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 July 2014 Issue of FYDI - For Your Drug Information
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Co-edited by:
Ricky Jackson & Mary Ann Vu, PharmD Candidates
Gregory W. Smith, PharmD, 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

FDA MedWatch and Other Safety Alerts...


Baxter Recalls Four Lots of IV Solutions
Four Baxter intravenous (IV) solutions, including 0.9% sodium chloride 100 mL (Quad Pack), 0.9% sodium chloride 100 mL MINI-BAG Plus, 0.9% sodium chloride, 50 mL (Single Pack), and highly concentrated potassium chloride injection, 20 mEq/50 mL, VIAFLEX Plus Container have been voluntarily recalled due to the presence of particulate matter.
View Here
 
Products by Downing Labs LLC May Be Unsterile
19 failed sterility tests and 3 endotoxin failures have led the FDA to advise health care professionals and consumers not to use sterile products by Downing Labs LLC.
View Here

More than 40,000 Bottles of Venlafaxine Recalled by Sun Pharma
The voluntary recall of venlafaxine hydrochloride by Sun Pharma a the formulation failed to meet dissolution standards, resulting in a Class II recall.
View Here
 
Hospira Recalls 1000 ML, Flexible Containers of Lactated Ringer’s and 5% Dextrose Injection
The voluntary recall by Hospira of their Lactated Ringer’s and 5% Dextrose Injection in 1000 mL flexible containers is the result of a filamentous-structured particulate being found.
View Here
 
Products Produced by Unique Pharmaceuticals Ltd Possibly Not Sterile
All drugs marked as sterile by Unique Pharmaceuticals Ltd are not to be used due to possible contamination.
View Here
 
Undeclared Drug Ingredients in Some Weight Loss Products
Products including the following: Mix Fruit Slimming, Lingzhi Cleansed Slim Tea, 24 Ince, Lipo 8 Burn Slim Capsules, Sliming (sic) Diet By Pretty White, and Trim-Fast Slimming Softgel have caused the FDA to recommend to consumers not to purchase or consume them, as these products contain sibutramine and Mix Fruit Slimming contains phenolphthalein.
View Here
 
Vascular Solutions Issues Class I Recall of Langston V2 Dual Lumen Catheters
Although no patient injuries have been documented, the potential for the inner catheter of some Langston V2 Dual Lumen Catheters to come apart from the hub has led to a Class I recall of the product.
View Here
 
Faulty Tubing Leads to Medtronic Duet External Drainage and Monitoring System Recall
A Class I recall of Medtronic Duet External Drainage and Monitoring has been issued because patient line tubing may detach from the line connectors, leading to pneumocephalus, infection, or improper drainage of the CSF.
View Here
 
Marcaine Vials Recalled by Hospira
30-mL vials of 0.5% Marcaine have been recalled due to particulates found in the drug solution and embedded in the glass vial.
View Here
 
Bristol-Myers Squibb Recalls Coumadin (warfarin sodium) for Injection
Six lots of Coumadin for Injection, 5 mg single-use vials have been recalled due to the presence of visible particulate matter.
View Here
 
Products with “Sunshine Labs” Label Not FDA Approved
Medical Supply Liquidators has issued a recall on all products labeled as Sunshine Labs.
View Here
 
FDA: Risk for Venous Thromboembolism with All Testosterone Products
Current labeling address risk for clots associated with polycythemia, but the FDA is mandating an expanded label for all approved testosterone products to include risk of blood clots unrelated to polycythemia.
View Here
 
Lidocaine Viscous Should Not be Used for Teething Pain
Several case reports have shown serious adverse effects in infants and young children, including death, associated with the unapproved use of lidocaine viscous for teething pain.
View Here
 
FDA Warns About Serious Reactions to OTC Acne Products
Several different products, such as Proactiv, Neutrogena, and Oxy have been associated with severe hypersensitivity reactions, warns the FDA.
View Here
 
FDA Recalls Another Batch of Generic Metoprolol
A failed dissolution test has led to the voluntary recall of over 13,000 bottles of metoprolol succinate by Dr Reddy’s Laboratories.
View Here
 
Olmesartan Cardiovascular Risks in Diabetics Inconclusive
No conclusive evidence was found linking olmesartan to increased cardiovascular risks in diabetic patients after an FDA safety review was conducted.
View Here
 
FDA Warns Consumers to Avoid Captomer and Captomer-250
The FDA has stated that all OTC products for chelation or detoxification containing DMSA (meso-2, 3-dimercaptosuccinic acid) are not approved and should be avoided.
View Here
 
Labeling Error Leads to Recall of Advocate Redi-Code+ Blood Glucose Test Strips
Suncoast is recalling all BMB-BA006A Advocate Redi-Code+ blood glucose test strips in order to prevent any potentially incorrect glucose results from causing detrimental effects.
View Here
 
Alexion Recalls Soliris (eculizumab) Concentrated Solution for IV Infusion
Some lots of Soliris have been recalled voluntarily by Alexion due to visible particulates.
View Here
 
Class I Recall of Baxter ABACUS TPN Calculation Software Issued
Baxter's ABACUS Total parenteral nutrition (TPN) calculation software has been recalled due to possible errors that could lead to overdose and severe toxicity.
View Here
 
Alaris Pump Module Software Recalled by Carefusion 303, Inc
Serious injury or death could result from improper infusion start times caused by this software.
View Here
 
New Study Done Comparing Pradaxa to Warfarin
While Pradaxa (dabigatran) was associated with a higher risk of gastrointestinal bleeding than warfarin, dabigatran was shown to have less risk of stroke, bleeding in the brain, and death than its competitor.
View Here
 
Alere INRatio2 PT/INR Professional Test Strips Have Been Recalled
Alere INRatio2 PT/INR Professional Test Strips were recalled due to significant disparity in test results reported by a central laboratory and due to nine serious adverse event reports linked to the test strips.
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News Items...


Dosing Errors Significantly Reduced Using Milliliters
A recent study suggests that using milliliters rather than teaspoons or tablespoons for dosing significantly reduces error when administering medicines to children.
View Here

Experimental Asthma Drug Has Novel Mechanism of Action
Quilizumab, an experimental drug that blocks the production of an inflammatory protein, could benefit patients with allergies or asthma.
View Here
 
Malaria Transmission May be Reduced by Primaquine Treatment
A single dose of primaquine was shown to reduce transmission but safety data must be further evaluated.
View Here
 
Safety of Vaccine to Treat Urinary Tract Infections Evaluated in Phase I Trial
GlycoVaxyn announced a phase I clinical trial that has begun safety testing an investigational vaccine that is a candidate to prevent infections caused by Estra-intestinal Pathogenic Escherichia coli (ExPEC).
View Here
 
Corticosteroid Injections Provide Little Relieve to Patients With Spine-Related Pain
According to an Agency for Healthcare Research and Quality (AHRQ) funded study, pain in patients with lumbar spinal stenosis is not reduced by epidural injections of corticosteroids.
View Here
 
CDC Polio Vaccine Travel Recommendations 
Due to the continued circulation of wild poliovirus, the CDC has issued recommendations for travels to and from infected countries.
View Here

Resistance to Antibiotics by Bacteria in Food Continued Threat to Public Health
Salmonella resistance to cephalosporins and fluoroquinolones remains low but other specific infections are associated with increased resistance due to this mechanism.
View Here
 
Changing Pill Appearance Make Interrupt Medication Use
Results of a recent study suggests that variations in medication appearance is associated with non persistent use of medications after myocardial infarction.
View Article

Review Finds Childhood Vaccines to Be Largely Safe
The results of 67 studies have shown that childhood vaccines are rarely associated with severe adverse events.
View Article  
View Commentary
 
Varenicline/NRT Combo More Effective Than Varenicline Alone
According to a clinical trial, varenicline in combination with nicotine replacement therapy(NRT) was more effective than varenicline monotherapy for tobacco abstinence.
View Article

Victoza Reduces Blood Glucose Levels in Maturity-Onset Diabetes of the Young
A form of diabetes, caused by a mutation in the hepatocyte nuclear factor 1-alpha gene, was treated equally effective with Victoza (liraglutide) but with less incidence of hypoglycemia, as compared to glimepiride.
View Here
 
Watchdog Group Public Citizen Alleges that Victoza Causes Pancreatitis
The Public Citizen states that 51 of the 278 reported cases of pancreatitis within the first 2 years of Victoza being on the market were probably caused by the drug.
View Here
 
Can a Single Dose of Antibiotic Clear Skin Infections?
Researchers report that a single dose of an antibiotic may be just as effective as a 10-day regimen in clearing bacterial skin infections such as methicillin-resistant Staphylococcus aureus.
View Here
 
CDC Article Stresses the Importance of Vaccination
A study, which assessed the safety of trivalent live attenuated influenza vaccine (LAIV3) in children in the Vaccine Adverse Events Reporting System (VAERS) during 2005-2012, did not find any new or unexpected adverse event patterns.
View Here
 
Blood-Pressure Drugs Spur Test Receive Thousands of Complaints
The FDA is planning an in-depth study of generic extended-release metoprolol succinate after receiving nearly 3500 complaints since 2009, including reports of adverse effects and poor efficacy related to the hypertensive medication. 
View Here
 
Oral HCV Regimen
Patients with hepatitis C (HCV) infection had sustained virologic response after treatment with an all-oral antiviral regimen.
View Here
 

Drug Approvals...


New Drug Approved for Hereditary Angioedema
The FDA announced that it has approved Salix Pharmaceuticals’ new biologic drug Ruconest, a recombinant C1 esterase inhibitor to treat acute attacks of HAE.
View Here

FDA Approves Octapharma USA Inc.’s Octagam 10%
Octagam 10%, a 10% IV immune globulin solution, has been approved by the FDA for the chronic immune thrombocytopenic purpura therapy in adult patients.
View Here

FDA Approves Beleodaq For Rare Form of Non-Hodgkin Lymphoma
The FDA has approved Beleodaq (belinostat) to treat peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma.
View Here
 
Upsher-Smith Testosterone Gel (1%) Receives OK from FDA
FDA has approved Testosterone Gel (1%), the first and only available generic testosterone replacement therapy; this generic of Vogelxo gel 1% comes in three configurations:  unit-dose tubes, metered-dose pumps, and packets.
View Here
 
Novel Inhaled Insulin Approved for Diabetes
Afrezza, a rapid-acting inhaled insulin powder for treating types 1 and 2 diabetes, has been approved by the FDA. Cough, throat pain, and hypoglycemia, are the most common side effects.
View FDA News Release Here
 
Sivextro Approved for Skin Infections
The FDA has approved tedizolid phosphate (Sivextro), a protein synthesis inhibitor that targets Gram-positive organisms.  The drug can be given orally or by injection and is the second drug that has recently been approved to treat acute skin and soft tissue infections.
View Here
 
Jublia Receives FDA Approval
Valeant Pharmaceuticals North America has received approval from the Food and Drug Administration for its new drug application for Jublia (efinaconazole 10% topical solution) for treatment of onychomycosis of the toenails.
View Here
 
Strativa’s Nsacobal Spray Approved
Nascobal, a prescription B-12 supplement administered once a week as one spray, has been approved by the FDA and will be available in pharmacies this September.  The new Nasocobal is a single-use device that does not require priming and delivers 500 mcg of cyanocobalamin, USP with each spray.
View Here
 
New Long-Acting Hemophilia A Drug Approved
Eloctate, a new intravenous drug used for the prophylactic treatment of hemophilia A in children and adults, has been approved by the FDA.  Eloctate consists of the coagulation factor VIII molecule linked to a protein fragment (Fc), and therefore is long-acting and will decrease the number of infusions needed from every other day to every 3 to five days.
View FDA News Release Here
 
First Buccal Therapy Approved for Opioid Dependence
Bunavail, a combination of buprenorphine and naloxone, is the first mucoadhesive buccal film therapy for the maintenance treatment of opioid dependence approved by the FDA. 
View Manufacturer's Press Release Here
View More Information Here
 
Dalvance Approved for MRSA Treatment
Dalvance, a new intravenous drug approved to treat bacterial skin infections like methicillin-resistant Staphylococcus aureus (MRSA), is the first drug labeled by the FDA as a Qualified Infectious Disease Product.
View Here
 
Omeros Eye Drug Receives FDA Approval
Later this year, Omero plans to launch Omidria, a drug for use in cataract and lens replacement surgeries.
View Here
 
Vectibix Plus FOLFOX Approved for Metastatic Colorectal Cancer
The FDA approved combination of Vectibix (panitbutmumab) and FOLFOX has shown to significantly benefit patients with wild-type KRAS metastatic colorectal cancer.
View Here
 
New High-Intensity Sweetener: Advantame - Approved
Advantame, a new food additive safe for use as a general-purpose sweetener and flavor enhancer in food, is the 6th high-intensity sweetener approved by the FDA.  This high-intensity sweetener contributes only a few or no calories to the diet, and generally will not raise blood sugar levels.
View Here
 
Entyvio Receives FDA Approval for Ulcerative Colitis
Takeda’s Entyvio (vedolizumab), the monoclonal antibody, is now FDA approved for the treatment of Crohn’s disease and moderate-to-sever ulcerative colitis in adults who have not fully responded to treatment with tumor necrosis factor inhibitors, steroids, or immunomodulators.
View Here
 
New Type of Anti-Clotting Drug Approved by FDA
The FDA has approved vorapaxar (Zontivity), the first in a new drug class known as protease-activated receptor-1 (PAR-1) antagonists, to reduce the risk for myocardial infarction (MI), stroke, cardiovascular death, and the need for revascularization in people with a history of MI or peripheral arterial disease. 
View Here
 
EPANOVA is FDA Approved for the Treatment of Adults with Severe Hypertriglyceridemia   
The FDA has approved Epanova, a new omega-3 supplement to treat adults with severe hypertriglyceridemia, defined as triglyceride levels 500 mg/dL or higher.
View Here
 
GlaxoSmithKline COPD Drug Approved by FDA
Incruse Ellipta (umeclidinium), a once-a-day anticholinergic drug, is now FDA approved for long-term treatment of chronic obstructive pulmonary disease (COPD). 
View Here
 

Guidelines...


New Guidelines Aim to Reduce MRSA in Hospitals
New strategies published aim to improve patient safety, prioritize current prevention efforts underway in hospitals, and reduce the prevalence of the drug-resistant bacterium, MRSA.
View Here
 
American Cancer Society Prostate Cancer Survivorship Care Guidelines
To help facilitate the provision of post-treatment care by clinicians for prostate cancer survivors, American Cancer Society has developed follow-up care guidelines that address surveillance of prostate cancer recurrence, screening for second primary cancers, health promotion, long-term and late effects assessment and management, psychosocial issues, and care coordination among the oncology team, primary care clinicians, and non-oncology specialists.
View Here  
 
ASCO Guideline Update on Adjuvant Endocrine Therapy
Updated clinical practice guidelines from the American Society of Clinical Oncology (ASCO) includes recommends for using tamoxifen for a total duration of 10 years if women are pre- or perimenopausal and have received 5 years of adjuvant tamoxifen.
View Abstract
 
Management of Atrial Fibrillation:  2014 Guidelines
New guidelines aim to reduce or prevent morbidity associated with atrial fibrillation by increasing the use of anticoagulation and providing more specific recommendations for the use of catheter ablation.
View Here
 
Updated HIV Treatment Guidelines
This major revision includes a recommendation for less-frequent CD4-count monitoring, an updated list of recommended regimens, a discussion of “switching,“ and a new section on treatment costs.
View Here
 
New Guidelines Aim to Prevent Most Common and Costly Infection
These broader and more inclusive evidence-based recommendations aim to reduce the number of infections by providing a framework for healthcare institutions to prioritize and implement strategies.
View Here
 
New Expert Guidelines for Hospitals' Infectious Diarrhea Prevention
New guidelines have been published in response to the increasing rates of Clostridium difficile (C. difficile).  The new practice recommendations have been purposed to help encourage healthcare institutions to implement and prioritize prevention efforts for this infectious diarrhea. 
View Here
 
ASCO Offers Guidance on Managing HER2-Positive Breast Cancer
New recommendations for treating women with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer, with separate guidelines for treating brain metastases, have been published by the American Society of Clinical Oncology.
View Abstract
 
Updated Guidelines for Preventing Recurrent Stroke
The American Heart Association and the American Stroke Association have released updated guidelines for preventing recurrent stroke in patients who have experienced a stroke or transient ischemic attack.
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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