October 2014 Issue of FYDI - For Your Drug Information
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Co-edited by:
Pharm.D. Candidates: Noor Azzawe, Tam Le, Hai Nguyen, & Melanie Stracener
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

Learn more about our Drug Information Services

FDA MedWatch and Other Safety Alerts...

Ketorolac Tromethamine Injection Voluntarily Recalled Due to Mislabeling
Sagent Pharmaceuticals recalled three lots of Ketorolac Tromethamine Injection, USP, 30mg/mL single-dose vials due to labeled expiration date being longer than known stability.
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FDA Warns Against the Use of Bo Ying Compound Due to Lead Poisoning Risk
Bo Ying compound manufactured by Eu Yan Sang Ltd. is used to treat multiple conditions including influenza, fever, sneezing, and nasal discharge.
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New Adverse Events Added to the Xolair (omalizumab) Drug Label
An FDA review of studies has determined an increased risk of cardiovascular and cerebrovascular events among patients being treated with Xolair (omalizumab).
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Shipping Carton Mislabeling Leads to Potassium Chloride Recall
One lot of Potassium Chloride Injection 10mEq per 100mL has been recalled by Baxter International Inc.
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Heparin Sodium Recall
Hospira Inc has recalled Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL) in 0.9 percent sodium chloride injection, 500mL due to particulate matter.
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Compounded Sterile Preparations by Martin Avenue Pharmacy Recall
Martin Avenue Pharmacy, Inc has recalled all in-date compounded sterile preparations in response to recent FDA inspection on quality control procedures.
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Sodium Chloride IV 0.9 Percent Injection, USP 1000 mL Recall
0.9% Sodium Chloride Injection, USP 1000 mL by Baxter International Inc have been recalled due to particulate matter near administration port.
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Cubicin (Daptomyocin For Injection) Recall by Cubist Pharmaceuticals
10-mL vials of 500 mg Cubicin (daptomycin for injection) have been recalled due to the potential presence of glass particulate matter in vials.
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Hospira Recalls Lidocaine
Lidocaine HCI Injection, USP, 2%, 20 mg/mL, preservative-free,  5 mL single-dose vials have been recalled due iron oxide particulate.
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Update to Advocate Redi-Code+ Blood Glucose Test Strips Recall
The recall of these test strips has been upgraded to a Class I Recall.
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Mislabeled Packaging Leads to Ibuprofen and Oxcarbazepine Recall
Two lots of 300 mg oxcarbazepine tablets and one lot of 600 mg ibuprofen tablets have been recalled by American Health Packaging.
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News Items...

Company Gets Emergency FDA Approval for Ebola Drug
The biopharmaceutical company Chimerex was granted emergency investigational new drug applications from the Food and Drug Administration on Monday for the potential use of the antiviral drug brincidofovir in patients with the Ebola virus.
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Chantix Label Updated to Assure Drug Safety
The manufacturer of the smoking cessation drug, Chantix (varenicline), has updated the label to include new study data on safety of the drug in an effort to petition the FDA to remove of the Black Box Warning.
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Tobacco Plant May Be Useful for Ebola Treatment Drug
Researchers are studying the use of tobacco plants to develop an experimental drug for the treatment of Ebola. The experimental drug is known as ZMapp serum, and it was used previously to treat past cases of Ebola in the United States.
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CDC Projection Estimates of the 2014 Ebola Outbreak
The CDC has released figures that estimate the future status of the current Ebola outbreak, reaching up to over 1 million infections in Sierra Leone and Liberia by January 2015 with the current transmission rate.
View CDC Report
View NEJM Article
View NEJM Ebola Website
New Drug Lowers Cholesterol in Patients with Inherited Hypercholesterolemia
A new injectable drug from the class PCSK9 inhibitors, Evolocumab, has been found to significantly reduce low-density lipoprotein (LDL) levels with few adverse events in patients with familial hypercholesterolaemia.
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Study Suggests Ibuprofen Can Reduce Lung Inflammation
New research supports that ibuprofen can help reduce inflammation in the lungs that increases with age.
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Energy Drinks May Cause Nervousness and Sleep Problems in Athletes
Although energy drinks were shown to improve sport performance in many athletes, a recent study found a resulting increase in insomnia, nervousness, and level of stimulation in the time after a competition.
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Par Pharmaceutical Ships Generic Exforge
Par Pharmaceutical has announced the shipment of generic hypertension medication, Exforge (amlodipine and valsaratan), in all of its dosage strengths.
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Neurologic Illness Presents in Some Enterovirus Patients
A number of the children who were hospitalized with the severe Enterovirus EV-D68 respiratory illness have recently been found to be experiencing limb weakness. A group of 10 children in Colorado were hospitalized for this weakness, and now 4 more children at Boston’s Children’s Hospital have been seen with the same symptoms. It is still unknown whether there is a link between the virus and the neurologic illness.
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Study Find New Heart Failure Drug Reduces Mortality More Than Enalapril
In a phase III clinical trial, a new angiotension and neprilysin inhibitor (drug LCZ696), showed reduced cardiovascular mortality compared to enalapril.
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First Needle-Free Flu Vaccine Injector Approved by FDA
A needle-free device for injecting influenza vaccine is now available in adults to increase vaccination compliance.
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Hydrocodone Combo Products Now Classified as Schedule II
The Drug Enforcement Administration has rescheduled hydrocodone combination products from schedule III to schedule II of the Controlled Substance Act.
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High-dose Flu Vax Protects Seniors Better than Standard Influenza Vaccine
Researcher report that trivalent vaccine containing four times the standard influenza vaccine had a relative efficacy of 24.2%, providing increased protection for patients 65 years and older.
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New Way to Track Hypoglycemia through Hypomap Innovation
A novel hypoglycemic tracker device logs hypoglycemic events, reports symptoms, and recommends appropriate treatment.
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Breast Cancer Risk Linked to the Pill
A new study suggests that women under 50 years old who were diagnosed with breast cancer were most likely on some kind of oral contraceptive. 
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Drug Approvals...

Generic Precedex Released by Sandoz
Sandoz announced release of dexmedetomidine hydrochloride injection, generic Precedex, for sedation in intubated patients in intensive care settings, as well as non-intubated patients during surgery and other procedures.
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Salix and Progenics Announce Relistor FDA Approval
Salix Pharmaceuticals and Progenics Pharmaceuticals have announced the FDA approval of Relistor (methylnaltrexone bromide) subcutaneous 12 mg dosage strength injection for the treatment of constipation in patients taking opioids for chronic non-cancer conditions.
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Humira Gets FDA Approval for New Indication
The Food and Drug Administration has approved Humira (adalimumab) for the treatment of pediatric Crohn’s disease in patients at least 6 years old when other treatments have been inadiquately effective.
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Spiriva Respimat Approved for COPD
Spiriva (tiotropium bromide) inhalation spray has been approved by the FDA for long-term treatment of bronchospasm related to COPD.
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Trulicity Approved for Type 2 Diabetes Mellitus
FDA approved Trulicity (dulaglutide) injection to enhance glycemic control in patients with T2DM.
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Movantik Approved for Opioid-Induced Constipation
Movantik (naloxegol) tablets have been FDA approved for the treatment of opioid-induced constipation in adults.
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Contrave Approved for Weight-Management
The FDA has approved the combination drug, Contrave, for weight-management in people who are classified as obese or overweight based on BMI.
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Arnuity Ellipta Approved for Asthma
Arnuity Ellipta (fluticasone furoate inhalation powder) is now FDA approved for the maintenance treatment of asthma.
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Cerdelga Approved for Gaucher Disease
The FDA announced that it has approved Cerdelga (eliglustat) for patients with Type 1 form of Gaucher disease.
View Here

Belsomra Approved for Insomnia
The FDA announced that it has approved Belsomra (suvorexant), an orexin receptor antagonist, for insomnia.
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Orbactive Approved for Skin Infections
The FDA announced that it has approved the antibiotic Orbactive (oritavancin) to treat patients with acute bacterial skin and skin structure infections (ABSSSI).
View Here

Lumizyme Receives Approval by FDA
Lumizyme (alglucosidase alfa) is now approved for treatment of patients younger than 8 years of age with infantile-onset Pompe disease, a rare genetic disorder that causes heart and skeletal muscle weakness.
View Here
Jardiance Approved for Treatment of Type 2 Diabetes
Jardiance (empagliflozin) aids in the management of diabetes by inhibiting kidney reabsorption of glucose and increasing glucose excretion.
View Here


US Preventative Services Task Force Diabetes Screening Recommendations
USPSTF Draft Recommendations suggest that all high-risk adults should be screened for type 2 diabetes and insulin resistance. These draft recommendations are open for public comment until November 3rd.
View Here
New Guideline for the Treatment of Advanced Prostate Cancer
A new guideline released by the American Society of Clinical Oncology and Cancer Care Ontario encourages indefinite androgen-deprivation therapy for treating men with metastatic castration-resistant prostate cancer.
View Here
Revised Guideline Aims to Improve Cardiac Conditions
The American College of Cardiology and the American Heart Association have released an updated guideline with new research findings on the management of non-ST-elevation acute coronary syndromes (NSTE-ACS).
View Guidelines
View Article
HIV Prevention and Treatment Guidelines Released
The International AIDS Society-USA released two sets of clinical guidelines in preventing and treating HIV.
View Prevention Guideline
View Treatment Guideline

American College of Gastroenterology Release New IBS and CIC Guidelines
New guidelines provide approaches to treating irritable bowel syndrome (IBS) and chronic idiopathic constipation (CIC), giving strong recommendations for lubriprostones.
View Guideline

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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