmaceutica Andromaco is voluntarily recalling four lots of Pasta De Lassar Skin Protectant 25% zinc oxide.
View Here 


News Items...


National Drug Takeback Day is April 28, 2018
The National Prescription Drug Take Back Day aims to provide a safe, convenient, and responsible means of disposing of prescription drugs, while also educating the general public about the potential for abuse of medications.  The following link can help find a collection site near you!
View Here
 
“Triple Therapy” Inhaler for COPD May Have Benefit
A study reported that triple therapy for COPD with an inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA), and a long-acting beta-2 agonists (LABA) resulted in a lower rate of moderate or severe COPD exacerbations.
View Here
 
Prediabetes Mellitus May Contribute to Increased Cardiovascular Events in Hypertensive Patients
A study reports a correlation for increased cardiovascular events in hypertensive patients with predisposed prediabetes when compared to a reference group with normal glucose and blood pressure.
View Here
 
Systematic Review of All-Cause Mortality in Patients on Type 2 Diabetes Therapy
A systematic review and meta-analysis compared the all-cause mortality in patients currently taking sodium-glucose cotransporter 2 (SGLT-2) inhibitors, glucagon-like peptide 1 (GLP-1) agonists, and dipeptidyl peptidase 4 (DPP-4) inhibitors.
View Here
 
US Preventive Service Task Forces Recommends Exercise Intervention to Prevent Falls
The US Preventive Service Task Forces recommends exercise in community-dwelling adults 65 years or older who are at risk of falls and recommends against vitamin D supplementation unless they present with osteoporosis or vitamin D deficiency.
View Here
 
Epstein-Barr Virus May Contribute to Autoimmune Diseases
A study reports that the Epstein-Barr Virus protein could potentially activate transcription factors associated with risk of lupus and other autoimmune diseases.
View Here
 
Infliximab Biosimilar Safe Option Alternative in IBD Patients in Remission
A prospective open-label phase 4 trial reports the biosimilar infliximab is a safe option for Irritable Bowel Disease (IBD) patients in remission.
View Here (Review)
View Here (Original Article)
 
Red Meats and Processed Food May Contribute to Non-Alcoholic Fatty Liver Disease and Insulin Resistance
A cross-sectional observational study reports an association of non-alcoholic fatty liver disease and insulin resistance with the consumption of high red meats and processed food.
View Here
 
FDA Takes Step to Protect Consumers Against Supplements Containing High Levels of Caffeine
New guidance from the FDA was issued clarifying that dietary supplements containing high levels of pure or highly concentrated caffeine is unlawful when sold in bulk quantities.
View Here
 
Zika Virus Detectable in Semen Up to Nine Months
A recent study reports the zika virus was detectable in the RNA of the semen as late as nine months after becoming symptomatic with the virus.
View Here (Original Article)
View Here (Supportive Article)
 
American Diabetes Association Updates Standard of Care in Diabetes
The ADA revised standards of care with two updates to include a glycemic target within a hospital setting to align with hypoglycemia definition in the Consensus Report and two newly FDA-approved drugs, Ozempic and Steglatro.
View Here
 
Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers
A new study reports further evidence that smoking cessation medications do not increase the risk of serious cardiovascular events.
View Here
 
FDA Restricts Sale and Distribution of Essure to Protect Women
The FDA issued an order to restrict the sale and distribution of the Essure device. Providers and facilities must provide information to patients about the risks and benefits of the device.
View Here
 
Odilorhabdins May Potentially Help Combat Resistant Bacteria
Researchers at the University of Illinois in Chicago have isolated a new class of antibiotics, odilorhabdins, which have been reported to disrupt resistant bacterias’ RNA integrity unexploited by current antibiotics.
View Here
 
Effects of Sacubitril/Valsartan on Physical and Social Activity Limitations
The heart failure drug marketed as Entresto leads to greater improvements in patients’ physical and social activities relative to enalapril according to a secondary analysis from the industry-supported PARADIGM-HF trial.
View Here
 
Effectiveness of PCT in Prevention of Relapse or Recurrence of Depression
According to a Lancet Psychiatry study, maintenance antidepressant treatment is not superior to Preventative Cognitive Therapy (PCT) following recovery, while adding PCT to antidepressant treatment following recovery is superior to antidepressants monotherapy. 
View Here
 
Dangerous Antibiotic-Resistant Bacteria Identified Across U.S.
The CDC identified 221 bacterial isolates with rare antibiotic-resistance genes during the first 9 months of 2017 with an effort to react quickly to new multidrug-resistant organisms.
View Here
 
Acid-Suppressive Drug and Antibiotic Use in Infancy Linked to Increased Allergy Risk
Children who received prescriptions for histamine-2 receptor antagonists or proton pump inhibitors in the first 6 months of life were at greater risk for all allergic diseases studied except seafood allergy during a median 4.6 years follow up.
View Here
 
AHRQ Review of Immunotherapy in Treatment of Asthma
The Agency for Research and Quality (AHRQ) has published a review to assess the efficacy and safety of immunotherapy for treating allergic asthma. The AHRQ suggests that subcutaneous immunotherapy reduces use of long-term control medications, and may also improve quality of life and FEV1.
View Here


Drug Approvals...


FDA Approves Fostamatinib for ITP
The FDA has approved fostamatinib (Tavalisse) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to previous therapy.
View Here
 
FDA Approves Crysvita First Therapy for Inherited Rickets
The FDA has approved Crysvita (burosumab) as the first breakthrough drug approved to treat a rare inherited form of rickets for adults and children ages 1 year and older.
View Here
 
FDA Approves Nivolumab-Ipilimumab Combination for Advanced Renal Cell Carcinoma
The FDA has approved the combination of nivolumab and ipilimumab for treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma supported by a randomized, open-label trial.
View Here
 
FDA Approves Everolimus for Tuberous Sclerosis with Partial-Onset Seizures
The FDA has approved everolimus (Afinitor) oral suspension for patients two years and older with tuberous sclerosis complex-associated partial-onset seizures supported by a randomized, double-blind trial, EXIST-3. 
View Here
 
FDA Approves Rucaparib for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
The FDA has approved rucaparib (Rubraca), a poly ADP-ribose polymerase (PARP) inhibitor for the maintenance treatment to recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy supported by ARIEL3, a randomized double-blind placebo control trial. 
View Here
 
FDA Approved the Use of Sargramostim for Acute Radiation Syndrome
The FDA has approved sargramostim (Leukine) to increase survival in adults and pediatric patients exposed to myelosuppressive doses of radiation.
View Here

FDA Expands Approval of Blincyto for Patients with ALL
The FDA has approved blinatumomab (Blincyto) as the first drug indicated for treating patients with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission while positive for minimal residual disease (MRD).
View Here
 
FDA Approves First Interoperable Continuous Glucose Monitoring System
The FDA has approved a streamlined and interoperable continuous glucose monitoring system (iCGM) for patients aged two and older who require constant monitoring of blood glucose.
View Here
 


Guidelines...


New Guideline in the Eradication Therapy for Patients with Barrett’s Esophagus
The American Society for Gastrointestinal Endoscopy released their recommendation and clinical guidelines in the use of endoscopic eradication therapy for Barrett’s esophagus associated with dysplasia and intramucosal cancer.
View Here
 
Diagnosis and Treatment of Osteoporosis Guideline Update
The Institute of Clinical Systems Improvement updated their guidelines for diagnosing and treating osteoporosis to include a strong recommendation for lifestyle modifications consultation.
View Here
 
NICE Smoking Cessation Guideline Update
The National Institute for Health and Care Excellence (NICE) has updated their smoking cessation guideline with recommendations to include brief advices, very brief advices, behavioral support, and pharmacological therapies while removing 2006 recommendations and amending 2008 recommendations.
View Here
 
Deprescribing Antipsychotics: New Algorithm
The Ontario Pharmacy Evidence Network (OPEN) published their clinical practice guideline in deprescribing antipsychotic medications in the elderly population in order to reduce adverse drug effects and improve quality of life.
View Here
 
Clinical Practice Guidelines Clostridium difficile Infections in Adults and Children: 2017 Update
The Infectious Diseases Society of America and Society for Healthcare Epidemiology of America have updated guidelines for treating Clostridium difficile infections. This guideline updates recommendations regarding epidemiology, diagnosis, treatment, infection prevention, and environmental management.
View Here (Abstract)
View Here (Full Text)
 
University of Louisiana Monroe
College 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 College of Pharmacy in the Bienville Building of the University of Louisiana 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

return to top


Thank you for reading the FYDI newsletter!

Visit us at...
University of Louisiana Monroe College 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 College of Pharmacy and is not intended for commercial promotion.


return to top







This email was sent to <<Email Address>>
why did I get this?    unsubscribe from this list    update subscription preferences
ULM Drug Information Center · 1800 Bienville Drive · Monroe, LA 71201 · USA

Email Marketing Powered by Mailchimp