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May 2014 Issue of FYDI - For Your Drug Information
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Co-edited by:
Clay Allen, PharmD Candidate
Gregory W. Smith, PharmD, Director, Drug Information Services

Congratulations to our graduating pharmacy class of 2014!!  
We wish you all the best!
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.  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...
          FDA MedWatch and Other Safety Alerts
          News Items
          Drug Approvals
          New Guidelines

FDA MedWatch and Other Safety Alerts...


FDA Drug Safety Communication: Acetaminophen
FDA is reminding health care officials to stop supplying patients with prescription combination products containing more than 325 mg of acetaminophen; doctors are urged to stop prescribing these products, and pharmacists are urged to stop dispensing these products.
View Communication
 
Drug Recall: Flawless Beauty and Skin Products
Flawless Beauty and Skin is recalling 11 lots of various products, as they are currently unapproved drugs in the US.
View Alert

Product Safety Communication: GenStrip Blood Glucose Test Strips
FDA is advising against the use of GenStrip blood glucose test strips by Shasta Technologies, as the strips may report incorrect blood glucose levels.
View Alert
 
Drug Recall: Super Arthgold by Nano Well-being Health
Nano Well-being Health has issued a recall of Super Arthgold, as the product contains undeclared amounts of chlorzoxazone, diclofenac, and indomethacin.
View Alert
 
Drug Safety Communication: Epidural Corticosteroid Injection
FDA is warning that epidural corticosteroid injections may result in rare but serious neurological adverse effects, such as vision loss, stroke, paralysis, and death.
View Alert
 
Drug Recall: Marcaine (Bupivacaine HCl Injection) by Hospira
Hospira announced a nationwide recall of one lot of 0.25% Marcaine due to the presence of visible particulates.
View Alert
 
Drug Recall: Lidocaine Injection by Hospira
Hospira has recalled one lot of 1% Lidocaine HCl Injection due to a report of orange and black particulate presence.
View Alert
 
Drug Recall: CUBICIN by Cubist Pharmaceuticals
Cubist Pharmaceuticals has recalled one lot of CUBICIN due to the presence of particulate matter.
View Alert
 
Drug Recall: Thinogenics Products by Nature’s Universe
Nature’s Universe has issued a recall of all lots of Thinogenics product sold prior February 6, 2014, as the product contains undeclared amounts of sibutramine.
View Alert
 
Drug Recall: Propofol Injectable Emulsion by Hospira
Hospira has recalled seven lots of Propofol Injectable Emulsion due to the presence of free-floating visible particulates.
View Alert
 
Public Notification: S.W.A.G
FDA advises consumers not to purchase or use S.W.A.G, a product marketed for sexual enhancement, as it contains undeclared amounts of the ingredient sildenafil.
View Alert
 
Public Notification: Infinity
FDA advises consumers not to purchase or use Infinity, a product marketed and sold for weight loss, as it contains undeclared amounts of sibutramine.
View Alert
 
Drug Warning: Zi Xiu Tang Bee Pollen Capsules
Multiple Zi Xiu Tang Bee Pollen products from various U.S. distributors have been tested and contain undeclared potentially dangerous drug ingredients sibutramine and/or phenolphthalein.
View Alert
 
Drug Safety Communication: Revatio
FDA is clarifying its previous warning about use of Revatio for pulmonary hypertension in children; health care professionals must consider risks vs. benefits for each patient.
View Alert
 
Drug Recall: Nova Products Dietary Supplements
Nova Products is recalling some of its products marketed as dietary supplements for sexual enhancement that contain undeclared amounts of active ingredients approved by the FDA to treat erectile dysfunction.
View Alert
 
Drug Recall: Alli (GlaxoSmithKline)
GlaxoSmithKline is recalling all Alli products from U.S. and Puerto Rico retailers due to product tampering; some packages may contain tablets and capsules that are not Alli.
View Alert
 
Drug Recall: New Life Nutritional Center Dietary Supplements
New Life Nutritional Center is recalling all lots of “Super Fat Burner capsules, Maxi Gold capsules and Esmeralda softgels” after the products were revealed to contain undeclared active ingredients sibrutramine and/or phenolphthalein, which may be harmful to patients.
View Alert
 
Drug Recall: Bella Vi Brand Products by Pure Edge Nutrition
Pure Edge Nutrition is recalling one lot of each of its Bella Vi line of products, as the products were revealed to contain undeclared active ingredients sibutramine or a combination of both sibutramine and phenolphthalein, which may be harmful to patients.
View Alert

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News Items...


WHO Report: New Drugs Are Needed to Combat Worldwide Antimicrobial Resistance
The World Health Organization has released a report of antimicrobial resistance—worldwide bacterial resistance may lead to a post-antibiotic era, in which common infections can kill.
View Item
View Report

Patients Taking Statins Have Higher Caloric Intake than 10 Years Ago
A new study shows that statin-users have increased caloric intake by almost 10 percent from 2000 to 2010, highlighting the potential need for emphasis on lifestyle changes.
View Item
View Abstract
 
CDC Report Shows Millions of Children Spared from Diseases by US Immunization Program
Among children born in the last 20 years, the CDC estimates that vaccinations will prevent more than 21 million hospitalizations and 700,000 deaths, resulting in savings of $295 billion in direct costs and $1.38 trillion in societal costs; in wake of a recent surge in measles cases, the importance of sustaining high vaccination coverage is more becoming more apparent.
View Item
 
Long-Term Metformin Use May Reduce Risk of Gastric Cancer
A study shows that metformin use for longer than 3 years reduced gastric cancer risk by 43% in type 2 diabetics not using insulin.
View Abstract
 
FDA Proposes New Rule to Extend Authority to Cover Additional Tobacco Products
The FDA is proposing to extend its authority to cover currently unregulated products, including cigars, pipe tobacco, e-cigarettes, and other products.
View Item  
 
Melatonin Decreases Weight Gain from Atypical Antipsychotics
A small placebo-controlled trial of 44 patients being treated with atypical antipsychotics showed that melatonin use resulted in decreased diastolic blood pressure and less weight gain versus placebo.
View Abstract
 
Combination Opioid Pain Pill Rejected by FDA
An experimental pain pill, Moxduo, which combines two opioids, oxycodone and morphine, was rejected by the FDA, as studies did not show any benefit over regular oxycodone and morphine.
View Item
 
One-Quarter of Older Adults Would Not Want Emergency Thrombolysis for Stroke
A new survey found that 24% of participants aged 50 or older, when given a risk-benefit profile of thrombolysis, indicate that they would not want to receive tissue plasminogen activator (tPA) after the occurrence of a stroke.
View Item
View Abstract
 
Monoclonal Antibodies for Migraine Prevention Show Promise in Phase II Trials
Two phase II trials of new drugs affecting a relatively new protein target show efficacy in prevention of migraines.
View Item
View Abstract
View Abstract
 
Reports of Injury Related to Use of E-Cigarette on the Rise
Over the last year, 50 complaints about e-cigarettes were filed with the FDA, equaling the number of complaints of the last five years combined.
View Item
 
Chinese Herb Effective in Short-Term Treatment of Rheumatoid Arthritis
An herbal product used in traditional Chinese medicine was found to be as effective as methotrexate and superior when the two agents were given in combination for short-term treatment of rheumatoid arthritis.
View Item
View Abstract
 
Better Blood Pressure and Cholesterol Control in Stroke Patients Managed by a Pharmacist
Clinical trial shows pharmacist-managed care of stroke patients yielded a 12.5% improvement in blood pressure and cholesterol control.
View Item
View Abstract
 
More Opioid Painkillers Are Being Prescribed to Pregnant Women
Despite unknown risks associated with exposing a fetus to opioids, a study reveals that more than one in five pregnant women enrolled in Medicaid nationwide fill prescriptions for opioids.
View Item
View Abstract
 
New Drug Combination Proven Effective in Phase III Trial for Hepatitis C Treatment
A single tablet, 12-week regimen of ledipasvir and sofosbuvir were proven effective in the treatment of a broad range of patients with Hepatitis C genotype 1.
View Item
View Abstract
 
Current Public Education Strategies for Vaccination May Be Counterproductive
In a randomized study, pro-vaccine messages to parents with children in their household reduced misperceptions about a link between MMR and autism; however, the message still resulted in decreased intent to vaccinate.
View Abstract
 
Tamiflu and Relenza Disappoint in New Systematic Reviews
Despite widespread use, systematic reviews of the neuraminidase inhibitors Tamiflu and Relenza show minimal clinical benefit in treatment and prevention of influenza after receiving full access to all important trial data conducted by manufacturers for the first time.
View Item
View Abstract
View Abstract
 
Pharmacists Invited to Join the Medical Reserve Corps
The Medical Reserve Corps is a network of over 200,000 volunteers organized in nearly 1,000 local units across the U.S. that offers pharmacists the opportunity to utilize their skill sets to support local public health and safety in a variety of ways.
View Item
 
New Agent Undermines Defenses of “Superbugs” to Combat Antibiotic Resistance
A study shows that when pairing the new promising agents called metallopolymers with antibiotics that are normally ineffective, the combination was able to avoid the defensive enzymes of MRSA and destroy the bacteria.
View Item
View Abstract
 
New Study Shows NSAIDs Associated with Increased Risk of Atrial Fibrillation
A prospective follow-up study of elderly individuals without atrial fibrillation at baseline has shown that current and recent use of non-steroidal anti-inflammatory drugs are associated with an increased risk of developing A-fib.
View Abstract
 
Antimicrobial from Soaps Promotes Nasal Bacterial Colonization
A new study has found that triclosan, an antimicrobial found in many personal care products, is commonly found in the nasal secretions of healthy adults and is linked to nasal colonization by Staphylococcus aureus, which may lead to infection in some.
View Item
View Abstract
 
USPSTF Advises Low-Dose Aspirin for Women at Risk for Preeclampsia
Based on information presented in a new evidence review, the U.S. Preventative Services Task Force has issued a draft recommendation and is collecting comments regarding the use of low-dose aspirin to prevent preeclampsia in high-risk women.
View Item
View Abstract
 
Menopausal Hormone Therapy May Lower Risk of Non-Hodgkin Lymphoma
Researchers have found that menopausal hormone therapy, linked to increased risk of breast and endometrial cancer, may lower the risk of B-cell non-Hodgkin lymphoma.
View Item
View Abstract
 
Early Trial Yields Promising Results for Pfizer’s New Breast Cancer Drug
In an early clinical trial involving 165 patients, new drug palbociclib has been shown to prevent breast cancer from worsening for 20.2 months, an additional 10 months over current medications that do so for 10.2 months.
View Item
 
New Study Shows One-Third of New Prescriptions Are Never Filled
About one-third of the initial prescriptions written for the nearly 16,000 patients in the study were not filled; the most expensive drugs were least likely to be filled, along with skin agents, gastrointestinal drugs, and autonomic drugs.
View Item
View Abstract
 
PARADIGM-HF Trial Closes Early Based on Strength of Interim Results
New study stopped early, as patients taking LCZ696 of the new drug class, angiotensin-receptor neprilysin inhibitors (ARNIs), were already living longer with fewer heart failure hospitalizations than patients receiving the ACE-inhibitor enalapril.
View Item
 

Drug Approvals...


Zykadia Approved for Late-Stage Cancer
The FDA has allowed approval of Zykadia (ceritinib) to treat lung cancer patients with a particular genetic mutation.
View Item

Sylvant Approved for Castleman’s Disease
The FDA has approved Sylvant (siltuximab), the first drug to treat multicentric Castleman’s disease (MCD), a rare lymphoma-like disorder.
View Approval
 
Cyramza Approved for Stomach Cancer
The FDA has approved Cyramza (ramucirumab) to treat advanced stomach cancer or gastroesophageal junction adenocarcinoma.
View Approval
 
Otezla Approved for Psoriatic Arthritis
Otezla (apremilast) has been approved by the FDA to treat active psoriatic arthritis (PsA).
View Approval
 
Hemangeol Approved for Infantile Hemangioma
The FDA has approved Pierre Fabre’s Hemangeol (propranolol hydrochloride) for treatment of proliferating infantile hemangioma (IH) requiring systemic therapy.
View Item
 
FDA Approves Qudexy XR for Epilepsy
The FDA has approved Qudexy XR, and extended release formulation of the anticonvulsant, topiramate.
View Item
 
Combo Treatment for Chronic Lymphocytic Leukemia Approved
The FDA has approved the combined use of Arzerra (ofatumumab) and chlorambucil for the treatment of chronic lymphocytic leukemia.
View Item
 
Ragwitek Approved to Treat Hay Fever
The FDA has approved Ragwitek, sublingual allergen extract to treat short ragweed pollen induced allergic rhinitis.
View Approval
 
Tanzeum Approved for Type 2 Diabetes
Tanzeum (albiglutide) subcutaneous injection has been approved by the FDA to improve glycemic control in Type 2 diabetic adults.
View Approval
 
Evzio – Auto-injector Antidote for Opioid Overdose Reversal Approved
The FDA has approved Evzio (naloxone hydrochloride) as a single dose hand-held auto-injector for known or suspected opioid overdose by lay caregivers.
View Item
 
Oralair Approved for Grass Allergies
The FDA has approved Oralair, a sublingual allergen extract for the treatment of allergic rhinitis associated with certain grass pollens.
View Item
 
Pradaxa Approved for Venous Thromboembolism (VTE)
Pradaxa (dabagatran etexilate) has been given FDA approval for the treatment and reduction of recurrence risk of VTE, including deep venous thrombosis (DVT) and pulmonary embolism (PE).
View Item
 
Topamax Receives First Approval for Migraine Prevention in Teens
Topamax (topiramate) has received the first FDA approval of a drug for migraine prevention in adolescents ages 12 years to 17 years.
View Item
 

Guidelines...


USPSTF Releases Draft Recommendations for Behavioral Counseling and Screen for STIs at High Risk
The U.S. Preventive Services Task Force (USPSTF) has released draft recommendations that all sexually-active adolescents and high-risk adults receive intensive counseling to prevent sexually transmitted infections (STIs).
View Behavioral Intervention Draft
View Screening Draft

Guidelines on Use of Antiretroviral Drugs in Pregnancy Has Been Updated
The Recommendations for the Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women and Interventions to Reduce Perinatal HIV Transmission in the United States have been reorganized and revised to enhance usability.
View Guideline

Recommended Adult Immunization Schedule for 2014
The ACIP has updated recommendations for the current adult immunization schedule.
View Schedule
 
Guidelines for Treating Adult Cancer Survivors
The American Society of Clinical Oncology has released guidelines for the management of adult survivors of cancer.
Peripheral Neuropathy – View Guideline
Anxiety and Depression – View Guideline
Fatigue – View Guideline
 
Acute Otitis Externa: Updated Clinical Practice Guideline
This release is an update of the previous guideline by the American Academy of Otolaryngology—Head and Neck Surgery Foundation published in 2006.
View Guideline
 
WHO Guidelines for Managing Hepatitis C Infection
The WHO has issued its first guideline for the treatment of hepatitis C, to coincide with the availability of new safer and more effective medications.
View News Item
View Guideline
 
New Atrial Fibrillation (AF) Guideline Includes New Oral Anticoagulants
The American Heart Association, the American College of Cardiology and the Heart Rhythm Society has released this new guideline that includes information for the use of new oral anticoagulants and catheter ablation in treating AF.
View Executive Summary
View Guideline
 
Guidelines on Complementary and Alternative Medicine in Multiple Sclerosis
The Guideline Development Subcommittee of the American Academy of Neurology has developed this evidence-based guideline for using CAM for MS.
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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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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